Eltrombopag Zentiva

Thrombopoietin receptor agonist for increasing platelet production

Rx - Prescription Only TPO Receptor Agonist
Active Ingredient
Eltrombopag olamine
Dosage Form
Film-coated tablet
Available Strengths
25 mg
Known Brands
Eltrombopag Zentiva, Revolade
Medically reviewed | Last reviewed: | Evidence level: 1A
Eltrombopag Zentiva is a prescription medicine containing the active substance eltrombopag, a thrombopoietin (TPO) receptor agonist that stimulates the bone marrow to produce more platelets. It is used to treat chronic immune thrombocytopenia (ITP), thrombocytopenia associated with chronic hepatitis C, and acquired severe aplastic anemia. This medication requires regular blood monitoring and careful dose adjustment.
Updated:
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Written and reviewed by iMedic Medical Editorial Team | Specialists in hematology and clinical pharmacology

Quick Facts About Eltrombopag Zentiva

Active Ingredient
Eltrombopag
olamine salt
Drug Class
TPO Agonist
Thrombopoietin receptor
Common Uses
ITP & SAA
Low platelet conditions
Available Forms
Tablet 25 mg
Film-coated oral
Prescription Status
Rx Only
Specialist prescribing
Response Time
1-2 Weeks
Platelet count increase

Key Takeaways About Eltrombopag Zentiva

  • Increases platelet production: Eltrombopag Zentiva stimulates the bone marrow to produce more platelets, typically increasing counts within 1-2 weeks of starting treatment
  • Must be taken on an empty stomach: Avoid dairy products, calcium-fortified foods, antacids, and mineral supplements for at least 2 hours before and 4 hours after taking the medication
  • Regular liver monitoring is essential: Liver function tests should be performed before starting, every 2 weeks during dose adjustment, and monthly once a stable dose is achieved
  • Dose is individually adjusted: Treatment starts at a low dose and is gradually increased based on platelet count response, with the goal of reducing bleeding risk rather than normalizing counts
  • Do not stop suddenly: Abrupt discontinuation may cause platelet counts to drop below pre-treatment levels, increasing the risk of bleeding

What Is Eltrombopag Zentiva and What Is It Used For?

Eltrombopag Zentiva is a thrombopoietin (TPO) receptor agonist that stimulates the production of platelets in the bone marrow. It is primarily used to treat chronic immune thrombocytopenia (ITP) when other treatments have been insufficient, thrombocytopenia in chronic hepatitis C patients, and acquired severe aplastic anemia.

Eltrombopag Zentiva contains the active substance eltrombopag, which belongs to a class of medicines known as thrombopoietin receptor agonists. Platelets are small blood cells that play a critical role in blood clotting and wound healing. When platelet counts fall too low (a condition called thrombocytopenia), patients are at increased risk of bruising and bleeding, which in severe cases can be life-threatening.

The medication works by binding to the transmembrane domain of the thrombopoietin (TPO) receptor on megakaryocytes, which are the precursor cells in the bone marrow responsible for producing platelets. By activating specific signaling pathways (JAK-STAT and MAPK), eltrombopag promotes the growth, differentiation, and maturation of megakaryocytes, resulting in increased platelet production. Unlike recombinant thrombopoietin, eltrombopag binds at a different site on the TPO receptor, meaning it can work alongside the body's natural thrombopoietin.

Eltrombopag Zentiva is a generic version of the originator product Revolade (known as Promacta in the United States), which has been used clinically since 2008. As a generic medicine, it contains the same active substance and works in the same way as the reference product, having demonstrated bioequivalence in clinical studies submitted to regulatory authorities including the European Medicines Agency (EMA).

Approved Indications

Eltrombopag Zentiva is approved for the following indications in the European Union and other regulatory jurisdictions:

  • Chronic immune thrombocytopenia (ITP): For patients aged 1 year and older who have had their condition for at least 6 months after diagnosis and who have not responded adequately to other treatments, including corticosteroids and immunoglobulins. In adult patients, it is generally considered a second-line or subsequent therapy when splenectomy is contraindicated.
  • Chronic hepatitis C (HCV)-associated thrombocytopenia: For adult patients with chronic hepatitis C virus infection whose low platelet counts prevent them from starting or continuing optimal antiviral interferon-based therapy.
  • Acquired severe aplastic anemia (SAA): As part of first-line combination immunosuppressive therapy alongside horse anti-thymocyte globulin (hATG) and ciclosporin in adult patients, or as a single agent in patients who have had an insufficient response to at least one prior immunosuppressive therapy and are unsuitable for hematopoietic stem cell transplantation.
Important information about platelet counts:

The goal of eltrombopag treatment is to maintain platelet counts at a level sufficient to reduce the risk of bleeding, not to normalize platelet counts. Maintaining platelet counts in the normal range may increase the risk of thromboembolic events, particularly in patients with additional risk factors. Your doctor will adjust the dose to find the lowest effective level for your individual situation.

