Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Lenalidomide
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
L04AX04
5.0 mg
CAPSULE
Lenalidomide 5.0 mg
ORAL
Prescription Only
Celgene International Sarl
ACTIVE
2009-06-23
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 Read the complete document
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 Read the complete document