Eltrombopag Vivanta: Uses, Dosage & Side Effects
An oral thrombopoietin receptor agonist for the treatment of thrombocytopenia in chronic immune thrombocytopenia, severe aplastic anemia, and chronic hepatitis C
Eltrombopag Vivanta is a prescription oral thrombopoietin receptor agonist (TPO-RA) used to increase platelet counts in patients with thrombocytopenia. It is indicated for adults and children aged 1 year and older with chronic immune thrombocytopenia (ITP) who have had insufficient response to other treatments, for adults with severe aplastic anemia (SAA) who are refractory to immunosuppressive therapy, and for adults with chronic hepatitis C virus (HCV) infection who need adequate platelet levels to initiate or maintain antiviral treatment. Eltrombopag works by binding to the thrombopoietin receptor on megakaryocyte precursors in the bone marrow, stimulating platelet production through a mechanism distinct from endogenous thrombopoietin. Regular blood monitoring, including platelet counts and liver function tests, is essential throughout treatment.
Quick Facts: Eltrombopag Vivanta
Key Takeaways
- Eltrombopag Vivanta is an oral thrombopoietin receptor agonist that stimulates the bone marrow to produce more platelets, used primarily for chronic immune thrombocytopenia (ITP), severe aplastic anemia, and hepatitis C-associated thrombocytopenia.
- The starting dose for adults with ITP is typically 50 mg once daily (25 mg for patients of East Asian ancestry), adjusted based on platelet count response, with a maximum dose of 75 mg per day.
- Regular liver function monitoring is essential, as eltrombopag can cause hepatotoxicity; tests should be performed every 2 weeks during dose titration and monthly once stable.
- Eltrombopag must be taken on an empty stomach, separated by at least 2 hours before or 4 hours after dairy products, antacids, or mineral supplements containing polyvalent cations to ensure proper absorption.
- Treatment response typically begins within 1–2 weeks, with full platelet count response usually achieved within 2–4 weeks; the dose should not exceed what is needed to maintain platelet counts above 50 × 109/L.
What Is Eltrombopag Vivanta and What Is It Used For?
Eltrombopag Vivanta contains the active substance eltrombopag (present as eltrombopag olamine), a small molecule that belongs to the class of thrombopoietin receptor agonists. Thrombopoietin (TPO) is the primary physiological regulator of platelet production in the human body. It is produced mainly by the liver and kidneys and acts on the thrombopoietin receptor (also known as c-Mpl) found on the surface of megakaryocyte progenitor cells in the bone marrow. When TPO binds to its receptor, it triggers intracellular signaling cascades that promote the proliferation, maturation, and differentiation of megakaryocytes, the large bone marrow cells that ultimately fragment into platelets and release them into the bloodstream.
Eltrombopag is a non-peptide, small molecule TPO receptor agonist that mimics the action of endogenous thrombopoietin but binds to the transmembrane domain of the c-Mpl receptor at a site distinct from where natural TPO binds. This means that eltrombopag can work additively with the body's own thrombopoietin to enhance platelet production. Upon binding, eltrombopag activates the JAK2/STAT and MAPK signaling pathways within megakaryocyte precursor cells, driving their proliferation and differentiation into mature megakaryocytes, which in turn produce and release functional platelets into the circulation.
Unlike recombinant thrombopoietin proteins that were investigated historically but abandoned due to immunogenicity concerns (formation of anti-TPO antibodies that paradoxically worsened thrombocytopenia), eltrombopag is a synthetic small molecule that does not elicit neutralizing antibodies against endogenous TPO. This pharmacological distinction is clinically significant, as it enables long-term treatment without the risk of acquired TPO deficiency.
Eltrombopag Vivanta is indicated for several conditions characterized by low platelet counts (thrombocytopenia):
- Chronic Immune Thrombocytopenia (ITP): ITP is an autoimmune disorder in which the body's immune system mistakenly attacks and destroys its own platelets, leading to dangerously low platelet counts and an increased risk of bleeding. Eltrombopag is approved for adults and children aged 1 year and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. In pivotal clinical trials (RAISE, TRA100773A, TRA100773B, and PETIT/PETIT2 for pediatric populations), eltrombopag demonstrated statistically significant and clinically meaningful increases in platelet counts compared with placebo, with reduced bleeding episodes and decreased need for rescue medications.
