Vilena

Combination therapy w/ dexamethasone for adult patients w/ previously untreated multiple myeloma who are not eligible for transplant & who have relapsed or have progressive disease after receiving at least 1 prior therapy; w/ melphalan & prednisone for patient ≥65 yr w/ previously untreated multiple myeloma who are not eligible for transplant. Monotherapy for adult patients w/ transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated w/ an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate; w/ relapsed or refractory mantle cell lymphoma.

Newly diagnosed multiple myeloma In combination w/ dexamethasone until disease progression in patient not eligible for transplant Initially 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, >75 yr Dexamethasone 20 mg once daily on days 1, 8, 15 & 22 of each 28-day cycle. In combination w/ melphalan & prednisone followed by lenalidomide maintenance in patients who are not eligible for transplant Initially 10 mg once daily on days 1-21 of repeated 28-day 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 of therapy & then 40 mg once daily on days 1-4 every 28 days. Renal impairment Days 1-21 of repeated 28-day cycles: ESRD (CrCl <30 mL/min, requiring dialysis) 5 mg once daily. Administer dose following dialysis on dialysis days; severe (CrCl <30 mL/min, not requiring dialysis) 7.5 mg once daily or 15 mg every other day; Moderate (CrCl ≤30 to <50 mL/min) 10 mg once daily. May be escalated to 15 mg once daily after 2 cycles in unresponsive & tolerant patient. Myelodysplastic syndromes Initially 10 mg once daily on days 1-21 of repeated 28-day cycles. Renal impairment ESRD (CrCl <30 mL/min, requiring dialysis) Initially 2.5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg every other day on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg twice a wk on days 1-28 of repeated 28-day cycles. Administer dose following dialysis on dialysis days; severe (CrCl <30 mL/min, not requiring dialysis) Initially 2.5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg every other day on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg twice a wk on days 1-28 of repeated 28-day cycles; Moderate (CrCl ≤30 to <50 mL/min) Initially 5 mg once daily on days 1-21 of repeated 28-day cycles. Dose level -1: 2.5 mg once daily on days 1-28 of repeated 28-day cycles. Dose level -2: 2.5 mg once every other day on days 1-28 of repeated 28-day cycles. Mantle cell lymphoma Initially 25 mg once daily on days 1-21 of repeated 28-day cycles. Renal impairment Days 1-21 of repeated 28-day cycles: ESRD (CrCl <30 mL/min, requiring dialysis) 5 mg once daily. Administer dose following dialysis on dialysis days; severe (CrCl <30 mL/min, not requiring dialysis) 7.5 mg once daily or 15 mg every other day; Moderate (CrCl ≤30 to <50 mL/min) 10 mg once daily. May be escalated to 15 mg once daily after 2 cycles in unresponsive & tolerant patient.

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

Hypersensitivity. Women of childbearing potential. Pregnancy.

