Linadex 5/Linadex 10/Linadex 15/Linadex 25

Lenalidomide

As monotherapy for maintenance treatment of adults w/ newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. In combination therapy w/ dexamethasone, or bortezomib & dexamethasone, or melphalan & prednisone for adults w/ previously untreated multiple myeloma who are not eligible for transplant. In combination w/ dexamethasone for multiple myeloma in adults who have received at least 1 prior therapy. As monotherapy for adults 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. As monotherapy for adults w/ relapsed or refractory mantle cell lymphoma.

Newly diagnosed multiple myeloma In combination w/ dexamethasone until disease progression in patient who is 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. In combination w/ bortezomib & dexamethasone followed by lenalidomide & dexamethasone until disease progression in patient who is not eligible for transplant Initially 25 mg once daily on days 1-14 of each 21-day cycle w/ dexamethasone & bortezomib twice wkly on days 1, 4, 8 & 11 of each 21-day cycle. Up to eight 21-day treatment cycles (24 wk of initial treatment) are recommended. Continue 25 mg once daily on days 1-21 of repeated 28-day cycles w/ dexamethasone until disease progression. In combination w/ melphalan & prednisone followed by lenalidomide maintenance in patient who is 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 & prednisone 2 mg/kg on days 1-4 of repeated 28-day cycles. Patient who completes 9 cycles or who is unable to complete the combination therapy due to intolerance Monotherapy 10 mg once daily on days 1-21 of repeated 28-day cycles until disease progression. Maintenance in patient who have undergone autologous stem cell transplantation Initially 10 mg once daily continuously (on days 1-28 of repeated 28-day cycles) until disease progression or intolerance. May be increased to 15 mg once daily after 3 cycles of maintenance if tolerated. 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. 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. Patient >75 yr In combination w/ dexamethasone Initially, dexamethasone 20 mg once daily on days 1, 8, 15, & 22 of each 28-day treatment cycle. Renal impairment Multiple myeloma & mantle cell lymphoma Moderate (CrCl 30-<50 mL/min) 10 mg once daily; severe (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. Myelodysplastic syndromes Moderate (CrCl 30-<50 mL/min) Initially 5 mg once daily. Dose reduction: 2.5 mg once daily or 2.5 mg every other day (days 1-28 of repeated 28-day cycles); severe (CrCl <30 mL/min, not requiring dialysis) Initially 2.5 mg once daily. Dose reduction: 2.5 mg every other day or 2.5 mg twice a wk (days 1-28 of repeated 28-day cycles); ESRD (CrCl <30 mL/min, requiring dialysis) Initially 2.5 mg once daily. Dose reduction: 2.5 mg every other day or 2.5 mg twice a wk (days 1-28 of repeated 28-day cycles). Administer dose following dialysis on dialysis days.

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

Hypersensitivity. Women of childbearing potential. Pregnancy.

Cross-reaction w/ thalidomide; not to be used in patients w/ history of severe rash associated w/ thalidomide treatment. Discontinue use if exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected. Prophylactic antithrombotic medicines are recommended, especially in patients w/ additional thrombotic risk factors. Hypo- & hyperthyroidism; baseline & ongoing monitoring of thyroid function is recommended. Peripheral neuropathy. Tumour lysis syndrome & tumour flare reaction; not recommended for the treatment of patients w/ high tumour burden. Increased risk of secondary primary malignancies. Progression to AML in low- & intermediate-1-risk myelodysplastic syndromes; other malignancies in mantle cell lymphoma. Infection w/ or w/o neutropenia. Viral reactivation including herpes zoster or HBV reactivation. Permanently discontinue if progressive multifocal leukoencephalopathy is confirmed. Patients should not donate blood during therapy or for at least 7 days following discontinuation. Perform CBC including WBC w/ differential count, platelet count, Hb, & haematocrit at baseline every wk for the 1st 8 wk of treatment & mthly thereafter. Regularly monitor visual acuity. Concomitant use w/ medicinal products susceptible to induce bleeding. Co-administration w/ other myelosuppressive agents. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic disorders. Minor or moderate influence on the ability to drive and use machines. Women of childbearing potential must use effective method of contraception for at least 4 wk before, during, & until at least 4 wk after therapy; use of combined oral contraceptive pills are not recommended. Male patients should use condoms throughout treatment duration, during dose interruption & for 1 wk after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception. Discontinue use during lactation. Not to be used in childn & adolescents from birth to <18 yr. In combination w/ dexamethasone: MI particularly those w/ known risk factors (including prior thrombosis) & w/in the 1st 12 mth. Increased risk of venous (predominantly DVT & pulmonary embolism) or arterial (predominantly MI & cerebrovascular event) thromboembolism in patients w/ myeloma. Concomitant administration w/ erythropoietic agents, or other agents that may increase the risk of thrombosis eg, HRT.

