Generic Name: romidepsin (ROE mi DEP sin)Brand Names: Istodax
Romidepsin blocks certain enzymes in the body and interferes with the growth of tumor cells.
Romidepsin is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL).
Romidepsin is usually given after other medications have been tried without successful treatment of symptoms.
Romidepsin may also be used for other purposes not listed in this medication guide.
Before you receive romidepsin, tell your doctor if you have an electrolyte imbalance, a personal or family history of "Long QT syndrome," heart disease, kidney disease, or liver disease.Do not receive romidepsin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking romidepsin. You will need regular medical tests to be sure this medication is not causing harmful effects. Do not miss any follow-up visits to your doctor.
Call your doctor if you have a serious side effect such as severe nausea or vomiting, chest pain, fast or uneven heartbeats, feeling short of breath, fever, chills, flu symptoms, pale skin, easy bruising or bleeding, muscle cramps, confusion, pain or burning when you urinate, or worsening of your CTCL skin symptoms.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this medication:
an electrolyte imbalance (such as high or low levels of potassium or magnesium in your blood);
a personal or family history of "Long QT syndrome";
Romidepsin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.
Romidepsin is usually given every 7 days for 3 weeks. This treatment cycle may be repeated 28 days after your first dose. Your doctor will determine how long to treat you with romidepsin.
Romidepsin can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your heart rate may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.
Call your doctor for instructions if you miss an appointment for your romidepsin injection.
Symptoms of a romidepsin overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
severe nausea or vomiting;
chest pain, fast or uneven heartbeats, feeling short of breath;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
pain or burning when you urinate; or
worsening of CTCL skin symptoms.
Less serious side effects may include:
nausea, vomiting, loss of appetite;
tired feeling; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Cutaneous T-cell Lymphoma:
Recommended dose: 14 mg/m2 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 therapy.
Many drugs can interact with romidepsin. Below is just a partial list. Tell your doctor if you are using:
dexamethasone (Decadron, Hexadrol);
isoniazid (for treating tuberculosis);
St. John's wort;
an antibiotic such as clarithromycin (Biaxin), erythromycin (Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), telithromycin (Ketek);
antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend);
an antidepressant such as amitriptylline (Elavil, Vanatrip), nefazodone;
a barbiturate such as phenobarbital (Solfoton);
a blood thinner such as warfarin (Coumadin);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan);
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), quinidine (Quinidex, Quin-Release Quin-G), and others;
HIV or AIDS medications such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);
medicines used to prevent organ transplant rejection;
medicine to prevent or treat nausea and vomiting, such as droperidol (Inapsine) or ondansetron (Zofran);
medicines to treat a psychiatric disorder, such as clozapine (FazaClo, Clozaril), haloperidol (Haldol), or pimozide (Orap);
migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig);
narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.