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What should I discuss with my health care provider before receiving romidepsin (Istodax)?
You should not use this medication if you are allergic to it.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this medication:
FDA pregnancy category D. Romidepsin can cause harm to an unborn baby or cause birth defects. Before you receive romidepsin, tell your doctor if you are pregnant. Use an effective form of 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.
It is not known whether romidepsin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
How is romidepsin given (Istodax)?
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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