Product Introduction:
Trombopag contains Eltrombopag Olamine, a small molecule that mimics thrombopoietin and stimulates platelet production in bone marrow. It is used when patients are unresponsive to standard therapies, such as corticosteroids, immunoglobulins, or splenectomy. It helps maintain adequate platelet levels to reduce bleeding risk.
Uses (Indications):
Trombopag is used in the treatment of the following conditions:
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Chronic Immune Thrombocytopenia (ITP) – in adults and children ≥1 year with insufficient response to other treatments
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Severe Aplastic Anemia (SAA) – in patients unresponsive to immunosuppressive therapy
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Thrombocytopenia associated with Hepatitis C – to allow initiation and maintenance of interferon-based therapy
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Chemotherapy-induced thrombocytopenia (off-label use in some settings)
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Myelodysplastic syndromes (MDS) – under clinical investigation/off-label
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Post-hematopoietic stem cell transplantation thrombocytopenia
Storage Instructions:
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Store at room temperature between 20–25°C
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Protect from moisture and direct sunlight
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Keep in original packaging until use
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Do not refrigerate or freeze
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Store out of reach of children
How It Works (Mechanism of Action):
Eltrombopag is a non-peptide TPO receptor agonist that binds to the transmembrane domain of the thrombopoietin receptor (c-Mpl) on megakaryocyte precursors.
Mechanism details:
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Stimulates proliferation and differentiation of megakaryocytes
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Enhances platelet production in the bone marrow
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Does not compete with endogenous TPO, so can be synergistic
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Helps maintain hemostatic platelet counts in patients with low baseline levels
Side Effects:
Common Side Effects:
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Nausea
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Headache
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Fatigue
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Diarrhea
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Cough
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Arthralgia (joint pain)
Serious Side Effects:
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Hepatotoxicity – elevated liver enzymes or bilirubin
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Thromboembolic events – including deep vein thrombosis (DVT), pulmonary embolism (PE)
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Cataracts – reported with long-term use
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Bone marrow fibrosis – rare but serious
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Rebound thrombocytopenia upon discontinuation
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Risk of hepatic decompensation in HCV patients
Dosage (Typical Recommended Dose):
For ITP (Adults):
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Initial dose: 50 mg once daily
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For East Asian patients: 25 mg once daily
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Adjust dose based on platelet response, aiming for >50,000/μL
For Severe Aplastic Anemia:
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Starting dose: 50 mg once daily
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Titrate every 2 weeks to max of 150 mg/day based on response
For Hepatitis C-associated Thrombocytopenia:
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Initial dose: 25 mg once daily, adjust per response
Method of Administration:
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Oral administration, with water
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Take on an empty stomach (at least 1 hour before or 2 hours after meals)
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Avoid taking with dairy products or supplements (calcium, iron, magnesium, aluminum)
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Should be swallowed whole, not crushed or chewed
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Dose adjustments must be done under supervision based on platelet counts
Precautions:
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Monitor liver function (ALT, AST, bilirubin) before and during treatment
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Risk of thrombotic complications if platelet count rises excessively
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Ophthalmic examination advised for long-term use (risk of cataract)
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Discontinue gradually to avoid rebound thrombocytopenia
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Not recommended during pregnancy or breastfeeding
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Use caution in patients with liver cirrhosis (Child-Pugh B or C)
Drug Interactions:
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Antacids or supplements containing polyvalent cations – reduce absorption
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Statins (e.g., Rosuvastatin) – increased plasma levels
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CYP1A2 and CYP2C8 inhibitors/inducers – may alter metabolism
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Ribavirin + Interferon combo – monitor for liver toxicity
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Co-administration with food rich in calcium or iron should be avoided
Allergies (Warnings for Allergic Reactions):
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Contraindicated in patients with known hypersensitivity to Eltrombopag or excipients
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Allergic symptoms may include rash, angioedema, or anaphylaxis
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Discontinue immediately in case of severe allergic or dermatological reaction
Overdose Information:
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No specific antidote for Eltrombopag overdose
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Symptoms may include excessively elevated platelet count, increasing thrombotic risk
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In case of overdose, discontinue medication, perform platelet monitoring, and provide symptomatic treatment
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Dialysis is not effective due to high plasma protein binding
Missed Dose Instructions:
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If a dose is missed, take it as soon as remembered on the same day
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Do not double the dose to make up for a missed one
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If missed for several days, consult a doctor before restarting
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Resume regular schedule the next day if close to next dose
Additional Notes:
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Platelet levels should be monitored weekly during dose adjustments and monthly thereafter
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Abrupt discontinuation can cause rebound thrombocytopenia—requires tapering
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May be used in combination with immunosuppressants in aplastic anemia
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Black Box Warning (U.S. FDA): hepatotoxicity risk
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Avoid grapefruit juice and high-fat meals around the dosing time
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Clinical benefit must be re-evaluated periodically; discontinue if no response in 3 months
