Medicine guide

Pomalidomide

1 mg · Capsule

Prescription only
Thalidomide Analog

Active substance: Pomalidomide
Used in: Cancer treatments and immune-system medicines
Made by: Teva Pharmaceuticals, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-10-01

What it is

Thalidomide Analog

Used for

In combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease…

The label’s usual adult dose

4 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression ( 2.2 ).

Full directions ↓

Serious warning

EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide is contraindicated in pregnancy.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

43other products contain Pomalidomide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients:

in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1 ). with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative.
This indication is approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) ( 1.2 ).
1.1 Multiple Myeloma Pomalidomide, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
1.2 Kaposi Sarcoma Pomalidomide is indicated for the treatment of:
Adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART).
Kaposi sarcoma (KS) in adult patients who are HIV-negative.
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14.2 )] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

From the official label · 2025-10-01 · DailyMed

How it works

From this product’s own US prescribing label.

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties.
Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex.

Peak level after2–3 h

Half-life9.5 h

Mostly cleared after≈ 47.5 hfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

Me tabolism Pomalidomide is primarily metabolized in the liver by CYP1A2 and CYP3A4.

How it leaves the body

Following a single oral administration of [ 14 C]-pomalidomide to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with approximately 2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-01

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide is contraindicated in pregnancy.
Pomalidomide is a thalidomide analogue.
Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death.
In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide treatment.
Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 , 8.3 )].
Pomalidomide is only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions ( 5.2 )].
Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide.
Prophylactic antithrombotic measures were employed in clinical trials.
Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [see Warnings and Precautions ( 5.3 )].
WARNING:
EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY Pomalidomide is contraindicated in pregnancy.
Pomalidomide is a thalidomide analogue.
Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ).
For females of reproductive potential: Exclude pregnancy before start of treatment.
Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1 , 8.3 ).
Pomalidomide is available only through a restricted program called PS-Pomalidomide REMS ( 5.2 ).
Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436 .
VENOUS AND ARTERIAL THROMBOEMBOLISM Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide.
Antithrombotic prophylaxis is recommended ( 5.3 ).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 )
4.1 Pregnancy Pomalidomide is contraindicated in females who are pregnant.
Pomalidomide can cause fetal harm when administered to a pregnant female [ s e e W arnings and Pr ec autions ( 5.1 ) and Use in Sp e c ific Populations ( 8.1 ) ] .
Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis.
If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
4.2 Hypersensitivity Pomalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients [see Warnings and Precautions ( 5.7 ), Description ( 11 )] .

