Eltrombopag Sandoz: Uses, Dosage & Side Effects
A thrombopoietin receptor agonist that stimulates platelet production for the treatment of chronic immune thrombocytopenia, severe aplastic anemia, and hepatitis C-associated thrombocytopenia
Eltrombopag Sandoz is a prescription oral thrombopoietin receptor agonist (TPO-RA) used to increase platelet counts in patients with chronic immune thrombocytopenia (ITP), severe aplastic anemia, and chronic hepatitis C-associated thrombocytopenia. The active substance, eltrombopag, works by stimulating the thrombopoietin receptor (c-Mpl) on megakaryocytes in the bone marrow, promoting their proliferation and differentiation into mature platelets. Unlike recombinant thrombopoietin, eltrombopag is a small-molecule agent taken orally as a film-coated tablet, offering a convenient non-injectable treatment option. Clinical trials have demonstrated that eltrombopag effectively raises platelet counts in the majority of patients, reducing the risk of bleeding and decreasing the need for rescue treatments. Regular monitoring of liver function and complete blood counts is required during therapy.
Quick Facts: Eltrombopag Sandoz
Key Takeaways
- Eltrombopag Sandoz is a thrombopoietin receptor agonist (TPO-RA) that stimulates platelet production in the bone marrow, used for chronic immune thrombocytopenia (ITP), severe aplastic anemia, and hepatitis C-associated thrombocytopenia.
- The medication is taken orally as a film-coated tablet, typically once daily on an empty stomach, and must not be taken with dairy products, calcium-fortified foods, or polyvalent cation-containing antacids, which significantly reduce absorption.
- Regular liver function monitoring is essential, as eltrombopag can cause hepatotoxicity; liver enzymes (ALT, AST, bilirubin) should be checked before treatment, every two weeks during dose adjustment, and monthly thereafter.
- Platelet counts typically begin to rise within 1–2 weeks, and doses are individually adjusted every 2 weeks to maintain platelet levels within the target range—the goal is not to normalize platelet counts but to reduce bleeding risk.
- Treatment should not be stopped abruptly, as platelet counts may drop below pre-treatment levels, potentially increasing bleeding risk; gradual dose reduction under medical supervision is recommended.
What Is Eltrombopag Sandoz and What Is It Used For?
Eltrombopag Sandoz contains the active substance eltrombopag, a small-molecule, non-peptide thrombopoietin receptor agonist. It belongs to a class of medications known as TPO-RAs (thrombopoietin receptor agonists) that work by mimicking the action of the body's natural platelet growth factor, thrombopoietin (TPO). Thrombopoietin is the primary cytokine responsible for regulating megakaryocyte development and platelet production. In conditions where platelet counts are dangerously low, eltrombopag helps restore platelet production by activating the same receptor that TPO uses, but through a distinct binding site.
Unlike recombinant thrombopoietin proteins that bind to the extracellular domain of the TPO receptor (c-Mpl), eltrombopag interacts with the transmembrane domain of the receptor. This unique binding mechanism means that eltrombopag does not compete with endogenous TPO for binding, and the two can have additive effects on receptor signaling. When eltrombopag binds to the transmembrane domain of c-Mpl, it initiates intracellular signaling cascades, primarily through the Janus kinase/signal transducer and activator of transcription (JAK/STAT) and mitogen-activated protein kinase (MAPK) pathways. These signaling events promote the proliferation, differentiation, and maturation of megakaryocyte progenitor cells in the bone marrow, ultimately leading to increased platelet production and release into the bloodstream.
Eltrombopag Sandoz is a generic version of eltrombopag, containing the same active substance as the originator products Revolade (marketed primarily in the European Union and other regions) and Promacta (marketed in the United States by Novartis). As a generic medication approved by regulatory authorities, Eltrombopag Sandoz has demonstrated bioequivalence to the reference product, meaning it delivers the same amount of active substance at the same rate and to the same extent, and is therefore expected to have equivalent therapeutic effects and safety profile.
