Consumer medicine information

Boxed Warnings

Do not use Revlimid during pregnancy.
Teratogenic effects. Revlimid (lenalidomide) is structurally related to thalidomide. Thalidomide is a known human teratogen that causes severe life threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking Revlimid (lenalidomide), during dose interruptions, and for 4 weeks after stopping the medication.

1 Name of Medicine

Lenalidomide.

2 Qualitative and Quantitative Composition

Each 2.5 mg capsule contains 2.5 mg lenalidomide and 73.5 mg of lactose (as anhydrous lactose).
Each 5 mg capsule contains 5 mg lenalidomide and 147 mg of lactose (as anhydrous lactose).
Each 7.5 mg capsule contains 7.5 mg lenalidomide and 144.5 mg of lactose (as anhydrous lactose).
Each 10 mg capsule contains 10 mg lenalidomide and 294 mg of lactose (as anhydrous lactose).
Each 15 mg capsule contains 15 mg lenalidomide and 289 mg of lactose (as anhydrous lactose).
Each 20 mg capsule contains 20 mg lenalidomide and 244.5 mg of lactose (as anhydrous lactose).
Each 25 mg capsule contains 25 mg lenalidomide and 200 mg of lactose (as anhydrous lactose).
For the full list of excipients, see Section 6.1 List of Excipients.
Description. Lenalidomide is an off-white to pale-yellow solid, with a melting point between 265°C and 270°C. Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1 N HCl buffer. The solubility of lenalidomide in water and at pH 1.21 is < 1.5 mg/mL and 18 mg/mL, respectively.
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+). Lenalidomide is produced as a racemic mixture with a net optical rotation of zero.

3 Pharmaceutical Form

Revlimid (lenalidomide) 2.5 mg capsules: white/blue-green size 4 capsules marked "2.5 mg REV".
Revlimid (lenalidomide) 5 mg capsules: white size 2 capsules marked "5 mg REV".
Revlimid (lenalidomide) 7.5 mg capsules: white/pale-yellow size 2 capsules marked "7.5 mg REV".
Revlimid (lenalidomide) 10 mg capsules: yellow/blue-green size 0 capsules marked "10 mg REV".
Revlimid (lenalidomide) 15 mg capsules: white/blue size 0 capsules marked "15 mg REV".
Revlimid (lenalidomide) 20 mg capsules: powder-blue/blue-green size 0 capsules marked "20 mg REV".
Revlimid (lenalidomide) 25 mg capsules: white size 0 capsules marked "25 mg REV".

4 Clinical Particulars

4.9 Overdose

There is no specific experience in the management of Revlimid overdose in patients with MM, MDS, or MCL. In dose-ranging studies, healthy subjects were exposed to up to 200 mg (administered 100 mg twice daily) and in single-dose studies, some subjects were exposed to up to 400 mg. Pruritus, urticaria, rash, and elevated liver transaminases were the primary reported adverse events. No clinically significant changes in ECGs, blood pressure, or pulse rate were observed.
While no haematologic events were associated with an overdose, such events may be expected since in clinical trials, the dose-limiting toxicity was essentially haematological. In the event of overdose, supportive care is advised. In Australia, contact the Poisons Advisory Centre on 13 11 26 for advice on management.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In vitro (mutation in bacteria, chromosomal aberration in human lymphocytes, mutation in mouse lymphoma cells, and Syrian hamster embryo cell transformation) and in vivo (rat micronucleus) genotoxicity studies revealed no drug-related effects at either the gene or chromosomal level.
Carcinogenicity. Carcinogenicity studies with Revlimid have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Molecular formula: C₁₃H₁₃N₃O₃.
Molecular weight: 259.25 g/mol.
ATC code: L04 AX04.
Chemical name: 3-(4'-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidinedione.
CAS number. Chemical Abstract Service (CAS) registry number: 191732-72-6.
Chemical structure.
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7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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