Version July 2025
Dosage guidance:
Safety: Correct electrolyte (potassium, magnesium) abnormalities prior to and during treatment.
Clinical considerations: Romidepsin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref). Consider antiviral prophylaxis in patients with a history of hepatitis B infection.
Cutaneous T-cell lymphoma: IV: 14 mg/m2 days 1, 8, and 15 of a 28-day treatment cycle; repeat cycle as long as benefit continues and treatment is tolerated.
Peripheral T-cell lymphoma, relapsed/refractory (off-label use): IV: 14 mg/m2 days 1, 8, and 15 of a 28-day treatment cycle for up to 6 cycles or until disease progression in patients with stable disease, partial response, or complete response (Ref) or until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, dosage adjustment is not likely necessary since pharmacokinetics are unaffected by renal impairment. Use with caution in patients with end-stage renal disease (has not been studied).
Mild impairment (bilirubin ≤ ULN and AST > ULN or bilirubin >1 to 1.5 times ULN and any AST): No initial dosage adjustment necessary.
Moderate impairment (bilirubin >1.5 to 3 times ULN): Reduce initial dose to 7 mg/m2; monitor frequently for toxicity.
Severe impairment (bilirubin >3 times ULN): Reduce initial dose to 5 mg/m2; monitor frequently for toxicity.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).
Hematologic toxicity:
Grade 3 or 4 neutropenia or thrombocytopenia: Delay treatment until ANC ≥1,500/mm3 and/or platelets ≥75,000/mm3 or baseline, then may restart at 14 mg/m2.
Grade 4 febrile neutropenia (≥38.5°C [≥101°F]) or thrombocytopenia requiring platelet transfusion: Delay treatment until toxicity returns to ≤ grade 1 or baseline, permanently reduce dose to 10 mg/m2.
Nonhematologic toxicity (excluding alopecia):
Grade 2 or 3: Delay treatment until toxicity returns to ≤ grade 1 or baseline, then may restart at 14 mg/m2.
Grade 4 or recurrent grade 3 toxicity: Delay treatment until toxicity returns to ≤ grade 1 or baseline, permanently reduce dose to 10 mg/m2.
Recurrent grade 3 or 4 toxicity despite dosage reduction: Discontinue romidepsin.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Abnormal T waves on ECG (ST-T wave changes: 2% to 63%), hypotension (7% to 23%)
Dermatologic: Dermatitis (≤27%), exfoliative dermatitis (≤27%), pruritus (7% to 31%)
Endocrine & metabolic: Hyperglycemia (2% to 51%), hypermagnesemia (27%), hyperuricemia (33%), hypoalbuminemia (3% to 48%), hypocalcemia (4% to 52%), hypokalemia (6% to 20%), hypomagnesemia (22% to 28%), hyponatremia (≤20%), hypophosphatemia (27%)
Gastrointestinal: Anorexia (23% to 54%), constipation (12% to 39%), diarrhea (20% to 27%), dysgeusia (15% to 40%), nausea (56% to 86%), vomiting (34% to 52%)
Hematologic & oncologic: Anemia (19% to 72%; grades 3/4: 3% to 16%), leukopenia (4% to 46%; grades 3/4: 22%), lymphocytopenia (4% to 57%; grades 3/4: 37%), neutropenia (11% to 57%; grades 3/4: 4% to 27%), thrombocytopenia (17% to 65%; grades 3/4: 14%)
Hepatic: Increased serum alanine aminotransferase (3% to 22%), increased serum aspartate aminotransferase (3% to 28%)
Infection: Infection (46% to 54%; serious infection: 8% to 31%, including infection of central line, pneumonia, reactivation of latent Epstein-Barr virus, sepsis, viral infection [reactivation])
Nervous system: Fatigue (≤77%)
Neuromuscular & skeletal: Asthenia (≤77%)
Miscellaneous: Fever (20% to 23%)
1% to 10%:
Cardiovascular: Edema (5%)
Hematologic & oncologic: Tumor lysis syndrome (1%)
Infection: Reactivation of HBV (1%)
Respiratory: Dyspnea (4%)
Frequency not defined:
Cardiovascular: Prolonged QT interval on ECG, supraventricular cardiac arrhythmia, ventricular arrhythmia
Endocrine & metabolic: Dehydration
There are no contraindications listed in the manufacturer’s US labeling.
Canadian labeling: Hypersensitivity to romidepsin or any component of the formulation.
Concerns related to adverse effects:
• Bone marrow suppression: Anemia, leukopenia, neutropenia, lymphopenia and thrombocytopenia may occur.
• Infection: Serious infections (occasionally fatal), including pneumonia, sepsis, and viral reactivation (eg, Epstein Barr and hepatitis B) have occurred during or following romidepsin treatment. Epstein Barr reactivation leading to liver failure has also been reported, with ganciclovir antiviral prophylaxis failure in one case. The risk of life-threatening infection may be increased in patients who have received prior treatment with antilymphocytic monoclonal antibodies or who have disease involvement in the bone marrow.
