ROMPAG 50MG TABLET
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Manufactured By HETERO HEALTHCARE LTD GENX
Composition ELTROMBOPAG 50MG
RS 1666.70
MRP RS 2381.00
(30% OFF)
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Description:
Rompag 50mg Tablet
(Eltrombopag 50mg) is a potent oral Thrombopoietin Receptor Agonist (TPO-RA) manufactured by Hetero Healthcare Ltd (GenX), indicated for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP), thrombocytopenia associated with chronic hepatitis C virus (HCV) infection, and severe aplastic anaemia (SAA). It works by binding to and activating the thrombopoietin receptor (c-Mpl) on bone marrow megakaryocytes, stimulating platelet production and raising platelet counts to clinically safe levels. Available from Shabbir Medical Hall at the best price in India, this genuine prescription tablet is available online with fast delivery nationwide.
BENEFITS: Rompag 50mg offers a targeted, non-immunosuppressive approach to raising platelet counts in conditions where platelets are dangerously low. Unlike corticosteroids or IV immunoglobulins, Eltrombopag directly stimulates the bone marrow to produce more platelets, providing a sustained platelet count response. In clinical trials (RAISE study for chronic ITP; ENABLE-1/2 for HCV), Eltrombopag significantly improved platelet counts, allowed completion of antiviral therapy in HCV patients, and reduced bleeding risk. In aplastic anaemia, it has shown haematological responses across all three cell lineages when combined with standard immunosuppressive therapy.
USAGE OVERVIEW: Rompag 50mg Tablets are taken orally, on an empty stomach (at least 2 hours before or 4 hours after food, antacids, dairy products, or mineral supplements such as iron, calcium, magnesium). The starting dose for chronic ITP in adults is 50mg once daily; doses are adjusted (25mg to 75mg daily) based on platelet count response. For patients of East Asian descent (Indian, Chinese, Japanese, Korean), the starting dose is typically 25mg daily due to higher drug exposure. Dosage and duration are strictly determined by the treating haematologist.
SAFETY OVERVIEW: The most common side effects include nausea, headache, upper respiratory tract infection, elevated liver enzymes, and cataract formation with prolonged use. Serious risks include hepatotoxicity, thromboembolic events (especially above target platelet counts), bone marrow reticulin fibre deposition, and rebound thrombocytopenia on discontinuation. Regular liver function tests, platelet counts, and ophthalmic evaluations are mandatory during therapy. This medicine is NOT for use in patients with platelet counts already ≥50,000/μL for the purpose of normalising counts.
Uses / Indications:
• Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP): adults and paediatric patients ≥1 year with ITP who are refractory to other treatments (corticosteroids, IVIg) — used to reduce bleeding risk when platelet count is dangerously low
• HCV-Associated Thrombocytopenia: treatment of thrombocytopenia in adults with chronic hepatitis C to allow initiation and maintenance of interferon-based antiviral therapy
• Severe Aplastic Anaemia (SAA): in combination with standard immunosuppressive therapy (IST) in treatment-naïve patients, or as monotherapy in patients ineligible for IST
ADDITIONAL USES:
• Refractory chronic ITP in patients who have failed splenectomy (off-label in some protocols)
• Myelodysplastic syndrome (MDS)-related thrombocytopenia (under investigation/off-label)
Interactions / Warnings:
HEPATOTOXICITY WARNING — LIVER MONITORING MANDATORY: Liver function tests (ALT, AST, bilirubin) must be performed at baseline, every 2 weeks during dose adjustment, then monthly once stable. If ALT rises to ≥3× ULN with direct bilirubin >2× ULN — DISCONTINUE immediately; do not restart. If ALT ≥3× ULN persisting for ≥4 weeks or with clinical hepatitis symptoms — DISCONTINUE.
THROMBOEMBOLIC RISK: Do NOT allow platelet counts to exceed 200,000/μL; target range is 50,000–200,000/μL for ITP. Eltrombopag should be DISCONTINUED if platelet count exceeds 400,000/μL. Use with caution in patients with known risk factors for thromboembolism (immobility, malignancy, prior VTE, oral contraceptive use, Factor V Leiden).
BONE MARROW FIBROSIS: A peripheral blood smear should be examined at baseline and monthly for morphological changes suggestive of reticulin deposition (teardrop cells, nucleated RBCs, immature white cells). If new or worsening morphological changes are identified — consider bone marrow biopsy; discontinue if fibrosis confirmed.
REBOUND THROMBOCYTOPENIA ON STOPPING: DO NOT abruptly stop without medical supervision. Platelet count must be monitored weekly for at least 4 weeks after discontinuation. Emergency treatment plan for severe thrombocytopenia must be in place before stopping.
