Revolade

Eltrombopag olamine

Chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have failed treatment w/ steroids & platelet count <30,000/mm³ w/ clinical bleeding. Patients w/ chronic HCV infection for treatment of thrombocytopenia. Cytopenias in patients w/ severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy.

Chronic ITP Adult & ped patients 6-7 yr Initially 50 mg once daily. East Asian & ped patients 1-5 yr Initially 25 mg once daily. Platelet count <50,000/microL following at least 2 wk of therapy Increase daily dose by 25 mg to a max of 75 mg once daily, ≥200,000/microL to ≤400,000/microL Decrease daily dose by 25 mg & wait 2 wk for assessment. Patients w/ hepatic impairment Initially 25 mg once daily. Chronic HCV associated thrombocytopenia Adult Initially 25 mg once daily. Max: 100 mg once daily. East Asian patients 1-5 yr Initially 25 mg once daily. Platelet count <50,000/microL Increase daily dose by 25 mg up to max dose of 100 mg, ≥200,000/microL to ≤400,000/microL Decrease daily dose by 25 mg & wait 2 wk to assess. Hepatic impairment Initially 25 mg once daily. Severe aplastic anaemia Adult Initially 50 mg once daily. East Asian patients Initially 25 mg once daily. Platelet count <50,000/microL following at least 2 wk of treatment Increase daily dose by 25 mg to a max of 150 mg/day, ≥100,000/microL to ≤200,000/microL at any point during treatment Reduce daily dose by 50 mg & wait 2 wk to assess. Hepatic impairment Initially 25 mg once daily.

Should be taken on an empty stomach: Take at least 2 hr before or 4 hr after antacids, dairy products or other Ca-containing food products or mineral supplements containing polyvalent cations.

Hypersensitivity.

Closely monitor thrombocytopenic HCV patients w/ advanced chronic liver disease. Chemotherapy-induced thrombocytopenia & myelodysplastic syndrome (MDS). Measure serum ALT, AST, bilirubin levels prior to initiation of therapy, 2 wkly during dose adjustment & mthly following an established dose. Hepatic decompensation in patients w/ chronic hepatitis C: Monitor patients w/ low albumin levels or w/ model for end-stage liver disease (MELD) score ≥10 at baseline. Close monitoring of platelet count. Patients w/ known risk factors for thromboembolism including but not limited to inherited eg, factor V Leiden, ATIII deficiency or anti-phospholipid syndrome; advanced age; prolonged periods of immobilisation, malignancies, contraceptives & hormone replacement therapy, surgery/trauma, obesity & smoking. Not for treatment of thrombocytopenia in patients w/ chronic liver disease in prep for invasive procedures. Monitor platelet counts wkly for 4 wk following discontinuation of Revolade. Examine closely peripheral blood smear prior to initiation of therapy. Perform CBC w/ WBC count differential mthly. Routinely monitor for cataracts. May impair ability to drive or use machinery. Patients w/ impaired renal impairment & liver cirrhosis. Women of childbearing potential should use effective contraception during & for at least 7 days after stopping treatment. Pregnancy & lactation. Elderly ≥65 yr. Childn w/ chronic HCV & severe aplastic anemia.

Diarrhoea, nausea; increased alanine aminotransferase; URTI, nasopharyngitis; anaemia; decreased appetite; insomnia; headache; cough; hyperbilirubinaemia; pruritus, alopecia; myalgia; fatigue, pyrexia, chills, asthenia, oedema, flu-like illness; oropharyngeal pain, dyspnoea, rhinorrhoea; abdominal pain; increased transaminases; ecchymosis; arthralgia; pain in extremity; muscle spasms; febrile neutropenia. Cataract; hepatic failure, drug-induced liver injury; thromboembolic events; hyperbilirubinaemia; rash.

Decreased AUC_inf & C_max w/ polyvalent cation-containing antacids (Al hydroxide & Mg carbonate); dairy products. Decreased conc w/ lopinavir/ritonavir. Increase plasma C_max & AUC_inf of rosuvastatin; other OATP1B1 & BCRP substrates. Cyclosporine. 

Haemostatics

B02BX05 - eltrombopag ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.

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