Revolade

Eltrombopag olamine

Treatment of previously treated adult & ped patients ≥1 yr w/ immune thrombocytopenia (ITP) lasting ≥6 mth from diagnosis to increase platelet counts & reduce or prevent bleeding; patients w/ chronic HCV infection for the treatment of thrombocytopenia to enable the initiation of interferon based therapy & optimize interferon based therapy; in combination w/ standard immunosuppressive therapy for the 1st-line treatment of adult & ped patients ≥2 yr w/ severe aplastic anemia (1st-line SAA); for the treatment of cytopenia in patients w/ severe aplastic anemia (refractory SAA) who have had an insufficient response to immunosuppressive therapy.

Individualized dosage based on patient's platelet count. ITP Adult & ped patient 6-17 yr Initially 50 mg once daily. Max: 75 mg daily. Discontinue if platelet count does not increase to a level sufficient to avoid bleeding after 4 wk of therapy at 75 mg once daily. Ped patient 1-5 yr Initially 25 mg once daily. Chronic HCV associated thrombocytopenia Adult Initially 25 mg once daily. Adjust dose in 25 mg increments every 2 wk as necessary to achieve target platelet count required to initiate antiviral therapy. Max: 100 mg once daily. Terminate when antiviral therapy is discontinued. 1st-line SAA Adult & adolescent 12-17 yr Initially 150 mg once daily for 6 mth. Ped patient 6-11 yr Initially 75 mg once daily for 6 mth, 2-5 yr Initially 2.5 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 to achieve the target platelet count ≥50,000/microL. Max: 150 mg daily. Tapering for tri-lineage (WBC, RBC, & platelets) responders: Reduce dose up to 50% once platelet count is >50,000/microL, Hb >10g/dL in the absence of RBC transfusion, & ANC is >1x10⁹/L for >8 wk. Discontinue if counts stay stable after 8 wk at the reduced dose. ITP patient w/ hepatic impairment Initially 25 mg once daily, & wait 3 wk before increasing the dose. Chronic HCV & refractory SAA patient w/ hepatic impairment Initially 25 mg once daily. ITP, chronic HCV, & refractory SAA patient of Asian ancestry Initially 25 mg once daily. SAA patient of Asian ancestry Adult & adolescent Initially 75 mg once daily for 6 mth. Ped patient 6-11 yr Initially 37.5 mg once daily for 6 mth, 2-5 yr Initially 1.25 mg/kg once daily for 6 mth.

Should be taken on an empty stomach: Take at least 2 hr before or 4 hr after antacids, dairy products or mineral supplements containing polyvalent cations (eg, Al, Ca, Fe, Mg, Se, Zn).

Not established for use in other thrombocytopenic conditions including chemotherapy-induced thrombocytopenia & myelodysplastic syndromes (MDS). Measure serum ALT, AST, & bilirubin prior to initiation of treatment every 2 wk during the dose adjustment phase & mthly following establishment of stable dose in patients w/ ITP, HCV, & refractory SAA; prior to initiation in the 1st-line setting of SAA. Risk of hepatic decompensation w/ α-interferon therapy in chronic HCV patients w/ cirrhosis. Patients w/ known risk factors for thromboembolism (eg, factor V Leiden, ATIII deficiency, antiphospholipid syndrome). Not indicated for thrombocytopenia in patients w/ chronic liver disease in prep for invasive procedures. Increased bleeding risk following discontinuation. Malignancies & progression of malignancies. Routine monitoring for cataract is recommended. Serum discoloration & interference w/ total bilirubin & creatinine testing. Hepatic disease. Hepatic impairment (Child-Pugh score; ≥5). Use of effective contraception during & for at least 7 days after stopping treatment in sexually-active females of reproductive potential. Pregnancy & lactation. Childn (<2 yr w/ chronic HCV, refractory SAA, & definitive immunosuppressive therapy-naive SAA & <1 yr w/ ITP). Elderly ≥65 yr.

Adult ITP: Diarrhea, nausea; Increased ALT; back pain. Pharyngitis; cataract; thromboembolic events, thrombotic microangiopathy w/ acute renal failure; vomiting; increased AST, hyperbilirubinemia; rash, alopecia; musculoskeletal pain (including musculoskeletal chest pain), myalgia. Ped ITP: Upper resp tract infection, nasopharyngitis; cough; abdominal pain; pyrexia. Oropharyngeal pain, rhinorrhea; toothache. HCV: Anemia; decreased appetite; headache; cough; nausea, diarrhea; hyperbilirubinemia; pruritus; myalgia; pyrexia, fatigue, flu-like illness, asthenia, chills. Cataract; thromboembolic events (including portal vein thrombosis); drug-induced liver injury, hepatic failure; rash, alopecia; edema. 1st-line SAA: Increased ALT, AST, & blood bilirubin (including ocular icterus). Abdominal pain; rash, skin discoloration including hyperpigmentation. Refractory SAA: Headache, dizziness; cough, oropharyngeal pain, rhinorrhea; nausea, diarrhea, abdominal pain; increased transaminases; pain in extremity, arthralgia, muscle spasms; fatigue, pyrexia. Cataract; hyperbilirubinemia; rash.

Decreased plasma AUC_inf w/ polyvalent cation-containing antacid. Reduced absorption w/ antacids, dairy products, or mineral supplements containing polyvalent cations. May decrease conc w/ lopinavir/ritonavir. Increased plasma C_max & AUC_inf of rosuvastatin. Reduced plasma AUC_inf w/ a standard high-calorie, high-fat breakfast including dairy products.

Haemostatics

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

Rx