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

MM:
4 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression ( 2.2 ).
Refer to section 14.1 for dexamethasone dosing ( 14.1 ).
KS:
5 mg per day taken orally on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity ( 2.3 ).
Modify the dosage for certain patients with renal impairment ( 2.7 , 8.6 ) or hepatic impairment ( 2.8 , 8.7 ).
2.1 Pregnancy Testing Prior to Administration Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating pomalidomide capsules [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 , 8.3 )] .
2.2 Recommended Dosage for Multiple Myeloma The recommended dosage of pomalidomide capsules is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression.
Give pomalidomide capsules in combination with dexamethasone [see Clinical Studies ( 14.1 )] .
2.3 Recommended Dosage for Kaposi Sarcoma The recommended dosage of pomalidomide capsules is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity.
Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS) [see Clinical Studies ( 14.2 )] .
2.4 Dosage Modifications for Hematologic Adverse Reactions Multiple Myeloma:
Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.
Dosage modification for pomalidomide capsules for hematologic adverse reactions in patients with MM are summarized in Table 1.
Table 1:
Dosage Modifications for Pomalidomide Capsules for Hematologic in MM Adverse Reaction Severity Dosage Modification Neutropenia [see Warnings and Precautions ( 5.5 )] ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL) Withhold pomalidomide capsules until ANC is greater than or equal to 500 per mcL; follow CBC weekly.
Resume pomalidomide capsules dose at 1 mg less than the previous dose.* For each subsequent drop of ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 500 mcL.
Resume pomalidomide capsules dose at 1 mg less than the previous dose.* Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly.
Resume pomalidomide capsules dose at 1 mg less than the previous dose* For each subsequent drop of platelets less than 25,000 per mcL Withhold pomalidomide capsules until platelets are greater than or equal to 50,000 per mcL.
Resume pomalidomide capsules at 1 mg less than the previous dose* * Permanently discontinue pomalidomide capsules if unable to tolerate 1 mg once daily.
ANC= absolute neutrophil count Kaposi Sarcoma:
Dosage Modifications for Hematologic Adverse Reactions Initiate a new cycle of pomalidomide capsules in patients with KS when the neutrophil count is at least 1,000 per mcL and the platelet count is at least 75,000 per mcL.
Dose modifications for pomalidomide capsules for hematologic adverse reactions in patients with KS are summarized in Table 2.
Table 2:
Dosage Modifications for Pomalidomide Capsules for Hematologic Adverse Reactions in KS Adverse Reaction Severity Dosage Modification Neutropenia [see Warnings and Precautions (5.5)] ANC 500 to less than 1,000 per mcL Day 1 of cycle Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL.
Resume pomalidomide capsules at the same dose.
During cycle Continue pomalidomide capsules at the current dose.
ANC less than 500 per mcL Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL.
Resume pomalidomide capsules at the same dose.
Febrile Neutropenia [see Warnings and Precautions (5.5)] ANC less than 1,000 per mcL and single temperature greater than or equal to 38.3°C or ANC less than 1,000 per mcL and sustained temperature greater than or equal to 38°C for more than 1 hour Withhold pomalidomide capsules until ANC is greater than or equal to 1,000 per mcL.
Resume pomalidomide capsules at dose 1 mg less than the previous dose. * Thrombocytopenia [see Warnings and Precautions (5.5)] Platelet count 25,000 to less than 50,000 per mcL Day 1 of cycle Withhold pomalidomide capsules until platelet count is greater than or equal to 50,000 per mcL.
Resume pomalidomide capsules at the same dose.
During cycle : Continue pomalidomide capsules at the current dose.
Platelet count less than 25,000 per mcL Permanently discontinue pomalidomide capsules. * Permanently discontinue pomalidomide capsules if unable to tolerate 1 mg once daily.
ANC= absolute neutrophil count
2.5 Dosage Modifications for Non-Hematologic Adverse Reactions Permanently discontinue pomalidomide capsules for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction [see Warnings and Precautions ( 5.7 , 5.12 )] .
For other Grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion.
Dosage Modifications for Strong CYP1A2 Inhibitors
Avoid concomitant use of pomalidomide capsules with strong CYP1A2 inhibitors.
If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide capsule dose to 2 mg [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .
2.7 Dosage Modification for Severe Renal Impairment on Hemodialysis Take pomalidomide capsules after completion of dialysis procedure on hemodialysis days [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .
For patients with MM with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily.
For patients with KS with severe renal impairment requiring dialysis, reduce the recommended dosage to 4 mg orally daily.
2.8 Dosage Modification for Hepatic Impairment Multiple Myeloma For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily.
For patients with MM with severe hepatic impairment (Child-Pugh C), reduce the recommended dosage to 2 mg [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] .
Kaposi Sarcoma For patients with KS with mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C), reduce the recommended dosage to 3 mg orally daily [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] .
2.9 Administration Swallow capsules whole with water.
Do not break, chew, or open the capsules.
Pomalidomide capsules may be taken with or without food.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Increased Mortality:
Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.4 ).
Hematologic Toxicity:
Neutropenia was the most frequently reported Grade 3/4 adverse event.
Monitor patients for hematologic toxicities, especially neutropenia ( 5.5 ).
Hepatotoxicity:
Hepatic failure including fatalities; monitor liver function tests monthly ( 5.6 ).
Severe Cutaneous Reactions:
Discontinue pomalidomide capsules for severe reactions ( 5.7 ).
Tumor Lysis Syndrome (TLS):
Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions ( 5.11 ).
Hypersensitivity: Monitor patients for potential hypersensitivity.
Discontinue pomalidomide capsules for angioedema and anaphylaxis ( 5.12 ).
5.1 Embryo-Fetal Toxicity Pomalidomide is a thalidomide analogue and is contraindicated for use during pregnancy.
Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death [ s e e Use in Sp ec ific P opulations ( 8.1 ) ] .
Pomalidomide is only available through PS-Pomalidomide REMS [ s e e W arnings and Pr ec autions ( 5.2 ) ] .
Fe males of Reproductive Potential Females of reproductive potential must
avoid pregnancy for at least 4 weeks before beginning pomalidomide therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy.
The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles [ s e e Use i n Sp e c ific Populations ( 8.3 ) ] .
M a l es Pomalidomide is present in the semen of patients receiving the drug.
Male patients taking pomalidomide must not donate sperm [ s e e Use in Sp ec ific Populations ( 8.3 ) ] .
B lood Don a tion Patients must not donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide.
5.2 PS-Pomalidomide REMS Because of the embryo-fetal risk [ s e e W arnings and Pr ec autions ( 5.1 ) ] , pomalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), "PS-Pomalidomide R E M S" .
Required components of PS-P omalidomide R E M S include the following:
Prescribers must be certified with PS-P omalidomide R E M S by enrolling and complying with the REMS requirements.
Patients must sign a Patient-Physician Agreement Form and comply with the REMS requirements.
In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [ s e e Use in Sp ec ific Populations ( 8.3 ) ] and males must comply with contraception requirements [ s e e Use in Sp ec ific Populations ( 8.3 ) ] .
Pharmacies must be certified with PS-P omalidomide R E M S , must only dispense to patients who are authorized to receive pomalidomide and comply with REMS requirements.
Further information about PS- Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by telephone at 1-888-423-5436.
5.3 Venous and Arterial Thromboembolism Venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboembolic events (myocardial infarction and stroke) have been observed in patients treated with pomalidomide.
In Trial 2, where anticoagulant therapies were mandated, thromboembolic events occurred in 8.0% of patients treated with pomalidomide and low dose-dexamethasone (Low-dose Dex), and 3.3% of patients treated with high-dose dexamethasone.
Venous thromboembolic events (VTE) occurred in 4.7% of patients treated with pomalidomide and Low-dose Dex, and 1.3% of patients treated with high-dose dexamethasone.
Arterial thromboembolic events include terms for arterial thromboembolic events, ischemic cerebrovascular conditions, and ischemic heart disease.
Arterial thromboembolic events occurred in 3.0% of patients treated with pomalidomide and Low-dose Dex, and 1.3% of patients treated with high-dose dexamethasone.
Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking).
5.4 Increased Mortality in Patients with Multiple Myeloma when Pembrolizumab is Added to a Thalidomide Analogue and Dexamethasone In two randomized clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone, a use for which no PD-1 or PD-L1 blocking antibody is indicated, resulted in increased mortality.
Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
5.5 Hematologic Toxicity Multiple Myeloma In trials 1 and 2 in patients who received pomalidomide + Low-dose Dex, neutropenia was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia.
Neutropenia of any grade was reported in 51% of patients in both trials.
The rate of Grade 3 or 4 neutropenia was 46%.
The rate of febrile neutropenia was 8%.
Monitor patients for hematologic toxicities, especially neutropenia.
Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter.
Patients may require dose interruption and/or modification [see Dosage and Administration ( 2.4 )] .
Kaposi Sarcoma In Trial 12-C-0047, hematologic toxicities were the most common (all grades and Grade 3 or 4) adverse reactions [see Adverse Reactions ( 6.1 )] .
Fifty percent of patients had Grade 3 or 4 neutropenia.
Monitor patients for hematologic toxicities, especially decreased neutrophils.
Monitor complete blood counts every 2 weeks for the first 12 weeks and monthly thereafter.
Withhold, reduce the dose, or permanently discontinue pomalidomide based on the severity of the reaction [see Dosage and Administration ( 2.4 )] .
5.6 Hepatotoxicity Hepatic failure, including fatal cases, has occurred in patients treated with pomalidomide.
Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with pomalidomide.
Monitor liver function tests monthly.
Stop pomalidomide upon elevation of liver enzymes and evaluate.
After return to baseline values, treatment at a lower dose may be considered.
5.7 Severe Cutaneous Reactions Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis.
These reactions can be fatal.
Consider pomalidomide interruption or discontinuation for Grade 2 or 3 skin rash.
Permanently discontinue pomalidomide capsules for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN or DRESS [see Dosage and Administration ( 2.5 )] .
5.8 Dizziness and Confusional State In trials 1 and 2 in patients who received pomalidomide + Low-dose Dex, 14% of patients experienced dizziness and 7% of patients experienced a confusional state; 1% of patients experienced Grade 3 or 4 dizziness, and 3% of patients experienced Grade 3 or 4 confusional state.
Instruct patients to
5.9 Neuropathy In trials 1 and 2 in patients who received pomalidomide + Low-dose Dex, 18% of patients experienced neuropathy, with approximately 12% of the patients experiencing peripheral neuropathy.
Two percent of patients experienced Grade 3 neuropathy in trial 2.
There were no cases of Grade 4 neuropathy adverse reactions reported in either trial.
5.10 Risk of Second Primary Malignancies Cases of acute myelogenous leukemia have been reported in patients receiving pomalidomide as an investigational therapy outside of MM.
5.11 Tumor Lysis Syndrome Tumor lysis syndrome (TLS) may occur in patients treated with pomalidomide.
Patients at risk for TLS are those with high tumor burden prior to treatment.
These patients should be monitored closely and appropriate precautions taken.
5.12 Hypersensitivity Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to pomalidomide have been reported.
Permanently discontinue pomalidomide capsules for angioedema or anaphylaxis [see Dosage and Administration ( 2.5 )] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

