Mediclarum
Medicine guide

Ibrance

75 mg · Capsule

  • Prescription only
  • Kinase Inhibitor
Active substance
Palbociclib
Made by
Pfizer Laboratories Div Pfizer Inc

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 · 2026-07-02

What it is

Kinase Inhibitor

Used for
  • O an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. ( 1.1 )
The label’s usual adult dose

125 mg once daily taken with food for 21 days followed by 7 days off treatment. ( 2.1 )

Full directions ↓
Do not take it if

None. None. ( 4 )

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
8other products contain Palbociclib — compare makers, forms and strengths

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

What it is for

IBRANCE is a kinase inhibitor indicated:

  • for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
  • o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. ( 1.1 )
  • in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy. ( 1.1 )
  • in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2 positive locally advanced or metastatic breast cancer following induction treatment. ( 1.2 ) 1.1 HER2-Negative Metastatic Breast Cancer IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy; or
  • fulvestrant in patients with disease progression following endocrine therapy. IBRANCE is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA- authorized test, following recurrence on or after completing adjuvant endocrine therapy. 1.2 HER2-Positive Metastatic Breast Cancer IBRANCE is indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

From the official label · 2026-07-02 · DailyMed

How it works

From this product’s own US prescribing label.

Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6.

Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation.

Peak level after6–12 h
How the body breaks it down

Palbociclib was extensively metabolized with unchanged drug accounting for 2.3% and 6.9% of radioactivity in feces and urine, respectively.

With food

Food effect: Palbociclib absorption and exposure were very low in approximately 13% of the population under the fasted condition.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-02

Do not take it if

None. None. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

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

  • Recommended starting dose:
  • 125 mg once daily taken with food for 21 days followed by 7 days off treatment. ( 2.1 )
  • Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE capsule should be taken with food [see Clinical Pharmacology (12.3) ] . Advise patients to take their dose of IBRANCE at approximately the same time each day. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). Capsules should not be ingested if they are broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant, IBRANCE plus inavolisib and fulvestrant therapy , or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards. For men treated with combination IBRANCE plus aromatase inhibitor, IBRANCE plus inavolisib and fulvestrant therapy, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy, consider treatment with an LHRH agonist according to current clinical practice standards. Refer to the Prescribing Information for recommended dosage for endocrine therapy, inavolisib, trastuzumab and pertuzumab administered in combination with IBRANCE. 2.2 Dose Modification The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3. Table 1. Recommended Dose Modification for Adverse Reactions Dose Level Dose Recommended starting dose 125 mg/day First dose reduction 100 mg/day Second dose reduction 75 mg/day If further dose reduction below 75 mg/day is required, discontinue. Table 2. Dose Modification and Management – Hematologic Toxicities Table applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections). Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal. Monitor complete blood counts prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, monitor complete blood counts for subsequent cycles every 3 months, prior to the beginning of a cycle and as clinically indicated. CTCAE Grade Dose Modifications Grade 1 or 2 No dose adjustment is required. Grade 3 Day 1 of cycle :
  • Withhold IBRANCE, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose . Day 15 of first 2 cycles :
  • If Grade 3 on Day 15, continue IBRANCE at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles. Grade 3 neutropenia Absolute neutrophil count (ANC):
  • Grade 1:
  • ANC < LLN - 1500/mm 3 ; Grade 2:
  • ANC 1000 - <1500/mm 3 ; Grade 3:
  • ANC 500 - <1000/mm 3 ; Grade 4:
  • ANC <500/mm 3 . with fever ≥38.5 ºC and/or infection At any time :
  • Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . Grade 4 At any time :
  • Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . Table 3. Dose Modification and Management – Non-Hematologic Toxicities CTCAE Grade Dose Modifications Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events. Grade 1 or 2 No dose adjustment is required. Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment) Withhold until symptoms resolve to:
  • Grade ≤1;
  • Grade ≤2 (if not considered a safety risk for the patient) Resume at the next lower dose . Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis. Refer to the Full Prescribing Information for endocrine therapy, inavolisib , trastuzumab, and pertuzumab administered in combination with IBRANCE for dose adjustment guidelines in the event of toxicity and for other relevant safety information or contraindications. Dose Modifications for Use With Strong CYP3A Inhibitors
  • Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Dose Modifications for Hepatic Impairment No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].

