lenalidomide 5 mg capsule
1 INDICATIONS AND USAGE Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). • Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Limitations of Use: • Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ). 1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). 1.2 Myelodysplastic Syndromes Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 1.3 Mantle Cell Lymphoma Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. 1.4 Follicular Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). 1.5 Marginal Zone Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL). 1.6 Limitations of Use Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5) ] .
mylan pharmaceuticals inc.
CAPSULE WHITE Mylan LL 5
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mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LENALIDOMIDE capsules are available containing 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg or 25 mg of
LENALIDOMIDE. The 2.5 mg capsules are hard-shell gelatin capsules with a green opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 2.5 in black ink on both the cap and body. They are available as follows: NDC 0378-1935-28 bottles of 28 capsules NDC 0378-1935-01 bottles of 100 capsules The 5 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 5 in black ink on both the cap and body. They are available as follows: NDC 0378-1936-28 bottles of 28 capsules NDC 0378-1936-01 bottles of 100 capsules The 10 mg capsules are hard-shell gelatin capsules with a green opaque cap and light gray opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 10 in black ink on both the cap and body. They are available as follows: NDC 0378-1937-28 bottles of 28 capsules NDC 0378-1937-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 15 in red ink on both the cap and body. They are available as follows: NDC 0378-1941-21 bottles of 21 capsules NDC 0378-1941-01 bottles of 100 capsules The 20 mg capsules are hard-shell gelatin capsules with a green opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 20 in red ink on both the cap and body. They are available as follows: NDC 0378-1942-21 bottles of 21 capsules NDC 0378-1942-01 bottles of 100 capsules The 25 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LL 25 in black ink on both the cap and body. They are available as follows: NDC 0378-1940-21 bottles of 21 capsules NDC 0378-1940-01 bottles of 100 capsules 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 16.3 Handling and Disposal Care should be exercised in the handling of
LENALIDOMIDE capsules.
LENALIDOMIDE capsules should not be opened or broken. If powder from
LENALIDOMIDE capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If
LENALIDOMIDE contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. 1 Dispense no more than a 28-day supply. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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