P re g n a n c y E x posu r e R e gist r y There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide.
This registry is also used to understand the root cause for the pregnancy.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
R isk S umm a r y Based on the mechanism of action [ s e e C lini c al Pharma c ology ( 12.1 ) ] and findings from animal studies, pomalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [ s e e C ontraindi c ations ( 4 ), and W arnings and Pr ec autions ( 5.1 ) ] .
Pomalidomide is a thalidomide analogue.
Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects.
Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants.
Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis.
Pomalidomide crossed the placenta after administration to pregnant rabbits (s e e Data) .
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
If pregnancy does occur during treatment, immediately discontinue the drug.
Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
D a ta Animal Data Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis.
In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1,000 mg/kg/day.
Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.
There was no maternal toxicity observed in this study.
The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day.
Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.
In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day.
Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day.
Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set kidney, altered liver morphology, incompletely or not ossified pelvis, an increased average for supernumerary thoracic ribs, and a reduced average for ossified tarsals.
No maternal toxicity was observed at the low dose (10 mg/kg/day) that resulted in cardiac anomalies in fetuses; this dose resulted in an exposure (AUC) approximately equal to that reported in humans at the recommended dose of 4 mg/day.
Additional embryo-fetal toxicity included increased resorption.
Following daily oral administration of pomalidomide from Gestation Day 7 through Gestation Day 20 in pregnant rabbits, fetal plasma pomalidomide concentrations were approximately 50% of the maternal C max at all dosages (5 to 250 mg/kg/day), indicating that pomalidomide crossed the placenta.
IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed ( 8.2 ).
8.1 Pregnancy P re g n a n c y E x posu r e R e gist r y There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide.
This registry is also used to understand the root cause for the pregnancy.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
R isk S umm a r y Based on the mechanism of action [ s e e C lini c al Pharma c ology ( 12.1 ) ] and findings from animal studies, pomalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [ s e e C ontraindi c ations ( 4 ), and W arnings and Pr ec autions ( 5.1 ) ] .
Pomalidomide is a thalidomide analogue.
Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects.
Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants.
Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis.
Pomalidomide crossed the placenta after administration to pregnant rabbits (s e e Data) .
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
If pregnancy does occur during treatment, immediately discontinue the drug.
Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
D a ta Animal Data Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis.
In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1,000 mg/kg/day.
Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels.
There was no maternal toxicity observed in this study.
The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day.
Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.
In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day.
Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day.
Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set kidney, altered liver morphology, incompletely or not ossified pelvis, an increased average for supernumerary thoracic ribs, and a reduced average for ossified tarsals.
No maternal toxicity was observed at the low dose (10 mg/kg/day) that resulted in cardiac anomalies in fetuses; this dose resulted in an exposure (AUC) approximately equal to that reported in humans at the recommended dose of 4 mg/day.
Additional embryo-fetal toxicity included increased resorption.
Following daily oral administration of pomalidomide from Gestation Day 7 through Gestation Day 20 in pregnant rabbits, fetal plasma pomalidomide concentrations were approximately 50% of the maternal C max at all dosages (5 to 250 mg/kg/day), indicating that pomalidomide crossed the placenta.
8.2 Lactation R isk Summary There is no information regarding the presence of pomalidomide in human milk, the effects of pomalidomide on the breastfed child, or the effects of pomalidomide on milk production.
Pomalidomide was excreted in the milk of lactating rats (see Data) .
Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from pomalidomide, advise women not to breastfeed during treatment with pomalidomide.
Data Animal Data Following a single oral administration of pomalidomide to lactating rats approximately 14 days postpartum, pomalidomide was transferred into milk, with milk to plasma ratios of 0.63 to 1.46.
8.3 Females and Males of Reproductive Potential P re g n a n c y T e sting Pomalidomide can cause fetal harm when administered during pregnancy [see Use in Specific Populations ( 8.1 )].
Verify the pregnancy status of females of reproductive potential prior to initiating pomalidomide therapy and during therapy.
Advise females of reproductive potential that they must
avoid pregnancy 4 weeks before therapy, while taking pomalidomide, during dose interruptions and for at least 4 weeks after completing therapy.
Females of reproductive potential must have 2 negative pregnancy tests before initiating pomalidomide.
The first test should be performed within 10 to 14 days, and the second test within 24 hours prior to prescribing pomalidomide.
Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles.
If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks.
Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding.
Pomalidomide treatment must be discontinued during this evaluation.
C ont race ption F e mal es Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously:
one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner’s vasectomy, and 1 additional effective contraceptive method – male latex or synthetic condom, diaphragm, or cervical cap.
Contraception must begin 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of pomalidomide therapy.
Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy.
Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed.
M al es Pomalidomide is present in the semen of males who take pomalidomide.
Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy.
Male patients taking pomalidomide must not donate sperm.
I n fer tili t y Based on findings in animals, female fertility may be compromised by treatment with pomalidomide [ s ee N on c lini c al T o x i c ology ( 13.1 ) ] .
8.4 Pediatric Use The safety and effectiveness of pomalidomide have not been established in pediatric patients.
The safety and effectiveness were assessed but not established in two open-label studies:
a dose escalation study in 25 pediatric patients aged 5 to <17 with recurrent, progressive or refractory CNS tumors [NCT02415153] and a parallel-group study conducted in 47 pediatric patients aged 4 to <17 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma, or diffuse intrinsic pontine glioma (DIPG) [NCT03257631].
No new safety signals were observed in pediatric patients across these studies.
At the same dose by body surface area, pomalidomide exposure in 55 pediatric patients aged 4 to <17 years old was within the range observed in adult patients with MM but higher than the exposure observed in adult patients with KS [see Clinical Pharmacology ( 12.3 )] .
8.5 Geriatric Use Multiple Myeloma Of the total number of patients in clinical studies of pomalidomide, 44% were aged older than 65 years, while 10% were aged older than 75 years.
No overall differences in effectiveness were observed between these patients and younger patients.
In these studies, patients older than 65 years were more likely than patients less than or equal to 65 years of age to experience pneumonia.
Kaposi Sarcoma Of the 28 patients who received pomalidomide, 11% were 65 years or older, and 3.6% were 75 years of age or older.
The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
8.6 Renal Impairment In patients with severe renal impairment requiring dialysis, the AUC of pomalidomide increased by 38% and the rate of SAE increased by 64% relative to patients with normal renal function; therefore, starting dose adjustment is recommended.
For patients with severe renal impairment requiring dialysis, administer pomalidomide after the completion of hemodialysis on dialysis days because exposure of pomalidomide could be significantly decreased during dialysis [see Dosage and Administration ( 2.7 ) and Clinical Pharmacology ( 12.3 )] .
8.7 Hepatic Impairment Pomalidomide is metabolized primarily by the liver.
Following single dose administration, the AUC of pomalidomide increased 51%, 58%, and 72% in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment, respectively compared to subjects with normal liver function.
Dose adjustment is recommended in patients with hepatic impairment [see Dosage and Administration ( 2.8 ) and Clinical Pharmacology ( 12.3 )] .
8.8 Smoking Tobacco Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction.
Advise patients that smoking may reduce the efficacy of pomalidomide [ s e e C lini c al Pharma c ology ( 12.3 ) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors.
If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide dose to 2 mg ( 2.6 , 7.1 , 12.3 ).
7.1 Drugs that Affect Pomalidomide Plasma Concentrations C YP1A2 inhibitors :
In healthy subjects, coadministration of fluvoxamine, a strong CYP1A2 inhibitor, increased C max and AUC of pomalidomide by 24% and 125% respectively [see Clinical Pharmacology ( 12.3 )] .
Increased pomalidomide exposure may increase the risk of exposure related toxicities.
Avoid coadministration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine).
If coadministration is unavoidable, reduce the pomalidomide dose [see Dosage and Administration ( 2.6 )].

