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Label Changes for:

Zerit (stavudine) Capsules

December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2008 and

December 2010



Fat Redistribution
  • In randomized controlled trials of treatment-naive patients, clinical lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir). Dual energy x-ray absorptiometry (DEXA) scans demonstrated overall limb fat loss in stavudine-treated patients compared to limb fat gain or no gain in patients treated with other nucleosides (abacavir, tenofovir, or zidovudine). The incidence and severity of lipoatrophy or lipodystrophy are cumulative over time with stavudine-containing regimens. In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy. Patients receiving Zerit should be monitored for symptoms or signs of lipoatrophy or lipodystrophy...


Postmarketing Experience
  • Metabolic Disorders: lipoatrophy, lipodystrophy


Renal Impairment
  • Data from two studies in adults indicated that the apparent oral clearance of stavudine decreased and the terminal elimination half-life increased as creatinine clearance decreased. Based on these observations, it is recommended that the ZERIT dosage be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

December 2008

Summary View


Sections Modified


  • What else should I know about Zerit?
    • ...Keep Zerit and all other medicines out of the reach of children and pets at all times.
    • Do not keep medicine that is out of date or that you no longer need. Dispose of unused Zerit through community take-back disposal programs when available or by placing it in an unrecognizable closed container in the household trash.