Lenangio 10/Lenangio 15

Lenalidomide

Monotherapy for adults w/ newly diagnosed multiple myeloma (NDMM) who have undergone autologous stem cell transplantation (ASCT); combination therapy for adults w/ previously untreated multiple myeloma who are not eligible for transplant; multiple myeloma in adults who have received at least 1 prior therapy in combination w/ dexamethasone. Monotherapy for adults w/ transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated w/ isolated deletion 5q cytogenic abnormality when other therapeutic options are insufficient or inadequate. Monotherapy for adults w/ relapsed or refractory mantle cell lymphoma (MCL). Adults w/ previously treated follicular lymphoma (Grade 1-3a) in combination w/ rituximab (anti-CD20 Ab).

NDMM Patient who has undergone ASCT Initially 10 mg once daily continuously (on days 1-28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of maintenance, dose can be increased to 15 mg once daily if tolerated. Patient who is not eligible for transplant in combination w/ dexamethasone 25 mg once daily on days 1-21 of repeated 28-day cycles + dexamethasone 40 mg once daily on days 1, 8, 15 & 22 of repeated 28-day cycles. Patient who is not eligible for transplant in combination w/ melphalan & prednisone followed by lenalidomide maintenance Initially 10 mg once daily on days 1-21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg on days 1-4 of repeated 28-day cycles, prednisone 2 mg/kg on days 1-4 of repeated 28-day cycles. Patients who complete 9 cycles or who are unable to complete combination therapy due to intolerance are treated w/ monotherapy: 10 mg once daily on days 1-21 of repeated 28-day cycles until disease progression. Multiple myeloma w/ at least 1 prior therapy Initially 25 mg once daily on days 1-21 of repeated 28-day cycles + dexamethasone 40 mg once daily on days 1-4, 9-12, & 17-20 of each 28-day cycle for the 1st 4 cycles of therapy & then 40 mg once daily on days 1-4 every 28 days. MDS Initially 10 mg once daily on days 1-21 of repeated 28-day cycles. MCL Initially 25 mg once daily on days 1-21 of repeated 28 cycles.

May be taken with or without food: Swallow whole preferably w/ water. Do not open/break/chew.

Hypersensitivity. Pregnancy & women w/ childbearing potential.

Birth defects. Increased risk of VTE in patients taking combined OCs. Increased risk of infection at the time of insertion of implants & levonorgestrel-releasing intrauterine systems & irregular vag bleeding. Not recommended w/ Cu-releasing IUD due to potential risks of infection at the time of insertion & menstrual blood loss which may compromise patients w/ neutropenia or thrombocytopenia. Pregnancy testing prior to starting treatment, follow-up & end of treatment is required. Do not donate blood during therapy or for 1 wk following discontinuation of treatment. MI. DVT & pulmonary embolism. Pulmonary HTN. Evaluate patients for signs & symptoms of underlying cardiopulmonary disease prior to initiating & during therapy. Neutropenia & thrombocytopenia. Perform CBC, including WBC count w/ differential count, platelet count, Hb, & haematocrit at baseline, every wk for the 1st 8 wk of treatment & mthly thereafter to monitor for cytopenias. Promptly report febrile episodes. Co-administration w/ other myelosuppressive agents. Hypo/hyperthyroidism. Peripheral neuropathy. Tumour flare reaction (TFR) & lysis syndrome in patients w/ high tumour burden prior to treatment. Monitoring & evaluation of TFR is recommended in patients w/ MCL & follicular lymphoma. High tumour burden in patients w/ MCL. Allergic reactions including angioedema, anaphylactic reaction & severe cutaneous reactions including SJS, TEN & DRESS. Second primary malignancies. Progression to AML in low- & intermediate-1-risk MDS. TP53 mutation. Progression to other malignancies in MCL. Monitor patients for development of second primary malignancies in follicular lymphoma. Hepatic disorders/failure. Monitoring of liver function particularly when there is history of or concurrent viral liver infection or when combined w/ medicinal products known to be associated w/ liver dysfunction. Infection w/ or w/o neutropenia. Viral reactivation. Monitor patients previously infected w/ HBV, including patients who are anti-HBc +ve but HBsAg -ve for signs & symptoms of active HBV infection throughout therapy. Progressive multifocal leukoencephalopathy. Cataract. Regular monitoring of visual ability is recommended. Renal impairment. Minor or moderate influence on the ability to drive & use machines. Use effective method of contraception for 4 wk before therapy, during therapy, & until 4 wk after therapy in women of childbearing potential. Pregnancy & lactation. Discontinue breastfeeding during therapy. Not to be used in childn & adolescents from birth to <18 yr. Elderly.

Pneumonia, lung infection; neutropenia, bronchitis, diarrhoea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough, thrombocytopenia, gastroenteritis & pyrexia; rash, URTI, fatigue & anemia.

May increase risk of thrombosis w/ erythropoietic agents, or HRT. Increased plasma exposure of digoxin. Increased risk of rhabdomyolysis w/ statins.

Cancer Immunotherapy

L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.

Rx