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 7, 2014
Health Canada has issued new restrictions concerning the use of Temodal (temozolomide). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth defects: Temozolomide can have genotoxic effects, meaning that it may damage the genetic material contained in sperm. This could lead to birth defects. If you are a man being treated with temozolomide, you should not father a child during treatment and for up to 6 months after treatment.
Blood disorders: This medication can cause the levels of certain blood cells to drop. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, chills, easy bruising, paleness, or bleeding (symptoms may include black and tarry stools, blood in the urine, or cuts that won't stop bleeding) while taking this medication. Your doctor will arrange periodic blood testing to monitor various blood components.
Hepatitis B infection: Temozolomide has been linked to reactivation of Hepatitis B infection. If you have had hepatitis B in the past 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.
Kidney function: The safety and effectiveness of using this medication have not been established for people with kidney problems. You should be closely monitored by your doctor if you have kidney problems.
Liver function: Temozolomide may reduce liver function and can cause liver failure, including death. 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 may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain, or swelling, and itchy skin, contact your doctor immediately.
Male infertility: Irreversible infertility may result from treatment with temozolomide. Therefore, men who may want to father a child in the future should seek advice on cryoconservation (freezing for long-term storage) of sperm prior to starting treatment.
Pneumocystis carinii pneumonia (PCP): People who take temozolomide daily along with radiation may be at a higher risk of developing a serious form of pneumonia called Pneumocystis carinii pneumonia (PCP). If you are taking temozolomide daily along with radiation, your doctor will prescribe medication to help prevent PCP.
Vomiting: Nausea and vomiting are very common with temozolomide treatment. Antinausea medications taken before or after taking temozolomide may be recommended.
Pregnancy: This medication may harm the baby if used during pregnancy. Women should avoid becoming pregnant while taking this medication. Use effective birth control while using this medication and for 6 months after stopping the medication. Tell your doctor immediately if you become pregnant.
Breast-feeding: It is not known if temozolomide passes into breast milk. It is recommended that women should stop breast-feeding while taking this medication.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 70 are more likely to experience a decrease in white blood cell counts or platelet cells. This can affect their body's ability to fight infection or their blood's ability to clot.