SPC changes
Aranesp
The summaries of product characteristics for Aranesp (darbepoetin alfa;
Amgen) and Aranesp SureClick now state that dialysis patients converting
from once-weekly to once every other week dosing should initially receive
a dose equivalent to twice the previous once-weekly dose. The SPCs recommend
that, during dose titration, if the rise in haemoglobin is greater than
2.0g/dl in four weeks, the dose should be reduced by approximately 25
per cent, depending on the rate of increase. The SPCs also state that,
when converting from recombinant human erythropoietin (r-HuEPO) to Aranesp
every other week dosing, the initial dose (in µg/every other week)
can be determined by dividing the total cumlative dose of r-HuEPO administered
over a two-week period by 200. See SPCs.
Arava
The summary of product characteristics for Arava (leflunomide; sanofi-aventis)
has been updated to include vasculitis (including cutaneous necrotising
vasculitis) as a very rare adverse effect. Severe infection (including
sepsis which may be fatal) has been moved from the very rare to the
rare undesirable effects section. Paediatric information has been included
in the pharmacodynamic properties section, and information about pharmacokinetics
in paediatrics and the elderly has been added. See SPC.
Mimpara
The summary of product characteristics for Mimpara (cinacalcet; Amgen)
now includes hypersensitivity reactions as an uncommon adverse event.
See SPC.
Zyvox
The summary of product characteristics for Zyvox (linezolid; Pharmacia)
has been updated and now states that the following adverse reactions
can occur, primarily in patients receiving Zyvox for longer than the
maximum recommended duration of 28 days: serious anaemia often requiring
blood transfusion; peripheral neuropathy and optic neuropathy sometimes
progressing to loss of vision; and lactic acidosis. See SPC.
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