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Hemodialysis can remove pomalidomide from circulation.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of pomalidomide have not been established in pediatric patients.
The safety and effectiveness were assessed but not established in two open-label studies:
a dose escalation study in 25 pediatric patients aged 5 to <17 with recurrent, progressive or refractory CNS tumors [NCT02415153] and a parallel-group study conducted in 47 pediatric patients aged 4 to <17 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma, or diffuse intrinsic pontine glioma (DIPG) [NCT03257631].
No new safety signals were observed in pediatric patients across these studies.
At the same dose by body surface area, pomalidomide exposure in 55 pediatric patients aged 4 to <17 years old was within the range observed in adult patients with MM but higher than the exposure observed in adult patients with KS [see Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Pediatric Use”.

Use in older people

Multiple Myeloma Of the total number of patients in clinical studies of pomalidomide, 44% were aged older than 65 years, while 10% were aged older than 75 years.
No overall differences in effectiveness were observed between these patients and younger patients.
In these studies, patients older than 65 years were more likely than patients less than or equal to 65 years of age to experience pneumonia.
Kaposi Sarcoma Of the 28 patients who received pomalidomide, 11% were 65 years or older, and 3.6% were 75 years of age or older.
The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following clinically significant adverse reactions are described in detail in other labeling sections:
Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 , 5.2 )] Venous and Arterial Thromboembolism [see Warnings and Precautions ( 5.3 )] Increased Mortality in Patients with Multiple Myeloma when Pembrolizumab is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions ( 5.4 )] Hematologic Toxicity [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.7 )] Dizziness and Confusional State [see Warnings and Precautions ( 5.8 )] Neuropathy [see Warnings and Precautions ( 5.9 )] Risk of Second Primary Malignancies [see Warnings and Precautions ( 5.10 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.11 )] Hypersensitivity [see Warnings and Precautions ( 5.12 )] MM:
Most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia ( 6.1 ).
KS:
Most common adverse reactions including laboratory abnormalities (≥30%) are decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Multiple Myeloma (MM) In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (112 patients) or pomalidomide alone (107 patients).
Median number of treatment cycles was 5.
Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions.
Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions.
The discontinuation rate due to adverse reactions was 11%.
In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with pomalidomide + Low-dose Dex (300 patients) or High- dose Dexamethasone (High-dose Dex) (150 patients).
The median number of treatment cycles for the pomalidomide + Low-dose Dex arm was 5.
In the pomalidomide + Low-dose Dex arm, 67% of patients had a dose interruption of pomalidomide, the median time to the first dose interruption of pomalidomide was 4.1 weeks.
Twenty-seven percent of patients had a dose reduction of pomalidomide, the median time to the first dose reduction of pomalidomide was 4.5 weeks.
Eight percent of patients discontinued pomalidomide due to adverse reactions.
Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.
Table 3:
Adverse Reactions in Any Pomalidomide Treatment Arm in Trial 1* All Adverse Reactions ≥10% in E ither Arm G rade 3 or 4 ≥5 % in Either Arm Body System Adverse Reaction Pomalidomide a (N=107) Pomalidomide + Low-dose Dex (N=112) Pomalidomide (N=107) Pomalidomide + Low-dose Dex (N=112) Number (%) of patients with at least one adverse reaction 107 (100) 112 (100) 98 (92) 102 (91) B lood and lymphatic system disorders Neutropenia b 57 (53) 55 (49) 51 (48) 46 (41) Anemia b 41 (38) 47 (42) 25 (23) 24 (21) Thrombocytopenia b 28 (26) 26 (23) 24 (22) 21 (19) Leukopenia 14 (13) 22 (20) 7 (7) 11 (10) Febrile neutropenia b <10% <10% 6 (6) 3 (3) Lymphopenia 4 (4) 17 (15) 2 (2) 8 (7) G eneral disorders and administration site conditions Fatigue and asthenia b 62 (58) 70 (63) 13 (12) 19 (17) Edema peripheral 27 (25) 19 (17) 0 (0.0) 0 (0.0) Pyrexia b 25 (23) 36 (32) <5% <5% Chills 11 (10) 14 (13) 0 (0.0) 0 (0.0) G a s t rointestinal disorders Nausea b 39 (36) 27 (24) <5% <5% Constipation b 38 (36) 41 (37) <5% <5% Diarrhea 37 (35) 40 (36) <5% <5% Vomiting b 15 (14) 16 (14) <5% 0 (0.0) M usculoskeletal and connective tissue disorders Back pain b 37 (35) 36 (32) 15 (14) 11 (10) Musculoskeletal chest pain 25 (23) 22 (20) <5% 0 (0.0) Muscle spasms 23 (21) 22 (20) <5% <5% Arthralgia 18 (17) 17 (15) <5% <5% Muscular weakness 15 (14) 15 (13) 6 (6) 4 (4) Bone pain 13 (12) 8 (7) <5% <5% Musculoskeletal pain 13 (12) 19 (17) <5% <5% Pain in extremity 8 (7) 16 (14) 0 (0.0) <5% I nfections and infestations Upper respiratory tract infection 40 (37) 32 (29) <5% <5% Pneumonia b 30 (28) 38 (34) 21 (20) 32 (29) Urinary tract infection b 11 (10) 19 (17) 2 (2) 10 (9) Sepsis b <10% <10% 6 (6) 5 (4) M e ta bolism and nutrition disorders Decreased appetite 25 (23) 21 (19) <5% 0 (0.0) Hypercalcemia b 23 (21) 13 (12) 11 (10) 1 (<1) Hypokalemia 13 (12) 13 (12) <5% <5% Hyperglycemia 12 (11) 17 (15) <5% <5% Hyponatremia 12 (11) 14 (13) <5% <5% Dehydration b <10% <10% 5 (4.7) 6 (5.4) Hypocalcemia 6 (6) 13 (12) 0 (0.0) <5% Respiratory, thoracic and mediastinal disorders Dyspnea b 38 (36) 50 (45) 8 (7) 14 (13) Cough 18 (17) 25 (22) 0 (0.0) 0 (0.0) Epistaxis 18 (17) 12 (11) <5% 0 (0.0) Productive cough 10 (9) 14 (13) 0 (0.0) 0 (0.0) Oropharyngeal pain 6 (6) 12 (11) 0 (0.0) 0 (0.0) Nervous system disorders Dizziness 24 (22) 20 (18) <5% <5% Peripheral neuropathy 23 (21) 20 (18) 0 (0.0) 0 (0.0) Headache 16 (15) 15 (13) 0 (0.0) <5% Tremor 11 (10) 15 (13) 0 (0.0) 0 (0.0) S k in and subcutaneous tissue disorders Rash 22 (21) 18 (16) 0 (0.0) <5% Pruritus 16 (15) 10 (9) 0 (0.0) 0 (0.0) Dry skin 10 (9) 12 (11) 0 (0.0) 0 (0.0) Hyperhidrosis 8 (7) 18 (16) 0 (0.0) 0 (0.0) Night sweats 5 (5) 14 (13) 0 (0.0) 0 (0.0) I nvestigations Blood creatinine increased b 20 (19) 11 (10) 6 (6) 3 (3) Weight decreased 16 (15) 10 (9) 0 (0.0) 0 (0.0) Weight increased 1 (<1) 12 (11) 0 (0.0) 0 (0.0) P s y chiatric disorders Anxiety 14 (13) 8 (7) 0 (0.0) 0 (0.0) Confusional state b 13 (12) 15 (13) 6 (6) 3 (3) Insomnia 7 (7) 18 (16) 0 (0.0) 0 (0.0) Renal and urinary disorders Renal failure b 16 (15) 11 (10) 9 (8) 8 (7) * Regardless of attribution of relatedness to pomalidomide. a Pomalidomide alone arm includes all patients randomized to the pomalidomide alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period. b Serious adverse reactions were reported in at least 2 patients in any pomalidomide treatment arm.
