- Fatal and nonfatal cases have occurred in combination with didanosine with or without hydroxyurea.
Lactic Acidosis & Hepatomegaly
- Reported with steatosis (including fatal cases) reported with the use of nucleoside analogues alone or in combination. Reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Use the combination with caution in pregnant women.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patients with prodromal symptoms of hepatitis should seek medical attention immediately and promptly discontinue drug.
- 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.
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.
Based on limited data, stavudine has been detected in human milk. No data are available regarding the effects of stavudine on the breastfed infant, or the effects on milk production.
Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants) and (3) adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving stavudine.
Patient Counseling Information