REBOPAG 50MG TABLETS
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Manufactured By MSN Laboratories
Composition ELTROMBOPAG 50MG
RS 1876.88
MRP RS 2887.50
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Description:
Rebopag 50mg Tablet
(Eltrombopag 50mg) is a potent oral thrombopoietin receptor agonist (TPO-RA) manufactured by MSN Laboratories, indicated for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP), thrombocytopenia associated with chronic hepatitis C virus (HCV) infection to allow initiation and maintenance of interferon-based therapy, and severe aplastic anaemia (SAA) in patients with insufficient response to immunosuppressive therapy. It works by binding to and activating the thrombopoietin receptor (c-Mpl) on bone marrow progenitor cells, stimulating platelet production and raising platelet counts to reduce the risk of bleeding. Available from Shabbir Medical Hall at the best price in India, this genuine prescription tablet is available online with fast delivery nationwide.
BENEFITS: Rebopag 50mg offers targeted platelet count restoration without the need for immunosuppression or splenectomy. In chronic ITP, eltrombopag has been shown in multiple randomised controlled trials (RAISE, EXTEND) to achieve clinically meaningful platelet responses (≥50 × 10⁹/L) in the majority of patients refractory to standard therapies. It enables stable platelet counts that significantly reduce bleeding events and transfusion requirements. In HCV-associated thrombocytopenia, it allows full-dose antiviral therapy to be initiated and maintained. In SAA, it improves multilineage haematopoietic responses when added to standard immunosuppressive regimens.
USAGE OVERVIEW: Rebopag 50mg Tablets are taken orally, once daily, on an empty stomach (at least 2 hours before or 4 hours after food, antacids, dairy products, or mineral supplements containing calcium, aluminium, magnesium, iron, or selenium). The dose is titrated to the lowest effective dose that maintains a platelet count of ≥50 × 10⁹/L. Dosage and duration are strictly determined by the treating haematologist.
SAFETY OVERVIEW: The most common side effects include nausea, diarrhoea, elevated liver enzymes, headache, and fatigue. Serious risks include hepatotoxicity, thromboembolic events, bone marrow reticulin formation, and rebound thrombocytopenia on discontinuation. Regular liver function tests and complete blood counts are mandatory throughout therapy. This medicine must only be used under specialist haematological supervision.
Uses / Indications:
• Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP): treatment of adults with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; used to raise platelet counts and reduce bleeding risk
• Thrombocytopenia in Chronic HCV Infection: to allow initiation and maintenance of interferon-based therapy in patients where the degree of thrombocytopenia is the main obstacle to initiating/maintaining antiviral therapy
• Severe Aplastic Anaemia (SAA): in combination with standard immunosuppressive therapy (horse anti-thymocyte globulin + cyclosporin) for first-line treatment, or in patients with refractory SAA
ADDITIONAL USES:
• Chemotherapy-induced thrombocytopenia (off-label in some protocols)
• Myelodysplastic syndrome (MDS)-associated thrombocytopenia (investigational/specialist use)
Interactions / Warnings:
HEPATOTOXICITY WARNING: Liver function tests (ALT, AST, bilirubin) MUST be performed before starting, every 2 weeks during dose adjustment, then monthly once stable. Discontinue if ALT ≥3× ULN with bilirubin ≥2× ULN, or ALT ≥5× ULN alone.
THROMBOEMBOLIC RISK: Do NOT target platelet counts above 200 × 10⁹/L — dosing must be titrated to the lowest effective dose. Use with extreme caution in patients with known thromboembolic risk factors (obesity, previous DVT/PE, immobility, active malignancy).
REBOUND THROMBOCYTOPENIA: NEVER stop Rebopag abruptly without haematologist guidance — platelet counts can drop below pre-treatment baseline. Weekly platelet monitoring is mandatory for 4 weeks after discontinuation.
BONE MARROW RETICULIN: Long-term use may stimulate reticulin deposition; bone marrow biopsy should be considered if new cytopenias develop.
RENAL / HEPATIC IMPAIRMENT: Hepatic impairment: use with caution; start at 25mg/day in Child-Pugh B/C; hepatotoxicity risk is higher. Renal impairment: no dose adjustment required but monitor carefully.
