Lenangio

Lenangio

lenalidomide

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Lenalidomide
Indications/Uses
Monotherapy for maintenance of adult patients w/ newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. In combination w/ dexamethasone for previously untreated multiple myeloma patients not eligible for transplant & for multiple myeloma in patients who have received at least 1 prior therapy.
Dosage/Direction for Use
Newly diagnosed multiple myeloma 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 after 3 cycles 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 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. 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: 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 the same time each day. Swallow whole w/ water, do not open/chew/break.
Contraindications
Hypersensitivity. Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue use if exfoliative or bullous rash; SJS, TEN or DRESS 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. MI; venous & arterial thromboembolism, history of thromboembolic events; neutropenia & thrombocytopenia; hypo- & hyperthyroidism; peripheral neuropathy; tumour flare reaction & tumour lysis syndrome; increased 2nd primary malignancies; infection w/ or w/o neutropenia; viral reactivation eg, herpes zoster or HBV reactivation. Monitor visual acuity 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 & men must use effective contraception for at least 4 wk prior to, during & at least 4 wk after therapy. Not to be used during pregnancy. Discontinue lactation during therapy. Not to be used in childn & adolescents <18 yr. Elderly.
Adverse Reactions
Pneumonia, upper resp tract infection, bronchitis, nasopharyngitis; neutropenia, thrombocytopenia, anemia, leucopenia; hypokalaemia; diarrhoea, constipation, abdominal pain, nausea; rash; muscle spasms; fatigue, asthenia, pyrexia. Monotherapy: Neutropenic infection, flu, gastroenteritis, sinusitis, rhinitis; febrile neutropenia, lymphopenia; paraesthesia; cough; abnormal liver function tests; dry skin. Combination w/ dexamethasone: Bacterial, viral & fungal infections, pharyngitis; haemorrhagic disorder; hyperglycaemia, hypocalcaemia, decreased appetite & wt; depression, insomnia; peripheral neuropathies (excluding motor neuropathy), dizziness, tremor, dysgeusia, headache; cataracts, blurred vision; venous thromboembolic events predominantly DVT & pulmonary embolism; dyspnoea, epistaxis; vomiting, dyspepsia; pruritus; bone pain, musculoskeletal & connective tissue pain & discomfort, arthralgia; renal failure; oedema, flu-like illness syndrome.
Drug Interactions
Reduced efficacy of OCs w/ dexamethasone. Increased plasma exposure of digoxin. Increased risk of rhabdomyolysis w/ statins. Erythropoietic agents or other agents increasing risk of thrombosis eg, hormone replacement therapy. Close monitoring of warfarin conc.
ATC Classification
L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Lenangio hard cap 25 mg
Packing/Price
3 × 7's
Form
Lenangio hard cap 15 mg
Packing/Price
3 × 7's
Form
Lenangio hard cap 5 mg
Packing/Price
3 × 7's
Form
Lenangio hard cap 10 mg
Packing/Price
3 × 7's
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