What Should You Know Before Taking Eltrombopag Zentiva?

Before starting Eltrombopag Zentiva, your doctor must evaluate your liver function, check for cataracts, and review your complete medical history including any history of blood clots, liver disease, or bone marrow disorders. Certain patients require lower starting doses, including those of East Asian ancestry.

Eltrombopag Zentiva is a prescription medication that should only be initiated and supervised by a specialist physician experienced in the treatment of hematological conditions. Before starting treatment, a thorough medical evaluation is necessary to ensure the medication is appropriate and safe for your specific situation. Understanding the contraindications, warnings, and precautions is essential for safe and effective use of this medicine.

Contraindications

You must not take Eltrombopag Zentiva if you are allergic (hypersensitive) to eltrombopag or any of the other ingredients in the tablets. Signs of a serious allergic reaction may include skin rash, swelling of the face, lips, tongue or throat, and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

Warnings and Precautions

Several important warnings apply to the use of Eltrombopag Zentiva. Your doctor needs to be aware of all relevant medical conditions before prescribing this medication:

  • Liver problems (hepatotoxicity): Eltrombopag can cause liver damage, including elevated liver enzymes (ALT, AST, bilirubin). Liver function must be monitored regularly throughout treatment. Patients with pre-existing liver disease, particularly those with hepatic impairment of Child-Pugh class B or C, should be treated with caution and may require dose reductions. Treatment should be discontinued if ALT levels rise to 3 times the upper limit of normal or higher and are progressive, persistent, or accompanied by other signs of liver injury.
  • Thromboembolic events: Increasing platelet counts with thrombopoietin receptor agonists may increase the risk of blood clots (thrombosis). This risk exists even at normal or below-normal platelet counts. Patients with known risk factors for thromboembolism, such as Factor V Leiden mutation, antiphospholipid syndrome, advanced age, prolonged immobilization, malignancy, or use of oral contraceptives, require careful monitoring.
  • Bone marrow changes (reticulin fibrosis): Long-term use of eltrombopag may lead to increased reticulin fiber deposition in the bone marrow. Your doctor may recommend periodic blood smears to check for abnormal cell morphology (tear-drop cells, nucleated red blood cells), which may indicate fibrosis. A bone marrow biopsy may be necessary if abnormalities are detected.
  • Worsening thrombocytopenia after discontinuation: Stopping eltrombopag may cause platelet counts to drop below pre-treatment levels (rebound thrombocytopenia), typically within 2 weeks of discontinuation. This increases the risk of bleeding and may require close monitoring for at least 4 weeks after stopping treatment.
  • Cataracts: Cataracts were observed in preclinical toxicology studies and in some clinical trial patients. Baseline eye examinations and regular monitoring are recommended during treatment.
  • Malignancy risk in aplastic anemia: In patients with aplastic anemia, there is a theoretical concern that thrombopoietin receptor agonists may stimulate the progression of pre-existing bone marrow malignancies, including myelodysplastic syndrome (MDS). Cytogenetic testing should be performed before starting treatment.

Pregnancy and Breastfeeding

Eltrombopag Zentiva is not recommended during pregnancy. Animal reproductive studies have shown adverse effects on the developing fetus, including reduced fetal weight and increased embryolethality. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should use effective contraception throughout treatment and for at least 7 days after the last dose.

It is not known whether eltrombopag is excreted in human breast milk. Studies in lactating rats have shown excretion of eltrombopag in milk. A decision must be made whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Due to the potential for serious adverse reactions in nursing infants, breastfeeding is generally not recommended during treatment.

Special Populations

Patients of East Asian ancestry: Patients of East Asian descent (including Japanese, Chinese, Taiwanese, and Korean heritage) should start at a lower dose of 25 mg once daily for ITP, rather than the standard 50 mg starting dose. This is because clinical studies have shown that these patients have higher plasma concentrations of eltrombopag, possibly due to differences in drug metabolism.

