Lenalidomide Alvogen

Lenalidomide

Monotherapy for newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Combination therapy w/ dexamethasone, or bortezomib & dexamethasone or melphalan & prednisone for previously untreated multiple myeloma who are not eligible for transplant. Combination w/ dexamethasone for multiple myeloma in patients who have received at least 1 prior therapy. Monotherapy for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated w/ isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Monotherapy for relapsed or refractory mantle cell lymphoma. Combination w/ rituximab for previously treated follicular lymphoma (Grade 1-3a).

Newly diagnosed multiple myeloma Maintenance in patient who have undergone autologous stem cell transplantation Initially 10 mg once daily on days 1-28 of repeated 28-day cycles. After 3 cycles, the dose may be increased to 15 mg once daily if tolerated. In combination w/ dexamethasone until disease progression in patient not eligible for transplant Initially 25 mg once daily on days 1-21 & dexamethasone 40 mg once daily on days 1, 8, 15 & 22 of repeated 28-day cycles. In combination w/ bortezomib & dexamethasone followed by lenalidomide & dexamethasone until disease progression in patient not eligible for transplant Initially 25 mg once daily on days 1-14 of each 21-day cycle for up to 8 cycles. Bortezomib 1.3 mg/m² SC inj twice wkly on days 1, 4, 8 & 11 of each 21-day. Continued treatment: 25 mg once daily on days 1-21 of repeated 28-day cycles in combination w/ dexamethasone. In combination w/ melphalan & prednisone followed by lenalidomide maintenance in patient not eligible for transplant 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. Monotherapy in patient who complete 9 cycles or are unable to complete combination therapy due to intolerance 10 mg once daily on days 1-21 of repeated 28-day cycles given 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 1st 4 cycles & then 40 mg once daily on days 1-4 every 28 days. Moderate renal impairment 10 mg once daily, may be increased to 15 mg once daily after 2 cycles. Severe renal impairment 15 mg every other day. ESRD 5 mg once daily. On dialysis days, administer dose following dialysis. Myelodysplastic syndromes Initially 10 mg once daily on days 1-21 of repeated 28-day cycles. Moderate renal impairment Initially 5 mg once daily. Dose level 1: 2.5 mg once daily. Dose level 2: 2.5 mg once every other day. Severe renal impairment Initially 2.5 mg once daily. Dose level 1: 2.5 mg every other day. Dose level 2: 2.5 mg twice wkly. ESRD Initially 2.5 mg once daily. Dose level 1: 2.5 mg every other day. Dose level 2: 2.5 mg twice wkly. On dialysis days, administer dose following dialysis. Mantle cell lymphoma Initially 25 mg once daily on days 1-21 of repeated 28-day cycles. Moderate renal impairment 10 mg once daily, may be increased to 15 mg once daily after 2 cycles. Severe renal impairment 15 mg every other day. ESRD 5 mg once daily. On dialysis days, administer dose following dialysis. Follicular lymphoma Initially 20 mg once daily on days 1-21 of repeated 28-day cycles for up to 12 cycles. Rituximab 375 mg/m² IV every wk in Cycle 1 (days 1, 8, 15 & 22) & day 1 of every 28-day cycle for cycles 2-5. Moderate renal impairment 10 mg once daily, may be increased to 15 mg once daily after 2 cycles.

May be taken with or without food: Swallow whole, do not open/chew/break.

Hypersensitivity. Women of childbearing potential. Pregnancy.

Allergic/hypersensitivity reactions; discontinue use if exfoliative or bullous rash or SJS, TEN or DRESS occur. Perform pregnancy test prior to & repeat at least every 4 wk including at least 4 wk after end of treatment. Do not donate blood during or at least 7 days following discontinuation. Closely monitor patients w/ known risk factors including prior thrombosis & minimize modiafiable risk factors eg, smoking, HTN, hyperlipidaemia; tumour lysis syndrome & tumour flare reaction especially during 1st cycle or dose-escalation; patients w/ known risk factors to develop infections including pneumonia; for signs & symptoms of active HBV infection throughout therapy. Increased risk of venous & arterial thromboembolic events; peripheral neuropathy. Observe signs & symptoms of bleeding including petechiae & epistaxes especially in concomitant use w/ medicinal products susceptible to induce bleeding. Perform CBC including WBC w/ differential count, platelet count, Hb & haematocrit every wk for 1st 8 wk & mthly thereafter; baseline & ongoing monitoring of thyroid function. Grade 4 neutropenia & febrile neutropenia; grade 3 & 4 thrombocytopenia. Ensure optimal control of comorbid conditions influencing thyroid function prior to treatment. Patients w/ high tumour burden prior to treatment. Evaluate secondary primary malignancies prior to & during treatment. Monitor liver function particularly when there is history of or concurrent viral liver infection or when combined w/ medicinal products associated w/ liver dysfunction. Patients previously infected w/ HBV including anti-HBc +ve but HBsAg -ve. Patients w/ ISS stage III, ECOG PS 2. Regularly monitor visual ability. May cause allergic reactions due to sunset yellow FCF (E110) & tartrazine (E102). Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ erythropoeitic agents or other agents that increase risk of thrombosis eg, HRT; myelosuppressive agents. Not recommended w/ combined OCs, implants, levonorgestrel-releasing intrauterine systems, copper-releasing intrauterine devices. May affect ability to drive & use machines. Patients w/ CrCl <60 mL/min. Hepatic disorders. Women of childbearing potential should use effective contraception for 4 wk prior to, during & 4 wk after last dose. Not to be used during lactation. Not to be used in childn & adolescents ≤18 yr. Elderly >75 yr.

Pneumonia, lung infection; neutropenia, bronchitis, diarrhoea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough, thrombocytopenia, gastroenteritis, pyrexia; URTI, fatigue, anaemia; hypotension, dehydration; peripheral neuropathy, constipation, hypocalcaemia; renal failure, back pain, insomnia, rash, decreased appetite; febrile neutropenia; peripheral oedema; venous thromboembolism, DVT, pulmonary embolism; grade 3 or 4 neutropenia & thrombocytopenia; nausea, pruritus.

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

Cancer Immunotherapy

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

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