Darbepoetin alfa

There is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus. If darbepoetin is given concomitantly with any of these treatments, blood levels of these substances should be monitored and the dosage adjusted as the haemoglobin rises.

Darbepoetin alfa should also be used with caution in those patients with sickle cell anaemia.

Active liver disease was an exclusion criteria in all studies of darbepoetin, therefore no data are available from patients with impaired liver function. Since the liver is thought to be the principal route of elimination of darbepoetin alfa and r-HuEPO, darbepoetin should be used with caution in patients with liver disease.

There are no adequate and well-controlled studies with darbepoetin alfa in pregnant women.

Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. No alteration of fertility was detected.

Caution should be exercised when prescribing darbepoetin alfa to pregnant women.

It is unknown whether darbepoetin alfa is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from darbepoetin alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Darbepoetin alfa has no or negligible influence on the ability to drive and use machines.