What is ISTODAX (Romidepsin)?
ISTODAX is a prescription medicine used to treat people 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 ISTODAX is safe and effective in children under 18 years of age.
What is the most important information I should know about ISTODAX?
ISTODAX can cause serious side effects. These serious side effects include:
- Low blood cell counts: Your doctor will regularly do blood tests to check your blood counts.
- Low platelets: can cause unusual bleeding, or bruising under the skin. Talk to your doctor right away if this happens.
- Low red blood cells: may make you feel tired and you may get tired easily. You may look pale, and feel short of breath. Tell your doctor if you have these symptoms
- Low white blood cells: can cause you to get infections, which may be serious.
- Infection can also happen with normal white blood cells counts.
- Tell your doctor right away if you have any of these symptoms: fever, cough, flu-like symptoms, burning on urination, muscle aches, or worsening of skin problems
- Changes in the electrical activity of your heart seen on ECG (electrocardiogram). Your doctor may check your ECG as needed for this problem. Tell your doctor if your feel an abnormal heart beat, chest pain or shortness of breath.
- Common side effects of ISTODAX include:
- Nausea, vomiting, diarrhea, and loss of appetite
- Tiredness
How should I take ISTODAX ?
- ISTODAX will be given to you by a healthcare provider as an intravenous (IV) injection into your vein usually over 4 hours.
- ISTODAX is usually given on Day 1, Day 8, and Day 15 of a 28 day cycle of treatment.
- Your doctor will decide how long you will receive treatment with ISTODAX.
- Your doctor will check your blood cell counts and other blood tests regularly during your treatment with ISTODAX to check for side effects of ISTODAX. Your doctor may decide to do other tests to check your health as needed.
- Your doctor may stop your treatment, change when you get your treatment, or change the dose of your treatment if you have certain side effects while taking ISTODAX.
Important Safety Information
- ISTODAX may harm your unborn baby. Talk to your doctor about the best way to prevent pregnancy while taking ISTODAX. Tell your doctor right away if you become pregnant while taking ISTODAX.
- It is not known if ISTODAX passes into your breast milk. You and your doctor should decide if you will take ISTODAX or breast-feed. Talk to your doctor about the best way to feed your baby while you are being treated with ISTODAX.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking ISTODAX?
Before taking ISTODAX, tell your doctor if you:
- Have any heart problems, including an irregular or fast heartbeat, or a condition called QT prolongation.
- Have kidney problems
- Have liver problems
- Have problems with the amount of potassium or magnesium in your blood
- Have any other medical conditions
- Have nausea, vomiting, or diarrhea
- Are pregnant or plan to become pregnant. ISTODAX may harm your unborn baby. Talk to your doctor about the best way to prevent pregnancy while taking ISTODAX. Tell your doctor right away if you become pregnant while taking ISTODAX.
- Are breastfeeding or plan to breastfeed. It is not known if ISTODAX passes into your breast milk. You and your doctor should decide if you will take ISTODAX or breast-feed. Talk to your doctor about the best way to feed your baby while you are being treated with ISTODAX.
- Especially tell your doctor if you take or use:
- Warfarin sodium (Coumadin, Jantoven) or any other blood thinner medicine. Ask your doctor if you are not sure if you are taking a blood thinner. Your doctor may want to test your blood more often.
- A medicine to treat abnormal heart beats
- Type of birth control that contains estrogen, such as birth control pills, patches, implants, or IUDs. ISTODAX may reduce the effectiveness of estrogen-containing contraceptives. You may become pregnant.
- St. John’s Wort (Hypericum perforatum)
- Dexamethasone (a steroid)
- Medicine for: tuberculosis (TB), Seizures (epilepsy), Bacterial infections (antibiotics), Fungal infections (antifungals), HIV (AIDS), Depression
Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
General information about ISTODAX
Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Your doctor may stop your treatment, change when you get your treatment, or change the dose of your treatment if you have certain side effects while taking ISTODAX
What are the ingredients in ISTODAX?
Active ingredient: Romidepsin
Other ingredient: Povidone. The diluent contains 80% propylene glycol and 20% dehydrated alcohol.