Patients with hepatic impairment: Patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C) should start at a reduced dose of 25 mg once daily for ITP. Dose adjustments should be made cautiously, with a minimum 3-week interval between increases.

Critical warning - Blood clots:

Eltrombopag Zentiva may increase the risk of blood clots (thromboembolism), including deep vein thrombosis, pulmonary embolism, and stroke. Seek emergency medical attention immediately if you experience sudden shortness of breath, chest pain, leg swelling, sudden numbness or weakness on one side of the body, or sudden severe headache. This risk is present even when platelet counts are low or within the normal range.

How Does Eltrombopag Zentiva Interact with Other Drugs?

Eltrombopag has clinically significant interactions with polyvalent cation-containing products (antacids, dairy, supplements), certain statins (rosuvastatin), immunosuppressants (ciclosporin), and chemotherapy agents (methotrexate, topotecan). Timing of administration is critical to avoid reduced absorption.

Drug interactions with eltrombopag can occur through several mechanisms, including chelation with polyvalent cations in the gastrointestinal tract, inhibition of drug transporters, and modulation of metabolic enzymes. Understanding these interactions is essential for effective treatment, as some can significantly reduce the absorption or increase the toxicity of either eltrombopag or concomitant medications.

Eltrombopag is primarily metabolized through glucuronidation (UGT1A1, UGT1A3) and oxidation (CYP1A2, CYP2C8). It is also a substrate and inhibitor of breast cancer resistance protein (BCRP) and organic anion transporting polypeptides (OATP1B1). These pharmacological properties give rise to several clinically significant drug interactions that prescribers and patients must be aware of.

Major Interactions

Major Drug Interactions Requiring Dose Adjustment or Avoidance
Interacting Substance Mechanism Clinical Effect Management
Polyvalent cation antacids (Al, Ca, Mg, Zn, Fe) Chelation in GI tract Up to 70% reduction in eltrombopag absorption Take eltrombopag at least 2 hours before or 4 hours after these products
Dairy products and calcium-fortified foods Chelation with calcium Significantly reduced absorption Avoid dairy for 2 hours before and 4 hours after eltrombopag
Rosuvastatin OATP1B1 and BCRP inhibition Increased rosuvastatin exposure (AUC increased ~55%) Reduce rosuvastatin dose; consider alternative statin
Ciclosporin (in SAA) BCRP and OATP1B1 inhibition; reduced ciclosporin concentrations Decreased ciclosporin blood levels Monitor ciclosporin levels closely; adjust dose as needed
Methotrexate BCRP substrate interaction Potentially increased methotrexate exposure Monitor for methotrexate toxicity; adjust dose if necessary
Topotecan BCRP substrate interaction Potentially increased topotecan exposure Use with caution; monitor for increased adverse effects

Minor Interactions and Other Considerations

In addition to the major interactions listed above, several other drug interactions should be considered:

  • CYP1A2 inducers and inhibitors: Smoking (CYP1A2 inducer) may reduce eltrombopag levels, while CYP1A2 inhibitors (such as fluvoxamine and ciprofloxacin) may increase them. Dose adjustments may be necessary based on clinical response.
  • Other BCRP substrates: Eltrombopag inhibits BCRP and may increase the plasma concentrations of other BCRP substrate drugs, including certain cancer chemotherapy agents (irinotecan, lapatinib, mitoxantrone) and antiretrovirals.
  • OATP1B1 substrates: Besides rosuvastatin, other OATP1B1 substrates such as atorvastatin, fluvastatin, and pravastatin may be affected. Repaglinide and rifampicin are also OATP1B1 substrates requiring consideration.
  • Anticoagulants and antiplatelet agents: While there is no direct pharmacokinetic interaction, the combination of eltrombopag with anticoagulants or antiplatelet drugs should be carefully managed given the complex interplay between increasing platelet counts and underlying thrombotic risk.

What Is the Correct Dosage of Eltrombopag Zentiva?

The starting dose of Eltrombopag Zentiva varies by indication and patient population. For ITP in adults, the typical starting dose is 50 mg once daily (25 mg for patients of East Asian ancestry or those with hepatic impairment). Doses are adjusted based on platelet count response, with a maximum of 75 mg daily.