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

Other warnings

  • Neutropenia:
  • Monitor complete blood count prior to start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. ( 2.2 , 5.1 )
  • Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/pneumonitis. Interrupt IBRANCE immediately in patients with suspected ILD/pneumonitis. Permanently discontinue IBRANCE if severe ILD/pneumonitis occurs. ( 5.2 )
  • Embryo-Fetal Toxicity:
  • IBRANCE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) 5.1 Neutropenia Neutropenia was the most frequently reported adverse reaction in PALOMA-2 with an incidence of 80% and PALOMA-3 with an incidence of 83%. A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving IBRANCE plus letrozole in PALOMA-2 and 66% of patients receiving IBRANCE plus fulvestrant in PALOMA-3. In PALOMA-2 and PALOMA-3, the median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days [see Adverse Reactions (6.1) ] . Neutropenia was the most frequently reported adverse reaction in PATINA with an incidence of 78%. Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Based on laboratory findings, 93% had a decrease in neutrophil counts including 47% with Grade 3 and 3.1% with Grade 4. The median time to first episode of any grade neutropenia was 22 days and the median duration of Grade ≥3 neutropenia events was 9 days [see Adverse Reactions (6.1) ] . Monitor complete blood counts prior to starting IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia [see Dosage and Administration (2.2) ] . Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study. Physicians should inform patients to promptly report any episodes of fever [see Patient Counseling Information (17) ] . 5.2 Interstitial Lung Disease (ILD)/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4 and no fatal cases were reported. In PATINA, 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade. No Grade 3, 4, or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the postmarketing setting, with fatalities reported [see Adverse Reactions (6.2) ] . Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis [see Dosage and Administration (2.2) ] . 5.3 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on area under the curve (AUC). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IBRANCE and for at least 3 weeks after the last dose [see Use in Specific Populations (8.1 and 8.3) and Clinical Pharmacology (12.1) ] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .
  • There are no available data in pregnant women to inform the drug-associated risk.
  • In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC (see Data ) .
  • Advise pregnant women of the potential risk to a fetus.
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.
  • Data Animal Data In a fertility and early embryonic development study in female rats, palbociclib was administered orally for 15 days before mating through to Day 7 of pregnancy, which did not cause embryo toxicity at doses up to 300 mg/kg/day with maternal systemic exposures approximately 4 times the human exposure (AUC) at the recommended dose.
  • In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of palbociclib up to 300 mg/kg/day and 20 mg/kg/day, respectively, during the period of organogenesis.
  • The maternally toxic dose of 300 mg/kg/day was fetotoxic in rats, resulting in reduced fetal body weights.
  • At doses ≥100 mg/kg/day in rats, there was an increased incidence of a skeletal variation (increased incidence of a rib present at the seventh cervical vertebra).
  • At the maternally toxic dose of 20 mg/kg/day in rabbits, there was an increased incidence of skeletal variations, including small phalanges in the forelimb.
  • At 300 mg/kg/day in rats and 20 mg/kg/day in rabbits, the maternal systemic exposures were approximately 4 and 9 times the human exposure (AUC) at the recommended dose, respectively.
  • CDK4/6 double knockout mice have been reported to die in late stages of fetal development (gestation Day 14.5 until birth) due to severe anemia.
  • However, knockout mouse data may not be predictive of effects in humans due to differences in degree of target inhibition.
  • IN SPECIFIC POPULATIONS
  • Lactation:
  • Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Data Animal Data In a fertility and early embryonic development study in female rats, palbociclib was administered orally for 15 days before mating through to Day 7 of pregnancy, which did not cause embryo toxicity at doses up to 300 mg/kg/day with maternal systemic exposures approximately 4 times the human exposure (AUC) at the recommended dose. In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of palbociclib up to 300 mg/kg/day and 20 mg/kg/day, respectively, during the period of organogenesis. The maternally toxic dose of 300 mg/kg/day was fetotoxic in rats, resulting in reduced fetal body weights. At doses ≥100 mg/kg/day in rats, there was an increased incidence of a skeletal variation (increased incidence of a rib present at the seventh cervical vertebra). At the maternally toxic dose of 20 mg/kg/day in rabbits, there was an increased incidence of skeletal variations, including small phalanges in the forelimb. At 300 mg/kg/day in rats and 20 mg/kg/day in rabbits, the maternal systemic exposures were approximately 4 and 9 times the human exposure (AUC) at the recommended dose, respectively. CDK4/6 double knockout mice have been reported to die in late stages of fetal development (gestation Day 14.5 until birth) due to severe anemia. However, knockout mouse data may not be predictive of effects in humans due to differences in degree of target inhibition. 8.2 Lactation Risk Summary There is no information regarding the presence of palbociclib in human milk, its effects on milk production, or the breastfed infant. Because of the potential for serious adverse reactions in breastfed infants from IBRANCE, advise a lactating woman not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Based on animal studies, IBRANCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Females of reproductive potential should have a pregnancy test prior to starting treatment with IBRANCE. Contraception Females IBRANCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with IBRANCE and for at least 3 weeks after the last dose. Males Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with IBRANCE and for 3 months after the last dose [see Nonclinical Toxicology (13.1) ] . Infertility Males Based on animal studies, IBRANCE may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of IBRANCE in pediatric patients have not been established. The safety and effectiveness of IBRANCE were assessed but not established in three trials:
  • one open-label trial [A5481092, (NCT03709680)] that included 98 pediatric patients 2 to <17 years of age who received IBRANCE in combination with chemotherapy for recurrent or refractory solid tumors and two open-label trials that included 42 pediatric patients 4 to <17 years of age who received IBRANCE as a single agent for recurrent or refractory solid tumors [APEC1621I, (NCT03526250)] or primary central nervous system (CNS) tumors [PBTC-042, (NCT02255461)]. No new safety signals were observed in these trials. Palbociclib exposures in pediatric patients who received IBRANCE as a single agent or in combination were within range of those observed in
  • adults given a similar dose based on body surface area. Juvenile Animal Toxicity Data Altered glucose metabolism (glycosuria, hyperglycemia, decreased insulin) associated with changes in the pancreas (islet cell vacuolation), eye (cataracts, lens degeneration), kidney (tubule vacuolation, chronic progressive nephropathy) and adipose tissue (atrophy) were identified in a 27 week repeat-dose toxicology study in rats that were immature at the beginning of the studies and were most prevalent in males at oral palbociclib doses ≥30 mg/kg/day (approximately 11 times the adult human exposure [AUC] at the recommended dose). Some of these findings (glycosuria/hyperglycemia, pancreatic islet cell vacuolation, and kidney tubule vacuolation) were present with lower incidence and severity in a 15 week repeat-dose toxicology study in immature rats. Altered glucose metabolism or associated changes in the pancreas, eye, kidney and adipose tissue were not identified in a 27-week repeat-dose toxicology study in rats that were mature at the beginning of the study and in dogs in repeat-dose toxicology studies up to 39 weeks duration. Toxicities in teeth independent of altered glucose metabolism were observed in rats. Administration of 100 mg/kg palbociclib for 27 weeks (approximately 15 times the adult human exposure [AUC] at the recommended dose) resulted in abnormalities in growing incisor teeth (discolored, ameloblast degeneration/necrosis, mononuclear cell infiltrate). Other toxicities of potential concern to pediatric patients have not been evaluated in juvenile animals. 8.5 Geriatric Use Of 444 patients who received IBRANCE in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age. Of 347 patients who received IBRANCE in PALOMA-3, 86 patients (25%) were ≥65 years of age and 27 patients (8%) were ≥75 years of age. Of the 260 patients who received IBRANCE in PATINA, 41 patients (16%) were ≥65 years of age and 13 patients (5%) were ≥75 years of age. No clinically significant differences in safety or effectiveness of IBRANCE were observed between patients 65 years of age and older and younger adult patients. Of the 162 patients who received IBRANCE in combination with inavolisib and fulvestrant in INAVO120, 15% were ≥ 65 years of age and 3% were ≥ 75 years of age. Dosage modifications or interruptions due to adverse reactions occurred at a higher incidence in patients ≥ 65 years of age compared with younger patients (79% versus 68%, respectively). Clinical studies of IBRANCE in combination with inavolisib and fulvestrant did not include sufficient numbers of patients ≥ 65 years of age to determine whether they respond differently from younger patients. 8.6 Hepatic Impairment No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Dosage and Administration (2.2) ] . Based on a pharmacokinetic trial in subjects with varying degrees of hepatic function, the palbociclib unbound exposure (unbound AUC INF ) decreased by 17% in subjects with mild hepatic impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, relative to subjects with normal hepatic function. Peak palbociclib unbound exposure (unbound C max ) increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function [see Clinical Pharmacology (12.3) ] . Review the Full Prescribing Information for the aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment. 8.7 Renal Impairment No dose adjustment is required in patients with mild, moderate, or severe renal impairment (CrCl >15 mL/min). Based on a pharmacokinetic trial in subjects with varying degrees of renal function, the total palbociclib exposure (AUC INF ) increased by 39%, 42%, and 31% with mild (60 mL/min ≤ CrCl <90 mL/min), moderate (30 mL/min ≤ CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal renal function. Peak palbociclib exposure (C max ) increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function. The pharmacokinetics of palbociclib have not been studied in patients requiring hemodialysis [see Clinical Pharmacology (12.3) ] .

