Romidepsin

Romidepsin is a prescription medication used for the treatment of  cutaneous T-Cell lymphoma (CTCL)

• in patients who have received at least 1 prior systemic therapy.

Common side effects of romidepsin include:

• nausea
• vomiting
• tiredness
• loss of appetite
• diarrhea
• constipation
• mild itching

Serious side effects of romidepsin include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• flu symptoms
• muscle aches
• worsening skin symptoms
• burning sensation while urinating
• cough
• chest congestion
• shortness of breath
• chest pain
• fast, slow, or pounding heartbeats
• fluttering in the chest
• sudden dizziness
• chills
• tiredness
• mouth sores
• skin sores
• easy bruising
• unusual bleeding
• pale skin
• cold hands and feet
• light-headedness
• tiredness
• weakness
• muscle cramps
• nausea
• vomiting
• diarrhea
• tingling in the hands and feet or around the mouth

Rare side effects of romidepsin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 5 mg/mL (2-mL, 5.5-mL single-dose vials) (Istodax, generic)
• Includes diluent for reconstitution

Cutaneous T-cell lymphoma

Adult dosage

• 14 mg/m2 IV on days 1, 8, and 15 of the 28-day cycle
• Continue until disease progression or intolerable toxicity

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Romidepsin has severe interactions with the following drug:
  • lefamulin
• Romidepsin has serious interactions with at least 104 other drugs:
• Romidepsin has moderate interactions with at least 153 other drugs.
• Romidepsin has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • larotrectinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Romidepsin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Romidepsin?”

Cautions

• QT prolongation; potassium and magnesium should be within normal limits before administration
• Tumor lysis syndrome has been reported; patients with advanced-stage disease and/or high tumor burden should be closely monitored and appropriate precautions must be taken
• Monitor hematologic parameters; interrupt/discontinue treatment if thrombocytopenia, leukopenia, or anemia becomes severe
• Serious and sometimes fatal infections reported within 30 days after treatment including pneumonia, sepsis, and viral reactivation (eg, Epstein Barr, hepatitis B viruses); the risk may be greater in patients with a history of monoclonal antibodies treatment directed against lymphocyte antigens and in patients with disease involvement of the bone marrow
• In patients with evidence of prior hepatitis B infection, consider monitoring for reactivation, and consider antiviral prophylaxis; reactivation of Epstein Barr viral infection leading to liver failure has occurred in recipients of romidepsin including after ganciclovir prophylaxis
• Avoid romidepsin during pregnancy, no adequate trials exist; based on its mechanism of action, the drug is likely to cause fetal harm
• Drug interaction overview
  • Coadministration with other drugs that prolong QT interval (eg, sotalol, dofetilide, erythromycin) may increase the risk for serious arrhythmias
  • Binds to estrogen and may reduce the effectiveness of oral contraceptives
  • May increase the effect of warfarin (prolonged PT, increased INR)
  • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase romidepsin serum levels
  • Potent CYP3A4 inducers (eg, dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) may decrease romidepsin serum levels

Pregnancy and Lactation

• Based on its mechanism of action and findings from animal studies, the drug may cause embryofetal harm when administered to a pregnant woman
• There are no available data on use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage
• Advise women of the potential risk to the fetus and to avoid becoming pregnant during treatment and for at least 1 month after the last dose
• Pregnancy testing
  • Perform pregnancy testing in women of reproductive potential within 7 days before initiating
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for at least 1 month after the last dose
  • May reduce the effectiveness of estrogen-containing contraceptives; use alternative methods of contraception that contain no estrogen (eg, condoms, intrauterine devices)
  • Men with women partners of reproductive potential: Use effective contraception to avoid fathering a child during treatment and for at least 1 month after the last dose
• Infertility
  • Based on findings in animals, romidepsin  has the potential to affect male and female fertility
• Lactation
  • There are no data on the presence of the drug or its metabolites in human milk, its effects on breastfed children, or milk production
  • Advise lactating women not to breastfeed during treatment and for at least 1 week after the last dose