DRIVING & MACHINERY: May cause dizziness and fatigue; assess personal response before driving.
ELDERLY (≥65 years): Limited data; use with caution; monitor haematological and hepatic parameters closely.
Pregnancy interaction:
• Rebopag 50mg is NOT recommended during pregnancy — eltrombopag may cause foetal harm based on animal studies
• Women of childbearing potential must use effective contraception during treatment and for 7 days after the last dose
• If pregnancy occurs during treatment, discontinue immediately and consult the treating haematologist
• Pregnancy should be reported to the manufacturer's pharmacovigilance programme
BREASTFEEDING:
• Breastfeeding is NOT recommended during treatment and for 2 weeks after the last dose
• Eltrombopag may be excreted in breast milk; potential risk to the infant cannot be excluded
CONTRACEPTION WARNING:
• Use highly effective contraception (dual method recommended) during treatment
• Male patients: no specific reproductive toxicity data; consult haematologist regarding family planning
Expert advice:
1. THE CHELATION RULE — MOST CRITICAL INSTRUCTION FOR REBOPAG:
• Eltrombopag forms insoluble chelates with polyvalent metal cations (calcium, magnesium, aluminium, iron, zinc, selenium). Even a glass of milk, an antacid, or a calcium-fortified juice taken within 4 hours of the dose can reduce absorption by up to 90%, rendering the tablet virtually ineffective. Counsel patients rigorously: take Rebopag on an EMPTY stomach, at least 2 hours before or 4 hours after ANY food, dairy, antacid, or mineral supplement.
2. NEVER STOP REBOPAG WITHOUT HAEMATOLOGIST APPROVAL:
• Abrupt discontinuation can trigger severe rebound thrombocytopenia — platelet counts can drop below pre-treatment levels within days, dramatically increasing bleeding risk. Platelet counts must be monitored weekly for at least 4 weeks after stopping.
3. MONITOR LIVER FUNCTION REGULARLY — HEPATOTOXICITY IS A REAL RISK:
• Eltrombopag is metabolised hepatically and carries a risk of serious liver injury. LFTs (ALT, AST, bilirubin) must be checked before starting, every 2 weeks during dose titration, then monthly once stable. Report any yellowing of skin/eyes, dark urine, or severe abdominal pain immediately.
4. DOSE IS NOT FIXED — TITRATE TO TARGET PLATELET COUNT:
• Unlike most medicines, the dose of eltrombopag must be individually titrated. The goal is to maintain platelets at ≥50 × 10⁹/L using the LOWEST effective dose. Too high a dose can overshoot the target and trigger thromboembolism. Counsel patients never to self-adjust the dose between haematology appointments.
5. STATIN USERS REQUIRE SPECIAL ATTENTION:
• Eltrombopag inhibits the OATP1B1 transporter and can significantly increase plasma concentrations of statins, particularly rosuvastatin. If the patient is on a statin, inform the prescribing haematologist immediately — the statin dose may need to be reduced to prevent myopathy.