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

Other medicines

  • Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
  • CYP3A Inhibitors:
  • Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. ( 2.2 , 7.1 )
  • CYP3A Inducers: Avoid concurrent use of IBRANCE with strong CYP3A inducers. ( 7.2 )
  • CYP3A Substrates:
  • The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. ( 7.3 ) 7.1 Agents That May Increase Palbociclib Plasma Concentrations Effect of CYP3A Inhibitors Coadministration of a strong CYP3A inhibitor (itraconazole) increased the plasma exposure of palbociclib in healthy subjects by 87%.
  • Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole).
  • Avoid grapefruit or grapefruit juice during IBRANCE treatment. If coadministration of IBRANCE with a strong CYP3A inhibitor cannot be avoided, reduce the dose of IBRANCE [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] . 7.2 Agents That May Decrease Palbociclib Plasma Concentrations Effect of CYP3A Inducers Coadministration of a strong CYP3A inducer (rifampin) decreased the plasma exposure of palbociclib in healthy subjects by 85%.
  • Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort) [see Clinical Pharmacology (12.3) ] . 7.3 Drugs That May Have Their Plasma Concentrations Altered by Palbociclib Coadministration of midazolam with multiple doses of IBRANCE increased the midazolam plasma exposure by 61%, in healthy subjects, compared to administration of midazolam alone. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as IBRANCE may increase its exposure [see Clinical Pharmacology (12.3) ] .

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

Use in children

  • The safety and effectiveness of IBRANCE in pediatric patients have not been established.
  • The safety and effectiveness of IBRANCE were assessed but not established in three trials:
  • one open-label trial [A5481092, (NCT03709680)] that included 98 pediatric patients 2 to <17 years of age who received IBRANCE in combination with chemotherapy for recurrent or refractory solid tumors and two open-label trials that included 42 pediatric patients 4 to <17 years of age who received IBRANCE as a single agent for recurrent or refractory solid tumors [APEC1621I, (NCT03526250)] or primary central nervous system (CNS) tumors [PBTC-042, (NCT02255461)].
  • No new safety signals were observed in these trials.
  • Palbociclib exposures in pediatric patients who received IBRANCE as a single agent or in combination were within range of those observed in
  • adults given a similar dose based on body surface area.
  • Juvenile Animal Toxicity Data Altered glucose metabolism (glycosuria, hyperglycemia, decreased insulin) associated with changes in the pancreas (islet cell vacuolation), eye (cataracts, lens degeneration), kidney (tubule vacuolation, chronic progressive nephropathy) and adipose tissue (atrophy) were identified in a 27 week repeat-dose toxicology study in rats that were immature at the beginning of the studies and were most prevalent in males at oral palbociclib doses ≥30 mg/kg/day (approximately 11 times the adult human exposure [AUC] at the recommended dose).
  • Some of these findings (glycosuria/hyperglycemia, pancreatic islet cell vacuolation, and kidney tubule vacuolation) were present with lower incidence and severity in a 15 week repeat-dose toxicology study in immature rats.
  • Altered glucose metabolism or associated changes in the pancreas, eye, kidney and adipose tissue were not identified in a 27-week repeat-dose toxicology study in rats that were mature at the beginning of the study and in dogs in repeat-dose toxicology studies up to 39 weeks duration.
  • Toxicities in teeth independent of altered glucose metabolism were observed in rats.
  • Administration of 100 mg/kg palbociclib for 27 weeks (approximately 15 times the adult human exposure [AUC] at the recommended dose) resulted in abnormalities in growing incisor teeth (discolored, ameloblast degeneration/necrosis, mononuclear cell infiltrate).
  • Other toxicities of potential concern to pediatric patients have not been evaluated in juvenile animals.