Chronic Immune Thrombocytopenia (ITP)
The primary indication for Eltrombopag Sandoz is the treatment of chronic immune thrombocytopenia (ITP) in patients aged 1 year and older who have had an insufficient response to other treatments. ITP is an autoimmune disorder in which the body's immune system mistakenly attacks and destroys its own platelets, leading to a low platelet count (thrombocytopenia) and an increased risk of bleeding. In adults, chronic ITP is defined as ITP lasting more than 12 months from diagnosis. The condition affects approximately 3.3 per 100,000 adults annually and can significantly impact quality of life through spontaneous bruising, petechiae, mucosal bleeding, and in severe cases, life-threatening hemorrhage.
Eltrombopag was evaluated in several pivotal clinical trials for chronic ITP. The RAISE study, a randomized, double-blind, placebo-controlled trial involving 197 adults with chronic ITP, demonstrated that eltrombopag 50 mg daily significantly increased platelet counts compared with placebo. The primary endpoint—odds of achieving a platelet count between 50,000 and 400,000 per microliter during the treatment period—was achieved in significantly more patients in the eltrombopag group (79%) compared with placebo (28%). Furthermore, patients treated with eltrombopag had a significantly reduced incidence of bleeding events and required fewer rescue medications. The EXTEND study, a long-term open-label extension trial, demonstrated sustained platelet responses in approximately 85% of patients over a median treatment duration exceeding 2 years, with continued efficacy and an acceptable safety profile.
Severe Aplastic Anemia
Eltrombopag Sandoz is also indicated for the treatment of adult patients with acquired severe aplastic anemia (SAA) who have had an insufficient response to at least one prior course of immunosuppressive therapy (IST), or who are heavily pre-treated and unsuitable for hematopoietic stem cell transplantation. SAA is a rare and potentially life-threatening bone marrow failure syndrome characterized by pancytopenia (low counts of all blood cell types) and a hypocellular bone marrow. The condition results from immune-mediated destruction or suppression of hematopoietic stem cells.
The efficacy of eltrombopag in SAA was demonstrated in two National Institutes of Health (NIH) clinical studies. In these studies, eltrombopag was added to standard immunosuppressive therapy (horse antithymocyte globulin plus ciclosporin) as first-line treatment in treatment-naive SAA patients. The addition of eltrombopag resulted in significantly higher overall response rates and complete response rates compared with historical data for IST alone. In relapsed or refractory SAA, approximately 40% of patients achieved a multilineage hematologic response with eltrombopag monotherapy, with improvements not only in platelet counts but also in hemoglobin levels and neutrophil counts, suggesting a broader effect on hematopoietic stem cell stimulation beyond the megakaryocyte lineage.
Chronic Hepatitis C-Associated Thrombocytopenia
Eltrombopag is additionally indicated in adult patients with chronic hepatitis C virus (HCV) infection to allow the initiation and maintenance of interferon-based antiviral therapy when the degree of thrombocytopenia prevents its initiation or limits the ability to maintain optimal interferon dosing. Interferon-based treatment regimens can cause further suppression of platelet counts, and many patients with chronic hepatitis C already have low platelet counts due to liver disease, portal hypertension, and hypersplenism. By raising platelet counts to a safe level, eltrombopag enables these patients to receive adequate antiviral treatment.
The ENABLE 1 and ENABLE 2 studies, two large randomized, double-blind, placebo-controlled phase III trials, evaluated eltrombopag in patients with chronic HCV infection and thrombocytopenia. In these studies, eltrombopag 25 mg daily (initiated before starting antiviral therapy) enabled a significantly greater proportion of patients to initiate and maintain interferon-based antiviral treatment compared with placebo. Sustained virologic response (SVR) rates were significantly higher in the eltrombopag groups, demonstrating that raising platelet counts with eltrombopag facilitated successful antiviral therapy.
The goal of Eltrombopag Sandoz treatment in ITP is not to normalize platelet counts but to achieve a platelet count that reduces the risk of clinically significant bleeding. The lowest dose that maintains a platelet count above approximately 50,000 per microliter should be used. Excessive platelet elevation may increase the risk of thromboembolic events. Your doctor will individualize your dose based on regular platelet count monitoring.
What Should You Know Before Taking Eltrombopag Sandoz?