- Severe Aplastic Anemia (SAA): SAA is a rare and serious bone marrow failure disorder in which the marrow produces insufficient blood cells of all types, including platelets. Eltrombopag is indicated for adult patients with SAA who have had an inadequate response to at least one course of immunosuppressive therapy. In the landmark NHLBI study, eltrombopag combined with standard immunosuppressive therapy (horse anti-thymocyte globulin and ciclosporin) demonstrated significantly higher overall response rates and complete response rates compared with immunosuppressive therapy alone. The 2022 updated ASH guidelines recommend eltrombopag as part of first-line combination therapy for treatment-naive SAA patients.
- Chronic Hepatitis C-Associated Thrombocytopenia: Patients with chronic hepatitis C virus (HCV) infection frequently develop thrombocytopenia due to liver disease, portal hypertension, and direct viral effects on megakaryocytes. Low platelet counts may prevent these patients from initiating or maintaining interferon-based antiviral therapy. Eltrombopag is indicated to enable the initiation and maintenance of interferon-based antiviral therapy in adult patients with HCV-associated thrombocytopenia. The ENABLE trials demonstrated that eltrombopag successfully increased platelet counts, allowing more patients to begin and complete antiviral treatment regimens.
Eltrombopag was originally developed by GlaxoSmithKline and Ligand Pharmaceuticals and was first approved by the U.S. Food and Drug Administration (FDA) in 2008 under the brand name Promacta, and by the European Medicines Agency (EMA) in 2010 under the brand name Revolade. Eltrombopag Vivanta is a generic formulation that contains the same active substance and provides equivalent therapeutic efficacy. The availability of generic formulations has improved patient access to this important medication across many healthcare systems worldwide.
A normal platelet count ranges from 150,000 to 400,000 per microlitre of blood. Thrombocytopenia is defined as a platelet count below 150,000 per microlitre. Clinically significant bleeding risk increases substantially when counts fall below 20,000–30,000 per microlitre. The goal of eltrombopag treatment is not to normalize platelet counts but to raise them to a level sufficient to reduce the risk of clinically significant bleeding, typically above 50,000 per microlitre.
What Should You Know Before Taking Eltrombopag Vivanta?
Contraindications
Eltrombopag Vivanta must not be used if you have a known hypersensitivity to eltrombopag olamine or any of the excipients contained in the formulation. Allergic reactions, although uncommon, have been reported and may include skin rash, urticaria, angioedema, or more severe anaphylactoid reactions. If any signs of a serious allergic reaction occur, treatment should be discontinued immediately and appropriate medical intervention should be sought.
Eltrombopag is not indicated for the treatment of thrombocytopenia caused by myelodysplastic syndromes (MDS). Clinical studies have shown that TPO receptor agonists may stimulate the progression of MDS to acute myeloid leukemia (AML), and their use in this setting is associated with an increased risk of blast transformation. Before initiating treatment, your physician should confirm that your low platelet count is not due to an underlying myelodysplastic syndrome or other pre-malignant bone marrow condition.
Warnings and Precautions
Hepatotoxicity: Eltrombopag can cause significant liver injury. Elevated serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels have been observed in clinical trials across all approved indications. In some cases, these elevations were severe and accompanied by clinical symptoms. Liver function tests (including ALT, AST, and bilirubin) must be measured before treatment initiation, every 2 weeks during the dose titration phase, and monthly thereafter once a stable dose has been established. If liver enzyme levels rise to more than 3 times the upper limit of normal and are progressive, persistent, or accompanied by symptoms of liver damage such as jaundice, dark urine, fatigue, or abdominal pain, treatment should be discontinued. In patients with hepatitis C, the risk of hepatotoxicity is particularly important to monitor given the already compromised liver function.
Thromboembolic Events: Increasing platelet counts with TPO receptor agonists carries an inherent risk of thromboembolic complications, particularly in patients with additional risk factors such as advanced age, immobilization, obesity, smoking, hormonal contraceptive use, underlying cardiovascular disease, or inherited thrombophilia. Deep vein thrombosis (DVT), pulmonary embolism (PE), transient ischemic attacks (TIA), myocardial infarction, and stroke have been reported in patients receiving eltrombopag. The dose should not be increased beyond what is necessary to achieve a target platelet count that reduces bleeding risk, and the platelet count should not be raised above normal levels. Patients with chronic liver disease are at particular risk for portal vein thrombosis, and careful monitoring is warranted.
