Revolade (25mg / 50mg) - Eltrombopag Tablets

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1. Chronic Immune Thrombocytopenia (ITP) in adults and children over 1 year of age who are unresponsive to other treatments
2. Thrombocytopenia associated with chronic hepatitis C to enable initiation and maintenance of interferon-based therapy
3. Severe Aplastic Anemia (SAA) in patients unresponsive to immunosuppressive therapy
4. Refractory cytopenias in bone marrow failure syndromes
5. Prevention of bleeding in patients with severe thrombocytopenia undergoing invasive procedures
6. Investigational use in myelodysplastic syndromes (MDS) under clinical supervision

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1. Store at room temperature (15–30°C)
2. Protect from moisture and light
3. Keep in original packaging until use
4. Keep out of reach of children
5. Do not use after expiration date

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1. Activates JAK-STAT signaling pathways
2. Stimulates proliferation and differentiation of megakaryocytes
3. Enhances platelet production
4. Does not compete with endogenous thrombopoietin

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1. Headache
2. Nausea
3. Fatigue
4. Diarrhea
5. Elevated liver enzymes (ALT, AST)
6. Pain in muscles or bones

1. Hepatotoxicity – risk of liver injury, including potentially fatal liver failure
2. Thromboembolism – increased risk of blood clots even at normal platelet counts
3. Cataracts – especially with long-term use
4. Bone marrow fibrosis – long-term marrow changes possible
5. Hypersensitivity reactions – including rash, swelling, or anaphylaxis

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1. Initial dose: 50 mg once daily
2. Adjust based on platelet response (range: 25–75 mg/day)
3. Pediatric doses vary by age and weight

1. Start with 25 mg once daily, adjust to maintain platelets >90,000/μL

1. Start with 50 mg/day, increase by 25 mg every 2 weeks up to a maximum of 150 mg/day based on response and tolerability

Note: Dose adjustments are required in case of hepatic impairment or East Asian ancestry.

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1. Administered orally, once daily
2. Take on an empty stomach (at least 1 hour before or 2 hours after meals)
3. Avoid taking with calcium-rich foods, dairy, or mineral supplements (iron, magnesium, aluminum), as they reduce absorption
4. Swallow tablets whole with water
5. Regular monitoring of platelet counts and liver function is required

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1. Monitor liver function tests (LFTs) before and during treatment
2. Avoid in patients with active or uncontrolled liver disease
3. Caution in patients with risk of thrombosis
4. May cause cataracts – perform periodic eye exams
5. Use effective contraception in women of childbearing age
6. Discontinue if no response after 4 weeks at maximum dose
7. Use with caution in renal impairment

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1. Antacids or supplements with polyvalent cations (calcium, magnesium, aluminum, iron) – reduce absorption
2. Cyclosporine – may increase Eltrombopag plasma levels
3. Statins – may increase liver toxicity risk
4. Warfarin and anticoagulants – monitor closely for clotting changes
5. Peginterferon alfa-2a – combined use in hepatitis C may increase risk of hepatic decompensation

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1. Monitor for signs of hypersensitivity, including rash, itching, swelling, or breathing difficulty
2. Rare cases of anaphylaxis reported – immediate medical attention required
3. Do not use in patients with known allergy to Eltrombopag or any component of the formulation

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1. No specific antidote; symptomatic and supportive care
2. Monitor for excessively high platelet counts (risk of thromboembolism)
3. Consider platelet-lowering agents or temporary discontinuation
4. Gastric lavage may be considered if ingestion is recent
5. Continuous monitoring of platelet counts and vital signs

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1. Take the missed dose as soon as you remember
2. If it's close to the next scheduled dose, skip the missed dose
3. Do not double the next dose
4. Resume regular dosing schedule
5. Inform your doctor if multiple doses are missed

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1. Platelet counts usually rise within 1–2 weeks of starting therapy
2. Platelet production stops rapidly after discontinuation; monitor for rebound thrombocytopenia
3. Long-term safety should be assessed with regular bone marrow evaluations
4. Not intended for use in patients with myelodysplastic syndrome (MDS) unless specifically prescribed
5. Revolade has enabled many patients with chronic thrombocytopenia to avoid invasive interventions like splenectomy