OPHTHALMOLOGIC MONITORING: Baseline ophthalmic examination (slit-lamp) required before starting. Periodic eye exams during prolonged therapy — Eltrombopag may cause or worsen cataracts.
EAST ASIAN PATIENTS (including South Asian subgroups with higher exposure): Starting dose: 25mg once daily (half the standard adult dose) due to higher Eltrombopag plasma exposure in East/South Asian populations.
Pregnancy interaction:
• Rompag 50mg Tablet is CONTRAINDICATED during pregnancy — Eltrombopag may cause foetal harm based on animal data.
• Women of childbearing potential MUST use effective contraception during treatment and for at least 7 days after the last dose.
• A negative pregnancy test must be confirmed before initiating treatment in women of reproductive potential.
• If pregnancy occurs during treatment, discontinue immediately and report to the treating haematologist.
BREASTFEEDING:
• Eltrombopag is excreted in human breast milk. Due to the potential for serious adverse effects in nursing infants, breastfeeding should be DISCONTINUED during treatment and for at least 7 days after the final dose.
CONTRACEPTION WARNING:
• Both male and female patients should use effective contraception during therapy. Consult your haematologist regarding reproductive planning before starting Eltrombopag.
Expert advice:
1. THE 4-HOUR FOOD AND SUPPLEMENT RULE IS NON-NEGOTIABLE:
• Rompag 50mg MUST be taken on a completely empty stomach — at least 2 hours before OR 4 hours after any food, dairy products, antacids, or mineral supplements (especially iron, calcium, magnesium, zinc, selenium). This is the single most important administration instruction. Eltrombopag chelates divalent and trivalent cations, forming insoluble complexes that dramatically reduce absorption. A common patient error is taking the tablet with a morning glass of milk or a multivitamin — this can reduce bioavailability by up to 70%. Set an alarm for a mid-morning or bedtime dose to maintain the separation window.
2. PLATELET COUNT TARGET — NOT TOO LOW, NOT TOO HIGH:
• The goal of Eltrombopag therapy is to raise platelet count to a safe level to prevent bleeding (≥50,000/μL), NOT to normalise it. If platelet count rises above 200,000/μL, the dose must be reduced. Above 400,000/μL, the drug must be STOPPED as excessive platelet counts dramatically increase the risk of serious blood clots (DVT, pulmonary embolism, portal vein thrombosis, stroke). Patients and caregivers must understand: platelets too high is dangerous, not beneficial.
3. NEVER STOP ABRUPTLY WITHOUT MEDICAL SUPERVISION — REBOUND IS DANGEROUS:
• Stopping Rompag suddenly can trigger a severe rebound fall in platelet count — often below the pre-treatment baseline — lasting several weeks, during which life-threatening bleeding may occur. Always inform the treating haematologist before considering any change in dose or stopping. Weekly platelet count monitoring for at least 4 weeks after stopping is mandatory.
4. LIVER MONITORING IS MANDATORY AND TIME-CRITICAL:
• Eltrombopag can cause serious hepatotoxicity, including drug-induced liver injury (DILI). LFTs (ALT, AST, bilirubin) must be done at baseline, every 2 weeks during the dose adjustment phase, then monthly once stabilised. Patients must be counselled to report any yellowing of skin or eyes, dark urine, upper right abdominal pain, or unusual fatigue IMMEDIATELY — and must NOT wait for the next scheduled blood test.
5. DO NOT TAKE WITH STATINS WITHOUT CHECKING STATIN DOSE:
• Eltrombopag inhibits the OATP1B1/BCRP drug transporters, significantly increasing plasma levels of statins (especially rosuvastatin and simvastatin). Patients on concurrent statin therapy should have statin doses reviewed and reduced if necessary before starting Rompag, to prevent statin-related myopathy or rhabdomyolysis. This interaction is clinically significant and frequently overlooked.
