Romidepsin (Injection)

Introduction

Romidepsin (roe-mi-DEP-sin)

Treats certain types of cancer called cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).

Brand Name(s)

Istodax

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine is usually given on Day 1, Day 8, and Day 15 of a 28-day cycle treatment. This 3-day treatment is given again every 28 days until your body responds to the medicine. Each treatment usually takes about 4 hours.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using St. John's wort, medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, flecainide, procainamide, propafenone, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Quinaglute®, Procanbid®, Rythmol®, Tambocor®, or Tikosyn®), medicine to treat HIV or AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin®, Ketek®, Nizoral®, or Sporanox®), or medicine to treat depression (such as nefazodone, Serzone®). Tell your doctor if you are also using dexamethasone (Decadron®), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), medicine for tuberculosis (rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), or a blood thinner (such as warfarin, Coumadin®).
• Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, heart rhythm problems (such as congenital long QT syndrome), high or low potassium or magnesium in the blood, or any type of infection.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• You may get infections (including pneumonia and sepsis) more easily while using this medicine. These can occur during treatment and within 30 days after treatment. Tell your doctor right away if you have a fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems.
• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats; chest pain; or shortness of breath.
• This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate.
• Chest pain or shortness of breath.
• Confusion, body weakness, and muscle twitching.
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Increased hunger or thirst.
• Lightheadedness, dizziness, or fainting.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Worsening of skin problems.

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste.
• Diarrhea, constipation, loss of appetite, or stomach pain.
• Headache.
• Mild rash or itching skin.
• Sores or white patches on your lips, mouth, or throat.
• Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088