Cytopag^®

Cytopag® is the preparation of Eltrombopag Olamine which 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.

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Cytopag^®  is used for:

• Treatment of thrombocytopenia in patients with persistent or chronic immune lhrombocytopenia

• Treatment of thrombocytopenia in patients with hepatitis C infection

• Treatment of severe aplastic anemia

Limitations of use: Cytopag^® is not indicated for the treatment of patients with myelodysplastic syndromes (MDS). Safety and efficacy have not been established in combination with direct acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Persistent or chronic immune thrombocytopenia: Use the lowest dose of Cytopag^® to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily.

Adult and pediatric patients 6 years and older with ITP: Initiate Cytopag^® at a dose of 50 mg once daily, except in patients who are of Asian ancestry or who have mild to severe hepatic impairment. For patients of Asian ancestry with ITP, initiate Cytopag^® at a reduced dose of 25 mg once daily. For patients with ITP and mild, moderate or severe hepatic impairment, initiate Cytopag^® at a reduced dose of 25 mg once daily. For patients of Asian ancestry with ITP and hepatic impairment, consider initiating Cytopag^® at a reduced dose of 12.5 mg once daily.

Pediatric patients with ITP aged 1 to 5 years: Initiate Cytopag^® at a dose of 25

mg once daily.

Chronic hepatitis C associated thrombocytopenia: Initiate CytopagⓇ at a dose of 25 mg once daily. Adjust the dose of Cytopag^® in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Do not exceed a dose of 100 mg daily.

First line severe aplastic anemia: Initiate Cytopag^® once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old) or 150 mg for patients aged 12 years and older for 6 months concurrently with standard immunosuppressive therapy. For patients of Asian ancestry or those with mild, moderate or severe hepatic impairment, decrease the initial dose by 50%. Modify the dose regimen of Cytopag^® based on platelet counts, ALT or AST elevations and thromboembolic events.

Refractory severe aplastic anemia: Initiate Cytopag^® at 50 mg once daily. Hematologic response requires dose titration, generally up to 150 mg and may take up to 16 weeks after starting Cytopag". For patients of Asian ancestry or those with mild, moderate, or severe hepatic impairment, initiate Cytopag^® at a reduced dose of 25 mg once daily. Adjust the dose of CytopagⓇ in 50 mg increments every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 109/L as necessary. Do not exceed a dose of 150 mg per day.

Use in pregnancy and lactation Pregnancy: No sufficient data is available to assess any drug-associated risksfor major birth defects, miscarriage or adverse maternal or fetal outcomes. Lactation: There are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. Due to the potential for serious adverse reactions in a breastfed child from eltrombopag, breastfeeding is not recommended during treatment.

Use in children and adolescents

Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established. Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.

In patients with chronic hepatitis C, Eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Monitor liver function before and during therapy. There is increased risk of death and progression of myelodysplastic syndromes to acute myeloid leukemia. Portal vein thrombosis has been reported in patients with chronic liver disease receiving eltrombopag. Monitor platelet counts regularly.

The most common side effects are anemia, nausea, pyrexia, ALT increased, cough, fatigue, headache and diarrhea.

Eltrombopag is contraindicated in patients with known hypersensitivity to eltrombopag or any components of this product.

Drug interaction

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.

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.

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Cytopag^® 25 tablet: Each coated tablet contains Eltrombopag Olamine INN equivalent to Eltrombopag 25 mg.
Cytopag^® 50 tablet: Each coated tablet contains Eltrombopag Olamine INN equivalent to Eltrombopag 50 mg.

Cytopag^Ⓡ 25 tablet: Carton of 5 tablets in blister pack and Carton of 7 tablets or 14 tablets in plastic container.

Cytopag^Ⓡ 50 tablet: Carton of 5 tablets in blister pack.