MONITORING ADVICE:
• Platelet count (CBC): Baseline; weekly during dose adjustment; monthly once stable
• Liver Function Tests (ALT, AST, bilirubin): Baseline; every 2 weeks during dose adjustment; monthly once stable
• Peripheral blood smear: Monthly — to detect early reticulin deposition (bone marrow fibrosis marker)
• Ophthalmologic examination (slit-lamp): Baseline; annually or if visual symptoms develop — cataract surveillance
• Serum creatinine/eGFR: Baseline; periodically — renal function monitoring
• Pregnancy test (women of childbearing age): Negative test required before initiation
• HCV viral load (for HCV indication): Monitored by treating gastroenterologist/hepatologist alongside antiviral therapy
COMPLIANCE/HANDLING TIPS:
• Set a phone alarm at a consistent time — ideally mid-morning or bedtime — to maintain food separation window
• Keep a medication diary noting dose time and weekly platelet count results from blood tests
• Store tablets in original blister pack below 30°C — avoid moisture and direct sunlight
• Do NOT crush, split, or chew tablets — swallow whole with plain water
• Carry a medical alert card listing Eltrombopag and dosage to all medical appointments
• Keep all haematology outpatient appointments and blood tests without skipping
SAFETY TIPS:
• Inform ALL treating doctors (hepatologist, ophthalmologist, GP, dentist, cardiologist) that you are on Eltrombopag
• Inform your doctor IMMEDIATELY if you develop leg pain/swelling, chest pain, or shortness of breath — these may indicate a blood clot
• Do NOT self-adjust dose based on bruising or bleeding; only adjust under haematologist supervision
• Avoid contact sports or activities with high injury/bleeding risk while on therapy unless platelet count is well above target
• Women of childbearing age must use effective contraception throughout treatment and for 7 days after last dose
Side Effects:
• Nausea, vomiting, diarrhoea, abdominal pain — take on empty stomach as directed; may reduce GI symptoms
• Headache, dizziness, fatigue
• Upper respiratory tract infections — cough, nasopharyngitis
• Elevated liver enzymes (ALT, AST, bilirubin) — regular LFT monitoring required
• Myalgia (muscle pain), arthralgia (joint pain)
• Alopecia (hair loss)
• Paraesthesia (tingling/numbness)
• Cataract — especially with prolonged use; baseline and periodic ophthalmologic examination required
SERIOUS SIDE EFFECTS (contact your doctor immediately):
• Hepatotoxicity: jaundice (yellow skin/eyes), dark urine, severe upper right abdominal pain, extreme fatigue — DISCONTINUE and seek urgent review; LFTs must be monitored throughout therapy
• Thromboembolic Events: DVT, pulmonary embolism, portal vein thrombosis, stroke — risk increases if platelet count rises above target (>200,000/μL); maintain platelet count at lowest effective level
• Bone Marrow Reticulin Fibre Deposition: new/worsening blood count abnormalities, peripheral blood smear changes — may progress to marrow fibrosis on prolonged use; periodic peripheral blood smear review required
• Rebound Thrombocytopenia on Discontinuation: platelet counts may fall below pre-treatment baseline for several weeks after stopping — serious bleeding risk; taper and monitor carefully
• Haematological Malignancy Progression Risk: in MDS/haematological malignancies — Eltrombopag is NOT approved for thrombocytopenia from these causes; risk of stimulating malignant clone
EMERGENCY SIGNS — SEEK IMMEDIATE MEDICAL HELP:
• Sudden leg pain/swelling, chest pain, shortness of breath (thromboembolic event)
• Jaundice or severe right upper abdominal pain (hepatotoxicity)
• Unusual, severe, or spontaneous bleeding (rebound thrombocytopenia)
How to use:
• Chronic ITP (adults & children ≥6 years): Starting dose 50mg once daily (25mg once daily for East Asian patients) — Adjust dose to achieve and maintain platelet count ≥50,000/μL; maximum dose: 75mg daily
• Chronic ITP (children 1–5 years): Starting dose 25mg once daily (dose adjusted by body weight — specialist only)
• HCV-Associated Thrombocytopenia: Starting dose 25mg once daily; adjust to achieve platelet count needed for antiviral therapy initiation; max 100mg daily
• Severe Aplastic Anaemia (SAA): Starting dose 150mg once daily (75mg for East Asian patients); continued under strict haematologist supervision
ROUTE OF ADMINISTRATION:
• Oral (tablet) — swallow whole with water
• MUST be taken on an EMPTY STOMACH: at least 2 hours BEFORE OR 4 hours AFTER food, dairy products, antacids, or mineral supplements (iron, calcium, magnesium, aluminium, selenium, zinc)
• Polyvalent cations in food and supplements significantly reduce Eltrombopag absorption — this is the most critical administration rule
TIMING:
• Take at the same time each day
• Separate from any polyvalent cation-containing supplement or antacid by at least 4 hours
MISSED DOSE:
• If a dose is missed, take the next scheduled dose the following day. Do NOT take two doses in one day.
STORAGE:
• Store below 30°C in a dry place, away from moisture and sunlight
• Keep in original blister packaging
• Keep out of reach of children
• Do not use after the expiry date printed on the label
How it works:
Rompag 50mg contains Eltrombopag Olamine, a small-molecule, orally bioavailable, non-peptide Thrombopoietin Receptor Agonist (TPO-RA).
