lenalidomide 5 mg
1 INDICATIONS AND USAGE Lenalidomide is 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 ) Limitations of Use: Lenalidomide capsules is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. 1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone is 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 is 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. 1.6 Limitations of Use Lenalidomide capsules is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5) ] .
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CAPSULE WHITE AA18A
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LENALIDOMIDE capsules, 2.5 mg are supplied as size “4” hard gelatin capsules, filled with white to off-white powder, imprinted “AA17A” on blue green opaque cap with black ink and white opaque body. They are available as below: Bottles of 28: NDC 60219-1714-1 Bottles of 100: NDC 60219-1714-2
LENALIDOMIDE capsules, 5 mg are supplied as size “2” hard gelatin capsules, filled with white to off-white powder, imprinted “AA18A” on white opaque cap with black ink and white opaque body. They are available as below: Bottles of 28: NDC 60219-1715-1 Bottles of 100: NDC 60219-1715-2
LENALIDOMIDE capsules, 10 mg are supplied as size “0” hard gelatin capsules, filled with white to off-white powder, imprinted “AA19A” on blue green opaque cap with black ink and pale yellow opaque body. They are available as below: Bottles of 28: NDC 60219-1716-1 Bottles of 100: NDC 60219-1716-2
LENALIDOMIDE capsules, 15 mg are supplied as size “0” hard gelatin capsules, filled with white to off-white powder, imprinted “AA20A” on powder blue opaque cap with black ink and white opaque body. They are available as below: Bottles of 21: NDC 60219-1717-1 Bottles of 100: NDC 60219-1717-2
LENALIDOMIDE capsules, 20 mg are supplied as size “0” hard gelatin capsules, filled with white to off-white powder, imprinted “AA21A” on blue green opaque cap with black ink and powder blue opaque body. They are available as below: Bottles of 21: NDC 60219-1718-1 Bottles of 100: NDC 60219-1718-2
LENALIDOMIDE capsules, 25 mg are supplied as size “0” hard gelatin capsules, filled with white to off-white powder, imprinted “AA22A” on white opaque cap with black ink and white opaque body. They are available as below: Bottles of 21: NDC 60219-1719-1 Bottles of 100: NDC 60219-1719-2 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°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 capsules 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.
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