Multiple myeloma: Pneumonia, URTI, bronchitis, nasopharyngitis, rhinitis; neutropenia, thrombocytopenia, anemia, leucopenia, lymphopenia; hypokalaemia; paraesthesia; cough; diarrhoea, constipation, abdominal pain, nausea; rash; muscle spasms; fatigue, asthenia, pyrexia. UTI, lung infection. Maintenance therapy: Neutropenic infection, flu, gastroenteritis, sinusitis; febrile neutropenia; abnormal LFTs; dry skin. Infection, lower resp tract infection, myelodysplastic syndrome; peripheral neuropathy; pulmonary embolism; dyspnoea, rhinorrhoea; vomiting, upper abdominal pain; myalgia, musculoskeletal pain. Combination therapy: Bacterial, viral & fungal infections (including opportunistic infections), pharyngitis, haemorrhagic disorder, hyperglycaemia, hypoglycaemia, hypocalcaemia, hyponatraemia, dehydration, decreased appetite, decreased wt; depression, insomnia, peripheral neuropathies, dizziness, tremor, dysgeusia, headache; cataracts, blurred vision; VTE predominantly DVT & pulmonary embolism, hypotension; dyspnoea, epistaxis, vomiting, dyspepsia, dry mouth, stomatitis; increased ALT & AST; pruritus; muscular weakness, bone pain, musculoskeletal & connective tissue pain & discomfort (including back pain), pain in extremity, myalgia, arthralgia; renal failure (including acute); oedema (including peripheral oedema), flu-like illness syndrome; increased blood alkaline phosphatase. Sepsis, sinusitis; febrile neutropenia, pancytopenia; hypothyroidism; hypomagnesaemia, hyperuricaemia, hypercalcaemia; ataxia, impaired balance, syncope, neuralgia, dysaesthesia; reduced visual acuity; deafness (including hypoacusis), tinnitus; atrial fibrillation, bradycardia; HTN, ecchymosis; dysphonia; GI haemorrhage (including rectal/haemorrhoidal/peptic ulcer haemorrhage & gingival bleeding), dysphagia; hepatocellular injury, abnormal LFTs, hyperbilirubinaemia; urticaria, hyperhidrosis, dry skin, skin hyperpigmentation, eczema, erythema; joint swelling, haematuria, urinary retention/incontinence; erectile dysfunction, chest pain, lethargy; increased c-reactive protein; fall, contusion. Myelodysplastic syndromes & mantle cell lymphoma: Bacterial, viral & fungal infections (including opportunistic infections); thrombocytopenia, neutropenia, leucopenia; decreased appetite; diarrhoea, nausea, vomiting, constipation; rashes, pruritus; muscle spasms; fatigue; peripheral oedema, flu-like syndrome. Myelodysplastic syndromes: Hypothyroidism; dizziness, headache; epistaxis; abdominal pain (including upper); dry skin; musculoskeletal pain (including back pain & pain in extremity), arthralgia, myalgia. Fe overload, decreased wt; paraesthesia; HTN, haematoma; dry mouth, dyspepsia; abnormal LFTs. Mantle cell lymphoma: Nasopharyngitis, pneumonia; anemia; decreased wt, hypokalemia; dyspnoea; back pain; asthenia. Sinusitis; tumour flare reaction; febrile neutropenia; dehydration; insomnia; dysguesia, headache, peripheral neuropathy; vertigo; hypotension; abdominal pain; night sweats, dry skin; arthralgia, pain in extremity, muscular weakness; chills.

Erythropoietic agents or other agents that may increase risk of thrombosis eg, HRT. Increased plasma exposure of digoxin. Increased risk of rhabdomyolysis w/ statins.

Cancer Immunotherapy / Immunosuppressants

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

Rx