Bone Marrow Reticulin Formation: Eltrombopag may increase reticulin fiber deposition in the bone marrow. Reticulin formation has been observed in clinical trials and post-marketing reports, and in rare cases, progression to collagen fibrosis (myelofibrosis) has been described. A baseline peripheral blood smear should be obtained before starting treatment to establish the morphological appearance of blood cells. Regular peripheral blood smears during treatment can help detect early signs of reticulin formation, such as the appearance of teardrop-shaped red blood cells (dacrocytes), nucleated red blood cells, or immature white blood cells (left shift). If abnormalities are detected, a bone marrow biopsy including reticulin staining should be considered, and treatment discontinuation may be necessary.
Platelet Count Rebound After Discontinuation: When eltrombopag is discontinued, platelet counts typically return to pre-treatment baseline levels within 1–2 weeks. In some patients, platelet counts may fall below the pre-treatment baseline, creating a temporary period of increased bleeding risk. During this period, which usually resolves within 2–4 weeks, patients should be monitored closely with weekly complete blood counts and should avoid situations that increase the risk of bleeding.
Eltrombopag should only be used under the supervision of a physician experienced in the treatment of hematological conditions. Regular monitoring of platelet counts, liver function tests, and peripheral blood smears is essential throughout the duration of treatment. Do not adjust the dose or discontinue treatment without medical guidance.
Pregnancy and Breastfeeding
Eltrombopag Vivanta should not be used during pregnancy unless the potential benefit to the mother clearly justifies the potential risk to the fetus. Animal reproductive toxicity studies conducted in rats and rabbits showed evidence of embryo-fetal toxicity, including reduced fetal body weights and increased skeletal variations, at doses that were clinically relevant when adjusted for body surface area. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should use effective contraception during treatment with eltrombopag and for at least 7 days following the last dose.
It is not known whether eltrombopag or its metabolites are excreted in human breast milk. Eltrombopag was detected in the milk of lactating rats at concentrations substantially higher than those in the maternal plasma. Given the potential for serious adverse reactions in nursing infants, a clinical decision must be made whether to discontinue breastfeeding or to discontinue eltrombopag treatment, taking into account the importance of the medication to the mother and the potential risks to the infant. If breastfeeding is continued during treatment, the infant should be monitored for signs of adverse effects.
How Does Eltrombopag Vivanta Interact with Other Drugs?
Eltrombopag has several important drug interactions that can significantly affect its efficacy or the safety of concomitant medications. Understanding these interactions is essential for optimal therapeutic outcomes and patient safety.
Polyvalent Cation Chelation: Eltrombopag chelates (binds to) polyvalent cations including calcium, iron, magnesium, aluminium, selenium, and zinc. When taken together with products containing these minerals, the absorption of eltrombopag from the gastrointestinal tract is dramatically reduced. Pharmacokinetic studies demonstrated that co-administration with an aluminium/magnesium-containing antacid reduced eltrombopag exposure (AUC) by approximately 70%, and co-administration with a calcium-rich dairy product reduced exposure by approximately 59%. This interaction is the primary reason eltrombopag must be taken on an empty stomach, with strict separation from foods and supplements containing polyvalent cations.
Drug Transporter Inhibition: Eltrombopag is an inhibitor of the organic anion transporting polypeptide 1B1 (OATP1B1) and the breast cancer resistance protein (BCRP). These transporters are involved in the hepatic uptake and renal excretion of many drugs. In clinical pharmacokinetic studies, co-administration of eltrombopag with rosuvastatin (an OATP1B1 and BCRP substrate) resulted in a 55% increase in rosuvastatin plasma exposure (AUC) and a 103% increase in peak plasma concentration (Cmax). When eltrombopag is used concomitantly with OATP1B1 or BCRP substrates, dose reduction of the substrate drug and enhanced clinical monitoring may be necessary.
