Eltropag 50, 1 Strip

✔️ Words of Advice:

Always take Eltropag 50 on an empty stomach

Maintain proper timing with dairy products and calcium-containing foods

Regular blood tests are essential to monitor platelet counts and liver function

Follow your doctor’s instructions carefully and do not adjust the dose on your own

✔️ General Administration | Eltropag 50

• Must be taken on an empty stomach
• Swallow the tablet whole; do not crush, chew, or break
• Take at least 1 hour before or 2 hours after meals
• Take at least 4 hours before or after antacids, dairy products, calcium-fortified juices, or mineral supplements containing polyvalent cations (e.g., calcium, magnesium, iron)
• If a dose is missed, skip the missed dose and continue with the regular dosing schedule.
• Do not take a double dose to compensate.

✔️ Side Effect | Eltropag 50

• Nausea
• Diarrhea
• Vomiting
• Upper respiratory tract infection
• Urinary tract infection
• Muscle pain
• Elevated liver enzymes

✔️ Adult Dosage

Chronic ITP

Initial dose: 50 mg once daily

Adjust dose to maintain platelet count ≥ 50 × 10⁹/L

Chronic Hepatitis C–Associated Thrombocytopenia

Initial dose: 50 mg once daily

Maximum dose: 100 mg per day

Severe Aplastic Anemia

Initial dose: 50 mg once daily

Adjust dose to maintain platelet count ≥ 50 × 10⁹/L

Maximum dose: 150 mg per day

After any dose adjustment, platelet counts should be monitored weekly for 2–3 weeks. At least 2 weeks should be allowed to assess platelet response before further dose changes.

Hepatic Impairment

Not recommended in ITP patients with liver cirrhosis unless the potential benefit outweighs the risk of portal vein thrombosis

Pediatric Dosage

Children ≥6 years (Chronic ITP)

Initial dose: 50 mg once daily

Children 1–5 years (Chronic ITP)

Initial dose: 25 mg once daily

Dose adjustments should be made to maintain platelet counts ≥ 50 × 10⁹/L.

Renal Impairment

No dose adjustment is required in ITP patients with renal impairment.

✔️ Contraindications

Eltrombopag is contraindicated in patients with severe hepatic impairment and in individuals with known hypersensitivity to eltrombopag or any of its excipients

✔️ Drug Interactions

• HMG-CoA reductase inhibitors (statins): Increased plasma Cmax and AUC; monitor closely and consider dose adjustment
• Methotrexate, Topotecan: Use with caution due to potential pharmacokinetic interactions
• Fluvoxamine: May increase eltrombopag concentrations
• Rifampicin, Lopinavir/Ritonavir: May reduce eltrombopag exposure
• Antacids, dairy products, and products containing polyvalent cations (e.g., iron, calcium, magnesium, aluminum, selenium, zinc): Significantly reduce eltrombopag absorption
• High-calorie or high-fat meals: Decrease plasma AUC and Cmax of eltrombopag

✔️ Pregnancy, Contraception & Lactation

Pregnancy

Available data from published case reports and post-marketing experience in pregnant women are insufficient to determine the risk of major congenital malformations, miscarriage, or adverse maternal or fetal outcomes associated with eltrombopag use.

Animal studies:
In reproductive and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryonic death and reduced fetal weight at maternally toxic doses. These effects occurred at systemic exposures approximately 6-fold higher than human exposure in patients with chronic ITP receiving 75 mg/day and 3-fold higher than exposure in patients with chronic hepatitis C receiving 100 mg/day, based on AUC comparisons.

Contraception

Based on findings from animal studies, eltrombopag may cause fetal harm if administered during pregnancy.

Sexually active women of reproductive potential should use effective contraception during treatment and for at least 7 days after discontinuation of therapy.

Lactation

There are no data on the presence of eltrombopag or its metabolites in human breast milk, nor on its effects on milk production or breastfed infants. However, eltrombopag has been detected in the offspring of lactating rats, indicating the potential for drug transfer during breastfeeding.

Due to the risk of serious adverse reactions in breastfed infants, breastfeeding is not recommended during eltrombopag therapy.

✔️ Storage:

• Eltropag 50 out of reach of children
• Do not store above 25°C