Contraindications
The primary contraindication to Eltrombopag Sandoz is hypersensitivity (allergy) to the active substance eltrombopag or to any of the excipients in the formulation. If you have experienced an allergic reaction to eltrombopag or any formulation of eltrombopag-containing products (including the originator products Revolade or Promacta), you must not use this medication.
There are no absolute additional contraindications listed in the prescribing information; however, several conditions require special caution, dose adjustments, or may constitute relative contraindications depending on clinical circumstances. These are detailed in the warnings and precautions section below.
Warnings and Precautions
Eltrombopag can cause serious liver damage (hepatotoxicity). Liver function tests (ALT, AST, bilirubin) must be measured before starting treatment, every 2 weeks during the dose adjustment phase, and monthly once a stable dose is established. If liver enzyme levels rise to 3 times the upper limit of normal or higher, or if abnormal liver function is accompanied by elevated direct bilirubin, treatment should be interrupted and investigated. Eltrombopag should be discontinued if liver enzyme abnormalities are not resolved within 4 weeks, or if other signs of significant liver injury develop.
Before starting Eltrombopag Sandoz, discuss the following with your healthcare provider:
- Liver disease: Patients with chronic liver disease (Child-Pugh class A, B, or C) and hepatitis C-associated thrombocytopenia may be at increased risk of hepatic decompensation when receiving eltrombopag in combination with interferon and ribavirin therapy. Patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) should not use eltrombopag for ITP unless the expected benefit outweighs the identified risk of portal vein thrombosis. Starting doses should be reduced in patients with hepatic impairment, and closer monitoring is required.
- Thromboembolic risk: Excessive elevation of platelet counts above the normal range can increase the risk of thromboembolic events, including deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. Patients with known risk factors for thromboembolism (such as Factor V Leiden, antithrombin III deficiency, antiphospholipid syndrome, chronic liver disease, advanced age, prolonged immobilization, or prior thromboembolic events) require careful consideration of the risk-benefit balance and closer monitoring. Platelet counts should be monitored weekly during dose adjustment and monthly thereafter to avoid excessive elevations.
- Bone marrow reticulin fiber deposition: Eltrombopag may increase reticulin fiber deposition in the bone marrow, which in rare cases may progress to bone marrow fibrosis. The clinical significance of this finding is not fully understood, but a peripheral blood smear should be examined before starting treatment and regularly during treatment. If new or worsening morphological abnormalities are detected (such as teardrop-shaped or nucleated red blood cells, or immature white blood cells), eltrombopag should be discontinued and a bone marrow biopsy considered, including staining for reticulin and collagen fibers.
- Rebound thrombocytopenia: Following discontinuation of eltrombopag, platelet counts may drop below pre-treatment levels, potentially increasing the risk of bleeding. This rebound thrombocytopenia typically occurs within 2 weeks of stopping treatment and generally resolves within 4 weeks. Platelet counts should be monitored weekly for at least 4 weeks after stopping eltrombopag, and clinically appropriate interventions should be considered to prevent excessive bleeding.
- Cataracts: In animal studies, eltrombopag caused cataracts and lens opacities. While the relevance to humans at therapeutic doses is uncertain, regular ophthalmological monitoring is recommended before and during treatment, particularly in patients receiving treatment for prolonged periods.
Children and Adolescents
Eltrombopag is indicated for the treatment of chronic ITP in pediatric patients aged 1 year and older who have had an insufficient response to other treatments (such as corticosteroids and immunoglobulins). The safety and efficacy in pediatric patients have been established in clinical trials for this indication. However, eltrombopag is not approved for use in children for the treatment of severe aplastic anemia or hepatitis C-associated thrombocytopenia, as data in these populations are limited or absent.
Dosing in pediatric patients aged 1 to 5 years typically starts at 25 mg once daily, while patients aged 6 to 17 years follow adult dosing recommendations (starting at 25–50 mg depending on the specific indication and clinical factors). Dose adjustments are made based on platelet count response, following the same titration principles used in adults. Pediatric patients of East Asian ancestry (Chinese, Japanese, Korean, or Taiwanese) should start at a reduced dose of 25 mg once daily, regardless of age group.