Data cutoff:
01 March 2013 Table 4:
Adverse Reactions in Trial 2 All Adverse Reactions (≥5 % in Pomalidomide + Low-dose Dex arm, and at least 2% higher than the High-dose-Dex arm) G rade 3 or 4 (≥1 % in Pomalidomide + Low-dose Dex arm, and at least 1% higher than the High-dose-Dex arm) Body System Adverse Reaction Pomalidomide + Low-dose Dex ( N=300) H igh-dose Dex ( N=150) Pomalidomide + Low-dose Dex ( N=300) H igh-dose Dex ( N=150) Number (%) of patients with at least one adverse reaction 297 (99) 149 (99) 259 (86) 127 (85) B lood and lymphatic system disorders Neutropenia b 154 (51) 31 (21) 145 (48) 24 (16) Thrombocytopenia 89 (30) a 44 (29) a 66 (22) a 39 (26) a Leukopenia 38 (13) 8 (5) 27 (9) 5 (3) Febrile neutropenia b 28 (9) 0 (0.0) 28 (9) 0 (0.0) G eneral disorders and administration site conditions Fatigue and asthenia 140 (47) 64 (43) 26 (9) a 18 (12) a Pyrexia b 80 (27) 35 (23) 9 (3) a 7 (5) a Edema peripheral 52 (17) 17 (11) 4 (1) a 3 (2) a Pain 11 (4) a 3 (2) a 5 (2) 1 (<1) I nfections and infestations Upper respiratory tract infection b 93 (31) 19 (13) 9 (3) 1 (<1) Pneumonia b 58 (19) 20 (13) 47 (16) 15 (10) Neutropenic sepsis b 3 (1) a 0 (0.0) a 3 (1) 0 (0.0) G a s t rointestinal disorders Diarrhea 66 (22) 28 (19) 3 (1) a 2 (1) a Constipation 65 (22) 22 (15) 7 (2) 0 (0.0) Nausea 45 (15) 17 (11) 3 (1) a 2 (1) a Vomiting 23 (8) 6 (4) 3 (1) 0 (0.0) M usculoskeletal and connective tissue disorders Back pain b 59 (20) 24 (16) 15 (5) 6 (4) Bone pain b 54 (18) 21 (14) 22 (7) 7 (5) Muscle spasms 46 (15) 11 (7) 1 (<1) a 1 (<1) a Arthralgia 26 (9) 7 (5) 2 (<1) a 1 (<1) a Pain in extremity 20 (7) a 9 (6) a 6 (2) 0 (0.0) Respiratory, thoracic and mediastinal disorders Dyspnea b 76 (25) 25 (17) 17 (6) 7 (5) Cough 60 (20) 15 (10) 2 (<1) a 1 (<1) a Chronic obstructive pulmonary disease b 5 (2) a 0 (0.0) a 4 (1) 0 (0.0) Nervous system disorders Peripheral neuropathy 52 (17) 18 (12) 5 (2) a 2 (1) a Dizziness 37 (12) 14 (9) 4 (1) a 2 (1) a Headache 23 (8) 8 (5) 1 (<1) a 0 (0.0) a Tremor 17 (6) 2 (1) 2 (<1) a 0 (0.0) a Depressed level of consciousness 5 (2) a 0 (0.0) a 3 (1) 0 (0.0) M e ta bolism and nutrition disorders Decreased appetite 38 (13) 12 (8) 3 (1) a 2 (1) a Hypokalemia 28 (9) a 12 (8) a 12 (4) 4 (3) Hypocalcemia 12 (4) a 9 (6) a 5 (2) 1 (<1) S k in and subcutaneous tissue disorders Rash 23 (8) 2 (1) 3 (1) 0 (0.0) Pruritus 22 (7) 5 (3) 0 (0.0) a 0 (0.0) a Hyperhidrosis 15 (5) 1 (<1) 0 (0.0) a 0 (0.0) a I nvestigations Neutrophil count decreased 15 (5) 1 (<1) 14 (5) 1 (<1) Platelet count decreased 10 (3) a 3 (2) a 8 (3) 2 (1) White blood cell count decreased 8 (3) a 1 (<1) a 8 (3) 0 (0.0) Alanine aminotransferase increased 7 (2) a 2 (1) a 5 (2) 0 (0.0) Aspartate aminotransferase increased 4 (1) a 2 (1) a 3 (1) 0 (0.0) Lymphocyte count decreased 3 (1) a 1 (<1) a 3 (1) 0 (0.0) Renal and urinary disorders Renal failure 31 (10) a 18 (12) a 19 (6) 8 (5) I njury, poisoning and procedural complications Femur fracture b 5 (2) a 1 (<1) a 5 (2) 1 (<1) Reproductive system and breast disorders Pelvic pain 6 (2) a 3 (2) a 4 (1) 0 (0.0) a Percentage did not meet the criteria to be considered as an adverse reaction for pomalidomide for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events). b Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.
Data cutoff:
01 March 2013 Other Adverse Reactions Other adverse reactions of pomalidomide in patients with MM, not described above, and considered important:
Cardiac Disorders:
Myocardial infarction, Atrial fibrillation, Angina pectoris, Cardiac failure congestive E ar and Labyrinth Disorders:
Vertigo G astrointestinal Disorders:
Abdominal pain G e ne r al Disorders and Administration Site Conditions:
General physical health deterioration, Non-cardiac chest pain, Multi-organ failure Hepatobiliary Disorders:
Hyperbilirubinemia Infections and Infestations:
Pneumocystis jiroveci pneumonia, Respiratory syncytial virus infection, Neutropenic sepsis, Bacteremia, Pneumonia respiratory syncytial viral, Cellulitis, Urosepsis, Septic shock, Clostridium difficile colitis, Pneumonia streptococcal, Lobar pneumonia, Viral infection, Lung infection Investigations:
Alanine aminotransferase increased, Hemoglobin decreased Injury, Poisoning and Procedural Complications:
Fall, Compression fracture, Spinal compression fracture Met abolism and Nutritional Disorders:
Hyperkalemia, Failure to thrive Nervous System Disorders:
Depressed level of consciousness, Syncope P sychiatric Disorders:
Mental status change Renal and Urinary Disorders:
Urinary retention, Hyponatremia Reproductive System and Breast Disorders:
Pelvic pain Respiratory, Thoracic, and Mediastinal Disorders:
Interstitial lung disease, Pulmonary embolism, Respiratory failure, Bronchospasm Vascular Disorders:
Hypotension Kaposi Sarcoma (KS) The safety of pomalidomide in patients with KS was evaluated in Trial 12-C-0047 [see Clinical Studies ( 14.2 )] .
Twenty-eight patients received pomalidomide 5 mg taken orally once daily on Days 1 through 21 of repeated 28-day cycles.
The study excluded patients with procoagulant disorders or a history of venous or arterial thromboembolism.
Patients received DVT prophylaxis with daily low dose aspirin.
Across all patients treated on Trial 12-C-0047, 75% were exposed to pomalidomide for 6 months or longer and 25% were exposed for greater than one year.
Serious adverse reactions occurred in 18% (5/28) of patients who received pomalidomide.
The following serious adverse reactions each occurred in 1 patient:
anemia, decreased neutrophil count, and hematuria.
Permanent discontinuation due to an adverse reaction occurred in 11% (3/28) of patients who received pomalidomide.
Dosage interruptions due to an adverse reaction occurred in 14% (4/28) of patients who received pomalidomide.
The most frequent adverse reaction requiring dosage interruption was decreased neutrophil count, which occurred in 3 patients.
The pomalidomide dose was reduced due to an adverse reaction in 1 patient due to gout.
Tables 5 and 6 summarize the adverse reactions and select laboratory abnormalities reported in Trial 12-C-0047.
Table 5:
Adverse Reactions (≥ 20%) in Patients Who Received Pomalidomide in Trial 12-C-0047 Adverse Reaction Grades 1-4 N=28 % Grade 3 or 4 N=28 % Rash, maculo-papular 71
Constipation 71 0 Fatigue 68 0 Nausea 36 0 Diarrhea 32
Cough 29 0 Dyspnea 29 0 Peripheral Edema 29
3.6 Upper respiratory tract infection 29 0 Muscle spasms 25 0 Hypothyroidism 21 0 Dry skin 21 0 Chills 21 0 Table 6:
Frequency of Select Laboratory Abnormalities (≥ 10%) Worsening from Baseline in Patients Who Received Pomalidomide in Trial 12-C-0047 Laboratory Abnormality Grades 1-4* % Grades 3-4* % Hematology Decreased Absolute Neutrophil Count 96 50 Decreased White Blood Cells 79
3.6 Decreased Hemoglobin 54 0 Decreased Platelets 54 0 Chemistry Elevated Creatinine 86