Platelet counts fall dangerously low in ITP and aplastic anaemia because:
• In ITP: autoantibodies destroy platelets AND suppress megakaryocyte platelet production in the bone marrow
• In SAA: immune destruction of haematopoietic stem cells depletes all blood cell lineages, including platelet-producing megakaryocytes
Eltrombopag works by:
• Binding to the transmembrane domain of the thrombopoietin receptor (c-Mpl/TPO-R) on megakaryocytes and haematopoietic stem cells — at a different binding site to natural TPO (no competition)
• Activating JAK2 and STAT signalling pathways, stimulating megakaryocyte proliferation and differentiation
• Increasing platelet production (thrombopoiesis) from the bone marrow
KEY ADVANTAGES:
• Oral once-daily dosing — avoids IV injections
• Effective even in splenectomised and splenectomy-naïve ITP patients
• Does not cause platelet activation or aggregation (unlike natural TPO at high doses)
• In SAA, stimulates tri-lineage haematopoietic recovery (platelets, red cells, neutrophils) alongside IST
• Clinically proven in RAISE, REPEAT, and EXTEND trials for ITP; ENABLE-1/2 for HCV-associated thrombocytopenia
Faq for medicine:
Rompag 50mg (Eltrombopag 50mg) is a thrombopoietin receptor agonist used to raise platelet counts in chronic ITP, HCV-associated thrombocytopenia, and severe aplastic anaemia, as prescribed by a haematologist.
2. How does Rompag 50mg Eltrombopag Tablet work?
Eltrombopag binds to the thrombopoietin receptor (c-Mpl) on bone marrow megakaryocytes, activating JAK2/STAT pathways to stimulate platelet production. It raises low platelet counts without directly activating or aggregating platelets.
3. What is the dose of Rompag 50mg Tablet for chronic ITP?
Standard starting dose for chronic ITP in adults: 50mg once daily on empty stomach (25mg for East Asian/South Asian patients). Dose adjusted between 25mg–75mg to maintain platelet count ≥50,000/μL. Always follow your haematologist's prescription exactly.
4. What are the side effects of Rompag 50mg Tablet?
Most common: nausea, headache, elevated liver enzymes, upper respiratory infections. Serious but rare: hepatotoxicity (jaundice), thromboembolic events (DVT, PE), bone marrow fibrosis, rebound thrombocytopenia on stopping, and cataract with long-term use.
5. Can I buy Rompag 50mg Tablet online at the best price in India?
Yes. Buy Rompag 50mg Tablet online from Shabbir Medical Hall at 30% OFF MRP (Rs 1,666.70 vs Rs 2,381.00 per strip of 7 tablets). Valid haematologist prescription required. Fast delivery across Hyderabad, Bangalore, Mumbai, Delhi, and Chennai.
Medicine interaction:
• Polyvalent Cation-Containing Products (CRITICAL INTERACTION): antacids (Mg, Al, Ca), mineral supplements (iron, calcium, magnesium, selenium, zinc), dairy products — Eltrombopag chelates these cations; separating administration by at least 4 hours is MANDATORY to prevent dramatically reduced absorption
• HMG-CoA Reductase Inhibitors (Statins — rosuvastatin, simvastatin, atorvastatin): Eltrombopag inhibits OATP1B1/BCRP transporters — can significantly increase statin plasma levels; dose reduction of statin may be required; monitor for statin toxicity (myopathy, rhabdomyolysis)
• Ciclosporin: reduced Eltrombopag exposure; monitor platelet response; used together in aplastic anaemia under specialist supervision
• Warfarin / Anticoagulants: monitor INR closely; thromboembolic risk may alter anticoagulant requirements
• Interferons (pegylated, ribavirin — HCV regimens): combined use as per HCV treatment protocol; Eltrombopag enables antiviral therapy completion in thrombocytopenic HCV patients
• Lopinavir/Ritonavir (HIV antiretrovirals): reduce Eltrombopag AUC significantly — monitor platelet response; dose adjustment may be needed
VACCINE INTERACTIONS:
• No vaccine interactions were listed in the document for Rompag 50mg.
SUPPLEMENT INTERACTIONS:
• Iron, calcium, magnesium, zinc, selenium supplements: SEPARATE by at least 4 hours — major absorption interaction
• St John's Wort: potential CYP1A2 interaction — avoid concurrent use
• Always inform your doctor of all medicines, vitamins, herbal products, and supplements