Eltrombopag Zentiva dosing is highly individualized and must be directed by a hematologist or other specialist physician experienced in managing thrombocytopenic conditions. The dose is adjusted based on regular platelet count monitoring, with the aim of achieving and maintaining a platelet count at or above 50 x 109/L to reduce the risk of bleeding. The lowest effective dose should always be used.

Eltrombopag Zentiva tablets should be taken once daily on an empty stomach, at least 2 hours before or 4 hours after eating dairy products, calcium-fortified foods, or taking antacids or mineral supplements. The tablet should be swallowed whole with water. Low-calcium foods (containing less than 50 mg of calcium) may be consumed during this fasting period.

Adults

Adult Dosing by Indication
Indication Starting Dose Dose Range Maximum Dose Notes
Chronic ITP 50 mg once daily 25-75 mg/day 75 mg/day 25 mg start for East Asian or hepatic impairment
Hepatitis C thrombocytopenia 25 mg once daily 25-100 mg/day 100 mg/day Titrate to target platelet count for antiviral therapy
Severe aplastic anemia (first-line) 150 mg once daily 150 mg/day 150 mg/day 75 mg for East Asian patients; given with hATG + ciclosporin
SAA (refractory, monotherapy) 50 mg once daily 50-150 mg/day 150 mg/day 25 mg start for East Asian patients; increase every 2 weeks

Children (1 Year and Older - ITP Only)

In pediatric patients aged 1 to 17 years with chronic ITP, the recommended starting dose is 25 mg once daily. Dose adjustments should follow the same principles as in adults, with increases of 25 mg every 2 weeks as needed. The maximum dose for pediatric patients is 75 mg once daily. For children of East Asian ancestry, the starting dose should be reduced to 12.5 mg once daily (half of a 25 mg tablet).

Children aged 1 to 5 years who have difficulty swallowing tablets may be prescribed eltrombopag oral suspension if available. The powder for oral suspension can be mixed with water and administered orally. It is important that the suspension is not mixed with dairy products or juices, and that the timing restrictions with food are followed carefully. Parental supervision is recommended for all pediatric dosing.

Elderly Patients

No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be at increased risk for thromboembolic events and should be monitored more closely. Concomitant medications and comorbidities common in older patients (such as hepatic or renal impairment, cardiovascular disease, and reduced mobility) should be considered when determining the starting dose and monitoring frequency.

Missed Dose

If you miss a dose of Eltrombopag Zentiva, take it as soon as you remember on the same day. Do not take two doses on the same day to make up for a missed dose. Simply resume your regular dosing schedule the following day. If you frequently forget to take your medication, speak with your doctor or pharmacist about strategies to help you remember, such as setting a daily alarm or using a pill organizer.

Overdose

In clinical trials, limited experience with overdose has been reported. Excessive doses may lead to dangerously high platelet counts (thrombocytosis), which significantly increases the risk of thromboembolic complications including stroke, heart attack, deep vein thrombosis, and pulmonary embolism. There is no specific antidote for eltrombopag overdose. If an overdose is suspected, contact your local poison control center or seek emergency medical attention immediately. Platelet counts should be monitored closely, and appropriate supportive treatment should be initiated. Eltrombopag is not expected to be removed by dialysis due to its high protein binding.

Dose adjustment schedule:

Platelet counts should be checked weekly for the first 4 weeks, then monthly once a stable dose is established. Dose adjustments should not be made more frequently than every 2 weeks. If the platelet count exceeds 200 x 109/L, reduce the dose. If the platelet count exceeds 400 x 109/L, stop treatment and monitor platelet counts twice weekly. Once the platelet count falls below 150 x 109/L, treatment may be restarted at a reduced dose.

What Are the Side Effects of Eltrombopag Zentiva?

Common side effects of Eltrombopag Zentiva include headache, nausea, diarrhea, elevated liver enzymes, and upper respiratory tract infections. Serious but less common side effects include hepatotoxicity, thromboembolic events, and bone marrow reticulin fibrosis. Most common side effects are manageable and tend to improve over time.

Like all medicines, Eltrombopag Zentiva can cause side effects, although not everybody gets them. The side effect profile has been extensively characterized through large-scale clinical trials and post-marketing surveillance. It is important to be aware of both common and serious side effects so that you can report any concerns to your healthcare provider promptly. The frequency categories below are based on clinical trial data and regulatory guidelines.

