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Zidovudine

Hematological  Adverse Evenets; Myopathy; Lactic Acidosis

Hematological

  • Neutropenia and severe anemia, particularly in patients with advanced HIV disease.

Myopathy

  • Prolonged use associated with symptomatic myopathy.

Lactic Acidosis & Hepatomegaly

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine.¬†Discontinue if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Pregnancy Risk

  • Hyperlactatemia, which may be due to mitochondrial dysfunction, has been reported in infants with in utero exposure to zidovudine-containing products. These events were transient and asymptomatic in most cases. There have been few reports of developmental delay, seizures, and other neurological disease. However, a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum has not been established.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Frequent blood counts strongly recommended during therapy in patients with advanced HIV disease. Periodic blood counts recommended for HIV infected individuals who are asymptomatic or have early HIV disease.
  • Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly. Therapy should be suspended in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Patient Counseling Information

Package Inserts

Zidovudine

Additional Information

Updated June 2019