Lenangio

Lenalidomide

Monotherapy for maintenance of adults w/ newly diagnosed multiple myeloma (NDMM) who have undergone autologous hematopoietic stem cell transplantation (Auto-HSCT). In combination w/ dexamethasone for multiple myeloma in adults.

NDMM Maintenance in patient who have undergone Auto-HSCT Initially 10 mg once daily continuously on days 1-28 of repeated 28-day cycles until disease progression or intolerance. May be increased after 3 cycles to 15 mg once daily if tolerated. In combination w/ dexamethasone until disease progression or intolerance 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. Patient ≥75 yr Dexamethasone 20 mg once daily on days 1, 8, 15 & 22 of each 28-day cycle. 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 (CrCl ≤30 to <50 mL/min) 10 mg once daily, may be escalated to 15 mg once daily after 2 cycles if unresponsive & tolerant to treatment, severe renal impairment (CrCl <30 mL/min, not requiring dialysis) 7.5 mg once daily or 15 mg every other day, ESRD (CrCl <30 mL/min, requiring dialysis) 5 mg once daily. Administer dose following dialysis on dialysis days.

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

Hypersensitivity. Women of childbearing potential. Pregnancy.

Permanently discontinue treatment if progressive multifocal leukoencephalopathy (PML) is confirmed. Discontinue treatment in case of angioedema, anaphylactic reaction, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected; if patient experiences any thromboembolic events. Consider interruption or discontinuation if other forms of skin reaction occur. Suspend further dosing if PML is suspected. Not to be used by patients w/ history of severe rash associated w/ thalidomide treatment. Not to donate blood during therapy or for 4 wk after discontinuation. MI particularly in patients at risk & w/in 1st 12 mth when used in combination w/ dexamethasone. Increased risk of VTE (DVT & pulmonary embolism), arterial thromboembolism (MI & cerebrovascular event) when used w/ dexamethasone. Higher frequency of cataract when used w/ dexamethasone for prolonged period. Neutropenia; thrombocytopenia; hypo-/hyperthyroidism; peripheral neuropathy; tumour lysis syndrome (TLS) & tumour flare reaction (TFR); angioedema, anaphylactic reaction & severe cutaneous reactions eg, SJS, TEN, DRESS; second primary malignancies (SPM); hepatic failure including fatal cases eg, acute hepatic failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis & mixed cytolytic/cholestatic hepatitis; abnormal LFTs; penumonia; viral reactivation including herpes zoster or HBV reactivation; PML. Acute graft-versus-host disease following allogeneic hematopoietic transplant. Monitor closely & minimize all modifiable risk factors eg, smoking, HTN & hyperlipidaemia in patients w/ known risk factors for MI; thromboembolism. Observe for signs & symptoms of thromboembolism. Control co-morbid conditions influencing thyroid function before initiating treatment. Closely monitor patients at risk of TLS & TFR especially during 1st cycle or dose-escalation; who had previous allergic reactions while concomitantly treated w/ thalidomide; w/ risk factors for infections; who were previously infected w/ HBV including those who are anti-HBc +ve but HBsAg -ve. Evaluate patients before & during treatment using standard cancer screening for occurrence of SPM. Establish HBV status before initiating treatment. Monitor patients at regular intervals & consider PML in the differential diagnosis in patients w/ new or worsening neurological symptoms, cognitive or behavioural signs or symptoms; thyroid function; liver function; visual ability regularly. Perform CBC including WBC count w/ differential & platelet count, Hb & hematocrit at baseline, every wk for 1st 8 wk & mthly thereafter. Observe signs & symptoms of bleeding including petechiae & epistaxes especially in patients receiving concomitant medicinal products susceptible to induce bleeding. Concomitant use w/ erythropoietic agents; other myelosuppressive agents. May affect ability to drive & use machines. Nondialysis patients w/ CrCl <11 mL/min or in ESRD patients on hemodialysis w/ CrCl <7 mL/min. Male patients w/ female partner of childbearing potential must use effective contraception during treatment & for at least 4 wk after dose interruption &/or cessation. Women of childbearing potential should use at least 1 effective method of contraception for at least 4 wk before, during & until at least 4 wk after therapy & in case of dose interruption. Perform pregnancy test w/ min sensitivity of 25 mIU/mL; 3 days prior or during consultation & repeated at least every 4 wk, including at least 4 wk after end of treatment. Stop treatment if pregnancy occurs. Discontinue lactation during therapy. Not to be used in childn & adolescents from birth to <18 yr. Increased incidence of serious adverse events in patients >75 yr.