Pregnancy and Breastfeeding
Eltrombopag Sandoz should not be used during pregnancy unless clearly necessary. There are no adequate and well-controlled studies of eltrombopag in pregnant women. Animal reproductive toxicity studies have shown that eltrombopag crosses the placenta and, at doses significantly higher than clinical doses, was associated with embryo-fetal toxicity including reduced fetal weight and increased incidence of certain developmental variations. Although these findings occurred at supra-therapeutic exposures, the relevance to humans cannot be fully excluded. Women of childbearing potential should use effective contraception during treatment.
It is not known whether eltrombopag or its metabolites are excreted in human breast milk. In animal studies, eltrombopag was detected in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, a decision must be made whether to discontinue breastfeeding or to discontinue eltrombopag treatment, taking into account the benefit of therapy for the mother and the benefit of breastfeeding for the infant. Discuss these considerations with your healthcare provider.
Driving and Operating Machinery
No studies on the effects of eltrombopag on the ability to drive or use machines have been performed. The pharmacology of eltrombopag does not suggest any direct effect on driving ability. However, some patients may experience dizziness, fatigue, or other adverse effects that could temporarily impair concentration and reaction time. If you experience such symptoms, exercise caution when driving or operating heavy machinery until you understand how the medication affects you personally.
Ethnicity-Related Dosing Considerations
Pharmacokinetic studies have shown that patients of East Asian ancestry (including Chinese, Japanese, Korean, and Taiwanese descent) have approximately 50% higher eltrombopag plasma concentrations compared with non-East Asian patients at the same dose. This increased exposure is thought to be related to differences in drug metabolism and possibly drug transporter activity. As a result, patients of East Asian ancestry with ITP should start eltrombopag at a reduced initial dose of 25 mg once daily (rather than the standard starting dose of 50 mg), and dose adjustments should be made cautiously based on platelet count response. This ethnicity-based dosing recommendation does not apply to the hepatitis C indication, where the starting dose is already 25 mg for all patients.
How Does Eltrombopag Sandoz Interact with Other Drugs?
Unlike many small-molecule drugs that are primarily metabolized by cytochrome P450 (CYP) enzymes and are therefore susceptible to classic drug-drug interactions, eltrombopag has a unique interaction profile dominated by chelation with polyvalent metal cations and inhibition of membrane drug transporters. Understanding these interactions is critical for ensuring adequate drug absorption and avoiding potentially dangerous increases in the exposure of concomitant medications.
Polyvalent Cation Chelation (Major Interaction)
The most clinically important interaction affecting Eltrombopag Sandoz involves polyvalent metal cations such as calcium (Ca2+), aluminum (Al3+), iron (Fe2+/Fe3+), magnesium (Mg2+), selenium, and zinc (Zn2+). Eltrombopag chelates (forms insoluble complexes) with these metal ions in the gastrointestinal tract, dramatically reducing its oral bioavailability. In pharmacokinetic studies, co-administration of eltrombopag with a polyvalent cation-containing antacid reduced eltrombopag plasma AUC by approximately 70% and Cmax by approximately 70%. This degree of reduction can render the medication clinically ineffective.
To avoid this interaction, Eltrombopag Sandoz must be taken at least 2 hours before or 4 hours after consuming any products containing polyvalent cations. This includes:
- Antacids containing aluminum hydroxide, magnesium hydroxide, or calcium carbonate
- Dairy products (milk, cheese, yogurt, butter, ice cream) and calcium-fortified foods or beverages (certain orange juices, cereals, non-dairy milks)
- Mineral supplements containing calcium, iron, magnesium, zinc, or selenium
- Multivitamins containing the above minerals
Drug Transporter Interactions
Eltrombopag is an inhibitor of several membrane drug transporters, most notably organic anion transporting polypeptide 1B1 (OATP1B1) and breast cancer resistance protein (BCRP). Inhibition of these transporters can increase the systemic exposure of drugs that rely on them for hepatic uptake and/or efflux, potentially leading to increased adverse effects.
