Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
Routine hepatic monitoring recommended for lenalidomide
The latest Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update recommends routine monitoring of hepatic function at baseline, every week for the first 8 weeks and then monthly, for patients being treated with lenalidomide (Revlimid®; Celgene, Uxbridge, UK). This follows reports of elevations of hepatic enzymes occurring in up to 10% of patients treated with lenalidomide for multiple myeloma in clinical trials. This is mostly without serious consequence and resolves when lenalidomide is stopped, at which point reintroduction of lenalidomide at a lower dose can be considered. However, in <1% of treated patients, acute hepatic failure, toxic hepatitis, hepatocellular hepatitis and cholestatic hepatitis have been reported.
Because lenalidomide is excreted predominantly renally, the dose should be adjusted in patients with renal impairment to avoid high plasma levels which may increase the risk of severe hepatotoxicity, as well as haematological undesirable effects. For more information click here.
Denosumab rare cases of atypical femoral fracture with long-term use
The Medicines and Healthcare products Regulatory Agency (MHRA) have reported rare cases of atypical femoral fracture in patients receiving denosumab 60mg (Prolia®; Amgen, Cambridge, UK) for post-menopausal osteoporosis for >2.5 years.
They advise during denosumab treatment:
- patients should report new or unusual thigh, hip, or groin pain which should be evaluated for an incomplete femoral fracture; these may occur with little/no trauma in the subtrochanteric and diaphyseal regions of the femur
- the contralateral femur should be examined carefully, as atypical femoral fractures are often bilateral
- consider discontinuing treatment while the patient is evaluated; benefits and risks should be assessed on an individual basis.
For more information click here.
Prepared by Sarah Charlesworth and Andrew Wilcock