3.6 Elevated Glucose 57 7 Decreased Albumin 54 0 Decreased Phosphate 54 25 Decreased Calcium 50 0 Increased Alanine Aminotransferase (ALT) 32 0 Increased Aspartate Aminotransferase (AST) 25 0 Elevated Creatine Kinase 25 7 Decreased Magnesium 14 0 Elevated Alkaline Phosphate 14 3.6 * Denominator is the number of patients for whom there is a baseline and at least one post baseline assessment for the laboratory parameter.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of pomalidomide.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders:
Pancytopenia Endocrine Disorders:
Hypothyroidism, hyperthyroidism Gastrointestinal Disorders:
Gastrointestinal hemorrhage Hepatobiliary Disorders:
Hepatic failure (including fatal cases), elevated liver enzymes Immune System Disorders:
Allergic reactions (e.g., angioedema, anaphylaxis, urticaria), solid organ transplant rejection Infections and Infestations:
Hepatitis B virus reactivation, Herpes zoster, progressive multifocal leukoencephalopathy (PML) Neoplasms benign, malignant and unspecified (incl cysts and polyps):
Tumor lysis syndrome, basal cell carcinoma, and squamous cell carcinoma of the skin Skin and Subcutaneous Tissue Disorders :
Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).
Embryo-Fetal Toxicity Advise patients that pomalidomide capsules are contraindicated in pregnancy [see Contraindications ( 4 )] .
Pomalidomide is a thalidomide analogue and may cause serious birth defects or death to a developing baby [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].
Advise females of reproductive potential that they must
avoid pregnancy while taking pomalidomide capsules and for at least 4 weeks after completing therapy.
Initiate pomalidomide capsules treatment in females of reproductive potential only following a negative pregnancy test.
Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use 2 different forms of contraception, including at least 1 highly effective form, simultaneously during pomalidomide capsules therapy, during dose interruptions, and for 4 weeks after she has completely finished taking pomalidomide capsules.
Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch, or implants) and a partner’s vasectomy.
Additional effective contraceptive methods include latex or synthetic condom, diaphragm, and cervical cap.
Instruct patient to immediately stop taking pomalidomide capsules and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant.
Advise patient that if her healthcare provider is not available, she should call the REMS Call Center at 1-888-423-5436 [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.3 )].
Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking pomalidomide capsules and for up to 4 weeks after discontinuing pomalidomide capsules, even if they have undergone a successful vasectomy.
Advise male patients taking pomalidomide capsules that they must not donate sperm [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations (8.3) ] .
All patients must be instructed to not donate blood while taking pomalidomide capsules and for 4 weeks following discontinuation of pomalidomide capsules [see Warnings and Precautions ( 5.1 )] .
PS-Pomalidomide R EMS Because of the risk of embryo-fetal toxicity, pomalidomide capsules are only available through a restricted program called PS-Pomalidomide REMS [see Warnings and Precautions ( 5.2 )] .
Patients must sign a Patient-Physician Agreement Form and comply with the requirements to receive pomalidomide capsules.
In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements, and participate in monthly telephone surveys.
Males must comply with the contraception requirements [see Use in Specific Populations ( 8.3 )] .
Pomalidomide capsules are available only from pharmacies that are certified in PS-Pomalidomide REMS.
Provide patients with the telephone number and website for information on how to obtain the product.
P re g n a ncy Exposure Registry Inform females that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations ( 8.1 )] .
Venous and Arterial Thromboembolism Inform patients of the risk of developing DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Warnings and Precautions ( 5.3 )] .
Hematologic Toxicities Inform patients on the risks of developing neutropenia, thrombocytopenia, and anemia and the need to report signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions ( 5.5 )] .
Hepatotoxicity Inform patients on the risks of developing hepatotoxicity, including hepatic failure and death, and to report signs and symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions ( 5.6 )] .
Severe Cutaneous Reactions Inform patients of the potential risk for severe skin reactions such as SJS, TEN and DRESS and to report any signs and symptoms associated with these reactions to their healthcare provider for evaluation [see Warnings and Precautions ( 5.7 )] .
Dizziness and Confusional State Inform patients of the potential risk of dizziness and confusional state with the drug, to
avoid situations where dizziness or confusional state may be a problem, and not to take other medications that may cause dizziness or confusional state without adequate medical advice [see Warnings and Precautions ( 5.8 )] .
Neuropathy Inform patients of the risk of neuropathy and to report the signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions ( 5.9 )] .
S ec ond Primary Malignancies Inform the patient that the potential risk of developing acute myelogenous leukemia during treatment with pomalidomide capsules is unknown [see Warnings and Precautions ( 5.10 )] .
Tumor Lysis Syndrome Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions ( 5.11 )] .
Hypersensitivity Inform patients of the potential for severe hypersensitivity reactions such as angioedema and anaphylaxis to pomalidomide capsules.
Instruct patients to contact their healthcare provider right away for any signs and symptoms of these reactions.
Advise patients to seek emergency medical attention for signs or symptoms of severe hypersensitivity reactions [see Warnings and Precautions ( 5.12 )] .
S moking Tobacco Advise patients that smoking tobacco may reduce the efficacy of pomalidomide capsules [see Use in Specific Populations ( 8.8 ) and Clinical Pharmacology ( 12.3 )] .
Dosing Instructions Inform patients on how to take pomalidomide capsules [see Dosage and Administration ( 2.2 , 2.3 , 2.9 )] Pomalidomide capsules should be taken once daily at about the same time each day.
Patients on hemodialysis should take pomalidomide capsules following hemodialysis, on hemodialysis days.
Pomalidomide capsules may be taken with or without food.
The capsules should not be opened, broken, or chewed.
Pomalidomide capsules should be swallowed whole with water.
Instruct patients that if they miss a dose of pomalidomide capsules, they may still take it up to 12 hours after the time they would normally take it.
If more than 12 hours have elapsed, they should be instructed to skip the dose for that day.
The next day, they should take pomalidomide capsules at the usual time.
Warn patients not to take 2 doses to make up for the one that they missed.
Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Iss. 10/2025

