SPC changes
Copegus
The summary of product characteristics for Copegus (ribavirin; Roche)
now includes an additional indication for use in patients with normal
aminotransferases and HIV/hepatitis C virus co-infected patients. For
HIV/HCV co-infected patients, the dosage of Copegus in combination with
once-weekly peginterferon alfa-2a is 800mg daily for 48 weeks, regardless
of genotype. Initiation of peginterferon alfa-2a in HIV-HCV patients
with cirrhosis and a Child-Pugh score >=6 is now included in the
list of contraindications of Copegus. Special warnings have also been
added to the SPC, relating to patients with: severe psychiatric conditions,
or a history of them; HIV/HCV co-infection; advanced cirrhosis and receiving
highly active antiretroviral therapy; neutropenia, thrombocytopenia and
anaemia; and low CD4 counts. The SPC also now states that co-administration
of ribavirin and didanosine is not recommended. See SPC.
Saquinavir
The summaries of product characteristics for Fortovase (saquinavir; Roche)
and Invirase (saquinavir; Roche) now state that concomitant use of
boosted saquinavir and fluticasone or other glucocorticoids metabolised
by CYP3A4 is not recommended unless the potential benefit of treatment
outweighs the risk of systemic corticosteroid effects.
See SPCs.
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