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Revolade 50mg - Eltrombopag Tablets

Revolade 50mg Tablets contain Eltrombopag, an oral thrombopoietin receptor agonist that stimulates platelet production. It’s indicated for thrombocytopenia in chronic immune thrombocytopenic purpura (ITP), chronic hepatitis C–related thrombocytopenia, and severe aplastic anemia.

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General Information:
Generic Name: Eltrombopag Olamine
Brand Name: Revolade
Packing: Blister pack of 10 tablets
Strength: 50 mg
Manufacturer: Novartis Pharma AG
Form: Film‑coated oral tablet
Category: Thrombopoietin Receptor Agonist / Hematopoietic Growth Factor
Product Introduction:
Revolade (Eltrombopag) is a once‑daily oral therapy that binds the thrombopoietin (TPO) receptor on megakaryocyte precursors, promoting proliferation and differentiation into platelets. It provides a non‑transfusional option for patients with refractory thrombocytopenia.

Uses of Revolade 50mg Tablets:
  1. Chronic Immune Thrombocytopenic Purpura (ITP) – Adults with insufficient response to corticosteroids, immunoglobulins, or splenectomy.
  2. Thrombocytopenia in Chronic Hepatitis C Virus (HCV) Infection – To initiate and maintain interferon‑based antiviral therapy.
  3. Severe Aplastic Anemia (SAA) – In combination with immunosuppressants for patients refractory to first‑line treatment.
  4. Myelodysplastic Syndromes (Off‑Label) – Investigational use for chemotherapy‑induced thrombocytopenia.
  5. Chemotherapy‑Induced Thrombocytopenia (Off‑Label) – Under clinical evaluation to reduce bleeding risk.

Storage Instructions:
  • Store at 20 °C to 25 °C (room temperature).
  • Keep in the original blister to protect from moisture.
  • Do not freeze.
  • Keep out of reach of children.

How It Works (Mechanism of Action):
Eltrombopag is a small‑molecule agonist of the TPO receptor (c‑Mpl) on megakaryocyte progenitors. Activation leads to increased megakaryocyte proliferation and differentiation, elevating peripheral platelet counts.

Side Effects:
Common:
  • Headache
  • Nausea
  • Diarrhea
  • Fatigue
  • Upper respiratory tract infection
  • Elevated liver enzymes
Severe (Rare):
  • Hepatotoxicity – Monitor ALT/AST regularly
  • Thromboembolic Events – DVT, PE; assess risk factors
  • Bone Marrow Fibrosis – Consider marrow biopsy if unexplained cytopenias
  • Cataracts – Periodic ophthalmologic exams recommended
  • Hypersensitivity Reactions – Rash, pruritus

Dosage (Typical Recommended Dose):
Indication
Starting Dose
Dose Adjustment
ITP (Adults)
50 mg once daily
If platelets <50×10⁹/L after 2 weeks, ↑ by 25 mg to 75 mg daily (max 75 mg)
HCV‑related Thrombocytopenia
75 mg once daily
Maintain platelets 50–100×10⁹/L; use 50 mg + 25 mg tablets as needed
Severe Aplastic Anemia
150 mg once daily
In combination with immunosuppression
  • Dose adjustments guided by platelet response; do not exceed 75 mg daily in ITP.

Method of Administration:
  • Oral, swallow whole with water.
  • Take on an empty stomach: at least 1 hour before or 2 hours after meals or products with polyvalent cations (e.g., dairy, antacids).
  • Same time each day for consistent plasma levels.

Precautions:
  • Platelet Monitoring: Weekly until stable, then monthly.
  • Liver Function Tests: Baseline, every 2 weeks during titration, then monthly.
  • Avoid in patients with heparin‑induced thrombocytopenia.
  • Not studied in pregnancy; use effective contraception.
  • Breastfeeding: Discontinue drug or avoid breastfeeding.

Drug Interactions:
  • Chelating Agents (Antacids, Dairy): ↓ Absorption—space dosing.
  • CYP1A2 / CYP2C8 Modulators: Potential interactions—monitor levels.
  • Anticoagulants (Warfarin): ↑ Bleeding/thrombosis risk—monitor INR/platelets.
  • Statins (CYP interactions): Monitor for toxicity.

Allergies (Warnings for Allergic Reactions):
  • Contraindicated in hypersensitivity to Eltrombopag or excipients.
  • Signs: rash, urticaria, angioedema, difficulty breathing—seek immediate care.

Overdose Information:
  • Symptoms: Excessive thrombocytosis (>400×10⁹/L), headache, dizziness.
  • Management: Hold doses until platelets ≤150×10⁹/L; supportive care—no specific antidote.

Missed Dose Instructions:
  • If <12 hours late, take as soon as remembered.
  • If >12 hours late, skip and resume next scheduled dose.
  • Do not double doses to compensate.

Additional Notes:
  • Clinical benefit may take 1–2 weeks for platelet rise.
  • Risk of rebound thrombocytopenia on abrupt discontinuation—taper if possible.
  • Maintain a patient diary for bleeding events and side effects.
  • Ophthalmologic exams periodically for cataract monitoring.

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