Eltrombopag Reddy: Uses, Dosage & Side Effects

A thrombopoietin receptor agonist (TPO-RA) that stimulates platelet production for the treatment of thrombocytopenia in chronic ITP, hepatitis C, and severe aplastic anemia

Rx ATC: B02BX05 TPO Receptor Agonist
Active Ingredient
Eltrombopag
Available Forms
Film-coated tablet
Strength
25 mg
Brand Names
Eltrombopag Reddy, Revolade, Promacta

Eltrombopag Reddy is a prescription oral thrombopoietin receptor agonist (TPO-RA) used to increase platelet production in patients with thrombocytopenia (abnormally low platelet counts). It is indicated for three main conditions: chronic immune thrombocytopenic purpura (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; thrombocytopenia associated with chronic hepatitis C virus (HCV) infection to enable the initiation and maintenance of interferon-based antiviral therapy; and severe aplastic anemia (SAA) in adults who have had an inadequate response to immunosuppressive therapy. Unlike recombinant thrombopoietin, eltrombopag is a small-molecule agent taken as a daily oral tablet, making it a convenient option for long-term platelet management.

Quick Facts: Eltrombopag Reddy

Active Ingredient
Eltrombopag
Drug Class
TPO-RA
ATC Code
B02BX05
Common Uses
Thrombocytopenia / ITP
Available Forms
Film-coated tablet
Prescription Status
Rx Only

Key Takeaways

  • Eltrombopag Reddy is a once-daily oral thrombopoietin receptor agonist that stimulates platelet production by activating the TPO receptor (c-Mpl) on megakaryocyte progenitor cells in the bone marrow.
  • It is approved for chronic immune thrombocytopenic purpura (ITP), hepatitis C-associated thrombocytopenia, and severe aplastic anemia in patients who have not responded adequately to other treatments.
  • The tablet must be taken on an empty stomach (at least 2 hours before or 4 hours after dairy products, antacids, or mineral supplements) because polyvalent cations significantly reduce absorption.
  • Regular liver function monitoring is essential, as hepatotoxicity is a known risk; treatment should be discontinued if ALT levels rise to 3 times or more the upper limit of normal and are progressive, persistent, or accompanied by clinical symptoms.
  • Platelet counts typically begin to rise within 1–2 weeks of starting treatment, and the dose should be adjusted to maintain platelets at the lowest level sufficient to reduce bleeding risk—not to normalize the count.

What Is Eltrombopag Reddy and What Is It Used For?

Quick Answer: Eltrombopag Reddy is an oral thrombopoietin receptor agonist that stimulates the bone marrow to produce more platelets. It is used to treat chronically low platelet counts (thrombocytopenia) in patients with immune thrombocytopenic purpura (ITP), chronic hepatitis C, or severe aplastic anemia who have not responded sufficiently to other therapies.

Eltrombopag Reddy contains the active substance eltrombopag (as eltrombopag olamine), a first-in-class, small-molecule, non-peptide thrombopoietin receptor agonist (TPO-RA). Thrombopoietin (TPO) is the primary physiological regulator of platelet production (thrombopoiesis). It is produced primarily by the liver and kidneys and acts on megakaryocyte progenitor cells in the bone marrow to stimulate their proliferation, differentiation, and maturation into mature megakaryocytes, which then shed fragments of their cytoplasm into the bloodstream as platelets. Each megakaryocyte can produce between 1,000 and 3,000 platelets, and the entire process from progenitor cell to platelet release takes approximately 7 to 10 days.

Eltrombopag interacts with the transmembrane domain of the human thrombopoietin receptor (also known as c-Mpl or MPL), binding at a site distinct from the binding site of endogenous TPO. This means that eltrombopag does not compete with the body's own thrombopoietin but rather works in an additive manner. By activating the TPO receptor, eltrombopag initiates intracellular signaling cascades—primarily the Janus kinase/signal transducer and activator of transcription (JAK-STAT) and mitogen-activated protein kinase (MAPK) pathways—that promote the growth and differentiation of megakaryocyte progenitor cells. The net result is an increase in platelet production from the bone marrow within 1 to 2 weeks of initiating treatment.

