Romidepsin

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

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

• 14 mg/m 2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle.
• Repeat cycles every 28 days provided that the patient continues to benefit from and tolerates the drug.
• ( 2.1 ) Discontinue or interrupt treatment (with or without dose reduction to 10 mg/m 2 ) to manage drug toxicity.
• ( 2.2 ) Reduce starting dose in patients with moderate and severe hepatic impairment.
• ( 2.3 )
• 2.1 Dosage Information The recommended dosage of romidepsin injection is 14 mg/m 2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle.
• Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug.
• 2.2 Dosage Modification Nonhematologic toxicities except alopecia Grade 2 or 3 toxicity:
• Treatment with romidepsin injection should be delayed until toxicity returns to Grade 0 to 1 or baseline, then therapy may be restarted at 14 mg/m 2 .
• If Grade 3 toxicity recurs, treatment with romidepsin injection should be delayed until toxicity returns to Grade 0 to 1 or baseline and the dose should be permanently reduced to 10 mg/m 2 .
• Grade 4 toxicity:
• Treatment with romidepsin injection should be delayed until toxicity returns to Grade 0 to 1 or baseline, then the dose should be permanently reduced to 10 mg/m 2 .
• Romidepsin injection should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
• Hematologic toxicities Grade 3 or 4 neutropenia or thrombocytopenia:
• Treatment with romidepsin injection should be delayed until the specific cytopenia returns to ANC greater than or equal to 1.5 × 10 9 /L and platelet count greater than or equal to 75 × 10 9 /L or baseline, then therapy may be restarted at 14 mg/m 2 .
• Grade 4 febrile (greater than or equal to 38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion:
• Treatment with romidepsin injection should be delayed until the specific cytopenia returns to less than or equal to Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m 2 .
• 2.3 Dosage in Patients with Hepatic Impairment For patients with moderate or severe hepatic impairment, reduce the starting dose of romidepsin injection as shown in Table 1 and monitor for toxicities more frequently.
• Dosage adjustment is not required for patients with mild hepatic impairment.
• Table 1:
• Recommendations for Starting Dose in Patients with Moderate and Severe Hepatic Impairment Hepatic Impairment Bilirubin Levels Romidepsin Injection Dose Moderate greater than 1.5 × ULN to less than or equal to 3 × ULN 7 mg/m 2 Severe greater than 3 × ULN 5 mg/m 2 ULN = Upper limit of normal.
• 2.4 Instructions for Preparation and Intravenous Administration Romidepsin injection is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1 Romidepsin injection must be diluted with 0.9% Sodium Chloride Injection, USP before intravenous infusion.
• Extract the appropriate amount of romidepsin injection from the vial to deliver the desired dose, using proper aseptic technique.
• Before intravenous infusion, dilute romidepsin injection in 500 mL 0.9% Sodium Chloride Injection, USP.
• Infuse over 4 hours.
• Discard unused portion.
• The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE) infusion bags as well as glass bottles, and is chemically stable for up to 24 hours when stored at room temperature.
• However, it should be administered as soon after dilution as possible.
• Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

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

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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

Other medicines

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.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of romidepsin injection in pediatric patients have not been established.

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

Use in older people

• Of the 186 patients with CTCL who received romidepsin in clinical studies, 51 (28%) were 65 years of age and older, while 16 (9%) were 75 years of age.
• No overall differences in safety or effectiveness were observed between patients 65 years or age and over and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.

