Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, dolasetron mesylate, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with romidepsin. You are more at risk for this type of abnormal heart rhythm and its complications if you:
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have diabetes
- have had a stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Anemia: Romidepsin may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Bleeding: Romidepsin may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Fertility: Romidepsin can cause changes to sperm production in men and changes to the ovaries in women. These changes may be permanent, resulting in decreased fertility. Speak to your doctor about preserving fertility before starting to take this medication, if you have concerns about these changes.
Infection: As well as killing cancer cells, romidepsin can reduce the number of cells that fight infection in the body (white blood cells). Serious and sometimes fatal infections such as blood infections (sepsis) and pneumonia have occurred with the use of romidepsin. If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Tumour Lysis Syndrome: Romidepsin, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.
Pregnancy: This medication is expected to cause harm and possibly death to an unborn fetus and should not be used during pregnancy, based on the way that it works to treat cancer. If you become pregnant while taking this medication, contact your doctor immediately. Women of childbearing age who are taking romidepsin should use an effective method of birth control such as condoms during treatment and for 8 weeks after stopping the medication. Romidepsin is likely to decrease the effectiveness of birth control pills and should not be used as the only form of birth control.
It is not known if romidepsin is present in the semen of a male taking this medication. It is important for men who are taking romidepsin to use appropriate birth control, such as condoms, to avoid exposing their partner to the medication.
Breast-feeding: It is not known if romidepsin passes into breast milk. Because there is a high likelihood of causing harm to a nursing infant if this medication does pass into breast milk, it is advisable that either breast-feeding be stopped or the medication not used. Talk to your doctor about the risks and benefits of breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.