Importantly, eltrombopag does not affect platelet function. The platelets produced under eltrombopag stimulation have been shown in studies to have normal morphology, normal aggregation responses, and normal activation markers. This distinguishes eltrombopag from treatments that simply prevent platelet destruction (such as immunosuppressive agents in ITP) and positions it as a therapy that addresses the underlying deficit in platelet production.

Eltrombopag Reddy is a generic formulation of eltrombopag, containing the same active pharmaceutical ingredient as the originator product (marketed as Revolade in Europe and Promacta in the United States by Novartis). It is bioequivalent to the originator, meaning it delivers the same amount of active drug to the bloodstream at the same rate and extent, ensuring comparable clinical efficacy and safety. The availability of generic eltrombopag has improved access to this important medication for patients worldwide.

Approved Indications

Eltrombopag Reddy is approved for the following indications:

  • Chronic Immune Thrombocytopenic Purpura (ITP): For adults and children aged 1 year and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ITP is an autoimmune condition in which the body produces antibodies against its own platelets, leading to accelerated platelet destruction and inadequate platelet production. Eltrombopag addresses both aspects by boosting platelet production through TPO receptor stimulation. In the pivotal RAISE trial, eltrombopag significantly increased the proportion of patients achieving platelet counts of 50,000/µL or greater compared with placebo, and reduced the need for rescue therapy.
  • Chronic Hepatitis C Virus (HCV) Infection: For the treatment of thrombocytopenia in adult patients with chronic HCV infection to allow the initiation and maintenance of interferon-based antiviral therapy. Thrombocytopenia is a common complication of chronic liver disease due to reduced TPO production by the diseased liver, splenic sequestration of platelets, and direct viral effects on megakaryocytes. The ENABLE-1 and ENABLE-2 trials demonstrated that eltrombopag allowed more patients to initiate and maintain antiviral therapy, and increased the proportion achieving sustained virologic response (SVR).
  • Severe Aplastic Anemia (SAA): For adult patients with severe aplastic anemia who have had an insufficient response to at least one prior course of immunosuppressive therapy. Aplastic anemia is a rare and serious condition in which the bone marrow fails to produce adequate numbers of all blood cell types, including platelets. The addition of eltrombopag to standard immunosuppressive therapy (horse anti-thymocyte globulin plus ciclosporin) has been shown to improve overall and complete response rates in treatment-naive patients, as demonstrated in the landmark NIH study published in the New England Journal of Medicine.
Important Clinical Principle

Eltrombopag should be used at the lowest dose needed to achieve and maintain a platelet count sufficient to reduce the risk of bleeding. It should not be used to normalize platelet counts, as excessively high platelet counts may increase the risk of thromboembolic events. For ITP patients, the target is typically a platelet count above 50,000/µL. Your doctor will regularly monitor your blood counts and adjust the dose accordingly.

What Should You Know Before Taking Eltrombopag Reddy?

Quick Answer: Do not use Eltrombopag Reddy if you are allergic to eltrombopag or any of its ingredients. Your doctor must check your liver function before and during treatment, as hepatotoxicity is a known risk. Tell your doctor if you have liver disease, risk factors for blood clots, cataracts, or if you are pregnant or breastfeeding.

Contraindications

The primary contraindication to Eltrombopag Reddy use is hypersensitivity (allergy) to eltrombopag olamine or to any of the excipients in the formulation. If you have experienced an allergic reaction to eltrombopag in the past, including rash, urticaria (hives), angioedema (swelling of the face, lips, tongue, or throat), or anaphylaxis, you must not take this medication. The excipients include magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid, along with the film-coating components hypromellose, macrogol, polydextrose, titanium dioxide, and triacetin.

