Eltromin
Generic Name
Eltrombopag
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| eltromin 25 mg tablet | ৳ 600.00 | N/A |
Description
Overview of the medicine
Eltrombopag is an oral thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP), severe aplastic anemia (SAA), and in some cases of chronic hepatitis C virus (HCV) infection.
Uses & Indications
Dosage
Adults
Chronic ITP: Initial 50 mg orally once daily. Adjust dose to achieve and maintain platelet count ≥ 50,000/µL. Max 75 mg/day. SAA: Initial 50 mg orally once daily. May increase to 150 mg/day. HCV Thrombocytopenia: Initial 25 mg orally once daily. Adjust to achieve platelet count for antiviral therapy, max 100 mg/day.
Elderly
No specific dose adjustment is required based on age, but caution is advised due to potential for decreased hepatic, renal, or cardiac function.
Renal_impairment
No initial dose adjustment for patients with renal impairment. Monitor platelet counts carefully.
How to Take
Take Eltromin tablet orally once daily on an empty stomach (at least 1 hour before or 2 hours after a meal) or at least 4 hours before or after consuming foods, supplements, or antacids containing polyvalent cations (e.g., calcium, iron, magnesium, aluminum, selenium, zinc).
Mechanism of Action
Eltrombopag is an orally active, small-molecule thrombopoietin (TPO) receptor agonist that interacts with the transmembrane domain of the human TPO receptor and initiates signaling cascades that lead to the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. This process results in an increased production of platelets.
Pharmacokinetics
Onset
Platelet count increases generally begin within 1 to 2 weeks.
Excretion
Excreted primarily in feces (59%), with a smaller portion excreted in urine (31%). Unchanged drug accounts for approximately 20% of the dose in feces and <1% in urine.
Half life
Mean terminal half-life is approximately 21 to 32 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations (Tmax) occur 2 to 6 hours post-dose. Absorption is significantly reduced by food, particularly calcium-containing foods.
Metabolism
Primarily metabolized via UGT1A1 and CYP1A2. No significant metabolism by cytochrome P450 enzymes.
Side Effects
Contraindications
- Hypersensitivity to eltrombopag or any components of the formulation.
Drug Interactions
UGT1A1 & CYP1A2 Substrates
Eltrombopag can inhibit UGT1A1 and CYP1A2. Caution is advised when co-administering with substrates of these enzymes (e.g., irinotecan, caffeine).
Statins (e.g., Rosuvastatin)
Eltrombopag may increase plasma concentrations of statins that are substrates of OATP1B1/OATP1B3 transporters. Consider a reduction in statin dose and monitor for adverse effects.
Polyvalent Cation-Containing Products
Antacids, dairy products, and mineral supplements containing polyvalent cations (e.g., calcium, iron, magnesium, aluminum, selenium, zinc) can significantly decrease eltrombopag absorption. Administer eltrombopag at least 4 hours before or after such products.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, platelet counts may become excessively high, leading to an increased risk of thrombotic/thromboembolic complications. Closely monitor platelet counts. Discontinue Eltromin and consider general supportive measures, including monitoring vital signs and observing for any signs of adverse events. Activated charcoal may be considered if administered within 4 hours of overdose to reduce absorption.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether eltrombopag is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to eltrombopag or any components of the formulation.
Drug Interactions
UGT1A1 & CYP1A2 Substrates
Eltrombopag can inhibit UGT1A1 and CYP1A2. Caution is advised when co-administering with substrates of these enzymes (e.g., irinotecan, caffeine).
Statins (e.g., Rosuvastatin)
Eltrombopag may increase plasma concentrations of statins that are substrates of OATP1B1/OATP1B3 transporters. Consider a reduction in statin dose and monitor for adverse effects.
Polyvalent Cation-Containing Products
Antacids, dairy products, and mineral supplements containing polyvalent cations (e.g., calcium, iron, magnesium, aluminum, selenium, zinc) can significantly decrease eltrombopag absorption. Administer eltrombopag at least 4 hours before or after such products.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, platelet counts may become excessively high, leading to an increased risk of thrombotic/thromboembolic complications. Closely monitor platelet counts. Discontinue Eltromin and consider general supportive measures, including monitoring vital signs and observing for any signs of adverse events. Activated charcoal may be considered if administered within 4 hours of overdose to reduce absorption.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether eltrombopag is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on manufacturer specifications.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Generic available
Clinical Trials
Eltrombopag has undergone extensive clinical trials (e.g., EXTEND, TRA100773B, TANDEM) demonstrating its efficacy and safety in various indications, including ITP and SAA. Ongoing trials explore its use in other hematologic disorders and in different patient populations.
Lab Monitoring
- Complete Blood Count (CBC) with differential and platelet count: Weekly until a stable platelet count (≥50,000/µL for ITP) is achieved, then monthly.
- Liver Function Tests (ALT, AST, total bilirubin): Prior to initiation, every 2 weeks during dose adjustment, and monthly after stabilization.
- Renal Function Tests: As clinically indicated.
- Bone marrow examination: Annually or as clinically indicated to monitor for marrow fibrosis.
Doctor Notes
- Strict adherence to monitoring guidelines for liver function and platelet counts is critical.
- Educate patients thoroughly about dietary restrictions (polyvalent cations) and signs/symptoms of hepatotoxicity or thrombosis.
- Consider a lower starting dose for patients of East Asian descent.
- Evaluate bone marrow for fibrosis annually or if clinical suspicion arises.
Patient Guidelines
- Take Eltromin exactly as prescribed by your doctor. Do not change your dose or stop taking the medication without consulting your doctor.
- Avoid taking Eltromin with dairy products, calcium-fortified juices, antacids, or mineral supplements containing polyvalent cations. Ensure at least a 4-hour interval.
- Report any signs of liver problems (e.g., yellow skin/eyes, dark urine, unusual tiredness) or blood clots (e.g., swelling/pain in leg, shortness of breath, chest pain) to your doctor immediately.
- Regular blood tests, including platelet counts and liver function tests, are essential during treatment.
Missed Dose Advice
If a dose of Eltromin is missed, do not take a double dose to make up for the missed dose. Take the next dose at the regularly scheduled time. If you are unsure, consult your doctor.
Driving Precautions
Eltromin may cause dizziness or blurred vision in some patients. If you experience these symptoms, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain good oral hygiene to minimize the risk of bleeding gums, and use a soft toothbrush.
- Avoid activities that may cause injury or bruising, especially during periods of low platelet counts.
- Report any unusual bleeding or bruising to your doctor immediately.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor to avoid potential interactions.
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