Revlimid Capsules 15 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Lenalidomide

Available from:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC code:

L04AX04

Dosage:

15.0 mg

Pharmaceutical form:

CAPSULE

Composition:

Lenalidomide 15.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Celgene International Sarl

Authorization status:

ACTIVE

Authorization date:

2009-06-23

Patient Information leaflet

1
1. NAME OF THE MEDICINAL
PRODUCT
Revlimid
®
5 mg hard capsules
Revlimid
®
10 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 the full list of excipients, see section 6.1.
3. PHARMACEUTICAL
FORM
Hard capsule.
Revlimid
®
5 mg hard capsules: White capsules, size 2, marked “REV 5 mg”.
Revlimid
®
10 mg hard capsules: Blue-green/pale yellow capsules, size 0, marked
“REV 10 mg”.
Revlimid
®
15 mg hard capsules: Pale blue/white capsules, size 0, marked “REV
15 mg”.
Revlimid
®
25 mg hard capsules: White capsules, size 0, marked “REV 25 mg”.
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Revlimid
®
(lenalidomide) as monotherapy is indicated for the maintenance
treatment of adult patients with
newly diagnosed multiple myeloma who have undergone autologous stem
cell transplantation.
Revlimid
®
(lenalidomide) in combination with dexamethasone is indicated for the
treatment of
previously untreated multiple myeloma patients who are not eligible
for transplant.
Revlimid
®
(lenalidomide) 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
Revlimid
®
(lenalidomide) should only be prescribed by Specialist Physician
experienced in the
management of malignancies, who have undergone the Revlimid
®
educational programme on
Pregnancy Prevention Programme.
2
Treatment must be initiated and

Summary of Product characteristics

1
1. NAME OF THE MEDICINAL
PRODUCT
Revlimid
®
5 mg hard capsules
Revlimid
®
10 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 the full list of excipients, see section 6.1.
3. PHARMACEUTICAL
FORM
Hard capsule.
Revlimid
®
5 mg hard capsules: White capsules, size 2, marked “REV 5 mg”.
Revlimid
®
10 mg hard capsules: Blue-green/pale yellow capsules, size 0, marked
“REV 10 mg”.
Revlimid
®
15 mg hard capsules: Pale blue/white capsules, size 0, marked “REV
15 mg”.
Revlimid
®
25 mg hard capsules: White capsules, size 0, marked “REV 25 mg”.
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Revlimid
®
(lenalidomide) as monotherapy is indicated for the maintenance
treatment of adult patients with
newly diagnosed multiple myeloma who have undergone autologous stem
cell transplantation.
Revlimid
®
(lenalidomide) in combination with dexamethasone is indicated for the
treatment of
previously untreated multiple myeloma patients who are not eligible
for transplant.
Revlimid
®
(lenalidomide) 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
Revlimid
®
(lenalidomide) should only be prescribed by Specialist Physician
experienced in the
management of malignancies, who have undergone the Revlimid
®
educational programme on
Pregnancy Prevention Programme.
2
Treatment must be initiated and