Eltrombopag is not indicated for the treatment of thrombocytopenia caused by myelodysplastic syndromes (MDS) or other malignant conditions, as stimulation of platelet production via the TPO receptor could theoretically promote the growth of malignant cells expressing c-Mpl. If you have a blood cancer or bone marrow disorder other than the approved indications, discuss the risks and benefits carefully with your hematologist.

Warnings and Precautions

Before starting Eltrombopag Reddy, discuss the following with your healthcare provider:

  • Liver disease: Patients with chronic liver disease (particularly those with hepatitis C and cirrhosis) may be at increased risk of hepatotoxicity and thromboembolic events. If you have impaired liver function, your doctor may start you on a lower dose (25 mg daily for ITP). The dose should not exceed 75 mg daily in patients with hepatic impairment. Patients with moderate to severe hepatic impairment (Child-Pugh score 7 or higher) should not use eltrombopag for ITP unless the expected benefit outweighs the identified risk of portal venous thrombosis.
  • Thromboembolic risk: Eltrombopag increases platelet counts, and excessively high platelet levels can increase the risk of blood clots (thrombosis). This risk is particularly relevant in patients with chronic liver disease, who may develop portal vein thrombosis. Patients with known risk factors for thromboembolism (such as Factor V Leiden mutation, antiphospholipid syndrome, advanced age, prolonged immobilization, malignancy, oral contraceptive use, or hormone replacement therapy) should be monitored carefully. The goal of treatment is to achieve the lowest platelet count sufficient to reduce bleeding risk—not to normalize the count.
  • Bone marrow fibrosis: Eltrombopag, like all TPO receptor agonists, may increase the risk of reticulin fiber deposition in the bone marrow. This is generally mild and reversible upon discontinuation but, in rare cases, can progress to collagen fibrosis. Your doctor should examine a peripheral blood smear before starting treatment and regularly thereafter to look for new or worsening morphological abnormalities (such as teardrop-shaped red blood cells or nucleated red blood cells). If these findings develop, a bone marrow biopsy may be warranted.
  • Cataracts: Cataracts (lens opacities) have been observed in animal toxicology studies and in some patients in clinical trials. An ophthalmologic (eye) examination is recommended before starting eltrombopag and regularly during treatment.
  • Rebound thrombocytopenia: After discontinuation of eltrombopag, platelet counts may fall below baseline levels (rebound thrombocytopenia), potentially increasing the risk of bleeding. This typically occurs within 2 weeks of stopping the drug and returns to pre-treatment levels within 2 to 4 weeks. Your doctor will monitor your platelet counts for at least 4 weeks after stopping treatment.

Pregnancy and Breastfeeding

Eltrombopag Reddy should not be used during pregnancy unless clearly necessary. Animal reproductive toxicology studies have demonstrated embryo-fetal toxicity at clinically relevant exposures, including reduced fetal body weights and increased rates of pre-implantation and post-implantation loss. There are no adequate and well-controlled studies of eltrombopag in pregnant women. If you are a woman of childbearing potential, effective contraception should be used during treatment. If you become pregnant while taking eltrombopag, contact your doctor immediately to discuss the risks and benefits of continuing treatment.

It is not known whether eltrombopag is excreted in human breast milk. In animal studies, eltrombopag was detected in breast milk. Given the potential for serious adverse reactions in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue eltrombopag therapy, taking into account the importance of the drug to the mother. Discuss this with your healthcare provider.

Children and Adolescents

Eltrombopag is approved for the treatment of chronic ITP in children aged 1 year and older who have had an insufficient response to other treatments. The safety and efficacy in this age group were established in the PETIT and PETIT2 clinical trials. For children aged 1 to 5 years, the recommended starting dose is 25 mg once daily. For children aged 6 to 17 years, the starting dose is 50 mg once daily, with dose adjustments based on platelet count response. Eltrombopag has not been studied in children younger than 1 year, nor is it approved for pediatric use in hepatitis C-associated thrombocytopenia or severe aplastic anemia.

