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Didanosine

Pancreatitis, Lactic Acidosis and Hepatomegaly with Steatosis

Pancreatitis

  • Fatal and nonfatal cases have occurred with monotherapy or in combination in both treatment naive and treatment of experienced patients.
  • Drug should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis.
  • Coadministration of didanosine and stavudine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs.

Hepatotoxicity with Steatosis

  • Including fatal cases have been reported with nucleoside analogues alone or in combination.
  • Lactic Acidosis with hepatomegaly and steatosis (sometimes fatal) reported with use of nucleoside analogues alone or in combination. Reported fatal lactic acidosis 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.
  • Drug should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis.
  • Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly. Threapy should be suspended in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatoxicity.
  • The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. It is not known whether didanosine is present in human breast milk, affects human milk production, or has effects on the breastfed infant. When administered to lactating rats, didanosine was present in milk.
    Because of the potential for (1) HIV-1 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 didanosine.

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Didanosine

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Updated June 2018