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Pomalidomide is available in the following capsule strengths:
1 mg - Each hard gelatin, size 4 capsule with yellow opaque cap and body imprinted with “A018” on cap in black ink, containing yellow color powder contains 1 mg of pomalidomide. 2 mg - Each hard gelatin, size 2 capsule with peach opaque cap and body imprinted with “A022” on cap in black ink, containing yellow color powder contains 2 mg of pomalidomide. 3 mg - Each hard gelatin, size 2 capsule with light green opaque cap and body imprinted with “A029” on cap in black ink, containing yellow color powder contains 3 mg of pomalidomide. 4 mg - Each hard gelatin, size 2 capsule with blue opaque cap and body imprinted with “A035” on cap in black ink, containing yellow color powder contains 4 mg of pomalidomide.
Capsules: 1 mg, 2 mg, 3 mg, and 4 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Pomalidomide capsules are supplied as follows:
1 mg - Each hard gelatin, size 4 capsule with yellow opaque cap and body imprinted with “A018” on cap in black ink, containing yellow color powder contains 1 mg of pomalidomide.
Capsules are supplied in bottles of 21 (NDC 0480-4018-21). 2 mg - Each hard gelatin, size 2 capsule with peach opaque cap and body imprinted with “A022” on cap in black ink, containing yellow color powder contains 2 mg of pomalidomide.
Capsules are supplied in bottles of 21 (NDC 0480-4022-21). 3 mg - Each hard gelatin, size 2 capsule with light green opaque cap and body imprinted with “A029” on cap in black ink, containing yellow color powder contains 3 mg of pomalidomide.
Capsules are supplied in bottles of 21 (NDC 0480-2601-21). 4 mg - Each hard gelatin, size 2 capsule with blue opaque cap and body imprinted with “A035” on cap in black ink, containing yellow color powder contains 4 mg of pomalidomide.
Capsules are supplied in bottles of 21 (NDC 0480-4035-21).
Dispense in a tight, light-resistant container as defined in the USP.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Care should be exercised in handling of pomalidomide.
Do not open or crush pomalidomide capsules.
If powder from pomalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water.
If pomalidomide contacts the mucous membranes, flush thoroughly with water.
Follow procedures for proper handling and disposal of hazardous drugs. 1