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

Use in older people

  • Of 444 patients who received IBRANCE in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age.
  • Of 347 patients who received IBRANCE in PALOMA-3, 86 patients (25%) were ≥65 years of age and 27 patients (8%) were ≥75 years of age.
  • Of the 260 patients who received IBRANCE in PATINA, 41 patients (16%) were ≥65 years of age and 13 patients (5%) were ≥75 years of age.
  • No clinically significant differences in safety or effectiveness of IBRANCE were observed between patients 65 years of age and older and younger adult patients.
  • Of the 162 patients who received IBRANCE in combination with inavolisib and fulvestrant in INAVO120, 15% were ≥ 65 years of age and 3% were ≥ 75 years of age.
  • Dosage modifications or interruptions due to adverse reactions occurred at a higher incidence in patients ≥ 65 years of age compared with younger patients (79% versus 68%, respectively).
  • Clinical studies of IBRANCE in combination with inavolisib and fulvestrant did not include sufficient numbers of patients ≥ 65 years of age 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 elsewhere in the labeling:
  • Neutropenia [see Warnings and Precautions (5.1) ]
  • ILD/Pneumonitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥20%) in combination with either letrozole or fulvestrant, including laboratory abnormalities, were white blood cell count decreased, neutrophils decreased, blood creatinine increased, hemoglobin decreased, platelets decreased, infections, aspartate aminotransferase increased, alanine aminotransferase increased, fatigue, nausea, stomatitis, diarrhea, and alopecia. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with inavolisib and fulvestrant, including laboratory abnormalities, were neutrophils decreased, hemoglobin decreased, fasting glucose increased, platelets decreased, lymphocytes decreased, stomatitis, diarrhea, calcium decreased, fatigue, potassium decreased, creatinine increased, alanine aminotransferase (ALT) increased, nausea, sodium decreased, magnesium decreased, rash, decreased appetite, COVID-19 infection, and headache. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy, including laboratory abnormalities, were white blood cell decreased, neutrophil count decreased, creatinine increased, hemoglobin decreased, diarrhea, infections, platelet count decreased, stomatitis, aspartate aminotransferase increased, decreased calcium, alanine aminotransferase increased, decreased potassium, fatigue, alkaline phosphatase increased, nausea, asthenia, headache, rash, pruritus, and muscle spasms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies 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. PALOMA-2:
  • IBRANCE plus Letrozole Patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy The safety of IBRANCE plus letrozole was evaluated in a randomized, double-blind trial (PALOMA-2) in 666 patients with ER-positive, HER2-negative advanced breast cancer [see Clinical Studies (14.1) ] . The median duration of treatment for IBRANCE plus letrozole was 19.8 months while the median duration of treatment for placebo plus letrozole arm was 13.8 months. Dose reductions due to an adverse reaction of any grade occurred in 36% of patients receiving IBRANCE plus letrozole. No dose reduction was allowed for letrozole in PALOMA-2. Permanent discontinuation associated with an adverse reaction occurred in 43 of 444 (10%) patients receiving IBRANCE plus letrozole and in 13 of 222 (6%) patients receiving placebo plus letrozole. Adverse reactions leading to permanent discontinuation for patients receiving IBRANCE plus letrozole included neutropenia (1.1%) and alanine aminotransferase increase (0.7%). The most common adverse reactions (≥10%) of any grade reported in patients in the IBRANCE plus letrozole arm by descending frequency were neutropenia, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, and dysgeusia. The most frequently reported Grade ≥3 adverse reactions (≥5%) in patients receiving IBRANCE plus letrozole by descending frequency were neutropenia, leukopenia, infections, and anemia. Adverse reactions (≥10%) reported in patients who received IBRANCE plus letrozole or placebo plus letrozole in PALOMA-2 are listed in Table 4. Table 4. Adverse Reactions (≥10%) in PALOMA-2 IBRANCE plus Letrozole (N=444) Placebo plus Letrozole (N=222) Adverse Reaction All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 % Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable; Infections and infestations Infections Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations. 60 Most common infections (≥1%) include:
  • nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, and folliculitis. 6 1 42 3 0 Blood and lymphatic system disorders Neutropenia 80 56 10 6 1 1 Leukopenia 39 24 1 2 0 0 Anemia 24 5 <1 9 2 0 Thrombocytopenia 16 1 <1 1 0 0 Metabolism and nutrition disorders Decreased appetite 15 1 0 9 0 0 Nervous system disorders Dysgeusia 10 0 0 5 0 0 Gastrointestinal disorders Stomatitis Stomatitis includes:
  • aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oral discomfort, oropharyngeal pain, and stomatitis. 30 1 0 14 0 0 Nausea 35 <1 0 26 2 0 Diarrhea 26 1 0 19 1 0 Vomiting 16 1 0 17 1 0 Skin and subcutaneous tissue disorders Alopecia 33 Grade 1 events – 30%; Grade 2 events – 3%. N/A N/A 16 Grade 1 events – 15%; Grade 2 events – 1%. N/A N/A Rash Rash includes the following PTs:
  • rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption. 18 1 0 12 1 0 Dry skin 12 0 0 6 0 0 General disorders and administration site conditions Fatigue 37 2 0 28 1 0 Asthenia 17 2 0 12 0 0 Pyrexia 12 0 0 9 0 0 Clinically relevant adverse reactions in <10% of patients who received IBRANCE plus letrozole in PALOMA-2 included epistaxis (9%), lacrimation increased (6%), dry eye (4.1%), vision blurred (3.6%), and febrile neutropenia (2.5%). Table 5. Laboratory Abnormalities in PALOMA-2 IBRANCE plus Letrozole (N=444) Placebo plus Letrozole (N=222) Laboratory Abnormality All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 % N=number of patients; WBC=white blood cells. WBC decreased 97 35 1 25 1 0 Blood creatinine increased 96 2 <1 91 0 0 Neutrophils decreased 95 56 12 20 1 1 Hemoglobin decreased 78 6 0 42 2 0 Platelets decreased 63 1 1 14 0 0 Aspartate aminotransferase increased 52 3 0 34 1 0 Alanine aminotransferase increased 43 2 <1 30 0 0 PALOMA-3:
  • IBRANCE plus Fulvestrant Patients with HR-positive, HER2-negative advanced or metastatic breast cancer who have had disease progression on or after prior adjuvant or metastatic endocrine therapy The safety of IBRANCE plus fulvestrant was evaluated in a randomized, double-blind trial (PALOMA-3) in 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer [see Clinical Studies (14.1) ] . The median duration of treatment for IBRANCE plus fulvestrant was 10.8 months while the median duration of treatment for placebo plus fulvestrant arm was 4.8 months. Dose reductions due to an adverse reaction of any grade occurred in 36% of patients receiving IBRANCE plus fulvestrant. No dose reduction was allowed for fulvestrant in PALOMA-3. Permanent discontinuation associated with an adverse reaction occurred in 19 of 345 (6%) patients receiving IBRANCE plus fulvestrant, and in 6 of 172 (3%) patients receiving placebo plus fulvestrant. Adverse reactions leading to discontinuation for those patients receiving IBRANCE plus fulvestrant included fatigue (0.6%), infections (0.6%), and thrombocytopenia (0.6%). The most common adverse reactions (≥10%) of any grade reported in patients in the IBRANCE plus fulvestrant arm by descending frequency were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, diarrhea, thrombocytopenia, vomiting, alopecia, rash, decreased appetite, and pyrexia. The most frequently reported Grade ≥3 adverse reactions (≥5%) in patients receiving IBRANCE plus fulvestrant in descending frequency were neutropenia and leukopenia. Adverse reactions (≥10%) reported in patients who received IBRANCE plus fulvestrant or placebo plus fulvestrant in PALOMA-3 are listed in Table 6. Table 6. Adverse Reactions (≥10%) in PALOMA-3 Adverse Reaction IBRANCE plus Fulvestrant (N=345) Placebo plus Fulvestrant (N=172) All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 % % % % % % Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable. Infections and infestations Infections Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations. 47 Most common infections (≥1%) include:
  • nasopharyngitis, upper respiratory infection, urinary tract infection, bronchitis, rhinitis, influenza, conjunctivitis, sinusitis, pneumonia, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, and paronychia. 3 1 31 3 0 Blood and lymphatic system disorders Neutropenia 83 55 11 4 1 0 Leukopenia 53 30 1 5 1 1 Anemia 30 4 0 13 2 0 Thrombocytopenia 23 2 1 0 0 0 Metabolism and nutrition disorders Decreased appetite 16 1 0 8 1 0 Gastrointestinal disorders Nausea 34 0 0 28 1 0 Stomatitis Stomatitis includes:
  • aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis. 28 1 0 13 0 0 Diarrhea 24 0 0 19 1 0 Vomiting 19 1 0 15 1 0 Skin and subcutaneous tissue disorders Alopecia 18 Grade 1 events – 17%; Grade 2 events – 1%. N/A N/A 6 Grade 1 events – 6%. N/A N/A Rash Rash includes:
  • rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, toxic skin eruption. 17 1 0 6 0 0 General disorders and administration site conditions Fatigue 41 2 0 29 1 0 Pyrexia 13 <1 0 5 0 0 Clinically relevant adverse reactions in <10% of patients who received IBRANCE plus fulvestrant in PALOMA-3 included asthenia (8%), dysgeusia (7%), epistaxis (7%), lacrimation increased (6%), dry skin (6%), vision blurred (6%), dry eye (3.8%), and febrile neutropenia (0.9%). Table 7. Laboratory Abnormalities in PALOMA-3 Laboratory Abnormality IBRANCE plus Fulvestrant (N=345) Placebo plus Fulvestrant (N=172) All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 % N=number of patients; WBC=white blood cells. WBC decreased 99 45 1 26 0 1 Neutrophils decreased 96 56 11 14 0 1 Blood creatinine increased 95 1 0 82 0 0 Hemoglobin decreased 78 3 0 40 2 0 Platelets decreased 62 2 1 10 0 0 Aspartate aminotransferase increased 43 4 0 48 4 0 Alanine aminotransferase increased 36 2 0 34 0 0 INAVO120:
  • IBRANCE plus Inavolisib and Fulvestrant
  • Adults with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer whose disease progressed during or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for locally advanced or metastatic disease The safety of the combination of IBRANCE plus inavolisib and fulvestrant was evaluated in a randomized, double-blind, placebo-controlled study (INAVO120) in 324 patients with PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer [see Clinical Studies (14.1) ] . Patients received either IBRANCE 125 mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a cycle of 28 days plus fulvestrant in combination with inavolisib (n=162) or placebo (n=162). The median duration of treatment for IBRANCE plus inavolisib and fulvestrant was 9 months (range:
  • 0 to 39 months). Serious adverse reactions occurred in 24% of patients who received IBRANCE plus inavolisib and fulvestrant. Serious adverse reactions occurring in ≥1% of patients receiving IBRANCE plus inavolisib and fulvestrant included anemia (1.9%), diarrhea (1.2%), and urinary tract infection (1.2%). Fatal adverse reactions occurred in 3.7% of patients who received IBRANCE plus inavolisib and fulvestrant, including (0.6% each) acute coronary syndrome, cerebral hemorrhage, cerebrovascular accident, COVID-19 infection, and gastrointestinal hemorrhage. Permanent discontinuation of IBRANCE associated with an adverse reaction occurred in 8 of 162 (4.9%) patients receiving IBRANCE plus inavolisib and fulvestrant and in 0 of 162 patients receiving IBRANCE plus placebo and fulvestrant. Adverse reactions leading to discontinuation of IBRANCE in patients receiving IBRANCE plus inavolisib and fulvestrant were neutropenia, infections, alanine aminotransferase increased, gastric ulcer, intestinal perforation, hyperglycemia, type 2 diabetes mellitus, bone pain, musculoskeletal pain, transitional cell carcinoma, and acute kidney injury (0.6% each). Dose reduction of IBRANCE due to an adverse reaction occurred in 38% of patients receiving IBRANCE plus inavolisib and fulvestrant and in 30% of patients receiving IBRANCE plus placebo and fulvestrant. Adverse reactions leading to dose reductions of IBRANCE in ≥2% patients receiving IBRANCE plus inavolisib and fulvestrant were neutropenia (30%), leukopenia (6%), and thrombocytopenia (3.7%). Dose interruption of IBRANCE due to an adverse reaction occurred in 71% of patients receiving IBRANCE plus inavolisib and fulvestrant and in 61% of patients receiving IBRANCE plus placebo and fulvestrant. Adverse reactions leading to dose interruption of IBRANCE in ≥2% patients receiving IBRANCE plus inavolisib and fulvestrant were neutropenia (56%), infections (29%), leukopenia (12%), stomatitis (4.9%), anemia (6%), thrombocytopenia (4.3%), diarrhea (3.7%), pyrexia (3.1%), alanine aminotransferase increased (2.5%), hyperglycemia (2.5%), and nausea (2.5%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased alanine aminotransferase (ALT), nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache. Adverse reactions and laboratory abnormalities in INAVO120 are summarized in Table 8 and Table 9, respectively. Table 8. Adverse Reactions (≥10% with ≥5% [All Grades] or ≥2% [Grade 3-4] Higher Incidence in the IBRANCE plus inavolisib and fulvestrant Arm) in INAVO120 Adverse Reaction IBRANCE plus Inavolisib and Fulvestrant (N=162) IBRANCE plus Placebo and Fulvestrant (N=162) All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Gastrointestinal Disorders Stomatitis Includes aphthous ulcer, glossitis, glossodynia, lip ulceration, mouth ulceration, mucosal inflammation, and stomatitis. 51 6 No Grade 4 adverse reactions were observed. 27 0 Diarrhea 48 3.7 16 0 Nausea 28 0.6 17 0 Vomiting 15 0.6 4.9 1.2 General Disorders and Administration Site Conditions Fatigue 38 1.9 25 1.2 Skin and Subcutaneous Tissue Disorders Rash Includes other related terms. 26 0 19 0 Alopecia 19 0 6 0 Dry skin Includes dry skin, skin fissures, xerosis, and xeroderma. 13 0 4.3 0 Metabolism and Nutrition Disorders Decreased appetite 24 0 9 0 Infections and Infestations COVID-19 infection 23 1.9 10 0.6 Urinary tract infection 15 1.2 9 0 Nervous System Disorders Headache 22 0 14 0 Investigations Decreased weight 17 3.7 0.6 0 Clinically relevant adverse reactions occurring in <10% of patients who received the triplet combination of IBRANCE plus inavolisib and fulvestrant included abdominal pain, dry eye, dysgeusia, and dyspepsia. Table 9. Select Laboratory Abnormalities (≥10% with a ≥2% [All Grades or Grade 3-4] Higher Incidence in the IBRANCE plus Inavolisib and Fulvestrant Arm) in INAVO120 ALT=alanine aminotransferase. Laboratory Abnormality IBRANCE plus Inavolisib and Fulvestrant The denominator used to calculate the rate varied from 122 to 160 based on the number of patients with a baseline value and at least one post-treatment value. IBRANCE plus Placebo and Fulvestrant The denominator used to calculate the rate varied from 131 to 161 based on the number of patients with a baseline value and at least one post-treatment value. All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Hematology Neutrophils (total, absolute) decreased 95 82 97 79 Hemoglobin decreased 88 8 No Grade 4 laboratory abnormalities were observed. 85 2.5 Platelets decreased 84 16 71 3.7 Lymphocytes (absolute) decreased 72 9 68 14 Chemistry Glucose (fasting) increased Grading according to CTCAE version 4.03. 85 12 43 0 Calcium decreased 42 3.1 32 3.7 Potassium decreased 38 6 21 0.6 Creatinine increased 38 1.9 30 1.2 ALT increased 34 3.1 29 1.2 Sodium decreased 28 2.5 19 2.5 Magnesium decreased 27 0.6 21 0 Lipase (fasting) increased 16 1.4 7 0 PATINA:
  • IBRANCE in Combination with Trastuzumab, with or without Pertuzumab, and Endocrine Therapy Patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer after induction therapy. The safety of IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy was evaluated in a randomized, open-label trial (PATINA) in 509 patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer [see Clinical Studies (14.2) ] . Patients received either IBRANCE 125 mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a cycle of 28 days in combination with trastuzumab, with or without pertuzumab, and endocrine therapy (n=260) or trastuzumab, with or without pertuzumab, and endocrine therapy (n=249). The median IBRANCE treatment duration was 28 months (range:
