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Linadex

Linadex

lenalidomide

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Lenalidomide
Indications/Uses
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. In combination 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 for patient ≥65 yr w/ previously untreated multiple myeloma who are not eligible for transplant.
Dosage/Direction for Use
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. Patients who complete 9 cycles or who are unable to complete combination therapy due to intolerance Monotherapy 10 mg orally 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. Myelodysplastic syndromes Initially 10 mg once daily on days 1-21 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: 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, severe (CrCl <30 mL/min, not requiring dialysis) 15 mg every other day, end-stage renal disease (CrCl <30 mL/min, requiring dialysis) 5 mg once daily. Administer dose following dialysis on dialysis days.
Administration
May be taken with or without food: Take at approx the same time each day. Swallow whole w/ water, do not open/break/chew.
Contraindications
Hypersensitivity. Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue use if exfoliative or bullous rash; Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction w/ eosinophilia & systemic symptoms is suspected; progressive multifocal leukoencephalopathy is confirmed. Not to be used in patients w/ history of severe rash associated w/ thalidomide treatment. Not to donate blood during therapy or for 4 wk following discontinuation. Not recommended for patients w/ high tumour burden. MI; venous & arterial thromboembolism, history of thromboembolic events; neutropenia & thrombocytopenia; hypo- & hyperthyroidism; peripheral neuropathy; tumour flare reaction & tumor lysis syndrome; increased 2nd primary malignancies; infection w/ or w/o neutropenia; viral reactivation eg, herpes zoster or HBV reactivation. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Monitor visual ability regularly for cataract. Concomitant use w/ erythropoietic agents; drugs inducing bleeding; other myelosuppressive agents. Not recommended w/ combined OC pills & copper-releasing IUD. May affect ability to drive & use machines. Hepatic disorders. Renal impairment. Women of childbearing potential should use effective method of contraception for 4 wk prior to, during & at least 4 wk after therapy. Pregnancy. Discontinue lactation during therapy. Not to be used in childn & adolescents <18 yr. Elderly.
Adverse Reactions
Pneumonia, upper resp tract infection, bacterial, viral & fungal infections including opportunistic infections, nasopharyngitis, pharyngitis, bronchitis; neutropenia, thrombocytopenia, anemia, hemorrhagic disorder, leucopenias; hypokalemia, hyperglycemia, hypocalcemia, decreased appetite, decreased wt; depression, insomnia, peripheral neuropathies excluding motor neuropathy, dizziness, tremor, dysgeusia, headache, paresthesia; cataracts, blurred vision; venous thromboembolic events, predominantly DVT & pulmonary embolism; dyspnoea, epistaxis, cough; diarrhea, constipation, abdominal pain, nausea, vomiting, dyspepsia, dry mouth, stomatitis; increased ALT & AST; rashes, pruritus; muscle spasm, bone pain, musculoskeletal pain & discomfort including back pain, arthralgia, pain in extremity, myalgia; renal failure including acute; fatigue, oedema including peripheral oedema, pyrexia, asthenia, influenza-like illness syndrome; increased blood alkaline phosphatase. Febrile neutropenia, pancytopenia; hypothyroidism; hypomagnesaemia, hyperuricemia, dehydration, hypercalcaemia; ataxia, impaired balance, neuralgia, dysaesthesia; reduced visual acuity; deafness including hypoacusis, tinnitus; atrial fibrillation, bradycardia; hypotension, HTN, ecchymosis; dysphonia; abnormal liver function tests, hyperbilirubinemia; urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema; muscular weakness, joint swelling; hematuria, urinary retention & incontinence; erectile dysfunction; chest pain, lethargy; increased C-reactive protein; fall, contusion.
Drug Interactions
Erythropoietic agents or other agents increasing risk of thrombosis eg, hormone replacement therapy. Reduced efficacy of OCs w/ dexamethasone. Close monitoring of warfarin conc during treatment. Increased plasma exposure of digoxin. Increased risk of rhabdomyolysis w/ statins.
MIMS Class
Cancer Immunotherapy
ATC Classification
L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Linadex cap 10 mg
Packing/Price
3 × 7's
Form
Linadex cap 15 mg
Packing/Price
3 × 7's
Form
Linadex cap 25 mg
Packing/Price
3 × 7's
Form
Linadex cap 5 mg
Packing/Price
3 × 7's
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