Revolade

Revolade

Manufacturer:

Novartis Oncology

Distributor:

DKSH
Concise Prescribing Info
Contents
Eltrombopag olamine
Indications/Uses
Treatment of chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts & reduce or prevent bleeding. Patients w/ chronic HCV infections for the treatment of thrombocytopenia. Treatment of cytopenias in patients w/ severe aplastic anemia (SAA).
Dosage/Direction for Use
Individualized dosage based on patient's platelet count. Immune thrombocytopenia Adult & ped 6-17 yr Starting dose: 50 mg once daily. Max: 75 mg daily. Ped 1-5 yr Starting dose: 25 mg once daily. Chronic HCV-associated thrombocytopenia Adult Starting dose: 25 mg once daily. Should be adjusted in 25-mg increments every 2 wk to achieve target platelet count. Max dose: 100 mg once daily. Severe aplastic anemia Adult Starting dose: 50 mg once daily. Max dose: 150 mg once daily. Hepatic impairment & Asian ancestry Initially 25 mg once daily.
Administration
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.
Special Precautions
Not established for use in other thrombocytopenic conditions. Measure serum ALT, AST & bilirubin prior to initiation of treatment 2 wkly during dose adjustment phase & mthly following establishment of stable dose. Hepatic disease. Known risk factors for thromboembolism. Not for treatment of thrombocytopenia in patients w/ chronic liver disease in prep for invasive procedures. Closely monitor complete blood counts including platelet counts & peripheral blood smear. Malignancies & progression of malignancies. Cataracts. May interfere w/ serological testing. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Adult ITP: Pharyngitis; diarrhoea, nausea, vomiting, dry mouth; cataract; increased AST & ALT, hyperbilirubinaemia; alopecia, rash; back pain, musculoskeletal pain, myalgia, thromboembolic events, thrombotic microangiopathy w/ acute renal failure. Ped ITP: Upper resp tract infection, nasopharyngitis; cough, oropharyngeal pain, rhinorrhoea; abdominal pain, toothache; pyrexia. HCV in combination w/ interferon therapy: Anaemia; decreased appetite; headache; cataract; nausea, diarrhoea; hyperbilirubinaemia, hepatic failure, drug-induced liver injury; pruritus, alopecia, rash; myalgia; fatigue, pyrexia, chills, asthenia, oedema, flu-like illness; thromboembolic events. SAA: Headache; cataract; oropharyngeal pain, cough, rhinorrhoea; nausea, diarrhoea, abdominal pain; increased transaminases, hypebilirubinaemia; rash; arthralgia, pain in extremity, muscle spasms; fatigue, dizziness, pyrexia.
Drug Interactions
Decreased Cmax & AUC w/ cyclosporine. Decreased plasma eltrombopag & Cmax w/ polyvalent cations (chelation) eg, antacids, dairy products & other products containing polyvalent cations eg Al, Ca, Fe, Mg, selenium, Zn (administer at least 2 hr before or 4 hr after). Decreased conc w/ lopinavir/ritonavir. May increase plasma conc of rosuvastatin & other OATP1B1 & BCRP substrates.
MIMS Class
ATC Classification
B02BX05 - eltrombopag ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Revolade FC tab 25 mg
Packing/Price
2 × 7's
Form
Revolade FC tab 50 mg
Packing/Price
2 × 7's
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