The reported side effects may differ depending on the indication being treated. Patients with aplastic anemia or hepatitis C may experience different side effect profiles compared to those with ITP, partly due to the underlying condition and concomitant medications. The frequencies listed below represent the overall side effect profile across all approved indications.

Very Common (affects more than 1 in 10 people)

Reported in >10% of patients

  • Headache
  • Nausea
  • Diarrhea
  • Elevated liver transaminases (ALT, AST)
  • Fatigue
  • Upper respiratory tract infection (cold symptoms, sore throat)
  • Decreased appetite (particularly in aplastic anemia patients)

Common (affects up to 1 in 10 people)

Reported in 1-10% of patients

  • Abdominal pain (upper and lower)
  • Vomiting
  • Oropharyngeal pain (mouth and throat discomfort)
  • Rash and skin reactions
  • Alopecia (hair thinning or loss)
  • Musculoskeletal pain (back pain, myalgia, arthralgia)
  • Paresthesia (tingling or numbness)
  • Insomnia
  • Cough
  • Urinary tract infection
  • Elevated bilirubin
  • Dry eye and cataracts
  • Influenza

Uncommon (affects up to 1 in 100 people)

Reported in 0.1-1% of patients

  • Deep vein thrombosis
  • Pulmonary embolism
  • Myocardial infarction (heart attack)
  • Cerebrovascular events (transient ischemic attack, stroke)
  • Portal vein thrombosis (particularly in hepatitis C patients)
  • Retinal vascular occlusion
  • Hepatotoxicity (severe liver injury)
  • Bone marrow reticulin deposition
  • Increased creatinine
  • Skin discoloration (hyperpigmentation)

Rare (affects up to 1 in 1,000 people)

Reported in 0.01-0.1% of patients

  • Severe hepatic failure
  • Thrombotic microangiopathy
  • Bone marrow fibrosis (with collagen)
  • Severe skin reactions
  • Rebound thrombocytopenia (severe, after discontinuation)
  • Myelodysplastic syndrome progression (in aplastic anemia patients)
When to seek immediate medical attention:

Contact your doctor or seek emergency medical care immediately if you experience: sudden severe headache, confusion or changes in vision (possible stroke); sudden shortness of breath or chest pain (possible pulmonary embolism); swelling, warmth or pain in a limb (possible deep vein thrombosis); yellowing of the skin or eyes, dark urine, or severe abdominal pain (possible liver injury); unusual bruising or bleeding that is worse than before treatment (possible rebound thrombocytopenia after stopping treatment).

How Should You Store Eltrombopag Zentiva?

Store Eltrombopag Zentiva tablets below 30°C in the original packaging to protect from moisture. Keep out of sight and reach of children. Do not use after the expiry date printed on the carton and blister.

Proper storage of Eltrombopag Zentiva is essential 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 the original blister packaging until ready to take, as this protects the medicine from moisture and light exposure that could degrade the active ingredient.

Do not use Eltrombopag Zentiva after the expiry date which is stated on the carton and blister strip after "EXP." The expiry date refers to the last day of that month. Do not store the medication in a bathroom or near a kitchen sink, where humidity levels can be high. Keep this medicine out of the sight and reach of children.

Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. If you notice any visible changes in the appearance of the tablets, such as discoloration or crumbling, do not use them and consult your pharmacist.

What Does Eltrombopag Zentiva Contain?

Each Eltrombopag Zentiva 25 mg film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag as the active substance, along with several inactive excipients required for tablet formulation.

The active substance in Eltrombopag Zentiva is eltrombopag, present as eltrombopag olamine. Each 25 mg film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. The olamine salt form was selected to optimize the oral bioavailability and stability of the active substance.

The other ingredients (excipients) serve various pharmaceutical functions:

  • Tablet core: Magnesium stearate, sodium starch glycolate, povidone, microcrystalline cellulose, and mannitol. These excipients ensure proper tablet compression, disintegration in the gastrointestinal tract, and uniform drug distribution throughout the tablet.
  • Film coating: The tablet is coated with a film that may contain hypromellose, titanium dioxide (E171), macrogol, and polysorbate 80. The film coating protects the active ingredient from environmental exposure, makes the tablet easier to swallow, and may help mask the taste of the active substance.

Eltrombopag Zentiva 25 mg tablets are round, white to off-white, film-coated tablets. The exact appearance may vary slightly between batches, which is normal for generic pharmaceutical products. Patients with known allergies to any of the listed excipients should inform their healthcare provider before starting treatment.

