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Kyprolis▼ (carfilzomib) - patient safety update

Kyprolis▼, for Multiple myeloma from Amgen

The Medicines and Healthcare products Regulatory Agency (MHRA) have advised of a new possible side effect for patients taking Amgen's multiple myeloma treatment carfilzomib, brand name Kyprolis▼.

The Agency advises that following reports of hepatitis B reactivation associated with carfilzomib; screening for hepatitis B before a patient starts treatment is recommended; as well as screening patients already under treatment with unknown hepatitis B virus serology.

This means that patients taking or about to take Kyprolis and who have previously suffered from hepatitis B should be screened for the condition. If a patients hepatitis B status be unknown they too should be screened for the virus.

You can follow developments on Kyprolis by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

Advice for healthcare professionals:
  • hepatitis B virus reactivation has been reported in patients treated with carfilzomib
  • screen all patients for hepatitis B virus before initiation of carfilzomib; patients with unknown serology who are already on treatment should also be screened
  • consider prophylaxis with antivirals for patients with positive serology who are treated with carfilzomib
  • monitor patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during and after treatment
  • advise patients with positive serology to seek medical help immediately if they experience signs and symptoms suggestive of hepatitis B virus reactivation
  • in patients who have hepatitis B reactivation, it is recommended to consult relevant experts when making decisions regarding hepatitis B virus treatment and the continuation, interruption, or resumption of carfilzomib
  • report any suspected adverse drug reactions associated with carfilzomib to the Yellow Card Scheme
About Kyprolis (source EMA)
Kyprolis is a cancer medicine used together with the medicines lenalidomide and dexamethasone or with dexamethasone alone, to treat multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least one previous treatment for their cancer.

Kyprolis contains the active substance carfilzomib. Multiple myeloma is rare, and Kyprolis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 June 2008.

The active substance in Kyprolis, carfilzomib, is a proteasome inhibitor. This means that it blocks the proteasome, which is a system within the cells that breaks down proteins that are no longer needed. Cancer cells have an increased need to produce and break down proteins because they multiply rapidly. When carfilzomib stops the proteasome from breaking down proteins in the cancer cells, the proteins build up and cause the cells to die, slowing down the growth of the cancer.

Kyprolis was first made available in the EU in 2015. It is manufactured by Amgen.

Sources
European Medicines Agency website page for Kyprolis
Accessed 25/11/19
Links available in External Resources

Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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