دواعي استعمال ريفليميد 10مجم 21 كبسولة

Lenalidomide 10 mg hard capsules (Revlimid), thalidomide-analogue immunomodulatory antineoplastic agent.

• Multiple myeloma: maintenance after autologous stem cell transplantation (monotherapy); previously untreated transplant-ineligible patients in combination with dexamethasone, bortezomib/dexamethasone or melphalan/prednisone; and patients with at least one prior therapy in combination with dexamethasone (adults).الفئة: AdultsEuropean Medicines Agency (EMA)
• Transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q when other options are insufficient (adults).الفئة: AdultsEuropean Medicines Agency (EMA)
• Relapsed or refractory mantle cell lymphoma (adults, monotherapy).الفئة: AdultsEuropean Medicines Agency (EMA)
• Previously treated follicular lymphoma (grade 1-3a) in combination with rituximab (adults).الفئة: AdultsEuropean Medicines Agency (EMA)

• With maintenance after ASCT, adverse reactions more frequent than placebo included neutropenia, bronchitis, diarrhoea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough and thrombocytopenia; serious reactions included pneumonia and lung infection.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or any excipient.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Women who are pregnant.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Teratogenicity: lenalidomide is structurally related to thalidomide and a teratogenic effect in humans is expected; the Pregnancy Prevention Programme (contraception, pregnancy testing, condom use by male patients) must be followed.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• Boxed warning: embryo-fetal toxicity, hematologic toxicity (neutropenia and thrombocytopenia), and venous and arterial thromboembolism; available only through a restricted distribution programme in the US.نشرة دولية لنفس المنتج · DailyMed (U.S. National Library of Medicine)
• Increased risk of venous thromboembolism (mainly deep vein thrombosis and pulmonary embolism) and arterial thromboembolism, particularly in combination with dexamethasone in multiple myeloma.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• An increase in second primary malignancies has been observed in clinical trials.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• DigoxinLenalidomide 10 mg daily increased digoxin plasma exposure by about 14%; monitoring of digoxin concentration is advised.European Medicines Agency (EMA)
• WarfarinNo pharmacokinetic interaction shown, but the effect during clinical use with dexamethasone is unknown; close monitoring of warfarin concentration is advised.European Medicines Agency (EMA)

• Contraindicated in pregnancy; if taken during pregnancy a teratogenic effect in humans is expected.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
• It is not known whether lenalidomide is excreted in breast milk; breast-feeding should be discontinued during therapy.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• Complete blood count (including differential, platelets, haemoglobin, haematocrit) at baseline, weekly for the first 8 weeks and monthly thereafter.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)

• ليناليدوميد: Immunomodulatory, antiangiogenic and antineoplastic actions (cereblon-mediated); thalidomide analogue.