Driving and Operating Machinery

Eltrombopag may cause dizziness or blurred vision in some patients. If you experience these side effects, do not drive or operate heavy machinery until these symptoms resolve. Based on pharmacological properties and the known adverse reaction profile, clinically significant impairment of the ability to drive or use machines is not expected in most patients, but individual responses may vary.

How Does Eltrombopag Reddy Interact with Other Drugs?

Quick Answer: Eltrombopag has clinically significant interactions with polyvalent cation-containing products (calcium, iron, magnesium, aluminium, selenium, zinc), which dramatically reduce its absorption. It also inhibits OATP1B1 and BCRP drug transporters, increasing blood levels of rosuvastatin and other substrates. Eltrombopag must be taken on an empty stomach, separated from dairy products and mineral supplements by at least 2–4 hours.

Eltrombopag has several clinically important drug and food interactions that must be understood and managed to ensure effective therapy. Unlike many biologic agents, eltrombopag is a small-molecule drug that is absorbed from the gastrointestinal tract and metabolized by hepatic enzymes and transporter systems, creating multiple opportunities for interaction with other substances.

Major Interactions

The most critical interaction involves polyvalent cations. Eltrombopag is an avid chelator of polyvalent metal ions, including calcium (Ca2+), iron (Fe2+/Fe3+), magnesium (Mg2+), aluminium (Al3+), selenium, and zinc. When eltrombopag is taken together with products containing these minerals, it forms insoluble chelate complexes in the gastrointestinal tract that cannot be absorbed, reducing eltrombopag bioavailability by up to 70%. This interaction is not merely theoretical—it can result in treatment failure if not managed properly.

Major Drug and Food Interactions with Eltrombopag
Interacting Substance Mechanism Clinical Effect Management
Antacids (Al/Mg/Ca) Chelation in GI tract Up to 70% reduction in absorption Take eltrombopag 2 hours before or 4 hours after
Iron supplements Chelation in GI tract Significant reduction in absorption Separate by at least 4 hours
Dairy products Calcium chelation Reduced bioavailability Take eltrombopag 2 hours before or 4 hours after dairy
Calcium-fortified foods/drinks Calcium chelation Reduced bioavailability Separate by at least 2 hours
Rosuvastatin (and OATP1B1/BCRP substrates) OATP1B1 and BCRP transporter inhibition 55% increase in rosuvastatin AUC Start with lower rosuvastatin dose; monitor for myopathy
Ciclosporin Reduced ciclosporin levels (mechanism unclear) Decreased ciclosporin exposure Monitor ciclosporin levels and adjust dose

Other Interactions and Considerations

Eltrombopag is metabolized primarily by CYP1A2 and CYP2C8, with additional glucuronidation by UGT1A1 and UGT1A3. Strong inhibitors of CYP1A2 (such as fluvoxamine, ciprofloxacin) may increase eltrombopag exposure, while strong inducers of CYP1A2 (such as tobacco smoking, omeprazole at high doses) may decrease it. However, no formal dose adjustments are currently recommended for these interactions, as their clinical significance has not been fully characterized in dedicated studies.

Eltrombopag is also a substrate and inhibitor of the breast cancer resistance protein (BCRP/ABCG2) transporter. Co-administration with other BCRP substrates (including methotrexate, mitoxantrone, imatinib, topotecan, and certain statins) may result in increased plasma concentrations of these drugs. Monitor patients closely when eltrombopag is used concomitantly with these agents and consider dose reductions if adverse effects occur.

In patients with severe aplastic anemia who receive eltrombopag in combination with ciclosporin and horse anti-thymocyte globulin (hATG), close monitoring of ciclosporin trough levels is important, as eltrombopag has been associated with decreased ciclosporin exposure. The mechanism is not fully understood but may involve induction of ciclosporin metabolism or changes in distribution. Your doctor may need to increase the ciclosporin dose to maintain therapeutic levels.