Lactose-free formulation:

Eltrombopag Zentiva tablets do not contain lactose, making them suitable for patients with lactose intolerance. However, patients with rare hereditary problems of galactose intolerance should consult their doctor before taking this medicine due to the presence of other sugar excipients.

Frequently Asked Questions About Eltrombopag Zentiva

Eltrombopag Zentiva is used to treat chronic immune thrombocytopenia (ITP) in patients aged 1 year and older who have not responded adequately to other treatments such as corticosteroids or immunoglobulins. It is also used to treat low platelet counts in adults with chronic hepatitis C to allow initiation of antiviral therapy, and as part of treatment for acquired severe aplastic anemia. It works by stimulating the bone marrow to produce more platelets.

Eltrombopag is a thrombopoietin (TPO) receptor agonist. It binds to the transmembrane domain of the TPO receptor on megakaryocytes (the cells in bone marrow that produce platelets). This binding activates signaling pathways that stimulate the growth, maturation, and differentiation of megakaryocytes, leading to increased platelet production. Most patients see an increase in platelet counts within 1-2 weeks of starting treatment.

Dairy products contain calcium, which forms insoluble complexes (chelates) with eltrombopag in the gastrointestinal tract. This chelation dramatically reduces the absorption of eltrombopag, potentially decreasing its effectiveness by up to 70%. For this reason, you must take eltrombopag on an empty stomach at least 2 hours before or 4 hours after consuming dairy products, calcium-fortified foods, antacids, or mineral supplements containing iron, calcium, magnesium, aluminium, selenium, or zinc.

Several blood tests are required during Eltrombopag Zentiva treatment. Platelet counts should be checked weekly during the first 4 weeks and then monthly once a stable dose is achieved. Liver function tests (ALT, AST, bilirubin) should be performed before starting treatment, every 2 weeks during dose adjustment, and monthly thereafter. Your doctor may also periodically check your peripheral blood smear for abnormalities such as tear-drop cells or nucleated red blood cells, which could indicate bone marrow changes.

No, you should not stop taking Eltrombopag Zentiva suddenly without medical guidance. Abrupt discontinuation may cause platelet counts to drop below pre-treatment levels (rebound thrombocytopenia), which typically occurs within 2 weeks of stopping and can significantly increase the risk of bleeding. Your doctor will monitor your platelet counts closely for at least 4 weeks after discontinuation. If treatment needs to be stopped, your doctor may recommend a gradual dose reduction in some cases.

All information is based on international medical guidelines and peer-reviewed research: the European Medicines Agency (EMA) Summary of Product Characteristics, FDA prescribing information, American Society of Hematology (ASH) 2019 guidelines for immune thrombocytopenia, NICE technology appraisal guidance, International Working Group (IWG) consensus reports, and published clinical trial data from The New England Journal of Medicine and Blood. All medical claims have evidence level 1A, the highest quality of evidence.

References and Sources

This article is based on peer-reviewed medical literature and international clinical guidelines. All information has been reviewed according to the GRADE evidence framework.

  1. European Medicines Agency (EMA). Summary of Product Characteristics: Revolade (eltrombopag). Last updated 2024. Available from: EMA - Revolade
  2. 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
  3. Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia. N Engl J Med. 2017;376(16):1540-1550. doi:10.1056/NEJMoa1613878
  4. 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
  5. National Institute for Health and Care Excellence (NICE). Eltrombopag for treating chronic immune (idiopathic) thrombocytopenic purpura. Technology appraisal guidance [TA293]. Last updated 2023.
  6. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Advances. 2019;3(22):3780-3817. doi:10.1182/bloodadvances.2019000812
  7. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: World Health Organization.
  8. U.S. Food and Drug Administration (FDA). Prescribing Information: Promacta (eltrombopag). Reference ID: 5088254. Last updated 2024.

Medical Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, comprising specialists in hematology and clinical pharmacology. Our editorial process follows international medical standards and the GRADE evidence framework.

Medical Writing

Authored by licensed physicians with expertise in hematology and pharmacotherapy. All medical claims are supported by peer-reviewed evidence at the highest level (Level 1A).

Medical Review

Independently reviewed by the iMedic Medical Review Board. Reviewed for clinical accuracy, completeness, and adherence to current EMA, FDA, ASH, and NICE guidelines.

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