ZERIT (stavudine) is a nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection. (1)
DOSAGE AND ADMINISTRATION

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Recommended dosage for adults:

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less than 60 kg: 30 mg every 12 hours (2.1)

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at least 60 kg: 40 mg every 12 hours (2.1)

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Recommended dosage for pediatric patients:

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newborns from birth to 13 days old: 0.5 mg/kg every 12 hours (2.2)

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at least 14 days old and weighing less than 30 kg: 1 mg/kg every 12 hours (2.2)

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weighing at least 30 kg: adult dose (2.2)

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Renal impairment: Dose adjustment is recommended for CrCl ≤50 mL/min. (2.3)

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Oral solution: Requires preparation by a pharmacist. (2.4)

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Capsules: 15 mg, 20 mg, 30 mg, 40 mg (3, 16.1)

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Oral solution: 1 mg/mL following constitution (3, 16.2)
CONTRAINDICATIONS

Zerit is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components of this product. (4)
WARNINGS AND PRECAUTIONS

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Lactic acidosis/severe hepatomegaly with steatosis: Suspend treatment with ZERIT in patients who develop clinical symptoms or signs with or without laboratory findings. (5.1)

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Hepatic toxicity: May be severe, fatal. Consider interruption or discontinuation. Avoid use in combination with didanosine and hydroxyurea. Risk of hepatic decompensation exists when used in combination with interferon and ribavirin; closely monitor and consider discontinuation of stavudine. (5.2)

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Neurologic symptoms: Motor weakness, most often seen in the setting of lactic acidosis, may mimic Guillain-Barré syndrome; discontinue treatment. Monitor for peripheral neuropathy, which can be severe; treatment discontinuation should be considered. (5.3)

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Pancreatitis: Suspend treatment, resume with particular caution and close monitoring and avoid use in combination with didanosine. (5.4)

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Patients may develop redistribution/accumulation of body fat, monitor for signs and symptoms of lipoatrophy/lipodystrophy. Alternative antiretrovirals should be considered. (5.5)

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Patients may develop immune reconstitution syndrome. (5.6)

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In adults, the most common adverse reactions are headache, diarrhea, neuropathy, rash, nausea, and vomiting. (6.1)

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Adverse reactions in pediatric patients were consistent with those seen in adults. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Coadministration of ZERIT with zidovudine should be avoided. (7)

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Coadministration of ZERIT and doxorubicin or ribavirin should be undertaken with caution. (7)

USE IN SPECIFIC POPULATIONS

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Pregnancy: Fatal lactic acidosis has been reported in pregnant women who received both didanosine and stavudine with other agents. This combination should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk to the fetus. Pregnancy registry available. (8.1)

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Nursing mothers should be instructed not to breastfeed due to the potential for postnatal HIV transmission. (8.3)