Food Timing Is Critical

Eltrombopag Reddy must be taken on an empty stomach—at least 1 hour before or 2 hours after a meal. Additionally, allow at least 2 hours before or 4 hours after consuming dairy products, calcium-fortified juices, antacids, or mineral supplements. Many patients find it convenient to take their dose at bedtime, at least 2 hours after their evening meal and any calcium or mineral supplements.

What Is the Correct Dosage of Eltrombopag Reddy?

Quick Answer: The starting dose of Eltrombopag Reddy varies by indication: 50 mg once daily for adults with ITP, 25 mg once daily for HCV-associated thrombocytopenia, and 50 mg once daily for severe aplastic anemia. The dose is adjusted based on platelet count response, with a maximum of 75 mg daily. Patients of East Asian descent (Chinese, Japanese, Korean, Taiwanese) should start at 25 mg daily for ITP.

Eltrombopag Reddy should always be used exactly as prescribed by your doctor. The dose is individualized based on your underlying condition, platelet count response, and ethnic background. The goal is to achieve the lowest effective dose that maintains a platelet count sufficient to reduce the risk of bleeding—not to normalize the platelet count, as excessively high levels may increase thrombotic risk.

Adults with Chronic ITP

ITP Dosing in Adults

Starting dose: 50 mg once daily (25 mg for patients of East Asian descent).

Dose adjustment: Adjust in increments of 25 mg every 2 weeks based on platelet count response. Wait at least 2 weeks between dose changes.

Maximum dose: 75 mg once daily.

Target: Maintain platelets at the lowest count sufficient to reduce bleeding risk (typically ≥50,000/µL). Do not exceed 200,000/µL.

Discontinuation: If platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the maximum dose of 75 mg daily, discontinue treatment.

Dose Adjustment Guide for ITP Based on Platelet Count
Platelet Count Action
< 50,000/µL after 2 weeks Increase dose by 25 mg daily (max 75 mg/day)
50,000–200,000/µL Continue current dose
200,000–400,000/µL Decrease dose by 25 mg daily; re-assess in 2 weeks
> 400,000/µL Stop eltrombopag; increase monitoring. When <150,000/µL, restart at reduced dose

Adults with HCV-Associated Thrombocytopenia

HCV Dosing in Adults

Starting dose: 25 mg once daily.

Dose adjustment: Adjust in increments of 25 mg every 2 weeks to achieve the target platelet count required to initiate antiviral therapy (typically ≥75,000/µL depending on the regimen).

Maximum dose: 75 mg daily.

Duration: Continue during antiviral treatment. Discontinue when antiviral therapy is stopped.

Adults with Severe Aplastic Anemia

SAA Dosing in Adults

Starting dose: 50 mg once daily (25 mg for patients of East Asian descent).

Dose adjustment: After 2 weeks, increase to 75 mg if platelet count has not risen adequately. After an additional 2 weeks, may increase to 100 mg. Further increases by 25 mg every 2 weeks up to a maximum of 150 mg daily.

Maximum dose: 150 mg daily (note: this is higher than for ITP or HCV indications).

Children and Adolescents (ITP Only)

Pediatric ITP Dosing

Ages 1–5 years: Starting dose 25 mg once daily.

Ages 6–17 years: Starting dose 50 mg once daily (25 mg for East Asian descent).

Maximum dose: 75 mg once daily.

Adjustment: Same platelet-based algorithm as adults, with 2-week intervals between dose changes.

Elderly Patients

No specific dose adjustment is required for elderly patients based solely on age. However, elderly patients may have a higher prevalence of risk factors for thromboembolic events and may be more susceptible to hepatotoxicity. The dose should be titrated carefully with close monitoring of platelet counts and liver function. In clinical trials, patients aged 65 and older were included, and no overall differences in safety or efficacy were observed, though the number of elderly patients was limited.