  • 0.4 to 80 months). Serious adverse reactions occurred in 25% of patients who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Serious adverse reactions in ≥1% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy included infections (8%), headache and pyrexia (1.5% each), and femur fracture (1.2%). Fatal adverse reactions occurred in 1.2% of patients who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy including (0.4% each) death, hepatic hemorrhage, and sepsis. Permanent discontinuation of IBRANCE associated with an adverse reaction occurred in 46 (18%) patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Adverse reactions leading to discontinuation of IBRANCE in ≥1% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy included neutropenia (3.8%), infections and stomatitis (1.5% each), and fatigue (1.2%). Dose reduction of IBRANCE due to an adverse reaction occurred in 137 (53%) patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Adverse reactions leading to dose reductions of IBRANCE in ≥2% patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy were neutropenia (38%), diarrhea (6%), stomatitis (6%), fatigue, infections and leukopenia (2.7% each), and thrombocytopenia (2.3%). Dose interruption of IBRANCE due to an adverse reaction occurred in 181 (70%) patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Adverse reactions leading to dose interruption of IBRANCE in ≥2% patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy were neutropenia (54%), infections (22%), stomatitis (8%), diarrhea (7%), leukopenia (5%), thrombocytopenia (3.8%), anemia and abdominal pain (2.7% each), and cough (2.3%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were white blood cell decreased, neutrophil count decreased, creatinine increased, hemoglobin decreased, diarrhea, infections, platelet count decreased, stomatitis, aspartate aminotransferase increased, decreased calcium, alanine aminotransferase increased, decreased potassium, fatigue, alkaline phosphatase increased, nausea, asthenia, headache, rash, pruritus, and muscle spasms. Adverse reactions and laboratory abnormalities in PATINA are summarized in Table 10 and Table 11, respectively. Table 10. Adverse Reactions (≥10%) in PATINA Includes treatment-emergent events only. Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable. ILD=interstitial lung disease. Adverse Reaction Preferred Terms (PTs) are listed according to MedDRA 27.0. IBRANCE plus trastuzumab with or without pertuzumab and endocrine therapy (N=260) Trastuzumab with or without pertuzumab and endocrine therapy (N=249) All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 (%) (%) (%) (%) (%) (%) Gastrointestinal Disorders Diarrhea 70 10 0 37 1.2 0 Stomatitis Stomatitis includes the following PTs:
  • Aphthous ulcer, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis. 44 3.5 0 11 0 0 Nausea 30 0.4 0 15 0.4 0 Abdominal pain 17 1.2 0 6 2 0 Vomiting 15 0.8 0 9 1.2 0 Constipation 13 0 0 9 0 0 Infections and Infestations Infections Infections includes any reported PTs that are part of the System Organ Class Infections and infestations. 64 7 0.8 43 4 0.8 General Disorders and Administration Site Conditions Fatigue 32 3.5 0 21 0 0 Asthenia 27 1.9 0 21 0 0 Pyrexia 17 0.8 0.4 6 0.4 0 Nervous System Disorders Headache 26 1.5 0 18 0.8 0 Dizziness 14 0.8 0 9 0 0 Peripheral neuropathy 14 0 0 8 0.4 0 Skin and Subcutaneous Tissue Disorders Rash Rash includes the following PTs:
  • Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption. 22 0 0 17 0 0 Pruritus 21 1.5 0 17 0 0 Dry skin 10 0 0 6 0 0 Musculoskeletal and Connective Tissue Disorders Muscle spasms 20 0.4 0 11 0 0 Respiratory, Thoracic and Mediastinal Disorders Epistaxis 19 0 0 6 0 0 Cough 16 0 0 11 0 0 Dyspnea 10 0.8 0 9 0.8 0 Metabolism and Nutrition Disorders Decreased appetite 13 0.8 0 5 0 0 Reproductive System and Breast Disorders Vulvovaginal dryness 11 0.4 0 4 0 0 Clinically relevant adverse reactions in <10% of patients who received IBRANCE with trastuzumab, with or without pertuzumab, and endocrine therapy included alopecia, lacrimation increased, dry eye, dysgeusia, vision blurred, palmar-plantar erythrodysesthesia syndrome, interstitial lung disease/pneumonitis, and febrile neutropenia. Table 11. Select Laboratory Abnormalities (≥10% with a ≥2% [All Grades or Grade 3-4] Higher Incidence in the IBRANCE with anti-HER2 and Endocrine Therapies Arm) in PATINA Laboratory Abnormality IBRANCE plus trastuzumab with or without pertuzumab and endocrine therapy Trastuzumab with or without pertuzumab and endocrine therapy All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 % Grading according to CTCAE version 4.0. Grades appearing as NA - CTCAE grade not defined in the corresponding laboratory test. Hematology White blood cell decreased 94 25 0.8 25 0.4 0 Neutrophil count decreased 93 47 3.1 19 1.2 0 Hemoglobin decreased 81 3.5 NA 47 0 NA Platelet count decreased 59 0.8 1.5 6 0 0.8 Chemistry Creatinine increased 92 1.6 0.8 87 1.2 0 Aspartate aminotransferase increased 39 2.0 0 25 0.4 0 Calcium decreased 39 0.4 3.9 30 0.4 2.5 Alanine aminotransferase increased 38 2.4 0 28 0.4 0.4 Potassium decreased 33 3.1 0.8 17 0.4 0.8 Alkaline phosphatase increased 31 0.4 0.8 23 0 0 Other Clinical Trials Experience The following adverse reaction has been reported following administration of IBRANCE:
  • venous thromboembolism. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of IBRANCE. 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. Respiratory Disorders :
  • Interstitial lung disease (ILD)/non-infectious pneumonitis Skin and Subcutaneous Tissue Disorders:
  • Palmar-plantar erythrodysesthesia syndrome (PPES) Male Patients with HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Based on limited data from postmarketing reports and electronic health records, the safety profile for men treated with IBRANCE is consistent with the safety profile in women treated with IBRANCE.

