ROMPAG 25

Drug Identity & Classification

• Generic Name: Eltrombopag olamine

• Therapeutic Category:

  • Oral thrombopoietin receptor agonist (TPO-RA)

  • ATC Code: B02BX05

• Molecular Weight: 564.65 g/mol (as olamine salt)

2. Approved Therapeutic Indications

✅ Regulatory-Approved Uses:

1. Chronic Immune Thrombocytopenia (ITP)

   • Adults and pediatric patients ≥1 year

   • Second-line after corticosteroid/IVIG failure

2. Severe Aplastic Anemia (SAA)

   • First-line combined with cyclosporine

3. HCV-Related Thrombocytopenia

   • Enables interferon-based antiviral therapy

🚫 Important Restrictions:

• Not for myelodysplastic syndromes (leukemia risk)

• Contraindicated in portal vein thrombosis history

3. Pharmacological Properties

4. Precision Dosing Guidelines

Standard Regimens:

• Adult ITP:

  • Start: 25 mg once daily

  • Titrate: ±25 mg every 2 weeks

  • Maximum: 75 mg/day

• Pediatric ITP (1-5 yrs):

  • Start: 12.5 mg daily (oral suspension preferred)

• SAA Combination Therapy:

  • Start: 50 mg daily

  • Target: 50-150 mg based on response

Ethnic Adjustments:

• East Asian patients: Reduce starting dose by 50%

• Consider UGT1A1*6/*28 genotyping in poor responders

5. Administration Protocol

• Optimal Timing:

  • Morning dosing preferred

  • Strict fasting: 1h before/2h after meals

• Food Interactions:

  • Avoid dairy products within 4 hours

  • Separate from antacids by 4+ hours

• Preparation:

  • Swallow tablet whole with water

  • Do not crush or split

6. Adverse Effect Profile

Frequent (≥10%):

• Headache (22%)

• Nausea (15%)

• ALT elevation (11%)

• Upper respiratory infection (10%)

Serious Risks:

1. Hepatotoxicity:

   • Monitor LFTs every 2 weeks initially

   • Discontinue if ALT >5×ULN

2. Thrombosis:

   • Risk increases with platelets >400,000/μL

3. Bone Marrow Fibrosis:

   • Reticulin staining recommended annually

7. Drug Interaction Management

8. Essential Monitoring Framework

Baseline Workup:

• CBC with differential

• Comprehensive metabolic panel

• Hepatitis serology

• Ophthalmologic exam

Treatment Surveillance:

9. Storage & Stability

• Temperature: 20-25°C (excursions 15-30°C permitted)

• Humidity: Keep in original blister with desiccant

• Light Protection: Required

• Shelf Life: 24 months unopened

10. Cost & Accessibility

• Price Range: $4,200-$5,800/month (brand)

• Generic Availability: Limited in some markets

• Patient Support: Co-pay assistance programs available

11. Clinical Decision Pathways

Initiation Criteria:

• ITP: Platelets <30K with bleeding or high-risk features

• SAA: ANC <500/μL with hypocellular marrow

• HCV: Platelets <70K preventing antiviral therapy

Discontinuation Triggers:

• No response after 16 weeks

• Intolerable adverse effects

• Platelets >400K for >4 weeks

12. Emerging Clinical Data

• EXTEND-ITP Study (2023):

  • 72% 5-year response sustainability

  • Lower bleeding rates vs romiplostim (HR 0.68)

• Real-World Evidence:

  • 85% adherence rate at 1 year

  • 40% dose reduction over time

13. Patient Counseling Essentials

Key Messages:

1. “Take this medication first thing in the morning before breakfast”

2. “Avoid dairy products and antacids within 4 hours of your dose”

3. “Report immediately: yellow eyes/skin, severe headaches, or leg swelling”

Monitoring Schedule:

• Weekly blood tests initially

• Regular eye exams

• Annual bone marrow evaluation (if chronic use)