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Lactic acidosis/
severe hepatomegaly with steatosis :
Lactic acidosis/ severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of antiretroviral
nucleoside analogues alone or in combination, including stavudine and lamivudine.
A majority of these cases have been in women. Obesity and prolonged nucleoside
exposure may be risk factors. Caution should be exercised when administering stavudine
to any patient, and particularly to those with known risk factors. Treatment should
be discontinued in any patient who develops clinical or laboratory findings suggestive
of lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis)
even in the absence of marked aminotransferase elevations.
Peripheral
neuropathy :
Stavudine therapy can be associated with severe peripheral
neuropathy, which is dose-related and occurs more frequently in patients with
advanced HIV infection or who have previously experienced peripheral neuropathy.
Patients should be monitored for the development of neuropathy that
is usually characterized by numbness, tingling or pain in the feet or hands. Stavudine-related
peripheral neuropathy may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy.
If symptoms resolve completely, resumption of treatment may be considered using
the following dosage schedule for adults :
20 mg twice daily for patients
³ 60 kg
15 mg twice daily for patients < 60 kg
In this case, therapy with imunaid is no longer appropriate.
Patients with HIV
and hepatitis B virus coinfection :
In clinical trials, some patients
with HIV infection who have chronic liver disease due to hepatitis B virus infection
experienced clinical or laboratory evidence of recurrent hepatitis upon discontinuation
of lamivudine. Consequences may be more severe in patients with decompensated
liver disease.
Hypersensitivity reactions :
Severe, life-threatening skin reactions, including fatal cases, have occurred in patients
treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings and organ dysfunction. Patients developing signs or symptoms
of severe skin reactions or hypersensitivity reactions (including, but not limited
to, severe rash or rash accompanied by fever, blisters, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise and/or significant hepatic
abnormalities) must discontinue nevirapine as soon as possible. Neviraine therapy
must be initiated with a 14-day lead-in period of 200 mg/day which has been shown
to reduce the frequency of rash. If rash is observed during this lead-in period, dose escalation and administration of imunaid should not occur until the rash
has resolved (see Dosage and Administration).
Severe or life-threatening
hepatotoxicity, including fatal fulminant hepatitis (transaminase elevations, with or without hyperbilirubinemia, prolonged partial thromboplastin time, or
eosinophilia), has occurred in patients treated with nevirapine. Some of these
cases began in the first week of therapy, and some were accompanied by rash. Nevirapine
administration should be interrupted in patients experiencing moderate or severe
ALT or AST abnormalities until these return to baseline values. Nevirapine should
be permanently discontinued if liver function abnormalities recur upon readministration.
Monitoring of ALT and AST is strongly recommended, especially during the first
six months of nevirapine treatment (See Side Effects, Dosage and Administration).
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