Missed Dose

If you miss a dose of Eltrombopag Reddy, take it as soon as you remember on the same day. Do not take a double dose on the following day to make up for a missed dose. Simply resume your normal dosing schedule. If you frequently forget doses, consider setting a daily alarm or using a pill organizer. Consistent daily dosing is important for maintaining stable platelet counts and achieving optimal treatment outcomes.

Overdose

In clinical studies, one healthy volunteer experienced a transient increase in platelet count and mild adverse events after receiving a single 200 mg dose. In the event of overdose, platelet counts may rise excessively, increasing the risk of thromboembolic complications. There is no specific antidote for eltrombopag overdose. Treatment is supportive, with monitoring of complete blood count (particularly platelet count) and liver function. Eltrombopag is not expected to be removed by hemodialysis due to its high degree of plasma protein binding (>99%).

What Are the Side Effects of Eltrombopag Reddy?

Quick Answer: The most common side effects of Eltrombopag Reddy include headache, nausea, diarrhea, elevated liver enzymes, upper respiratory tract infections, and fatigue. Serious but less common side effects include hepatotoxicity, thromboembolic events, and bone marrow reticulin deposition. Regular monitoring of liver function and blood counts is essential.

Like all medicines, Eltrombopag Reddy can cause side effects, although not everybody gets them. The frequency and severity of side effects depend on the underlying condition being treated, concomitant medications, and individual patient factors. Side effects are classified below according to their frequency in clinical trials.

It is important to report any new or worsening symptoms to your doctor promptly. Some side effects, particularly hepatotoxicity and thromboembolic events, can be serious and require immediate medical attention. Regular blood tests (complete blood count and liver function tests) are an essential part of treatment monitoring.

Very Common (may affect more than 1 in 10 people)

Frequency: >10%

  • Headache
  • Nausea
  • Diarrhea
  • Elevated ALT (alanine aminotransferase)
  • Upper respiratory tract infection (cold, sore throat)

Common (may affect up to 1 in 10 people)

Frequency: 1–10%

  • Fatigue
  • Insomnia
  • Cough
  • Nasopharyngitis (common cold)
  • Myalgia (muscle pain)
  • Arthralgia (joint pain)
  • Back pain
  • Abdominal pain
  • Vomiting
  • Rash
  • Alopecia (hair loss)
  • Elevated AST (aspartate aminotransferase)
  • Elevated bilirubin
  • Decreased appetite
  • Oropharyngeal pain (sore throat/mouth)
  • Paraesthesia (tingling or numbness)
  • Urinary tract infection

Uncommon (may affect up to 1 in 100 people)

Frequency: 0.1–1%

  • Thromboembolic events (deep vein thrombosis, pulmonary embolism, portal vein thrombosis)
  • Cataracts (lens opacities)
  • Hepatotoxicity (drug-induced liver injury)
  • Bone marrow reticulin fiber deposition
  • Jaundice (yellowing of skin/eyes)
  • Peripheral neuropathy
  • Dry eye
  • Skin discoloration
  • Increased creatinine

Rare (may affect up to 1 in 1,000 people)

Frequency: 0.01–0.1%

  • Severe hepatotoxicity/hepatic failure
  • Myocardial infarction (heart attack)
  • Stroke or transient ischemic attack
  • Bone marrow collagen fibrosis
  • Severe skin reactions
  • Renal impairment

In patients with severe aplastic anemia, additional side effects may include increased transaminases, skin hyperpigmentation, and infection-related events, as these patients are often immunocompromised. In patients with chronic hepatitis C, liver-related adverse events are more common due to the underlying liver disease. The overall safety profile of eltrombopag has been well-characterized through extensive clinical trial programs and post-marketing surveillance across all three approved indications.

How Should You Store Eltrombopag Reddy?

Quick Answer: Store Eltrombopag Reddy at room temperature below 30°C in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.

