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 Tivicay.
HEALTH CANADA ADVISORY
June 7, 2018
Health Canada has issued new restrictions concerning the use of dolutegravir. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Hepatitis: Dolutegravir may cause decreased liver function or liver failure. This may be more likely for people who also have hepatitis B or Hepatitis C. If you have hepatitis, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.
If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.
Hypersensitivity reactions: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people taking dolutegravir. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
Immune reconstitution inflammatory syndrome: Tivicay may cause immune reconstitution inflammatory 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 as soon as possible.
Kidney function: If you have kidney problems, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.
Liver function: Dolutegravir can cause liver problems, including liver failure. If you have liver disease or decreased liver function, discuss with your doctor how Tivicay may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tivicay, and whether any special monitoring is needed.
If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.
Stopping the medication: If you stop taking Tivicay, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.
Pregnancy: Dolutegravir may cause birth defects in the baby if the mother takes Tivicay while she is pregnant. Women who are of childbearing age should use effective birth control while taking Tivicay. If you are planning to become pregnant, discuss other options for medications with your doctor. If you become pregnant while taking Tivicay, contact your doctor immediately. Tivicay should not be used during pregnancy.
Breast-feeding: It is not known if dolutegravir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because this increases the risk of passing HIV to a baby who does not have the infection.
Children: The safety and effectiveness of using Tivicay have not been established for children less than 6 years old who weigh less than 15 kg.
