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Revolade 25mg - Eltrombopag Tablets

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Revolade 25mg - Eltrombopag Tablets

Revolade 25mg Tablets contain Eltrombopag, a thrombopoietin receptor agonist that stimulates platelet production in the bone marrow. It is indicated for thrombocytopenia in chronic immune (idiopathic) thrombocytopenic purpura (ITP), chronic hepatitis C–related thrombocytopenia, and severe aplastic anemia.

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Description Product Details
General Information:
Generic Name: Eltrombopag Olamine
Brand Name: Revolade
Packing: Blister pack of 10 tablets
Strength: 25 mg
Manufacturer: Novartis Pharma AG
Form: Film‑coated oral tablet
Category: Thrombopoietin Receptor Agonist / Hematopoietic Growth Factor
Product Introduction:
Revolade (Eltrombopag) is an oral hematopoietic agent that mimics the action of thrombopoietin, binding to and activating the TPO receptor on megakaryocyte precursors to increase platelet production and reduce bleeding risk. It offers a non‑transfusional option for patients with refractory thrombocytopenia.
Uses of Revolade 25mg Tablets:
  1. Chronic Immune Thrombocytopenic Purpura (ITP) – For adults with insufficient response to corticosteroids, immunoglobulins, or splenectomy.
  2. Thrombocytopenia in Chronic Hepatitis C Virus (HCV) Infection – To allow initiation and maintenance of interferon‑based therapy.
  3. Severe Aplastic Anemia (SAA) – In combination with immunosuppressive therapy in patients refractory to first‑line treatment.
  4. Off‑Label Uses (Investigational) – Thrombocytopenia associated with myelodysplastic syndromes and chemotherapy‑induced thrombocytopenia.
Storage Instructions:
  1. Store at 20 °C to 25 °C (room temperature).
  2. Keep in the original blister to protect from moisture.
  3. Do not freeze.
  4. Keep out of reach of children.
How It Works (Mechanism of Action):
Eltrombopag is a small‑molecule agonist of the thrombopoietin receptor (c‑Mpl) on megakaryocyte progenitor cells. Binding stimulates proliferation and differentiation of megakaryocytes, leading to increased platelet production and elevated peripheral platelet counts.
Side Effects:
Common:
  1. Headache
  2. Nausea
  3. Diarrhea
  4. Fatigue
  5. Upper respiratory tract infection
  6. Increased liver transaminases
Severe (Rare):
  1. Hepatotoxicity (elevated ALT/AST; monitor LFTs)
  2. Thromboembolic events (deep vein thrombosis, pulmonary embolism)
  3. Cataracts (periodic ophthalmologic exams recommended)
  4. Bone marrow fibrosis (monitor blood counts and consider marrow biopsy)
  5. Hypersensitivity reactions (rash, pruritus)
Dosage (Typical Recommended Dose):
  1. ITP in adults: Start at 50 mg once daily; if platelet count <50 × 10⁹/L after 2 weeks, increase by 25 mg increments up to 75 mg daily.
  2. HCV‑related thrombocytopenia: 75 mg once daily; adjust to maintain platelets 50–100 × 10⁹/L.
  3. Severe aplastic anemia: 150 mg once daily in combination with immunosuppression.
  4. Dose adjustments are guided by platelet response; do not exceed 75 mg daily in ITP.
Method of Administration:
  1. Oral, swallow whole with water.
  2. Empty stomach: take at least 1 hour before or 2 hours after a meal or products containing polyvalent cations (e.g., dairy, antacids).
  3. Same time each day for consistent blood levels.
Precautions:
  1. Monitor platelet counts weekly until stable, then monthly.
  2. Liver function tests before initiation, every 2 weeks during dose adjustment, then monthly.
  3. Avoid use in patients with known heparin‑induced thrombocytopenia.
  4. Not studied in pregnancy; use effective contraception.
  5. Breastfeeding: discontinue or avoid drug.
Drug Interactions:
  1. Chelating agents (antacids, dairy, mineral supplements): ↓ Eltrombopag absorption—space dosing.
  2. CYP1A2 and CYP2C8 substrates/inhibitors: potential interactions—monitor for altered levels.
  3. Warfarin & other anticoagulants: increased bleeding/thrombosis risk—monitor INR/platelets.
  4. Statins (CYP interactions): monitor for toxicity.
Allergies (Warnings for Allergic Reactions):
  1. Contraindicated in hypersensitivity to Eltrombopag or excipients.
  2. Signs of allergy: rash, urticaria, angioedema, difficulty breathing—seek immediate care.
Overdose Information:
  1. Symptoms: Excessive thrombocytosis (platelets >400 × 10⁹/L), headache, dizziness.
  2. Management: Hold further doses until platelet count ≤150 × 10⁹/L. Provide supportive care; no specific antidote.
Missed Dose Instructions:
  1. If <12 hours late, take as soon as remembered.
  2. If >12 hours late, skip and resume next scheduled dose.
  3. Do not double doses to compensate.
Additional Notes:
  1. Platelet counts may rise slowly; clinical benefit may take 1–2 weeks.
  2. Risk of rebound thrombocytopenia on abrupt discontinuation—taper when possible.
  3. Store patient diary to track bleeding events and side effects.
  4. Periodic ophthalmologic exams to monitor for cataracts.

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