Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT

 Revlimid 5 mg hard capsules

Revlimid10 mg hard capsules

Revlimid 15 mg hard capsules

Revlimid 25 mg hard capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each Revlimid 5 mg hard capsule contains 5 mg of lenalidomide.

Excipient: Each capsule contains 147 mg of anhydrous lactose.

Each Revlimid 10 mg hard capsule contains 10 mg of lenalidomide

Excipient: Each capsule contains 294 mg of anhydrous lactose.

Each Revlimid 15 mg hard capsule contains 15 mg of lenalidomide

Excipient: Each capsule contains 289 mg of anhydrous lactose.

Each Revlimid 25 mg hard capsule contains 25 mg of lenalidomide

Excipient: Each capsule contains 200 mg of anhydrous lactose.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Hard capsule.

Revlimid 5 mg hard capsules: White capsules marked “REV 5 mg”.

Revlimid 10 mg hard capsules: Blue-green/pale yellow capsules marked “REV 10 mg”.

Revlimid 15 mg hard capsules: Pale blue/white capsules marked “REV 15 mg”.

Revlimid 25 mg hard capsules: White capsules marked “REV 25 mg”.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

4.2 Posology and method of administration

 Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma (MM).
Administration
Revlimid capsules should be taken at about the same time each day. The capsules should not be opened, broken or chewed. The capsules should be swallowed whole, preferably with water, either with or without food. If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.

Recommended dose

The recommended starting dose of lenalidomide is 25 mg orally once daily on days 121 of repeated 28day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and