Proper storage of Eltrombopag Reddy is important to maintain the stability and effectiveness of the medication. The film-coated tablets should be stored at a temperature not exceeding 30°C (86°F). Keep the tablets in their original blister packaging or container to protect them from moisture and light. The medicine does not require refrigeration and should not be frozen.

Keep this medicine out of the sight and reach of children. Children may be at particular risk from accidental ingestion, and even a single adult dose could potentially cause a dangerous increase in platelet counts in a child. Store the medication in a secure location, preferably in a locked cabinet or container if children are present in the household.

Do not use Eltrombopag Reddy after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month. If you notice that the tablets appear damaged, discolored, or show any signs of deterioration, do not use them and consult your pharmacist for a replacement.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Proper disposal helps protect the environment and prevents accidental exposure to others. Many pharmacies and healthcare facilities offer medication take-back programs for safe disposal of unused or expired medications.

What Does Eltrombopag Reddy Contain?

Quick Answer: Each film-coated tablet of Eltrombopag Reddy 25 mg contains eltrombopag olamine (equivalent to 25 mg of eltrombopag) as the active substance, along with inactive excipients including mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, and stearic acid, with a film coating of hypromellose, macrogol, polydextrose, titanium dioxide, and triacetin.

The active pharmaceutical ingredient in Eltrombopag Reddy is eltrombopag olamine. Eltrombopag olamine is the olamine salt of eltrombopag, a synthetic non-peptide small molecule with the chemical name 3′-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazinyl}-2′-hydroxy-3-biphenylcarboxylic acid compound with 2-aminoethanol (1:2). The molecular formula is C25H22N4O4·2(C2H7NO). Each 25 mg tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag free acid.

The inactive ingredients (excipients) serve various functions in the tablet formulation:

  • Mannitol: A sugar alcohol used as a filler and sweetener in the tablet core.
  • Microcrystalline cellulose: A binding agent and filler that provides structural integrity to the tablet.
  • Povidone: A binder that helps hold the tablet ingredients together.
  • Sodium starch glycolate: A disintegrant that helps the tablet break apart when swallowed, allowing the active ingredient to be released for absorption.
  • Magnesium stearate: A lubricant that prevents the tablet from sticking to manufacturing equipment.
  • Stearic acid: An additional lubricant for the tablet manufacturing process.

The film coating consists of hypromellose, macrogol (polyethylene glycol), polydextrose, titanium dioxide (for the white color), and triacetin. The film coating protects the tablet core, makes it easier to swallow, and provides a smooth appearance. The 25 mg tablets are white, round, biconvex film-coated tablets.

Eltrombopag Reddy tablets do not contain lactose, gluten, or gelatin. However, they do contain sodium (from sodium starch glycolate). The sodium content is minimal (less than 1 mmol or 23 mg per tablet) and is not clinically significant for patients on a sodium-restricted diet.

Frequently Asked Questions About Eltrombopag Reddy

Eltrombopag Reddy is a thrombopoietin receptor agonist used to treat three main conditions involving low platelet counts (thrombocytopenia): chronic immune thrombocytopenic purpura (ITP) in adults and children aged 1 year and older who have not responded to other treatments; thrombocytopenia associated with chronic hepatitis C to enable antiviral therapy; and severe aplastic anemia in adults who have not responded adequately to immunosuppressive therapy. It works by stimulating the bone marrow to produce more platelets.

Eltrombopag forms insoluble complexes (chelates) with polyvalent metal ions found in food, particularly calcium, iron, magnesium, and aluminium. These chelate complexes cannot be absorbed from the gut, which can reduce the amount of eltrombopag entering your bloodstream by up to 70%. To ensure full absorption, take eltrombopag at least 1 hour before or 2 hours after a meal, and at least 2 hours before or 4 hours after dairy products, calcium-fortified foods, antacids, or mineral supplements. Many patients find it easiest to take their dose at bedtime.

