LENALIDE

What it is

Lenalide is a medicine containing lenalidomide, supplied as capsules in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg. Lenalide capsules are administered orally at about the same time each day, and should be swallowed whole with water preferably one hour before or two hours after food.

Approved indications

— Multiple myeloma. — Transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. — Relapsed and/or refractory mantle cell lymphoma.

Dosing overview

Treatment must be initiated and monitored under the supervision of a registered specialist physician experienced in the management of haematological and oncological malignancies. Dosing varies by indication and patient characteristics. For newly diagnosed multiple myeloma in patients ineligible for autologous stem cell transplantation receiving Lenalide in combination with bortezomib and dexamethasone, the starting dose is 25 mg once daily on days 1–14 of 21-day cycles for patients with no renal impairment. For patients aged 75 years or younger with no renal impairment receiving Lenalide in combination with dexamethasone, the dose is 25 mg once daily on days 1–21 of repeated 28-day cycles. For newly diagnosed multiple myeloma post-transplant maintenance monotherapy in patients with no renal impairment, the starting dose is 10 mg once daily continuously on days 1–28 of repeated 28-day cycles. For myelodysplastic syndromes monotherapy in patients with no renal impairment, the starting dose is 10 mg once daily on days 1–21 of repeated 28-day cycles. For previously treated mantle cell lymphoma monotherapy in patients with no renal impairment, the starting dose is 25 mg once daily on days 1–21 of repeated 28-day cycles. Lenalidomide is substantially excreted by the kidney, and for patients with impaired renal function, care should be taken in dose selection.

Key safety warnings

Lenalide must not be used during pregnancy as lenalidomide is structurally related to thalidomide, a known human teratogen that causes severe life-threatening birth defects, and if taken during pregnancy may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking Lenalide, during dose interruptions, and for 4 weeks after stopping the medication.

Regulatory history

Lenalide was first registered on the Australian Register of Therapeutic Goods on 23 July 2021, with registrations for 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules.

PBS listing

Lenalide 20 mg capsules are listed on the PBS with authority required restriction, with an ex-manufacturer price of A$757.74.