Revolade

Chronic immune thrombocytopaenia (ITP) in paed patients who have failed other treatments & either need an increased platelet conc for a planned procedure or are at a high risk of bleeding. Chronic ITP in adult patients who have had an inadequate response or are intolerant to corticosteroids & Ig. Thrombocytopenia in adult patients w/ chronic hepatitis C to allow the initiation & maintenance of interferon-based therapy. Severe aplastic anaemia (SAA) in combination w/ standard immunosuppressive therapy for the 1st-line treatment of adult & paed patients ≥2 yr. SAA in adult patients who have had an insufficient response to immunosuppressive therapy.

Chronic ITP Adult & childn 6-17 yr Initially 50 mg once daily. Max: 75 mg daily. Adult & childn 6-17 yr of East-/Southeast-Asian ancestry Initially 25 mg once daily. Childn 1-5 yr Initially 25 mg once daily. Max: 75 mg daily. Chronic hepatitis C associated thrombocytopenia Adult Initially 25 mg once daily. Adjust dose in 25 mg increments every 2 wk as necessary. Max: 100 mg once daily. 1st-line SAA Adult & childn 12-17 yr Initially 150 mg once daily for 6 mth. Adult & adolescent SAA patient of East-/Southeast-Asian ancestry Initially 75 mg once daily for 6 mth. Childn 6-11 yr Initially 75 mg once daily for 6 mth. Childn 6-11 yr of East-/Southeast-Asian ancestry Initially 37.5 mg once daily for 6 mth. Childn 2-5 yr Initially 2.5 mg/kg once daily for 6 mth. Childn 2-5 yr of East-/Southeast-Asian ancestry Initially 1.25 mg/kg once daily for 6 mth. Refractory SAA Adult Initially 50 mg once daily. Adjust dose in 50 mg increments every 2 wk as necessary. Max: 150 mg daily. East-/Southeast-Asian ancestry Initially 25 mg once daily.

Should be taken on an empty stomach: Swallow w/ a glass of water. Take at least 2 hr before or 4 hr after antacids/dairy products/Ca-containing food products/mineral supplements containing polyvalent cations.

Hypersensitivity.

Risk of hepatobiliary lab abnormalities, severe hepatotoxicity, & potentially fatal liver injury. Monitor serum ALT, AST, bilirubin levels prior to initiation of therapy, every 2 wk during dose adjustment phase & mthly following establishment of stable dose. Risk for hepatic decompensation in chronic HCV patients using α interferon therapy. Administer w/ caution in patients w/ known risk factors for thromboembolism (eg, advanced age, patients w/ prolonged periods of immobilisation, malignancies, contraceptives & HRT, surgery/trauma, obesity, smoking, Factor V Leiden, ATIII deficiency, & antiphospholipid syndrome). Closely monitor platelet count. Not indicated for treatment of thrombocytopenia in patients w/ chronic liver disease undergoing invasive procedures. Reports of QTc interval prolongation in patients w/ ITP & thrombocytopenic patients w/ HCV. Bleeding following discontinuation of Revolade; monitor platelet counts wkly for 4 wk after treatment discontinuation. Increased risk for development or progression of reticulin fibres w/in bone marrow. Cytogenic abnormalities in SAA patients. May stimulate progression of existing haematological malignancies eg, myelodysplastic syndromes. Perform routine monitoring for cataracts. Potential risk of photoallergy. Serum discoloration & interference w/ total bilirubin & creatinine testing. Should not be used in patients w/ hepatic impairment (Child-Pugh score ≥5) unless expected benefit outweighs identified risk of portal venous thrombosis. Caution w/ close monitoring in patients w/ impaired renal function. Should not be used during pregnancy & not recommended for nursing mothers unless expected benefit clearly outweighs potential risk. Safety & efficacy have not been established in paed patients w/ ITP younger than 1 yr, chronic HCV, refractory SAA, & definitive immunosuppressive therapy-naïve SAA younger than 2 yr.

Adult ITP patients: Diarrhoea, nausea; increased ALT; back pain. Paed ITP patients: Nasopharyngitis, URTI; cough; abdominal pain; pyrexia. HCV (in combination w/ antiviral interferon & ribavirin) population: Anaemia; decreased appetite; headache; cough; diarrhoea, nausea; hyperbilirubinaemia; pruritus, alopecia; myalgia; fatigue, pyrexia, chills, asthenia, oedema peripheral, flu-like illness; insomnia. Refractory SAA: Headache, dizziness; oropharyngeal pain, cough, dyspnoea, rhinorrhoea; nausea, diarrhoea, abdominal pain; increased transaminases; ecchymosis; arthralgia, pain in extremity, muscle spasms; fatigue, dizziness, pyrexia, febrile neutropenia; insomnia. 1st-line SAA (in combination w/ standard immunosuppressive therapy): increased ALT, AST, blood bilirubin (including ocular icterus).

Increased plasma C_max & AUC_0-∞ of rosuvastatin (OATP1B1 & BCRP substrate). Concomitant administration w/ OATP1B1 & BCRP substrates should be undertaken w/ caution. Decreased conc w/ lopinavir + ritonavir; polyvalent cations eg, Al, Ca, Fe, Mg, Se & Zn; ciclosporin; dairy products.

Haemostatics

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

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