Lenalidomide

Red

Brand Name(s):Revlimid

Indication:Previously treated follicular lymphoma in combination with Rituximab (Adults) Myelodysplastic syndrome with chromosome 5q deletion and Chronic lymphocytic leukaemia (CLL)
Mantle Cell Lymphoma

Rationale:1,2,3

Considered:May-07

Review Date:Feb-25

Comments:
NG35
Myeloma: diagnosis and management
Full document available at:http://www.nice.org.uk/guidance/ng35/resources/myeloma-diagnosis-and-management-1837394042821
Feb 2016

NICE TA 322 information at: http://www.nice.org.uk/guidance/ta322/resources/guidance-lenalidomide-for-treating-myelodysplastic-syndromes-associated-with-an-isolated-deletion-5q-cytogenetic-abnormality-pdf
Sept 2014

Lenalidomide (Revlimid): risk of second primary malignancy-update
Clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma-the authorised indication. Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide
Advice for healthcare professionals:
Use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial
Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated
Healthcare professionals should report all suspected adverse reactions, including second primary malignancy promptly to us via the Yellow Card Scheme
Volume 5, Issue 4 November 2011

…………………………
Lenalidomide in combination with dexamethasone is recommended, within its licensed indication, as an option for the treatment of multiple myeloma only in people who have received two or more prior therapies, with the following condition:

* The drug cost of lenalidomide (excluding any related costs) for people who remain on treatment for more than 26 cycles (each of 28 days; normally a period of 2 years) will be met by the manufacturer.

* People currently receiving lenalidomide for the treatment of multiple myeloma, but who have not received two or more prior therapies, should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
NICE TA 171
Lenalidomide for the treatment of multiple myeloma in people who have received at least one prior therapy June 2009
10 December 2012
Direct Healthcare Professional Communication on the risk of hepatic disorders associated with
Revlimid® (lenalidomide) use, in the context of other risk factors.

Summary
· In multiple myeloma patients treated with lenalidomide in combination with dexamethasone, some severe cases
of liver injuries, including fatal cases, have been reported: acute hepatic failure, toxic hepatitis, cytolytic
hepatitis, cholestatic hepatitis and mixed cytolytic/cholestatic hepatitis.
· Lenalidomide is excreted by the kidneys. It is important to adjust the dose of lenalidomide in patients with renal
impairment to avoid high plasma levels which may increase the risk of more severe haematological side effects
or hepatotoxicity.
· The mechanisms of severe drug-induced hepatotoxicity remain unknown and risk factors might be pre-existing
viral liver disease, elevated baseline liver-enzymes, and possibly treatment with antibiotics.
· Monitoring of liver function is recommended, particularly when there is a history of, or concurrent, viral liver
infection or when lenalidomide is combined with medications known to be associated with liver dysfunction
such as paracetamol.
Further information available at: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con218766.p