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Eltrombopag (Eltrombopag) drug label summary
1. Immune thrombocytopenia (ITP):
-Applicable to patients ≥1 years old with insufficient response to corticosteroids/immunoglobulin/splenectomy, and the degree of thrombocytopenia and clinical status need to significantly increase the risk of bleeding.
2. Chronic hepatitis C-related thrombocytopenia**:
-Used to initiate and maintain interferon therapy, only for those who are unable to initiate or maintain interferon therapy due to thrombocytopenia.
3. Aplastic anemia (SAA):
First-line treatment: patients ≥2 years old, combined with standard immunosuppressants (equine antithymocyte globulin + cyclosporine).
Refractory SA: those who have insufficient response to immunosuppressive treatment.
Restrictions on use:
Contraindicated in patients with myelodysplastic syndrome (MDS)** (which may progress to acute myeloid leukemia and increase the risk of death).
Establish the safety of combination with interferon-free direct-acting antivirals.
General medication rules:
Take on an empty stomach or on a low-calcium diet (≤50mg calcium)**, and avoid taking it with drugs/foods containing polyvalent cations (calcium, iron, magnesium, etc.). Required intervals:
Acid/calcium/mineral supplements: 2 hours before or 4 hours after taking the medicine.
High-calcium foods (dairy products, calcium-fortified juices, etc.): 2 hours before or 4 hours after taking the medicine.
Dosage by indication:
1.ITP*
Adults and children ≥6 years old: starting at 50 mg/day (25 mg/day for those of East Asian/Southeast Asian descent or with liver damage).
Children 1-5 years old: starting dose is 25mg/day.
Adjustment basis: maintain platelets ≥50×10⁹/L, maximum dose ≤75mg/day.
2. Chronic hepatitis C-related thrombocytopenia:
All patients start with 25 mg/day and gradually adjust to the target platelet count (≤100 mg/day).
3. First-line treatment of SAA:
≥12 years old: 150 mg/day × 6 months (75 mg/day for those of East Asian/Southeast Asian origin or liver damage).
6-11 years old: 75mg/day (East Asian/Southeast Asian 37.5mg/day).
2-5*: 2.5mg/kg/day (East Asian/Southeast Asians 1.25mg/kg/day).
4. Refractory SAA:
-Start at 50 mg/day (25 mg/day for people of East Asian/Southeast Asian origin or liver damage), gradually adjust to ≤150 mg/day, and maintain platelets >50×10⁹/L.
Dosage form specifications:
Tablets: 12.5mg (white), 25mg (orange), 50mg (blue), 75mg (pink).
Oral suspension**: 12.5mg/pack, 25mg/pack (require water to prepare, take within 30 minutes).
1. Hepatotoxicity (most common):
Performed by elevated ALT/AST and hyperbilirubinemia, with an incidence rate >5%.
2. Thrombosis/embolic events:
Portal vein thrombosis (patients with chronic liver disease are at higher risk), deep vein thrombosis, pulmonary embolism, etc.
3. Cataract:
- It may develop new or worsen, and ophthalmological monitoring is required before and during treatment.
4. Laboratory test interference:
Drug pigments affect the detection of bilirubin (false increase/lower) and creatinine (false increase). The laboratory needs to be informed that the patient is taking medication.
5. Other common reactions** (≥20%):
Anemia, nausea, fever, cough, fatigue, headache, diarrhea, and elevated ALT.
1. Pregnant women:
Animal experiments have shown embryotoxicity and are prohibited. Women of childbearing potential need effective contraception during treatment and for ≥7 days after stopping the drug.
2. Lactation period:
The drug can be excreted through breast milk, and breastfeeding is prohibited.
3. Children:
-TP is suitable for ≥1 years old, and SAA is suitable for first-line ≥2 years old; the safety of children with refractory SAA and hepatitis C thrombocytopenia has not been established.
4. Patients with liver damage:
ITP/refractory SAA needs to be started at a reduced dose (Child-Pugh A/B/C levels are 25 mg/day); patients with hepatitis C do not need to adjust.
5. East Asian/Southeast Asian descent:
-ITP and SAA patients need to start with a reduced dose (such as ITP adults 50mg → 25mg/day).
1. Principles of discontinuation:
ITP: The maximum dose of 75mg/day is ineffective after 4 weeks of treatment, or platelets are >400×10⁹/L for 2 weeks.
SAA: No hematological response after 16 weeks of treatment, or new cytogenetic abnormalities appear.
2. Drug interactions:
Polyvalent cationic preparations** (antacids, calcium preparations): significantly reduce absorption and need to be taken at intervals.
Statins (rosuvastatin, etc.): may increase their plasma concentration, so it is recommended to reduce the dosage by 50%.
3. Overtreatment:
Administer chelated drugs with oral calcium/aluminum/magnesium preparations, monitor platelets, and contact a poison control center if necessary.