Presentation

EltropagTM 25: Each film coated tablet contains Eltrombopag Olamine INN equivalent to Eltrombopag 25 mg.

Description

Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells.

Indications

Eltrombopag is indicated for: Thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune. (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Thrombocytopenia in patients with chronic hepatitis-C to allow the initiation and maintenance of interferon-based therapy. Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Dosage & Administration

Take on an empty stomach (1 hour before or 2 hours after a meal).Chronic ITP: Initial dose of Eltrombopag for most of the adult and pediatric patients of 6 years. & older is 50 mg once daily. For pediatric patients aged from 1 to 5 years the initial dose. should be 25 mg once daily. Adjust to maintain platelet count greater than or equal to 50 x 109/L.

Do not exceed 75 mg per day. Chronic Hepatitis C-associated Thrombocytopenia: Initiate Eltrombopag at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg. Severe Aplastic Anemia: Initiate Eltrombopag at 50 mg once daily for most patients. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 150 mg per day.

Side Effects

In adult patients with ITP, the most common adverse reactions were: Nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, and urinary tract infection etc.The most common adverse drug reactions seen in children of 1 year and older is upper respiratory tract infections and nasopharyngitis. Patients with chronic hepatitis C associated thrombocytopenia: Anemia, pyrexia, fatigue, headache, nausea, diarrhea, alopecia and peripheral edema is very common. Patents with severe aplastic anemia: The most common adverse effect is nausea, fatigue, cough, diarrhea, headache etc.

Precautions

Hepatotoxicity: In this case, monitor liver function before and during therapy. Thromboembolic complication: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag, so platelet count should be measured carefully.

Use in Pregnancy & Lactation

Pregnancy: Pregnancy Category C. Nursing mothers: It is not known whether eltrombopag is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue eltrombopag taking into account the importance of eltrombopag to the mother.

Drug Interaction

Eltrombopag interacts with polyvalent cation-containing Antacids. .Caution should be taken when administered with OATP1B1 substrate and BCRP substrate (Rosuvastatin), Protease inhibitors (Iopinavir) etc.

Over Dose

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate eltrombopag and thus limit absorption. Closely monitor platelet counts.

Storage

Store in a cool and dry place. Keep away from light and moisture and out of reach of children.

Commercial Pack

Eltropag 25: Each box contains 1 blister strip of 10 tablets.

Others

The safety and efficacy of eltrombopag in pediatric patients younger than 1 year with ITP and thrombocytopenia associated with chronic hepatitis C & severe aplastic anemia have not been established.