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

Side effects

• The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information.
• Myelosuppression [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Electrocardiographic Changes [see Warnings and Precautions (5.3) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritus.
• Grade 3 to 4 laboratory abnormalities (≥ 10%) include lymphopenia, neutropenia, anemia and thrombocytopenia.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 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.
• The data in the WARNINGS AND PRECAUTIONS reflect exposure to romidepsin in four clinical trials involving 363 patients with T-cell lymphoma, including 185 patients with CTCL.
• Romidepsin was administered as a single agent at a dosage of 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle.
• Among 363 patients who received romidepsin, 21% were exposed for 6 months or longer and 13% were exposed for greater than one year.
• Cutaneous T-Cell Lymphoma The safety of romidepsin was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a dosage of 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle.
• Treatment continued as long as the patient benefitted from and tolerated the drug.
• The mean duration of treatment in these studies was 5.6 months (range:
• < 1 month to 83.4 months).
• Common Adverse Reactions Table 2 summarizes the most frequent adverse reactions (> 20%) regardless of causality using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0).
• Due to methodological differences between the studies, the AE data are presented separately for Study 1 and Study 2.
• Adverse reactions are ranked by their incidence in Study 1.
• Laboratory abnormalities commonly reported (> 20%) as adverse reactions are included in Table 2.
• Table 2:
• Adverse Reactions Occurring in > 20% of Patients in Either CTCL Study (N=185) Adverse Reactions n (%) Study 1 (n = 102) Study 2 (n = 83) All grades Grade 3 or 4 All grades Grade 3 or 4 Any adverse reactions 99 (97) 36 (35) 83 (100) 68 (82) Nausea 57 (56) 3 (3) 71 (86) 5 (6) Asthenia/Fatigue 54 (53) 8 (8) 64 (77) 12 (14) Infections 47 (46) 11 (11) 45 (54) 27 (33) Vomiting 35 (34) 1 (< 1) 43 (52) 8 (10) Anorexia 23 (23) 1 (< 1) 45 (54) 3 (4) Hypomagnesemia 22 (22) 1 (< 1) 23 (28) 0 Diarrhea 20 (20) 1 (< 1) 22 (27) 1 (1) Pyrexia 20 (20) 4 (4) 19 (23) 1 (1) Anemia 19 (19) 3 (3) 60 (72) 13 (16) Thrombocytopenia 17 (17) 0 54 (65) 12 (14) Dysgeusia 15 (15) 0 33 (40) 0 Constipation 12 (12) 2 (2) 32 (39) 1 (1) Neutropenia 11 (11) 4 (4) 47 (57) 22 (27) Hypotension 7 (7) 3 (3) 19 (23) 3 (4) Pruritus 7 (7) 0 26 (31) 5 (6) Hypokalemia 6 (6) 0 17 (20) 2 (2) Dermatitis/Exfoliative dermatitis 4 (4) 1 (< 1) 22 (27) 7 (8) Hypocalcemia 4 (4) 0 43 (52) 5 (6) Leukopenia 4 (4) 0 38 (46) 18 (22) Lymphopenia 4 (4) 0 47 (57) 31 (37) Alanine aminotransferase increased 3 (3) 0 18 (22) 2 (2) Aspartate aminotransferase increased 3 (3) 0 23 (28) 3 (4) Hypoalbuminemia 3 (3) 1 (< 1) 40 (48) 3 (4) Electrocardiogram ST-T wave changes 2 (2) 0 52 (63) 0 Hyperglycemia 2 (2) 2 (2) 42 (51) 1 (1) Hyponatremia 1 (< 1) 1 (< 1) 17 (20) 2 (2) Hypermagnesemia 0 0 22 (27) 7 (8) Hypophosphatemia 0 0 22 (27) 8 (10) Hyperuricemia 0 0 27 (33) 7 (8) Serious Adverse Reactions Infections were the most common type of SAE reported in both studies with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.
• Serious adverse reactions reported in > 2% of patients in Study 1 were sepsis and pyrexia (3%).
• In Study 2, serious adverse reactions in > 2% of patients were fatigue (7%), supraventricular arrhythmia, central line infection, neutropenia (6%), hypotension, hyperuricemia, edema (5%), ventricular arrhythmia, thrombocytopenia, nausea, leukopenia, dehydration, pyrexia, aspartate aminotransferase increased, sepsis, catheter related infection, hypophosphatemia and dyspnea (4%).
• There were eight deaths not due to disease progression.
• In Study 1, there were two deaths:
• one due to cardiopulmonary failure and one due to acute renal failure.
• There were six deaths in Study 2:
• four due to infection and one each due to myocardial ischemia and acute respiratory distress syndrome.
• Discontinuations Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2.
• Discontinuations occurring in at least 2% of patients in either study included infection, fatigue, dyspnea, QT prolongation, and hypomagnesemia.
• Other Clinical Trials Experience The following common adverse reactions have been reported following administration of romidepsin as a single agent in 178 patients with peripheral T-cell lymphoma, for which romidepsin is not indicated or recommended.
• The most common adverse reactions (≥ 30%) included nausea (63%), fatigue (61%), thrombocytopenia (49%), vomiting (39%), neutropenia (39%), pyrexia (38%), diarrhea (36%) and anemia (35%).
• Other common (≥ 10%) clinically significant adverse reactions included dysgeusia (22%), headache (20%), cough (19%), dyspnea (15%), abdominal pain (13%) and stomatitis (10%).
• Grade 3 and higher adverse reactions in ≥ 10% were hematologic toxicities (including thrombocytopenia, neutropenia, leukopenia and anemia) and fatigue.