Quoted from the official label, section “How Supplied”.

What is in it

Pomalidomide is a thalidomide analog.
The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure:
The molecular formula for pomalidomide is C 13 H 11 N 3 O 4 and the gram molecular weight is 273.24.
Pomalidomide is a yellow crystalline powder.
It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL).
Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers.
Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration.
Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients:
1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide. str

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Colour dyesFD&C Blue No. 1; FD&C Red No. 40Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Sugar alcoholsmannitolSorbitol and similar can upset the stomach and matter with fructose intolerance.
GelatingelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (11)

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Same active substance, strength and form in other countries

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European UnionNo exact match for this strength and form

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France7 matching products

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Canada6 matching products

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Netherlands23 matching products

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Details

Made by	Teva Pharmaceuticals, Inc.
Active substance	Pomalidomide
Used in	Cancer treatments and immune-system medicines
Strength	1 mg
Form	Capsule
Route	Oral
Packs	21 CAPSULE in 1 BOTTLE
NDC	0480-4018

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

40 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Pomalidomide3 mgPrescription onlyCapsule Teva Pharmaceuticals, Inc. · Pomalidomide Pomalidomide2 mgPrescription onlyCapsule Teva Pharmaceuticals, Inc. · Pomalidomide Pomalidomide4 mgPrescription onlyCapsule Teva Pharmaceuticals, Inc. · Pomalidomide Pomalidomide1 mgPrescription onlyCapsule Sandoz Inc · Pomalidomide Pomalidomide2 mgPrescription onlyCapsule Sandoz Inc · Pomalidomide Pomalidomide3 mgPrescription onlyCapsule Sandoz Inc · Pomalidomide

See every product with Pomalidomide