Romidepsin (Istodax): Uses, Side Effects and Dosage

What is romidepsin injection?

Romidepsin injection is a prescription medicine used to treat adults with a type of cancer called cutaneous T-cell lymphoma (CTCL) after at least one other type of medicine by mouth or injection has been tried.

It is not known if romidepsin injection is safe and effective in children.

Before receiving romidepsin injection, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including an irregular or fast heartbeat, or a condition called QT prolongation.
• have liver problems, including a history of hepatitis B
• have problems with the amount of potassium or magnesium in your blood

• are pregnant or plan to become pregnant. Romidepsin injection can harm your unborn baby.

• Females who are able to become pregnant:

• Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with romidepsin injection.
• You should avoid becoming pregnant during treatment with romidepsin injection and for 1 month after the last dose.
• You should use effective birth control (contraception) during treatment with romidepsin injection and for 1 month after your last dose.
• Romidepsin injection may affect the way estrogen-containing birth control works. Talk to your healthcare provider for information about other types of birth control to use during treatment with romidepsin injection.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with romidepsin injection.

• Males with a female partner who can become pregnant:

• Romidepsin injection can harm the unborn baby of your partner.
• You should use effective birth control (contraception) and avoid fathering a child during treatment with romidepsin injection and for 1 month after the last dose. Talk to your healthcare provider if this is a concern for you.

• Romidepsin injection may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

• are breastfeeding or plan to breastfeed. It is not known if romidepsin passes into your breast milk. You should not breastfeed during treatment with romidepsin injection and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby while you are being treated with romidepsin injection.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may affect how romidepsin injection works, or romidepsin injection may affect how other medicines work. Especially tell your healthcare provider if you take or use:

• warfarin sodium (Coumadin, Jantoven) or any other blood thinner medicine. Ask your healthcare provider if you are not sure if you are taking a blood thinner. Your healthcare provider may want to test your blood more often.
• a medicine to treat abnormal heartbeats
• St. John’s wort (Hypericum perforatum)
• Dexamethasone (a steroid)

• Medicine for:

• tuberculosis (TB)
• seizures (epilepsy)
• bacterial infections (antibiotics)
• fungal infections (antifungals)
• HIV (AIDS)
• depression

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive romidepsin injection?

• Romidepsin injection will be given to you by your healthcare provider or nurse as an intravenous injection into your vein usually over 4 hours.
• Romidepsin injection is usually given on Day 1, Day 8, and Day 15 of a 28-day cycle of treatment.
• Your healthcare provider will decide how long you will receive treatment with romidepsin injection.
• Your healthcare provider may decrease your dose, or delay or stop your treatment with romidepsin injection if you have certain side effects.

What are the possible side effects of romidepsin injection?

Romidepsin injection may cause serious side effects, including:

• Low blood cell counts. Your healthcare provider will regularly do blood tests during treatment with romidepsin injection to check your blood counts. Tell your healthcare provider if you have signs or symptoms of:

• Low platelets: can cause unusual bleeding or bruising under the skin.
• Low red blood cells: may make you feel tired and you may get tired easily.
• Low white blood cells: can cause you to get infections, which may be serious.

• Serious infections. People receiving romidepsin injection can develop serious infections that can sometimes lead to death. These infections can happen during and after treatment with romidepsin injection. Your risk of infection may be higher if you have had chemotherapy in the past. Tell your healthcare provider right away if you have any of these symptoms of infection:

• fever

• burning with urination

• cough

• flu-like symptoms

• shortness of breath with or without chest pain

• muscle aches

• worsening skin problems

• Changes in your heartbeat. Your healthcare provider may check your heart by doing an ECG (electrocardiogram) and will do blood tests to check your potassium and magnesium levels before you start treatment with romidepsin injection. Tell your healthcare provider if you feel an abnormal heartbeat, feel dizzy or faint, have chest pain or shortness of breath.

• Tumor Lysis Syndrome (TLS). TLS is a problem of the rapid breakdown of cancer cells that can happen during your treatment with romidepsin injection. You should drink plenty of fluids for at least 3 days after each dose of romidepsin injection. Your healthcare provider may do blood tests to check for TLS and may give you medicine to prevent or treat TLS.

  The most common side effects of romidepsin injection include:

• nausea, tiredness, vomiting, loss of appetite, changes in sense of taste, constipation, and itching.

Tell your healthcare provider if you have nausea or vomiting during treatment with romidepsin injection. Your healthcare provider will treat your symptoms and may give you medicines before your dose of romidepsin injection to help prevent nausea and vomiting.

These are not all the possible side effects of romidepsin injection.

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

General information about the safe and effective use of romidepsin injection.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

This Patient Information leaflet summarizes the most important information about romidepsin injection. You can ask your pharmacist or healthcare provider for information about romidepsin injection that is written for health professionals.

What are the ingredients in romidepsin injection?

Active ingredient: romidepsin

Inactive ingredients: povidone, DL-alpha-tocopherol, dehydrated alcohol and propylene glycol.

Brands listed are the trademarks of their respective owners.

For more information, go to www.amneal.com or call 1-877-835-5472.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Amneal Oncology Pvt. Ltd.

Telangana 509301, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 09-2025-00