Stavudine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Less than 60 kg: 30 mg orally every 12 hours
60 kg or more: 40 mg orally every 12 hours

Usual Adult Dose for Nonoccupational Exposure

Less than 60 kg: 30 mg orally every 12 hours
60 kg or more: 40 mg orally every 12 hours

Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.

In general, the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include stavudine as part of protease inhibitor (PI)-based regimens.

Usual Pediatric Dose for HIV Infection

Birth to 13 days: 0.5 mg/kg orally every 12 hours

14 days or older:
Less than 30 kg: 1 mg/kg orally every 12 hours
30 kg or more: Adult dosage recommended.

Renal Dose Adjustments

Adult patients:
CrCl 26 to 50 mL/min:
Less than 60 kg: 15 mg orally every 12 hours
60 kg or more: 20 mg orally every 12 hours

CrCl 10 to 25 mL/min:
Less than 60 kg: 15 mg orally every 24 hours
60 kg or more: 20 mg orally every 24 hours

Pediatric patients: There are insufficient data to recommend a specific dose adjustment in this patient population.

Liver Dose Adjustments

Data not available

Precautions

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and only if potential benefit outweighs potential risk. Caution should be exercised when administering stavudine to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with stavudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis, symptomatic hyperlactatemia, or pronounced hepatotoxicity. Permanent discontinuation of stavudine should be considered for patients with confirmed lactic acidosis.

The safety and effectiveness of stavudine in HIV-infected patients with preexisting liver dysfunction, including patients with chronic active hepatitis, have not been established. During combination antiretroviral treatment, this patient population should be monitored due to an increased rate of liver function abnormalities, including serious and potentially fatal hepatic adverse reactions. Stavudine should be interrupted or discontinued in the event of worsening liver dysfunction.

Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing experience in HIV-infected patients treated with hydroxyurea and other antiretroviral agents. Fatal hepatic events were reported most often in patients receiving stavudine with didanosine and hydroxyurea; therefore, this combination should be avoided.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C who were receiving combination antiretroviral therapy for HIV-1 and interferon and ribavirin. Patients receiving interferon with or without ribavirin and stavudine should be monitored closely for therapy-associated toxicities, particularly hepatic decompensation. Stavudine discontinuation should be considered as medically appropriate. Dose reduction or discontinuation of interferon, ribavirin, or both should also be considered if clinical toxicities worsen, including hepatic decompensation (Child-Pugh greater than 6).

Pancreatitis (fatal and nonfatal) has occurred during therapy when stavudine was part of a combination regimen that included didanosine, in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Treatment with stavudine and didanosine and any other agents toxic to the pancreas should be suspended if pancreatitis is suspected. Caution and close patient monitoring are recommended if stavudine is restarted after pancreatitis is confirmed and the new regimen should not contain didanosine.

Motor weakness has been reported in patients receiving combination antiretroviral therapy. Stavudine should be discontinued if motor weakness develops. Symptoms may continue or worsen after discontinuation of therapy.

Patients should be monitored for the development of peripheral neuropathy. Peripheral neuropathy (which can be severe) is dose related and occurs more often in patients with advanced HIV-1 disease, with a history of peripheral neuropathy, or if being treated with other drugs associated with neuropathy, including didanosine. Stavudine-related peripheral neuropathy may resolve with prompt discontinuation of therapy. If peripheral neuropathy develops, permanent discontinuation of stavudine should be considered. Symptoms may temporarily worsen after discontinuation of therapy in some cases.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Patients should be monitored for signs or symptoms of and questioned about body changes related to lipoatrophy or lipodystrophy. A benefit-risk assessment is recommended for each patient given the potential risks of stavudine use, including lipoatrophy or lipodystrophy, and an alternate antiretroviral should be considered.

Dialysis

Hemodialysis:
Adult patients:
Less than 60 kg: 15 mg orally every 24 hours
60 kg or more: 20 mg orally every 24 hours
The dose should be taken after hemodialysis when given on dialysis days.

Pediatric patients: There are insufficient data to recommend a specific dose adjustment in this patient population.

Other Comments

Stavudine may be given with or without food.

The reconstituted oral solution should be stored in the refrigerator, shaken well before measuring the dose, and any unused portion should be discarded after 30 days.

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