Myelodysplastic syndromes

Active Ingredient: Lenalidomide

Indication for Lenalidomide

Population group: only adults (18 - 65 years old)

Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

For this indication, competent medicine agencies globally authorize below treatments:

10 mg once daily

Route of admnistration

Oral

Defined daily dose

10 mg

Dosage regimen

10 mg once every day

Detailed description

Lenalidomide treatment must not be started if the ANC <0.5 × 109/L and/or platelet counts <25 × 109/L.

Recommended dose: The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles.

Dose reduction steps:

Starting dose10 mg once daily on days 1 to 21 every 28 days
Dose level -15 mg once daily on days 1 to 28 every 28 days
Dose level -22.5 mg once daily on days 1 to 28 every 28 days
Dose level -32.5 mg every other day 1 to 28 every 28 days

Thrombocytopenia:

When plateletsRecommended course
Fall to <25 × 109/LInterrupt lenalidomide treatment
Return to ≥25 × 109/L - <50 × 109/L on at least 2 occasions for ≥7 days or when the platelet count recovers to ≥50 × 109/L at any timeResume lenalidomide at next lower dose level (dose level -1, -2 or -3)

Discontinuation of lenalidomide

Patients without at least a minor erythroid response within 4 months of therapy initiation, demonstrated by at least a 50% reduction in transfusion requirements or, if not transfused, a 1g/dl rise in haemoglobin, should discontinue lenalidomide treatment.

Active ingredient

Lenalidomide

The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.

Read more about Lenalidomide

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