New oral multiple myeloma treatment set for launch
A new oral therapy for people with multiple myeloma will be launched
next week. Lenalidomide, developed by Celgene and marketed as Revlimid,
is indicated for treatment of multiple myeloma in combination with
a dexamethasone regimen for patients who have received at least one
previous therapy.
Structurally related to thalidomide — known to cause severe, life-threatening
birth defects — lenalidomide is contraindicated in pregnancy and
in women of childbearing potential unless certain pregnancy prevention
conditions are met (see Panel).
The mechanism of action of lenalidomide is not fully understood. However,
one of the known antineoplastic actions of the drug is inhibition of
growth of various haematopoietic tumour cells, including those for multiple
myeloma. Lenalidomide has
also been shown to display antiangiogenic and
immunomodulatory properties.
The starting dose of lenalidomide is 25mg, taken orally, once a day on
days 1–21 of repeated 28-day cycles.
The dose of lenalidomide used should be adjusted on the basis of results
of clinical assessment and laboratory tests — such as low neutrophil
or platelet counts — aided by the four strengths of capsule available:
5mg, 10mg, 15mg and 25mg.
Adjustment of the lenalidomide dose is recommended for patients who have
impaired renal function because the drug is excreted substantially by
the kidney. Monitoring the renal function of all patients is advised.
The most serious adverse reactions associated with treatment are venous
thromboembolism (including deep vein thrombosis and pulmonary embolism)
and severe neutropenia.
Further information will be available on Notice-board in next week’s
Journal.
Prevention of pregnancy during treatment
A teratogenic effect of lenalidomide, if used during pregnancy, cannot
be ruled out, the summary of product characteristics states.
Women of childbearing potential must use one effective method of
contraception throughout lenalidomide therapy — beginning four
weeks before and continuing until four weeks after therapy — unless
the patient commits to absolute and continuous abstinence confirmed
on a monthly basis.
Combined oral contraceptive pills are unsuitable for use because
of an increased risk of venous thromboembolism in patients with multiple
myeloma taking both lenalidomide and dexamethasone. |
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The
Pharmaceutical Journal
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