LINAMIDE
LENALIDOMIDE · by HIMMEL
Composition
Cap 10 mg/25 mg: Lenalidomide 10 mg/25 mg
Indications & Dosage
Newly diagnosed multiple myeloma after autologous stem cell transplantation: Adult: 10 mg once daily for 28 consecutive days of repeated 28-day cycles; increased if tolerated to 15 mg once daily, after 3 cycles. Newly diagnosed multiple myeloma when transplant is not possible (in combination with dexamethasone), Multiple myeloma with prior therapy (in combination with dexamethasone): Adult: 25 mg once daily for 21 consecutive days of repeated 28-day cycles, for doses of dexamethasone, for dose adjustments due to side-effects consult product literature. Newly diagnosed multiple myeloma when transplant is not possible (in combination with melphalan and prednisone): Adult: 10 mg once daily for 21 consecutive days of repeated 28-day cycles for up to 9 cycles, patients who complete 9 cycles or are intolerant to combination therapy should continue treatment with lenalidomide as monotherapy. Newly diagnosed multiple myeloma in patients not eligible for transplant (in combination with bortezomib and dexamethasone): Adult: 25 mg once daily for 14 consecutive days of repeated 21-day cycles for up to 8 cycles, followed by 25 mg once daily for 21 consecutive days of repeated 28-day cycles (in combination with dexamethasone alone), for doses of bortezomib and dexamethasone, for dose adjustments due to side-effects consult product literature. Myelodysplastic syndromes: Adult: 10 mg once daily for 21 consecutive days of repeated 28-day cycles. Mantle cell lymphoma: Adult: 25 mg once daily for 21 consecutive days of repeated 28-day cycles.
Contraindications
Severe heart failure
Precautions
High tumour burden; risk of tumour lysis syndrome, patients with risk factors for myocardial infarction, Thromboembolism Risk factors for thromboembolism (such as smoking, hypertension, hyperlipidaemia) should be minimised and thromboprophylaxis should be considered in patients with multiple risk factors. Second primary malignancy Patients should be carefully evaluated before and during treatment. Reduce dose in moderate to severe renal impairment
Interactions
Hepatotoxic drugs, oral contraceptives, P-gp inhibitors, digoxin, warfarin, other myelosuppressive agents.
Pregnancy
Contraindicated
Lactation
Discontinue breast-feeding
Side Effects
Anaemia, appetite decreased, arthralgia, asthenia, atrial fibrillation, chills, constipation, decreased leucocytes, dehydration, diarrhoea, dizziness, dyspnoea, electrolyte imbalance, embolism and thrombosis, fever, GI discomfort, GI disorders, haemorrhage, headache, heart failure, hyperglycaemia, hypertension, hyperthyroidism, hypotension, hypothyroidism, insomnia, lethargy, muscle weakness, myocardial infarction, nausea, neoplasms, nerve disorders, neutropenia, night sweats, pain, pancytopenia, paraesthesia, peripheral oedema, renal failure, respiratory disorders, rhinorrhoea, sepsis, skin reactions, thrombocytopenia, tumour flare, vertigo, vomiting. Rare: Angioedema, severe cutaneous adverse reactions (SCARs), tumour lysis syndrome, acquired haemophilia, hepatic disorders, hypersensitivity, hypersensitivity vasculitis, pancreatitis, solid organ transplant rejection