Major Interactions
| Drug / Substance | Effect | Recommendation |
|---|---|---|
| Antacids (Al/Mg-containing) | Reduces eltrombopag AUC by ~70% | Separate by at least 4 hours |
| Calcium-containing products (dairy, supplements) | Reduces eltrombopag AUC by ~59% | Take 2 hours before or 4 hours after |
| Iron supplements | Significant reduction in eltrombopag absorption | Separate by at least 4 hours |
| Rosuvastatin (and other OATP1B1/BCRP substrates) | Increases rosuvastatin AUC by 55%, Cmax by 103% | Consider dose reduction of rosuvastatin; monitor for statin-related adverse effects |
| Ciclosporin (cyclosporine) | Eltrombopag AUC reduced by ~18%; ciclosporin levels may be affected | Monitor ciclosporin levels; dose adjustment may be needed |
| Lopinavir/ritonavir | Reduces eltrombopag AUC by ~17% | Monitor platelet response; dose adjustment may be required |
Minor Interactions
Eltrombopag is metabolized in the liver primarily through CYP1A2 and CYP2C8 oxidation and by UGT1A1 and UGT1A3 glucuronidation. In vitro studies suggest that eltrombopag is also an inhibitor of CYP1A2 and CYP2C8, though the clinical significance of this inhibition at therapeutic doses appears modest. However, caution is advised when eltrombopag is co-administered with drugs that are predominantly metabolized by these enzymes, such as theophylline (CYP1A2 substrate) or repaglinide and pioglitazone (CYP2C8 substrates). In these cases, enhanced clinical monitoring and potential dose adjustments of the substrate drug may be appropriate.
Eltrombopag is also a substrate of BCRP and OATP1B1 transporters itself, meaning that drugs that inhibit these transporters (such as ciclosporin) could theoretically increase eltrombopag plasma levels. In a clinical pharmacokinetic study, co-administration with ciclosporin reduced eltrombopag AUC by approximately 18%, suggesting a net effect that is modest but should be monitored through platelet count response.
Take Eltrombopag Vivanta on an empty stomach, at least 2 hours before or 4 hours after any dairy products, calcium-fortified foods, antacids, or mineral supplements. This is critical for ensuring the medication is properly absorbed. Water and low-calcium foods (<50 mg calcium) are acceptable at the time of dosing.
What Is the Correct Dosage of Eltrombopag Vivanta?
Eltrombopag Vivanta dosing is individualized based on the patient's specific condition, platelet count response, ethnicity, and liver function. The goal of treatment is to achieve and maintain a platelet count that reduces the risk of clinically significant bleeding, not to normalize the platelet count. Exceeding the minimum dose required to achieve this goal may increase the risk of thromboembolic events and other adverse effects.
Adults
Chronic Immune Thrombocytopenia (ITP)
The recommended starting dose is 50 mg once daily for most adult patients. For patients of East Asian ancestry (e.g., Chinese, Japanese, Korean, or Taiwanese descent), the starting dose should be reduced to 25 mg once daily due to increased systemic exposure observed in pharmacokinetic studies in these populations. The dose may be increased by 25 mg every 2 weeks to a maximum of 75 mg once daily to achieve and maintain a target platelet count of ≥50 × 109/L. If the platelet count exceeds 200 × 109/L, the dose should be reduced by 25 mg. If the platelet count exceeds 400 × 109/L, treatment should be temporarily interrupted and the platelet count monitored twice weekly until it falls below 150 × 109/L, at which point treatment may be resumed at a reduced dose.
Severe Aplastic Anemia (SAA)
The recommended starting dose is 50 mg once daily for most patients (25 mg for East Asian ancestry). When used as first-line therapy in combination with standard immunosuppressive therapy, treatment with eltrombopag should begin on Day 14 of the immunosuppressive regimen. The dose may be increased to 100 mg once daily after 2 weeks if the response is inadequate. For patients who remain refractory after an adequate trial at 100 mg, the dose may be further increased to a maximum of 150 mg once daily. However, the maximum dose for East Asian patients is 75 mg once daily.
Chronic Hepatitis C-Associated Thrombocytopenia
The recommended starting dose is 25 mg once daily. The dose may be increased in 25 mg increments every 2 weeks to achieve a target platelet count required for the initiation of antiviral therapy. Eltrombopag should not be used to maintain a platelet level beyond what is clinically needed to initiate and maintain antiviral treatment. Once antiviral therapy is discontinued, eltrombopag should also be discontinued.
Children
Eltrombopag is approved for children aged 1 year and older with chronic ITP. The dosing in pediatric patients is based on body weight and age:
| Age Group | Starting Dose | Maximum Dose |
|---|---|---|
| 1 to 5 years | 25 mg once daily | 75 mg once daily |
| 6 to 17 years | 50 mg once daily (25 mg for East Asian) | 75 mg once daily |
Pediatric dose adjustments follow the same principles as adult dosing, with increases of 25 mg every 2 weeks based on platelet count monitoring. The safety and efficacy of eltrombopag have not been established in children under 1 year of age for ITP or in pediatric patients for SAA or hepatitis C-associated thrombocytopenia.
