Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
LENALIDOMIDE (UNII: F0P408N6V4) (LENALIDOMIDE - UNII:F0P408N6V4)
Teva Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). 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. 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. 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)] . Lenalidomide capsules can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all
Lenalidomide capsules are available as follows: 5 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “5mg” on body in black ink contains 5 mg of lenalidomide. 5 mg bottles of 28 (NDC 0480‐1242‐28) 10 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “10mg” on body in black ink contains 10 mg of lenalidomide. 10 mg bottles of 28 (NDC 0480‐1243‐28) 15 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “15mg” on body in black ink contains 15 mg of lenalidomide. 15 mg bottles of 21 (NDC 0480‐1244‐21) 25 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “25mg” on body in black ink contains 25 mg of lenalidomide. 25 mg bottles of 21 (NDC 0480‐1246‐21) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 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.
Abbreviated New Drug Application
Teva Pharmaceuticals, Inc. ---------- MEDICATION GUIDE LENALIDOMIDE (len" a lid' oh mide) Capsules What is the most important information I should know about lenalidomide capsules? Before you begin taking lenalidomide capsules, you must read and agree to all of the instructions in the Lenalidomide REMS program. Before prescribing lenalidomide capsules, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form. Lenalidomide capsules may cause serious side effects including: • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take lenalidomide capsules. Lenalidomide is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects. Lenalidomide capsules have not been tested in pregnant females. Lenalidomide capsules have harmed unborn animals in animal testing. Females must not get pregnant: • For at least 4 weeks before starting lenalidomide capsules • While taking lenalidomide capsules • During any breaks (interruptions) in your treatment with lenalidomide capsules • For at least 4 weeks after stopping lenalidomide capsules Females who can become pregnant: • Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. • If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. • Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping lenalidomide capsules. • Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with lenalidomide capsules. • If you had unprotected sex or if you think y Läs hela dokumentet
LENALIDOMIDE- LENALIDOMIDE CAPSULE TEVA PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LENALIDOMIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LENALIDOMIDE CAPSULES. LENALIDOMIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2005 WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, AND VENOUS AND ARTERIAL THROMBOEMBOLISM _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EMBRYO-FETAL TOXICITY LENALIDOMIDE, A THALIDOMIDE ANALOGUE, CAUSED LIMB ABNORMALITIES IN A DEVELOPMENTAL MONKEY STUDY SIMILAR TO BIRTH DEFECTS CAUSED BY THALIDOMIDE IN HUMANS. IF LENALIDOMIDE IS USED DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR EMBRYO-FETAL DEATH. PREGNANCY MUST BE EXCLUDED BEFORE START OF TREATMENT. PREVENT PREGNANCY DURING TREATMENT BY THE USE OF TWO RELIABLE METHODS OF CONTRACEPTION (5.1). LENALIDOMIDE CAPSULES ARE AVAILABLE ONLY THROUGH A RESTRICTED DISTRIBUTION PROGRAM, CALLED THE LENALIDOMIDE REMS PROGRAM (5.2, 17). HEMATOLOGIC TOXICITY. LENALIDOMIDE CAPSULES CAN CAUSE SIGNIFICANT NEUTROPENIA AND THROMBOCYTOPENIA (5.3). VENOUS AND ARTERIAL THROMBOEMBOLISM SIGNIFICANTLY INCREASED RISK OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE), AS WELL AS RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH MULTIPLE MYELOMA RECEIVING LENALIDOMIDE CAPSULES WITH DEXAMETHASONE. ANTI-THROMBOTIC PROPHYLAXIS IS RECOMMENDED (5.4). RECENT MAJOR CHANGES Warnings and Precautions (5.1, 5.2) 8/2021 Warnings and Precautions (5.1, 5.11) 5/2022 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). 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, Läs hela dokumentet