MONITORING ADVICE:
• Liver Function Tests (ALT, AST, bilirubin): Before starting, every 2 weeks during titration, then monthly
• Complete Blood Count (CBC) with platelet count: Weekly during dose titration; monthly once stable
• Platelet monitoring post-discontinuation: Weekly for 4 weeks after stopping
• Ophthalmological examination (cataracts): Baseline and annually during long-term therapy
• Bone marrow biopsy: Consider if new or worsening cytopenia develops during long-term use
COMPLIANCE TIPS:
• Set a daily alarm for the same time — consistency is crucial for stable platelet counts
• Keep a food/supplement diary to ensure correct timing relative to dosing
• Carry a medication alert card listing all medicines and the chelation rule
• Do NOT crush or chew tablets — swallow whole with plain water only
• Store in original blister packaging away from moisture, heat, and sunlight
SAFETY TIPS:
• Do NOT stop Rebopag without explicit haematologist instruction
• Inform all treating doctors (GP, dentist, cardiologist) that you are on Eltrombopag
• Report any leg swelling, chest pain, or breathlessness immediately — these may signal a clot
• Avoid over-the-counter NSAIDs and aspirin without haematologist approval (bleeding risk management)
• Women of childbearing age: confirm use of effective contraception throughout therapy
Side Effects:
• Nausea, diarrhoea, abdominal pain, dyspepsia
• Elevated liver enzymes (ALT, AST) — monitor LFTs throughout therapy
• Headache, fatigue, dizziness
• Upper respiratory tract infections
• Myalgia (muscle pain), back pain
• Alopecia (hair thinning)
SERIOUS SIDE EFFECTS (contact your doctor immediately):
• Hepatotoxicity: jaundice, dark urine, severe right upper abdominal pain, elevated bilirubin — DISCONTINUE and seek urgent review; can progress to liver failure
• Thromboembolic events: DVT, pulmonary embolism, portal vein thrombosis, stroke — monitor closely, especially if platelet count overshoots target; risk increases significantly if platelet count >200 × 10⁹/L
• Rebound thrombocytopenia: severe platelet drop on discontinuation — can worsen bleeding beyond pre-treatment levels; never stop abruptly
• Bone marrow reticulin formation and fibrosis: risk increases with long-term use; bone marrow biopsy may be required
• Cataracts: new-onset or worsening lens opacities reported — periodic ophthalmological monitoring recommended
EMERGENCY SIGNS — SEEK IMMEDIATE MEDICAL HELP:
• Sudden leg pain/swelling, chest pain, shortness of breath (thromboembolism)
• Jaundice, severe abdominal pain, dark urine (hepatotoxicity)
• Unusual or severe bleeding after dose reduction or stopping (rebound thrombocytopenia)
How to use:
• Chronic ITP: Starting dose 50mg ONCE DAILY; adjust in 25mg increments every 2 weeks based on platelet response; max 75mg/day
— East/Southeast Asian patients: start at 25mg once daily due to higher plasma exposure
• HCV-associated thrombocytopenia: 25mg once daily; titrate to achieve target platelet count to allow antiviral initiation; max 100mg/day
• Severe Aplastic Anaemia: 150mg once daily (75mg/day for East/Southeast Asian patients); used in combination with IST
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 (especially high-calcium foods: dairy, fortified juices)
— Antacids (calcium, aluminium, magnesium carbonate)
— Mineral supplements (iron, calcium, magnesium, aluminium, selenium, zinc)
— Polyvalent cation-containing products (these form chelates with eltrombopag and reduce absorption by up to 90%)
TIMING:
• Take at the same time each day — consistency is critical for stable platelet levels
• Do NOT stop without haematologist approval — rebound thrombocytopenia may occur
MISSED DOSE:
• Take ONLY ONE dose per day; if a dose is missed, skip it and resume the next day
• Do NOT double up
STORAGE:
• Store below 30°C in a dry place, away from moisture and sunlight
• Keep in original blister packaging until use
• Keep out of reach of children
• Do not use after the expiry date printed on the strip
How it works:
Rebopag 50mg contains Eltrombopag, a small-molecule, non-peptide thrombopoietin receptor agonist.
Eltrombopag binds to the transmembrane domain of the thrombopoietin receptor (c-Mpl / MPL) on megakaryocytes and their progenitor cells in the bone marrow. Unlike endogenous thrombopoietin (TPO), it binds at a distinct site but activates the same downstream signalling cascades:
• JAK2/STAT pathway activation → promotes megakaryocyte proliferation and differentiation
• PI3K/Akt pathway → enhances megakaryocyte survival and maturation
• MAPK pathway → stimulates platelet production from mature megakaryocytes
NET RESULT: Increased production and release of platelets from bone marrow megakaryocytes → rising peripheral platelet counts → reduced bleeding risk in thrombocytopenic conditions.