Elderly
No specific dose adjustment is recommended for elderly patients (aged 65 years and older) based on age alone. However, elderly patients may have a higher prevalence of comorbidities and concomitant medications that could increase the risk of thromboembolic events or hepatotoxicity. Therefore, careful monitoring and conservative dose titration are advisable. In clinical trials, the safety profile of eltrombopag in elderly patients was generally consistent with that observed in younger adults, though the sample sizes in the older age groups were smaller.
Patients with Hepatic Impairment
For patients with hepatic impairment (Child-Pugh class A, B, or C), eltrombopag should be used with caution. Patients with hepatic impairment have increased systemic exposure to eltrombopag, and the starting dose for ITP patients with hepatic impairment should be reduced to 25 mg once daily. Dose escalation should proceed cautiously with close monitoring of liver function tests. In patients with hepatitis C-related thrombocytopenia who already have liver disease, the risk-benefit balance must be carefully evaluated, as these patients are at higher risk for both hepatotoxicity and portal vein thrombosis.
Missed Dose
If you miss a dose of Eltrombopag Vivanta, 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 doses, consider setting a daily alarm to help you remember. Consistent dosing at the same time each day, on an empty stomach, will help maintain stable platelet counts and optimal therapeutic response.
Overdose
In clinical trials and post-marketing experience, platelet counts exceeding the normal range have been reported with excessive doses of eltrombopag. Excessive platelet elevation may increase the risk of thromboembolic complications. There is no specific antidote for eltrombopag overdose. Due to its extensive plasma protein binding (>99%), eltrombopag is unlikely to be significantly removed by hemodialysis. In the event of an overdose, platelet counts should be monitored closely and eltrombopag should be withheld until platelet counts return to an acceptable range. Supportive measures, including careful observation for signs of thrombosis, should be implemented as clinically indicated.
If you suspect an overdose of Eltrombopag Vivanta, seek immediate medical attention. Excessive platelet elevation can significantly increase the risk of blood clots (thrombosis), which can be life-threatening if they occur in vital organs such as the lungs, brain, or heart.
What Are the Side Effects of Eltrombopag Vivanta?
Like all medicines, Eltrombopag Vivanta can cause side effects, although not everybody gets them. The following side effects have been observed in clinical trials and post-marketing surveillance across the approved indications. Side effects are classified by frequency according to the following convention: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).
The side effect profile of eltrombopag differs somewhat between the various clinical indications, partly because the underlying diseases and concomitant treatments contribute to the overall adverse event profile. For example, patients with hepatitis C and underlying liver disease have a higher baseline incidence of hepatobiliary adverse events, while patients with SAA receiving concomitant immunosuppressive therapy have a higher incidence of infections.
Very Common
Affects more than 1 in 10 people
- Headache
- Nausea
- Diarrhea
- Elevated liver enzymes (ALT, AST)
- Upper respiratory tract infection (nasopharyngitis, pharyngitis)
- Insomnia (in SAA patients)
- Cough
- Fatigue
Common
Affects 1 in 10 to 1 in 100 people
- Anemia
- Decreased appetite
- Dizziness
- Paresthesia (tingling, numbness)
- Dry eye, blurred vision
- Abdominal pain, vomiting
- Elevated bilirubin, abnormal liver function tests
- Rash, pruritus (itching), alopecia (hair loss)
- Myalgia (muscle pain), arthralgia (joint pain)
- Back pain, muscle spasms
- Urinary tract infection
- Pyrexia (fever)
- Influenza-like illness
- Oropharyngeal pain
- Peripheral edema (swelling)
Uncommon
Affects 1 in 100 to 1 in 1,000 people
- Thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Portal vein thrombosis (especially in hepatitis C patients)
- Retinal vein occlusion
- Cataracts, lens opacities
- Hepatotoxicity (drug-induced liver injury)
- Bone marrow reticulin deposition
- Jaundice
- Elevated creatinine
- Menorrhagia (heavy menstrual bleeding)
- Skin discoloration (hyperpigmentation)
Rare
Affects fewer than 1 in 1,000 people
- Myelofibrosis (collagen fibrosis of bone marrow)
- Thrombotic thrombocytopenic purpura (TTP)-like syndrome
- Severe cutaneous adverse reactions
- Nephrotoxicity (kidney injury)
- Hypersensitivity reactions (anaphylaxis, angioedema)
Ocular adverse events, including cataracts and lens opacities, were identified as a potential concern during preclinical studies in rodents. In subsequent clinical monitoring, cataracts have been reported in some patients receiving eltrombopag. The EMA recommends that patients receive a baseline ocular examination before starting treatment and regular follow-up eye examinations during treatment, particularly in patients receiving long-term therapy. Any visual symptoms such as blurred vision, reduced visual acuity, or visual field changes should be reported to the treating physician promptly.