Allergic/hypersensitivity reactions; discontinue use if exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected. Not to be used in patients w/ history of severe rash associated w/ thalidomide treatment. Teratogenic risk during pregnancy. Male patients, including those who have had a vasectomy, should use condoms during treatment, & for 1 wk after dose interruptions &/or cessation of treatment if their partner is pregnant or of childbearing potential & has no contraception. Combined OC pills & insertion of Cu-releasing IUD are not recommended. Perform medically supervised pregnancy test w/ min sensitivity of 25 mIU/mL in women of childbearing potential prior to starting treatment, to be repeated every 4 wk, & 4 wk after treatment. Not to donate blood during therapy or for 1 wk following discontinuation. Closely monitor patients w/ known risk factors of MI, thromboembolism including prior thrombosis, & should minimize all modifiable risk factors eg, smoking, HTN & hyperlipidaemia. Increased risk of venous & arterial thromboembolic events. Concomitant use w/ erythropoeitic agents or other agents that increase risk of thrombosis eg, HRT; myelosuppressive agents. Perform CBC including WBC w/ differential count, platelet count, Hb & haematocrit at baseline every wk for the 1st 8 wk of treatment & mthly thereafter. Promptly report febrile episodes. Observe signs & symptoms of bleeding including petechiae & epistaxes, especially in patients in concomitant use w/ medicinal products susceptible to induce bleeding. Grade 4 neutropenia & febrile neutropenia; grade 3 & 4 thrombocytopenia. Optimal control of comorbid conditions influencing thyroid function prior to start of treatment & baseline & on-going monitoring is recommended. Peripheral neuropathy. Closely monitor patients at risk of tumour lysis syndrome & tumour flare reaction especially during the 1st cycle or dose-escalation. Not recommended in patients w/ high tumour burden. Not to be taken by patients w/ galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption. Carefully evaluate for occurrence of hematologic secondary primary malignancies prior to initiating & during treatment. Closely monitor patients w/ known risk factors to develop infections including pneumonia; for signs & symptoms of active HBV infection throughout therapy. Patients previously infected w/ HBV, including anti-HBc +ve but HBsAg -ve. Regular monitoring of visual ability is recommended due to risk of cataract in prolonged use. Permanently discontinue if progressive multifocal leukoencephalopathy is confirmed. Minor or moderate influence on the ability to drive or use machines. Renal impairment. Hepatic disorders; monitor 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. Women of childbearing potential must use 1 effective method of contraception for 4 wk before, during, & until 4 wk after therapy & even in case of dose interruption. Discontinue breastfeeding during therapy. Not to be used in childn & adolescents <18 yr. Elderly. Patients >75 yr, ISS stage III, ECOG PS ≥2 or CrCl <60 mL/min.

Pneumonia, bacterial, viral & fungal infections (including opportunistic infections), nasopharyngitis, pharyngitis; neutropenia, thrombocytopenia, anemia, leucopenias; hypokalaemia, decreased appetite, decreased wt; insomnia; peripheral neuropathy, dizziness, dysgeusia, headache, paraesthesia; dyspnoea, epistaxis, cough; diarrhoea, constipation, abdominal pain, nausea, vomiting, dyspepsia, dry mouth; rashes, pruritus; muscle spasm, musculoskeletal pain (including back pain & pain in extremity), arthralgia, myalgia; fatigue, peripheral oedema, pyrexia, asthenia, flu-like illness syndrome. Sinusitis; febrile neutropenia; hypothyroidism; dehydration; hypotension, HTN; abnormal LFTs; dry skin; muscular weakness. Multiple myeloma: URTI, bronchitis; hemorrhagic disorder; hyperglycaemia, hypocalcaemia; depression, tremor; cataracts, blurred vision; venous thromboembolic events, predominantly DVT & pulmonary embolism; stomatitis; increased ALT & AST; bone pain, connective tissue pain & discomfort; renal failure (including acute); oedema; increased blood alkaline phosphatase. Sepsis; pancytopenia; hypomagnesaemia, hyperuricaemia, hypercalcaemia; ataxia, impaired balance, neuralgia, dysaesthesia; reduced visual acuity; deafness (including hypoacusis), tinnitus; atrial fibrillation, bradycardia; ecchymosis; dysphonia; GI haemorrhage (including rectal, haemorrhoidal, peptic ulcer haemorrhage & gingival bleeding), dysphagia; hyperbilirubinemia; urticaria, hyperhidrosis, skin hyperpigmentation, eczema, erythema; joint swelling; haematuria, urinary retention & incontinence; erectile dysfunction; chest pain, lethargy; increased C-reactive protein; fall, contusion. Myelodysplastic syndromes: Fe overload; haematoma. Mantle cell lymphoma: Allergic dermatitis. Tumour flare reaction; vertigo; night sweats; chills.

Increased risk of thrombosis w/ erythropoietic agents or other agents eg, HRT. Reduced efficacy of OCs w/ dexamethasone. Close monitoring of warfarin conc during treatment. 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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