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

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression/Infection
  • Advise patients to immediately report any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath, weakness, or any increased tendency to bleed and/or to bruise [see Warnings and Precautions (5.1) ] . Interstitial Lung Disease/Pneumonitis
  • Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.2) ] . Drug Interactions
  • Grapefruit may interact with IBRANCE. Patients should not consume grapefruit products while on treatment with IBRANCE.
  • Inform patients to avoid strong CYP3A inhibitors and strong CYP3A inducers.
  • Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7) ] . Dosing and Administration
  • Advise patients to take IBRANCE with food.
  • If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact.
  • Pre/perimenopausal women treated with IBRANCE should also be treated with LHRH agonists [see Dosage and Administration (2.1) ] .
  • When IBRANCE is used in combination, refer to the other products’ Full Prescribing Information for dosing and administration information [see Dosage and Administration (2.1 , 2.2 )] . Pregnancy, Lactation, and Infertility
  • Embryo-Fetal Toxicity o Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with IBRANCE therapy and for at least 3 weeks after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 and 8.3) ] . o Advise male patients with female partners of reproductive potential to use effective contraception during treatment with IBRANCE and for at least 3 months after the last dose [see Use in Specific Populations (8.3) ].
  • Lactation:
  • Advise women not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose [see Use in Specific Populations (8.2) ].
  • Infertility:
  • Inform males of reproductive potential that IBRANCE may cause infertility and to consider sperm preservation before taking IBRANCE [see Use in Specific Populations (8.3) ] .

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

Strengths and forms

  • FORMS AND STRENGTHS 125 mg capsules:
  • opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink "Pfizer" on the cap, "PBC 125" on the body. 100 mg capsules:
  • opaque, hard gelatin capsules, size 1, with caramel cap and light orange body, printed with white ink "Pfizer" on the cap, "PBC 100" on the body. 75 mg capsules:
  • opaque, hard gelatin capsules, size 2, with light orange cap and body, printed with white ink "Pfizer" on the cap, "PBC 75" on the body.
  • Capsules: 125 mg, 100 mg, and 75 mg.
  • ( 3 )

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

What it looks like and how it is packed

  • IBRANCE is supplied in the following strengths and package configurations:
  • IBRANCE Capsules Package Configuration Capsule Strength (mg) NDC Capsule Description Bottles of 21 capsules 125 NDC 0069-0189-21 opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink "Pfizer" on the cap, "PBC 125" on the body Bottles of 21 capsules 100 NDC 0069-0188-21 opaque, hard gelatin capsules, size 1, with caramel cap and light orange body, printed with white ink "Pfizer" on the cap, "PBC 100" on the body Bottles of 21 capsules 75 NDC 0069-0187-21 opaque, hard gelatin capsules, size 2, with light orange cap and body, printed with white ink "Pfizer" on the cap, "PBC 75" on the body
  • Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] .

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

How to store it

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] .

Quoted from the official label, section “Storage and Handling”.

What is in it

  • IBRANCE capsules for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor.
  • The molecular formula for palbociclib is C 24 H 29 N 7 O 2 .
  • The molecular weight is 447.54 daltons.
  • The chemical name is 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3- d ]pyrimidin-7(8 H )-one, and its structural formula is:
  • Palbociclib is a yellow to orange powder with pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen).
  • At or below pH 4, palbociclib behaves as a high-solubility compound.
  • Above pH 4, the solubility of the drug substance reduces significantly.
  • Inactive ingredients:
  • Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells.
  • The light orange, light orange/caramel, and caramel opaque capsule shells contain gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone.
  • Chemical Structure

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.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Gelatinhard gelatin capsule shellsAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.

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.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (2)

Spain2 matching products

Every strength and form (9)

France1 matching products

Every strength and form (3)

CanadaNo exact match for this strength and form

Every strength and form (12)

Netherlands1 matching products

Every strength and form (27)

Details

Made byPfizer Laboratories Div Pfizer Inc
Active substancePalbociclib
Used inCancer treatments and immune-system medicines
Strength75 mg
FormCapsule
RouteOral
Packs21 CAPSULE in 1 BOTTLE
NDC0069-0187

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

9 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.

Ibrance100 mgPrescription onlyCapsule Pfizer Laboratories Div Pfizer Inc · PalbociclibIbrance125 mgPrescription onlyCapsule Pfizer Laboratories Div Pfizer Inc · PalbociclibIbrance75 mgPrescription onlyTablet, Film Coated Pfizer Laboratories Div Pfizer Inc · PalbociclibIbrance100 mgPrescription onlyTablet, Film Coated Pfizer Laboratories Div Pfizer Inc · PalbociclibIbrance125 mgPrescription onlyTablet, Film Coated Pfizer Laboratories Div Pfizer Inc · PalbociclibIbrance75 mgPrescription onlyTablet, Film Coated U.S. Pharmaceuticals · Palbociclib

See every product with Palbociclib