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.
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 Telzir. Taking birth control pills while taking Telzir 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 Telzir.
Cholesterol and triglycerides: Telzir may cause increases in cholesterol and triglyceride levels. Your doctor will check these levels before and during treatment.
Fat redistribution: Over time, Telzir 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.
Diabetes: Telzir may increase blood glucose (sugar) levels in the body. It may also increase the risk of developing diabetes. If you have diabetes or have risk factors for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Telzir, and whether any special monitoring is needed. Although your doctor will check your blood glucose levels through blood tests while you are taking Telzir, 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 Telzir?" section for more details.
Heart rhythm: Fosamprenavir can cause a life-threatening irregular heartbeat when taken by someone who is also taking certain medications to control an irregular heart beat. If you are taking lidocaine, amiodarone, or quinidine, make sure your doctor is aware. These medications should not be taken by someone who is also taking fosamprenavir.
Immune reconstitution syndrome: Telzir 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.
Liver disease: Liver disease or reduced liver function may cause Telzir to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Telzir may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Telzir, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Telzir.
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.
People who also have hepatitis B or C may be more likely to experience liver problems.
Skin allergic reactions: Telzir 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 Telzir. 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). Some people who are allergic to sulfonamide antibiotics may also experience allergic reactions to fosamprenavir. Before you take fosamprenavir inform your doctor about any previous adverse reactions you have had to medications, especially sulfamethoxazole. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.
Pregnancy: Telzir should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Telzir, contact your doctor immediately.
Breast-feeding: It is not known if fosamprenavir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.
Children: The safety and effectiveness of Telzir have not been established for children less than 2 years of age.