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).
• Low Blood Counts Advise patients that treatment with romidepsin injection can cause low blood counts and that frequent monitoring of hematologic parameters is required.
• Patients should be instructed to report fever or other signs of infection, significant fatigue, shortness of breath, or bleeding [see Warnings and Precautions (5.1) ] .
• Infections Advise patients that infections may occur during treatment with romidepsin injection.
• Advise patients to report fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems.
• Advise patients to report any previous history of hepatitis B before starting romidepsin injection [see Warnings and Precautions (5.2) ] .
• Tumor Lysis Syndrome Advise patients of the risk of tumor lysis syndrome (especially those with advanced stage disease and/or high tumor burden) to maintain high fluid intake for at least 72 hours after each dose [see Warnings and Precautions (5.4) ] .
• Nausea and Vomiting Advise patients that nausea and vomiting are common following treatment with romidepsin injection.
• Prophylactic antiemetics are recommended for all patients.
• Advise patients to report these symptoms so that appropriate treatment can be instituted [see Adverse Reactions (6.1) ] .
• Embryo-Fetal Toxicity Advise patients that romidepsin injection can cause fetal harm when administered during pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1) ] .
• Contraception Advise females of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.
• Advise males with female partners of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose [ Use in Specific Populations (8.3) ] .
• Lactation Advise lactating women not to breastfeed during treatment with romidepsin injection and for 1 week after the last dose [see Use in Specific Populations (8.2) ] .
• Infertility Advise females and males of reproductive potential that romidepsin injection may cause infertility [see Nonclinical Toxicology (13.1) ] .
• Manufactured by: Amneal Oncology Pvt.
• Ltd.
• Telangana 509301, INDIA Distributed by:
• Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2025-00

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

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 27.5 mg/5.5 mL (5 mg/mL) in single-dose vial. Injection:
• 27.5 mg/5.5 mL (5 mg/mL) in single-dose vial. ( 3 )

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

What it looks like and how it is packed

• How Supplied Romidepsin Injection is supplied as a sterile, clear, colorless to pale yellow solution available in single-dose vial in the following carton packaged strength. 27.5 mg/5.5 mL (5 mg/mL) 1 Single-Dose Vial in 1 Carton:
• NDC 70121-2250-1 Storage and Handling
• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) in the carton [see USP Controlled Room Temperature].
• Protect from light.
• Romidepsin injection is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1

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

What is in it

• Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide.
• At room temperature, romidepsin is a white to off-white crystalline powder and is described chemically as (1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone.
• The molecular formula is C 24 H 36 N 4 O 6 S 2 .
• The molecular weight is 540.7 g/mol and the structural formula is:
• Romidepsin injection is intended for intravenous infusion only after dilution with 0.9% Sodium Chloride, USP.
• Romidepsin injection is a sterile, clear, colorless to pale yellow solution and is supplied in single-dose vial.
• Each mL contains romidepsin, 5 mg; povidone, 10 mg;
• DL-alpha-tocopherol, 0.05 mg; dehydrated alcohol, 157.8 mg (20% v/v) and propylene glycol, 828.8 mg. 1

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

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

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Same active substance

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