SPC changes
Aranesp
Aranesp (darbepoetin alfa;Amgen) is now licensed for once-monthly dosing
in the treatment of anaemia in chronic kidney disease patients not on
dialysis. The summary of product characteristics now states that, in
the maintenance phase of treatment, Aranesp may continue to be administered
as a single injection once weekly or once every two weeks. Alternatively,
in patients not on dialysis, once the target haemoglobin has been achieved
with fortnightly dosing, Aranesp may be administered once monthly using
an initial dose equal to twice the fortnightly dose. The dose regimens
for the correction phase in chronic renal failure patients and for the
treatment of anaemia in cancer patients have also been updated. See SPC.
NutropinAq
The summary of product characteristics for NutropinAq (somatropin;Ipsen)
now states that the product is not indicated for the long-term treatment
of paediatric patients who have growth failure due to genetically
confirmed Prader-Willi syndrome, unless they have a diagnosis of
growth hormone
deficiency. It says that there have been reports of sleep apnoea
and sudden death after initiation of NutropinAq therapy in paediatric
patients
with Prader-Willi syndrome who had one or more of the following risk
factors: severe obesity, history of upper airway obstruction or sleep
apnoea, or an unidentified respiratory infection. See SPC.
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