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 Istodax (Romidepsin).
Abnormal heart rhythms: Istodax (Romidepsin) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Istodax (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 are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Istodax (Romidepsin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Istodax (Romidepsin), and whether any special monitoring is needed.
Anemia: Istodax (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: Istodax (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.
Drowsiness/reduced alertness: Istodax (Romidepsin) may cause drowsiness or fatigue, affecting the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Istodax (Romidepsin) affects you.
Fertility: Istodax (Romidepsin) can cause changes to sperm production and changes to the ovaries. These changes may be permanent, resulting in decreased fertility. Speak to your doctor about preserving fertility before starting to take Istodax (Romidepsin) if you have concerns about these changes.
Infection: As well as killing cancer cells, Istodax (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 Istodax (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.
Liver function: Liver disease or reduced liver function may cause Istodax (Romidepsin) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Istodax (Romidepsin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Istodax (Romidepsin), and whether any special monitoring is needed.
Tumour lysis syndrome: Istodax (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, 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: Istodax (Romidepsin) 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 Istodax (Romidepsin), contact your doctor immediately. Women who could become pregnant who are taking Istodax (Romidepsin) should use an effective method of birth control such as condoms during treatment and for 8 weeks after stopping the medication. Istodax (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 Istodax (Romidepsin) is present in the semen of a male taking Istodax (Romidepsin). It is important for men who are taking Istodax (Romidepsin) to use appropriate birth control, such as condoms, to avoid exposing their partner to the medication during treatment and for 1 month after finishing treatment.
Breast-feeding: It is not known if Istodax (Romidepsin) passes into breast milk. Because there is a high likelihood of causing harm to a nursing infant if Istodax (Romidepsin) 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 Istodax (Romidepsin) have not been established for children.
