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Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for: •Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 1.1 Treatment of HIV-1 Zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3 )]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV-1-infected mothers 2. intrapartum therapy of HIV-1-infected mothers 3. post-partum therapy of HIV-1-exposed neonate Points to consider prior to initiating zidovudine in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: • In most cases, zidovudine for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs. • Prevention of HIV-1 transmission in women who have received zidovudine for a prolonged period before pregnancy has not been evaluated. • Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine during that period are not fully known, women in the first …

Zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome). ( 4 )

• See boxed warning for information about the following: hematologic toxicity, myopathy, and lactic acidosis and severe hepatomegaly ( 5.1 , 5.3 , 5.4 ) • Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. ( 5.5 ) • Hepatic decompensation, (some fatal), has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue zidovudine as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. ( 5.5 ) • Immune reconstitution syndrome ( 5.6 ) and lipoatrophy ( 5.7 ) have been reported in patients treated with combination antiretroviral therapy. 5.1 Hematologic Toxicity/Bone Marrow Suppression Zidovudine should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count less than 1,000 cells per mm 3 or hemoglobin less than 9.5 g per dL. Hematologic toxicities appear to be related to pretreatment bone marrow reserve and to dose and duration of therapy. In patients with advanced symptomatic HIV-1 disease, anemia and neutropenia were the most significant adverse events observed. In patients who experience hematologic toxicity, a reduction in hemoglobin may occur as early as 2 to 4 weeks, and neutropenia usually occurs after 6 to 8 weeks. There have been reports of pancytopenia associated with the …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zidovudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and …