SPC changes
Lescol XL
The summary of product characteristics for Lescol XL (fluvastatin; Novartis)
80mg prolonged release tablets now states that Lescol XL can be administered
as a single dose at any time of the day with or without food and must
be swallowed whole with a glass of water. See SPC.
Sustiva
The summary of product characteristics for Sustiva (efavirenz; Bristol-Myers
Squibb) tablets and capsules, but not oral solution, now states that
administration of Sustiva with food may increase efavirenz exposure
and may lead to an increase in the frequency of undesirable effects.
It is recommended that Sustiva be taken on an empty stomach, preferably
at bedtime. The SPC also states that efavirenz should not be used during
pregnancy unless there are no other appropriate treatment options.
Barrier contraception should be used in combination with other methods
of contraception in women treated with efavirenz and women of childbearing
potential should undergo pregnancy testing before initiation of efavirenz.
Mothers taking efavirenz should not breast feed infants. See SPC.
Videx
The summary of product characteristics for Videx (didanosine; Bristol-Myers
Squibb) now states that co-administration of didanosine and tenofovir
disoproxil fumerate is not recommended, especially in patients with
high viral load and low CD4 cell count, as some fatal cases of pancreatitis
and lactic acidosis have been reported. If this combination is judged
strictly necessary, patients should be carefully monitored for efficacy
and didanosine-related adverse events. The SPC also reports high rates
of virological failure and emergence of resistance at an early stage
when didanosine was combined with tenofovir disoproxil fumarate and
lamivudine as a once-daily regimen. See SPC.
Zerit
The summary of product characteristics for Zerit (stavudine; Bristol-Myers
Squibb) now states that hydroxyurea should not be used in the treatment
of HIV infection. Pancreatitis and peripheral neuropathy have been
reported in HIV patients receiving stavudine with hydroxyurea and didanosine.
Hepatotoxicity and hepatic failure have been reported in HIV patients
treated with antiretroviral agents and hydroxyurea. See SPC.
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