Zidovudine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Zidovudine. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF HEPATITIS B Zidovudine, a component of COMBIVIR (lamivudine and zidovudine) tablets, has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV ‑ 1) disease [see Warnings and Precautions ] . Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions ] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine (components of COMBIVIR). Discontinue COMBIVIR if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ] . Severe acute exacerbations of hepatitis B have been reported in patients who are co ‑ infected with hepatitis B virus (HBV) and HIV ‑ 1 and have discontinued lamivudine, which is one component of COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co ‑ infected with HIV ‑ 1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ] . WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF H
5 WARNINGS AND PRECAUTIONS • Hepatic decompensation, some fatal, has occurred in HIV‑1/HCV co‑infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin.
Discontinue COMBIVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. • 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. • Pancreatitis: Use with caution in patients with a history of pancreatitis or other significant risk factors for pancreatitis.
Discontinue treatment as clinically appropriate. • Immune reconstitution syndrome and lipoatrophy have been reported in patients treated with combination antiretroviral therapy. ( 5.7 , 5.8 ) 5.1 Hematologic Toxicity/Bone Marrow Suppression Zidovudine, a component of COMBIVIR, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV‑1 disease.
COMBIVIR 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 grams per dL [see Adverse Reactions ] .
Frequent blood counts are strongly recommended in patients with advanced HIV‑1 disease who are treated with COMBIVIR.
Periodic blood counts are recommended for other HIV‑1‑infected patients.
If anemia or neutropenia develops, dosage interruption may be needed.
5.2 Myopathy Myopathy and myositis, with pathological changes similar to that produced by HIV‑1 disease, have been associated with prolonged use of zidovudine, and therefore may occur with therapy with COMBIVIR.
5.3 Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine (components of COMBIVIR).
A majority of these cases have been in women.
Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues.
See full prescribing information for EPIVIR (lamivudine) and RETROVIR (zidovudine).
Treatment with COMBIVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.
5.4 Patients with Hepatitis B Virus Co-infection Posttreatment Exacerbations of Hepatitis Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine.
See full prescribing information for EPIVIR (lamivudine).
Patients should be closely monitored with both clinical and laboratory follow‑up for at least several months after stopping treatment.
Emergence of Lamivudine ‑ Resistant HBV Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV.
Emergence of hepatitis B virus variants associated with resistance to lamivudine has been reported in HIV–1-infected subjects who have received lamivudine‑containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.
See full prescribing information for EPIVIR (lamivudine).
5.5 Use with Interferon- and Ribavirin–Based Regimens Patients receiving interferon alfa with or without ribavirin and COMBIVIR should be closely monitored for treatment‑associated toxicities, especially hepatic decompensation, neutropenia, and anemia.
See full prescribing information for RETROVIR (zidovudine).
Discontinuation of COMBIVIR should be considered as medically appropriate.
Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh greater than 6) (see full prescribing information for interferon and ribavirin).
Exacerbation of anemia has been reported in HIV–1/HCV co–infected patients receiving ribavirin and zidovudine.
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