• QTc prolongation/ECG changes: QTc prolongation has been observed; use caution in patients with a history of QTc prolongation, congenital long QT syndrome, with medications known to prolong the QT interval, or with preexisting cardiac disease. T-wave and ST-segment changes have also been reported.
• Tumor lysis syndrome: Tumor lysis syndrome (TLS) has been observed; closely monitor patients with advanced disease and/or with a high tumor burden (risk of TLS is higher).
Disease-related concerns:
• Hepatic impairment: Mild hepatic impairment does not significantly influence the pharmacokinetics of romidepsin (based on pharmacokinetic analysis).
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Generic: 27.5 mg/5.5 mL (5.5 mL [DSC])
Solution Reconstituted, Intravenous:
Istodax: 10 mg (1 ea) [contains alcohol, usp, propylene glycol]
Generic: 10 mg (1 ea)
Yes
Solution (reconstituted) (Istodax Intravenous)
10 mg (per each): $3,838.38
Solution (reconstituted) (romiDEPsin Intravenous)
10 mg (per each): $3,802.38
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Istodax: 10 mg (1 ea) [contains alcohol, usp, propylene glycol]
In Canada, Istodax is only available under a Restricted Access Program for patients that were receiving treatment prior to March 2023.
Istodax was originally authorized under a Notice of Compliance with conditions for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma who were not eligible for transplant and had received at least 1 prior systemic therapy; however, a confirmatory phase 3 study comparing Istodax in combination with chemotherapy versus chemotherapy alone did not meet the primary efficacy end point of progression-free survival. Istodax will be withdrawn from the Canadian market once the last patient completes treatment under the Restricted Access Program.
Further information may be found at https://recalls-rappels.canada.ca/en/alert-recall/istodax-romidepsin-restricted-access-program.
IV: Romidepsin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Ref).
Must be diluted prior to administration. Infuse over 4 hours.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Cutaneous T-cell lymphoma: Treatment of cutaneous T-cell lymphoma in adult patients who have received at least 1 prior systemic therapy.
Peripheral T-cell lymphoma, relapsed/refractory
RomiDEPsin may be confused with romiPLOStim
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BSEP;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of RomiDEPsin. Risk X: Avoid
CYP3A4 Inhibitors (Strong): May increase serum concentration of RomiDEPsin. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
P-glycoprotein/ABCB1 Inhibitors: May increase serum concentration of RomiDEPsin. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
RifAMPin: May increase serum concentration of RomiDEPsin. Risk X: Avoid
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Taurursodiol: Histone Deacetylase Inhibitors may increase adverse/toxic effects of Taurursodiol. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Warfarin: RomiDEPsin may increase anticoagulant effects of Warfarin. Risk C: Monitor
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status in patients who may become pregnant, within 7 days prior to initiating treatment with romidepsin. Patients who may become pregnant should use an effective nonhormonal method of contraception during treatment and for 1 month after the final romidepsin dose. Patients with partners who may become pregnant should use effective contraception during treatment and for 1 month after the last romidepsin dose.
Based on the mechanism of action and findings from animal reproduction studies, romidepsin may cause fetal harm if administered to a pregnant patient.
It is not known if romidepsin is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends to discontinue breastfeeding during treatment and for 1 week after the last romidepsin dose.
Serum electrolytes (baseline and periodic; especially potassium and magnesium); CBC with differential and platelets (regularly during treatment). Evaluate pregnancy status (within 7 days prior to treatment initiation in patients who may become pregnant). ECG (baseline and periodic; in patients with significant cardiovascular disease, congenital long QT syndrome, and in patients taking QT-prolonging medications). Monitor for signs/symptoms of infection or tumor lysis syndrome.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Romidepsin is a histone deacetylase (HDAC) inhibitor; HDACs catalyze acetyl group removal from protein lysine residues (including histone and transcription factors). Inhibition of HDAC results in accumulation of acetyl groups, leading to alterations in chromatin structure and transcription factor activation causing termination of cell growth (induces arrest in cell cycle at G1 and G2/M phases) leading to cell death.
Protein binding: 92% to 94%; primarily to α1-acid glycoprotein
Metabolism: Hepatic, primarily via CYP3A4, minor metabolism from CYP3A5, 1A1, 2B6, and 2C19
Half-life elimination: ~3 hours
Hepatic function impairment: Romidepsin clearance decreased with increased severity of hepatic impairment. In patients with cancer, the geometric mean Cmax values after administration of 14, 7, and 5 mg/m2 romidepsin in patients with mild (bilirubin ≤ULN and AST >ULN or bilirubin 1 to 1.5 times ULN and any AST), moderate (bilirubin >1.5 to 3 times ULN and any AST), and severe (bilirubin >3 times ULN and any AST) impairment were approximately 111%, 96%, and 86%, respectively, compared to a 14 mg/m2 dose in patients with normal hepatic function. The geometric mean AUCinf values in patients with mild, moderate, and severe impairment were approximately 144%, 114%, and 116%, respectively, compared to patients with normal hepatic function.