Skin discoloration, typically presenting as hyperpigmentation, has been reported primarily in patients with darker skin tones. This reversible cosmetic change is thought to be related to eltrombopag's iron-chelating properties and its chemical structure, which has been shown to chelate intracellular iron in melanocytes. The discoloration usually resolves after discontinuation of treatment.
Contact your doctor or seek emergency medical care immediately if you experience: sudden severe headache, chest pain, shortness of breath, leg swelling or pain (signs of thromboembolism); yellowing of the skin or eyes, dark urine, severe fatigue (signs of liver injury); unusual bleeding or bruising after stopping eltrombopag; or signs of a severe allergic reaction such as facial swelling, difficulty breathing, or widespread rash.
How Should You Store Eltrombopag Vivanta?
Eltrombopag Vivanta film-coated tablets should be stored at a temperature not exceeding 30°C (86°F). The tablets should be kept in their original packaging (blister pack or bottle, as applicable) to protect them from moisture and light. Exposure to excessive humidity or direct sunlight may affect the stability of the active ingredient and could reduce the therapeutic efficacy of the medication.
As with all medicines, Eltrombopag Vivanta should be stored out of the reach and sight of children. Accidental ingestion by a child could lead to a dangerous increase in platelet counts and potentially life-threatening thromboembolic complications. If accidental ingestion is suspected, seek medical advice immediately.
Do not use Eltrombopag Vivanta after the expiry date stated on the carton and blister or bottle label. The expiry date refers to the last day of that month. Do not dispose of unused or expired medication via household waste or wastewater. Ask your pharmacist about appropriate disposal methods in accordance with local environmental regulations. Proper disposal helps protect the environment and prevents accidental exposure to others.
If you notice any change in the appearance of the tablets, such as discoloration, cracking, or a noticeable change in smell, do not use the medication and consult your pharmacist for a replacement. Film-coated tablets should appear uniform in color and shape; any visible alteration may indicate degradation of the product.
What Does Eltrombopag Vivanta Contain?
Active ingredient: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. Eltrombopag olamine is the salt form used in pharmaceutical formulations. The olamine (monoethanolamine) salt was selected for its favorable physicochemical properties, including improved aqueous solubility and tablet-forming characteristics compared with the free acid form.
Inactive ingredients (excipients): The inactive ingredients in the tablet core and film coating serve various pharmaceutical purposes including binding, disintegration, lubrication, and appearance. Typical excipients found in eltrombopag film-coated tablets include:
- Tablet core: Magnesium stearate (lubricant), sodium starch glycolate (disintegrant), microcrystalline cellulose (filler/binder), povidone (binder), mannitol (filler)
- Film coating: Hypromellose (film-forming agent), titanium dioxide (opacifier), macrogol/polyethylene glycol (plasticizer), polysorbate 80 (surfactant)
Patients with known allergies or intolerances to any of the listed excipients should inform their healthcare provider before starting treatment. While serious allergic reactions to excipients are rare, they can occur, and alternative formulations or therapeutic options should be considered in such cases.
The 25 mg tablet is typically round and film-coated with markings to identify the manufacturer and strength. The specific appearance may vary between different generic formulations, but all approved versions must demonstrate bioequivalence to the reference product through rigorous regulatory testing, ensuring equivalent therapeutic performance.
Frequently Asked Questions About Eltrombopag Vivanta
Eltrombopag Vivanta is a generic formulation of eltrombopag, while Revolade (known as Promacta in the United States) is the original branded product developed by GlaxoSmithKline and now marketed by Novartis. Both contain the same active ingredient (eltrombopag olamine) and have been demonstrated to be bioequivalent, meaning they deliver the same amount of drug to the bloodstream at the same rate. Generic formulations undergo rigorous regulatory review to ensure they meet the same quality, purity, and potency standards as the originator product. The primary difference is typically the price, with generic versions being more affordable.
