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.
HEALTH CANADA ADVISORY
December 22, 2015
Health Canada has issued new information concerning the use of Zelboraf (vemurafenib). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca .
Previous advisories on Zelboraf (vemurafenib) were issued on February 12, 2015, April 7, 2014 and August 21, 2013. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reactions: Some people may develop a serious allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, seek immediate medical attention.
QT prolongation: Vemurafenib can affect the electrical activity of the heart and cause QT prolongation. Your doctor will monitor your heart rhythm regularly while you are taking this medication with a test called an electrocardiogram (ECG). You should not take this medication is your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.
Grapefruit juice: Grapefruit juice affects how verafenib is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at anytime while taking this medication for treatment.
High blood pressure: Vemurafenib may increase your blood pressure. Your doctor will monitor your blood pressure while you are taking this medication.
Skin: Vemurafenib may cause changes in your skin, including a new melanoma and cutaneous squamous cell carcinoma. Talk to your doctor if there are any changes in your skin while taking this medication and up to 6 months after the last dose. Changes include new skin sores, warts, reddish bumps, a sore that bleeds or does not heal, or a change in size, shape or colour of a mole.
Vemurafenib may also cause extra sensitivity to sunlight. Use sunscreen with SPF greater than 30 and protective clothing while taking this medication.
Vision: Vemurafenib may cause vision problems. If you notice any vision changes or problems, contact your doctor as soon as possible.
Females: Females may be more at risk for experiencing certain side effects from this medication, including rash, sensitivity to sunlight, and joint pain.
Pregnancy: Vemurafenib may harm an unborn child. This medication should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant must use an effective birth control method while taking this medication and for at least 6 months after taking the last dose of medication. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if vemurafenib 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 and adolescents: The safety and effectiveness of using this medication have not been established for children and adolescents younger than 18 years of age.
Seniors: People aged 65 years or older may be more at risk for experiencing certain side effects from this medication, including cutaneous squamous cell carcinoma, decreased appetite, and heart conditions.