ETP 50

Chronic immune thrombocytopenia, Chronic hepatitis C virus infection, Aplastic anemia

THROMBOPOIETIN RECEPTOR AGONIST

Eltrombopag Olamine is a small molecule thrombopoietin (TPO) receptor agonist. Eltrombopag interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells finally leading to increased platelet production.

Treatment of chronic idiopathic thrombocytopenic purpura in splenectomised patients refractory to other treatments (such as corticosteroids or immunoglobulins) (under expert supervision) | Second-line treatment of chronic idiopathic thrombocytopenic purpura in nonsplenectomised patients when surgery is contraindicated (under expert supervision) BY MOUTH Adult: Initially 50 mg once daily, dose to be adjusted to achieve a platelet count of 50x109/litre or more- consult product literature for dose adjustments, discontinue if inadequate response after 4 weeks treatment at maximum dose; maximum 75 mg per day Adult (patients of East Asian origin): Initially 25 mg once daily, dose to be adjusted to achieve a platelet count of 50x109/litre or more-consult product literature for dose adjustments, discontinue if inadequate response after 4 weeks treatment at maximum dose; maximum 75 mg per day. Treatment of thrombocytopenia associated with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (under expert supervision) BY MOUTH Adult: Initially 25 mg once daily, dose to be adjusted to achieve a platelet count sufficient to initiate antiviral therapy then a platelet count of 50-75x109/litre during antiviral therapy-consult product literature for dose adjustments, discontinue if inadequate response after 2 weeks treatment at maximum dose; maximum 100 mg per day.

Drug interaction with medication: Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids and mineral supplements (e.g., iron, calcium, aluminium, magnesium, selenium and zinc). Drug interaction with food and others: Take eltrombopag at least 2 hours before or 4 hours after any calcium rich foods.

Patients of East Asian origin . risk factors for thromboembolism.

Common or very common Abdominal pain . alopecia . arthralgia . bone pain . cataract . constipation . diarrhoea . dry eye . fatigue . gastro-intestinal disturbances . headache . insomnia . myalgia . nausea . paraesthesia . peripheral oedema . pruritus . rash Uncommon Acute myocardial infarction . anaemia . anorexia . anxiety . blood disorders . changes in appetite . cholestasis . cough . deep vein thrombosis . depression . dizziness . dry mouth . ecchymosis . eosinophilia . epistaxis . eye disorders . flushing . gingival bleeding . gout . haemolysis . haemorrhoids . hemiparesis . hepatitis . hypertension . migraine . mood changes . myelocytosis . nocturia . palpitation . peripheral neuropathy . pulmonary embolism . QT-interval prolongation . rectosigmoid cancer . renal failure . respiratory infections . skin reactions . sleep disorders . sweating . tachycardia . taste disturbances . thromboembolic events . tremor . urinary tract infections . vertigo . weight gain.

PREGNANCY Avoid?toxicity in animal studies. BREAST FEEDING Manufacturer advises avoid.

In the event of overdose, platelet counts may increase excessively and result in thrombotic or thromboembolic complications. In case of an overdose, consider oral administration of a metal cation containing preparation such as calcium, aluminium or magnesium preparations to chelate eltrombopag and thus limit absorption.

Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.