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
February 19, 2014
Health Canada has issued new information concerning the use of Telzir® (fosamprenavir). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.
A previous advisory on Telzir ® was issued on July 17, 2009. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Birth control: Your doctor may advise that you stop using hormonal birth control pills while taking fosamprenavir. Birth control pills may be less effective while you are taking this medication. Taking birth control pills while taking this medication also can increase the risk of developing liver problems. An alternate nonhormonal birth control method (e.g., condoms) should be used to prevent pregnancy.
Bleeding risk: People with hemophilia may be more likely to bleed while taking this medication.
Body fat: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back, neck, and breasts, as well as around the back, chest, and stomach area. You may also notice loss of fat from the legs, arms, and face. The long-term effects of this are not known.
Cholesterol and triglycerides: This medication may cause increases in cholesterol and triglyceride levels. Your doctor will check these levels before and during treatment.
Diabetes: This medication may increase blood glucose (sugar) levels in the body. It may also increase the risk of developing diabetes. People with diabetes should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Although your doctor will check your blood glucose levels through blood tests while you are taking this medication, report any symptoms of high blood sugar (e.g., increased hunger, increased thirst, increased urination) to your doctor.
Drug interactions: There are life-threatening interactions that can occur between fosamprenavir and many other medications. For your safety, if you are thinking about or using any other medication, prescription or non-prescription, you should check with your doctor or pharmacist first. See the "What other medications could interact with this medication?" section for more details.
Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms, such as pneumonia, herpes, or tuberculosis. Report any new symptoms to your doctor immediately.
Kidney problem: People with reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver disease: People who have liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Skin allergic reactions: This medication has been associated with a life-threatening skin allergic reaction called Stevens-Johnson syndrome. If you have experienced any skin allergic reactions, tell your doctor before taking this medication. If you experience a severe rash or a rash with accompanying symptoms that affect the body (e.g., fever, nausea), contact your doctor immediately.
Sulfa medication allergy: Fosamprenavir is a sulfonamide (sulfa medication). If you are allergic to sulfa medications, you may also be allergic to fosamprenavir. Talk to your doctor or pharmacist if you are allergic to sulfa medications.
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 fosamprenavir passes into breast milk. Since HIV can be transmitted by breast milk, women who have HIV should not breast-feed.
Children: The safety and effectiveness of this medication have not been established for children under 2 years of age.