SPC changes
Erbitux
The summary of product characteristics for Erbitux (cetuximab; Merck)
2 mg/ml solution for infusion now states that hypomagnesaemia has been
reported. See SPC.
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
includes an additional indication for the treatment of moderate to
severe plaque psoriasis in adults who failed to respond to, have a
contraindication to or are intolerant to other systemic therapy. The
dose for this indication is 5mg/kg given as an intravenous infusion
over a two-hour period followed by 5mg/kg infusion doses at two and
six weeks after the first infusion and then every eight weeks thereafter.
If a patient shows no response after 14 weeks, no additional treatment
with infliximab should be given. The SPC states that limited experience
from retreatment with one single infliximab dose in psoriasis after
an interval of 20 weeks suggests that there is reduced efficacy and
a higher incidence of mild to moderate infusion reactions when compared
with the initial induction regimen. See SPC.
Taxol
The summary of product characteristics for Taxol (paclitaxel; Bristol-Myers
Squibb) now lists infection, with reported cases of death, and bleeding
as very common undesirable effects. Injection site reactions have been
added as common undesirable effects. See SPC.
ViraferonPeg
The summary of product characteristics for ViraferonPeg (peginterferon
alfa-2b;Schering Plough) has been updated. The section on combination
treatment with ViraferonPeg and ribavirin capsules now states that
in patients with genotype 1 infection and low viral load (<600,000IU/ml)
who become hepatitis C virus-RNA negative at week 4 and remain HCV-RNA
negative at week 24, the treatment could either be stopped or pursued
for an additional 24 weeks. However, it says that an overall 24-week
treatment duration may be associated with a higher risk of relapse
than a 48-week treatment course. See SPC.
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