Eltrombopag Vivanta should ideally be taken on an empty stomach. The most critical rule is that it must be separated from dairy products, antacids, and mineral supplements by at least 2 hours before or 4 hours after, because these products contain polyvalent cations (calcium, magnesium, iron, aluminium) that bind to eltrombopag and dramatically reduce its absorption. Taking it with a low-calcium meal (less than 50 mg calcium per serving) is acceptable if taking it on a completely empty stomach is not feasible. The best approach is to take it at bedtime, at least 2 hours after your last meal and any other medications.
Regular blood monitoring is essential during treatment with Eltrombopag Vivanta. Your doctor will typically perform a complete blood count (including platelet count) and liver function tests (ALT, AST, bilirubin) before starting treatment. During the dose-adjustment phase, these tests are usually done every 2 weeks. Once a stable dose is established, blood tests are generally required monthly. Additionally, a peripheral blood smear should be examined periodically to check for morphological abnormalities that could indicate bone marrow reticulin formation. Your doctor may adjust the monitoring frequency based on your individual clinical response and risk profile.
If you stop taking Eltrombopag Vivanta, your platelet count will typically return to pre-treatment levels within 1 to 2 weeks. In some patients, platelet counts may temporarily drop below the levels seen before treatment began, creating a period of increased bleeding risk. This rebound thrombocytopenia usually resolves within 2 to 4 weeks. Because of this risk, you should never stop taking Eltrombopag Vivanta without your doctor's guidance. Your doctor will monitor your platelet counts closely (weekly) after discontinuation and may implement precautionary measures to reduce bleeding risk during this transition period.
Eltrombopag Vivanta does not cure ITP or aplastic anemia. In ITP, it works by stimulating the bone marrow to produce more platelets, counteracting the effects of immune-mediated platelet destruction. However, it does not address the underlying autoimmune process. When treatment is stopped, platelet counts typically return to pre-treatment levels. In severe aplastic anemia, eltrombopag may contribute to more durable hematological responses when used as part of combination immunosuppressive therapy, with some patients achieving sustained responses even after discontinuation. However, this outcome varies between patients and depends on the severity and nature of the underlying bone marrow failure.
Pharmacokinetic studies have shown that patients of East Asian ancestry (including Chinese, Japanese, Korean, and Taiwanese descent) have approximately 50% higher plasma exposure to eltrombopag compared with non-East Asian patients when given the same dose. This increased drug exposure is thought to be related to genetic differences in drug-metabolizing enzymes and transporters that affect how the body processes eltrombopag. To achieve equivalent therapeutic effect while minimizing the risk of excessive platelet elevation and adverse effects, the recommended starting dose for East Asian patients with ITP is 25 mg once daily (compared with 50 mg for other populations). Dose adjustments are then made based on individual platelet count response.
References
- European Medicines Agency (EMA). Revolade (eltrombopag) Summary of Product Characteristics. Last updated 2025. Available at: EMA – Revolade.
- U.S. Food and Drug Administration (FDA). Promacta (eltrombopag) Prescribing Information. Revised 2024. Available at: FDA – Promacta Label.
- Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. doi:10.1182/bloodadvances.2019000966.
- 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.
- Cheng G, Saleh MN, Marcher C, et al. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011;377(9763):393-402. doi:10.1016/S0140-6736(10)60959-2.
- Afdhal NH, Giannini EG, Vaez-Azizi G, et al. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012;367(8):716-724. doi:10.1056/NEJMoa1110709.
- British Society for Haematology (BSH). Guidelines for the Management of Adult Immune Thrombocytopenia. Updated 2023. Br J Haematol. 2023;201(3):371-395.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO; 2023.
- Bussel JB, de Miguel PG, Despotovic JM, et al. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015;2(8):e315-e325.
- Grainger JD, Locatelli F, Chotsampancharoen T, et al. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet. 2015;386(10004):1649-1658.
Editorial Team
Medical Content
iMedic Medical Editorial Team – Specialists in Hematology and Clinical Pharmacology
Medical Review
iMedic Medical Review Board – Independent panel of medical experts
Evidence Level
Level 1A – Based on systematic reviews, meta-analyses, and randomized controlled trials
Guidelines
ASH, BSH, EMA, FDA, and WHO international guidelines
All content is independently produced without commercial funding. Our editorial team follows the GRADE evidence framework and adheres to international guidelines from the American Society of Hematology (ASH), British Society for Haematology (BSH), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and World Health Organization (WHO). Content is reviewed and updated regularly to reflect the latest medical evidence.