Pneumonia, URTI, neutropenic infection, bronchitis, flu, gastroenteritis, sinusitis, nasopharyngitis, rhinitis, bacterial, viral & fungal infections (including opportunistic infections), pharyngitis; neutropenia, febrile neutropenia, thrombocytopenia, anemia, leucopenia, lymphopenia, haemorrhagic disorder; hypokalaemia, hyper-/hypoglycaemia, hypocalcaemia, hyponatraemia, decreased appetite & wt, dehydration; paraesthesia, peripheral neuropathies (excluding motor neuropathy), dizziness, tremor, dysgeusia, headache; cough, dyspnoea, epistaxis; diarrhoea, constipation, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis; abnormal LFTs, increased ALT/AST; rash, dry skin, pruritus; muscle spasms/weakness, bone pain, musculoskeletal & connective tissue pain & discomfort (including back pain), pain in extremity, arthralgia, myalgia; fatigue, asthenia, pyrexia, oedema (including peripheral oedema), flu-like illness syndrome; depression, insomnia; cataracts, blurred vision; venous thromboembolic events (DVT & pulmonary embolism), hypotension; renal failure; increased blood alkaline phosphatase. Infection, UTI, lower resp tract & lung infection, sepsis, bacteraemia, bacterial lower resp tract infection, herpes zoster, cellulitis, infectious enterocolitis; myelodysplastic syndrome, AML, squamous cell carcinoma of skin; pancytopenia, haemolytic anemia; ataxia, impaired balance, neuralgia, dysaesthesia, CVA, syncope; HTN, ecchymosis, vasculitis; rhinorrhoea, dysphonia, resp distress; upper abdominal pain, GI haemorrhage (including rectal, haemorrhoidal & peptic ulcer haemorrhage & gingival bleeding), dysphagia; urticaria, hyperhidrosis, skin hyperpigmentation, eczema, erythema; joint swelling; hypothyroidism; hypomagnesaemia, hyperuricaemia, hypercalcaemia, DM, hypophosphataemia, gout, reduced visual acuity; deafness (including hypoacusis), tinnitus; atrial fibrillation, bradycardia, MI, CHF, tachycardia, cardiac failure, myocardial ischaemia; hyperbilirubinaemia, cholestasis, hepatotoxicity; haematuria, urinary retention & incontinence; erectile dysfunction; chest pain, lethargy; increased C-reactive protein; fall, contusion. Hyperthyroidism; SJS, TEN, DRESS.

May enhance adverse/toxic effect of abatacept; anakinra; bisphosphonate derivatives; canakinumab; clozapine; leflunomide; natalizumab; rilonacept; tofacitinib; live vaccines; vedolizumab. May diminish therapeutic effect of intravesical BCG; nivolumab; sipuleucel-T; inactivated vaccines. May enhance immunosuppressive effect of certolizumab pegol; fingolimod; tofacitinib. May diminish diagnostic effect of coccidioidin skin test. May enhance neutropenic effect of deferiprone. Enhanced adverse/toxic effect w/ denosumab; dipyrone; pimecrolimus; topical tacrolimus. Enhanced thrombogenic effect w/ systemic dexamethasone; erythropoiesis-stimulating agents; estrogen derivatives. Increased digoxin serum conc. Diminished therapeutic effect w/ echinacea. Enhanced immunosuppressive effect w/ roflumilast; tocilizumab. Additive effect w/ statins. Enhanced neutropenic effect w/ trastuzumab.

Cancer Immunotherapy

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

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