KEY ADVANTAGES:
• Oral once-daily dosing — no injections required
• Acts independently of endogenous TPO levels (effective even when TPO is already elevated)
• Effective in both splenectomised and non-splenectomised ITP patients
• Clinically validated across ITP, HCV thrombocytopenia, and SAA
Faq for medicine:
Rebopag 50mg contains Eltrombopag, a thrombopoietin receptor agonist used in chronic immune thrombocytopenia, thrombocytopenia in HCV, and as part of first-line treatment for severe aplastic anemia. Rebopag stimulates bone marrow megakaryocytes to produce more platelets, reducing the risk of spontaneous bleeding in patients with dangerously low platelet counts due to immune destruction or bone marrow failure.
2.What starting dose and titration schedule is used for Rebopag 50mg?
Rebopag 50mg is typically started at 50mg once daily for most adults with ITP, except East Asian patients who begin at 25mg. The dose is adjusted in 25mg increments every 2 weeks based on platelet count and tolerability. The maximum Eltrombopag dose is 75mg per day. Target platelet count to avoid bleeding is ≥50,000/µL. Rebopag should never be dosed to achieve normal platelet counts.
3.Can Rebopag 50mg cure ITP or is it a long-term management therapy?
Rebopag 50mg is a long-term management therapy for ITP, not a cure. Platelet counts typically fall after discontinuation. Some patients achieve sustained remission with prolonged Rebopag use, but this is not universal. Rebopag is a second-line option used after corticosteroids, IVIG, and anti-D immunoglobulin therapies have been tried or are not suitable for the patient.
4.What are the bone marrow risks associated with long-term Rebopag 50mg use?
Long-term Rebopag 50mg use may cause bone marrow reticulin fiber deposition, though clinically significant myelofibrosis is rare. Peripheral blood smears should be reviewed regularly for morphological changes suggesting bone marrow dysfunction. If new cytopenias, cellular abnormalities, or myelodysplastic features are detected on smear or biopsy, Rebopag therapy should be promptly discontinued.
5.Does Rebopag 50mg Eltrombopag work in aplastic anemia treatment?
Yes, Rebopag 50mg is used in combination with cyclosporine and horse anti-thymocyte globulin as first-line treatment for severe aplastic anemia, based on NIH trial data showing improved trilineage hematologic response. Rebopag promotes hematopoietic stem cell recovery in the bone marrow, extending its utility well beyond platelet-specific disorders and making it a significant advance in aplastic anemia management.
6.What is the significance of East Asian ancestry when dosing Rebopag 50mg?
East Asian patients metabolize Rebopag 50mg differently, resulting in approximately 87% higher drug exposure than non-East-Asian patients. For this reason, East Asian patients start at 25mg once daily for ITP. This pharmacogenomic difference is clinically important to prevent excessive platelet rises and hepatotoxicity. Dose adjustment based on ethnicity is a mandatory consideration when initiating Rebopag therapy.
Medicine interaction:
• Polyvalent cations (antacids, dairy, iron/calcium/magnesium/zinc/aluminium/selenium supplements): form chelates with eltrombopag and reduce absorption by up to 90% — SEPARATE by at least 4 hours
• Rosuvastatin / statins (OATP1B1 substrates): eltrombopag inhibits OATP1B1 transport — significantly increases statin exposure; reduce rosuvastatin dose to max 10mg/day; monitor for statin toxicity (myopathy, rhabdomyolysis)
• Cyclosporin (in SAA regimens): eltrombopag may affect cyclosporin metabolism — monitor levels closely
• CYP1A2 substrates (theophylline, caffeine, clozapine): eltrombopag is a moderate CYP1A2 inhibitor — may increase plasma levels
• Interferon alfa / ribavirin (HCV regimens): co-administration is the intended use in HCV thrombocytopenia; monitor platelets closely and adjust eltrombopag to maintain safe platelet levels
• Warfarin / anticoagulants: monitor INR closely; thrombotic risk may be increased if platelet counts overshoot target
VACCINE INTERACTIONS:
• No specific vaccine interactions listed in the document for Rebopag 50mg.
SUPPLEMENT INTERACTIONS:
• Iron, calcium, magnesium, zinc, selenium, aluminium supplements: MUST be separated by at least 4 hours
• Always inform your haematologist of all vitamins, herbal products, and supplements