Most patients begin to see an increase in their platelet count within 1 to 2 weeks of starting eltrombopag, though the full effect may take longer to achieve. In clinical trials for ITP, the median time to achieve a platelet count of 50,000/µL or above was approximately 2 weeks. Your doctor will check your blood count regularly and may adjust your dose every 2 weeks until the optimal platelet level is reached. If there is no adequate response after 4 weeks at the maximum dose, your doctor may consider discontinuing treatment.

Liver function tests (including ALT, AST, and bilirubin) must be checked before starting eltrombopag, every 2 weeks during dose adjustment, and then monthly once a stable dose is established. For patients with hepatitis C, monitoring should be more frequent due to the higher risk of liver complications. Treatment should be discontinued if ALT levels rise to 3 times or more the upper limit of normal and are progressive, persistent, or accompanied by clinical symptoms of liver damage such as jaundice, dark urine, or unusual fatigue. Regular monitoring is crucial for early detection and management of potential hepatotoxicity.

Yes, Eltrombopag Reddy contains the same active substance (eltrombopag olamine) as Revolade (the brand name used in Europe and many other countries) and Promacta (the brand name used in the United States). Eltrombopag Reddy is a generic version that has been demonstrated to be bioequivalent to the originator product, meaning it delivers the same amount of active drug to the bloodstream at the same rate and extent, ensuring comparable clinical efficacy and safety. The choice between brand-name and generic formulations is typically based on availability, cost, and physician or patient preference.

Yes, eltrombopag can be used alongside other ITP treatments, including corticosteroids, immunoglobulins, and other immunosuppressive agents. In clinical practice, many patients continue their existing ITP medications while starting eltrombopag, with the option to taper or discontinue other treatments as the platelet count improves. However, concurrent use with other thrombopoietin receptor agonists (such as romiplostim) is generally not recommended, as the combination has not been adequately studied and could lead to excessive platelet production. Always discuss all your current medications with your hematologist.

References

  1. European Medicines Agency (EMA). Revolade (eltrombopag) – Summary of Product Characteristics. Last updated 2025. Available at: EMA – Revolade.
  2. U.S. Food and Drug Administration (FDA). Promacta (eltrombopag) – Full Prescribing Information. Revised 2024. Available at: FDA – Promacta Label.
  3. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Advances. 2019;3(23):3829–3866. doi:10.1182/bloodadvances.2019000966.
  4. Cheng G, Saleh MN, Marcher C, et al. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. The Lancet. 2011;377(9763):393–402. doi:10.1016/S0140-6736(10)60959-2.
  5. Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag added to standard immunosuppression for aplastic anemia. New England Journal of Medicine. 2017;376(16):1540–1550. doi:10.1056/NEJMoa1613878.
  6. Afdhal NH, Giannini EG, Vaez-Zadeh N, et al. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia (ELEVATE). New England Journal of Medicine. 2012;367(8):716–724. doi:10.1056/NEJMoa1110709.
  7. National Institute for Health and Care Excellence (NICE). Eltrombopag for treating chronic immune (idiopathic) thrombocytopenic purpura. Technology Appraisal Guidance [TA293]. Published 2013, reviewed 2023.
  8. World Health Organization (WHO). Model List of Essential Medicines – 23rd list (2023). Geneva: World Health Organization; 2023.
  9. Grainger JD, Locatelli F, Chotsampancharoen T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. The Lancet. 2015;386(10004):1649–1658. doi:10.1016/S0140-6736(15)61107-2.
  10. British National Formulary (BNF). Eltrombopag – indications, dose, interactions, side effects. Available at: BNF – Eltrombopag.

Medical Editorial Team

Hematology Expert

Board-certified specialist in hematology with clinical expertise in thrombocytopenia, immune thrombocytopenic purpura, and bone marrow disorders

Clinical Pharmacologist

Specialist in drug safety, pharmacokinetics, and drug interactions with extensive experience in oncology and hematology therapeutics

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