"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
Advice for the Patient
Neutropenia and Anemia
Patients should be informed that the major toxicities of RETROVIR are neutropenia and/or anemia. The frequency and severity of these toxicities are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection. Patients should be informed that if toxicity develops, they may require transfusions or drug discontinuation. Patients should be informed of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced symptomatic HIV-1 disease [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Patients should be informed that myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of RETROVIR [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Patients should be informed that some HIV medicines, including RETROVIR, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly) [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Patients with HIV-1/HCV co-infection should be informed that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see WARNINGS AND PRECAUTIONS].
Use With Other Zidovudine-Containing Products
RETROVIR should not be administered with combination products that contain zidovudine as one of their components (e.g., COMBIVIR [lamivudine and zidovudine] Tablets or TRIZIVIR [abacavir sulfate, lamivudine, and zidovudine] Tablets) [see WARNINGS AND PRECAUTIONS].
Redistribution/Accumulation of Body Fat
Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see WARNINGS AND PRECAUTIONS].
Common Adverse Reactions
Patients should be informed that the most commonly reported adverse reactions in adult patients being treated with RETROVIR were headache, malaise, nausea, anorexia, and vomiting. The most commonly reported adverse reactions in pediatric patients receiving RETROVIR were fever, cough, and digestive disorders. Patients also should be encouraged to contact their physician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events while being treated with RETROVIR [see ADVERSE REACTIONS].
Patients should be cautioned about the use of other medications, including ganciclovir, interferon alfa, and ribavirin, which may exacerbate the toxicity of RETROVIR [see DRUG INTERACTIONS].
Pregnant women considering the use of RETROVIR during pregnancy for prevention of HIV-1 transmission to their infants should be informed that transmission may still occur in some cases despite therapy. The long-term consequences of in utero and infant exposure to RETROVIR are unknown, including the possible risk of cancer [see Use In Specific Populations].
HIV-1-infected pregnant women should be informed not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected [see Use In Specific Populations].
Information About HIV-1 Infection
RETROVIR is not a cure for HIV-1 infection, and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using RETROVIR.
Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
- Do not share needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
- Do not breastfeed. Zidovudine is excreted in human breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Patients should be informed to take all HIV medications exactly as prescribed.
Last reviewed on RxList: 6/21/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Retrovir Information
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