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.
HEALTH CANADA ADVISORY
May 3, 2016
Health Canada has issued new restrictions concerning the use of Zydelig (idelalisib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth control: Women who may become pregnant should use effective birth control while taking idelalisib and for at least one month after stopping treatment. Because idelalisib may reduce the effectiveness of birth control pills, a barrier form of birth control should also be used.
Diarrhea: People receiving idelalisib have experienced severe diarrhea or inflammation of the bowel. If you have a history of inflammatory bowel disease, 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.
Gastrointestinal problems can cause diarrhea that may lead to dehydration (loss of too much water from the body). If you experience severe diarrhea for more than a day, or if you have diarrhea along with fever, decreased urination, dizziness, or a fast heartbeat, contact your doctor immediately.
Infection: As well as killing cancer cells, idelalisib can reduce the number of cells that fight infection in the body (white blood cells). 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 this medication to build up in the body, causing side effects. Idelalisib may also reduce liver function and can cause liver failure. If you have liver problems, 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. Your doctor will want to test your liver function regularly with blood tests while you are taking this medication.
This medication is not recommended for people with hepatitis or active liver disease.
Lung inflammation: Lung inflammation (pneumonitis) causing difficulty breathing has occurred on rare occasions in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking idelalisib, contact your doctor immediately.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if idelalisib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.