| Interacting Substance | Mechanism | Effect | Management |
|---|---|---|---|
| Antacids (Al, Ca, Mg) | Chelation in GI tract | ~70% reduction in eltrombopag levels | Take eltrombopag 2h before or 4h after |
| Dairy products / Calcium-fortified foods | Chelation with calcium | Significantly reduced absorption | Take eltrombopag 2h before or 4h after |
| Iron supplements | Chelation with iron | Reduced eltrombopag absorption | Take eltrombopag 2h before or 4h after |
| Rosuvastatin | OATP1B1 and BCRP inhibition | ~55% increase in rosuvastatin AUC | Reduce rosuvastatin dose; monitor for myopathy |
| Other statins (OATP1B1 substrates) | OATP1B1 inhibition | Potentially increased statin levels | Use caution; monitor for statin-related side effects |
| Methotrexate | BCRP inhibition | Potentially increased methotrexate levels | Monitor closely; consider dose adjustment |
| Ciclosporin (cyclosporine) | OATP1B1 and BCRP inhibition by ciclosporin | ~18% decrease in eltrombopag AUC | Monitor platelet counts; may need dose adjustment |
| Lopinavir/ritonavir | OATP1B1 inhibition | Decreased eltrombopag exposure | Monitor platelet response closely |
In particular, co-administration of eltrombopag with rosuvastatin resulted in a 55% increase in rosuvastatin plasma AUC and an 103% increase in Cmax in a dedicated drug interaction study. This magnitude of increase is clinically significant and may increase the risk of statin-related adverse effects including myopathy and rhabdomyolysis. If co-administration of eltrombopag and rosuvastatin is necessary, a reduction in rosuvastatin dose should be considered, and patients should be monitored carefully for signs and symptoms of excessive statin exposure.
Eltrombopag is metabolized by CYP1A2 and CYP2C8 enzymes. Potent inhibitors of these enzymes (such as fluvoxamine for CYP1A2, and gemfibrozil for CYP2C8) may increase eltrombopag exposure, though the clinical significance is considered modest. Additionally, eltrombopag undergoes glucuronidation by UGT1A1 and UGT1A3. While no clinically relevant interactions have been demonstrated with specific UGT inhibitors, co-administration with potent UGT inhibitors should be approached with awareness of the theoretical potential for increased eltrombopag levels.
Always take Eltrombopag Sandoz on an empty stomach—at least 2 hours before or 4 hours after eating dairy products, calcium-fortified foods, or taking antacids, mineral supplements, or multivitamins containing polyvalent cations. Failure to observe these timing requirements can reduce drug absorption by up to 70%, potentially leading to treatment failure.
What Is the Correct Dosage of Eltrombopag Sandoz?
Eltrombopag Sandoz should always be used exactly as your doctor has prescribed. The dose is highly individualized and is based on your platelet count response, the specific condition being treated, your ethnic background, and the presence of any hepatic impairment. Platelet counts must be monitored regularly to guide dose adjustments, and the lowest dose that achieves and maintains a platelet count sufficient to reduce the risk of clinically significant bleeding should be used.
Adults with Chronic ITP
| Phase | Dose | Notes |
|---|---|---|
| Starting dose | 50 mg once daily | 25 mg for East Asian patients; reduced dose for hepatic impairment |
| Dose titration | Increase by 25 mg every 2 weeks | If platelets <50,000/µL after at least 2 weeks |
| Maximum dose | 75 mg once daily | Do not exceed; reassess if no response at maximum dose |
| Dose reduction | Decrease by 25 mg | If platelets >200,000/µL; stop if >400,000/µL |
| Maintenance | Lowest effective dose | Target platelets ≥50,000/µL to reduce bleeding risk |
Adults with Severe Aplastic Anemia
Severe Aplastic Anemia Dosing
The recommended starting dose of eltrombopag for severe aplastic anemia is 50 mg once daily. After 2 weeks, if the platelet count has not increased sufficiently, the dose may be increased to 75 mg once daily. Further increases may be made every 2 weeks in 25 mg increments up to a maximum dose of 150 mg once daily. East Asian patients should start at 25 mg once daily. The dose should be adjusted to maintain the platelet count at or above 50,000/µL. If no adequate hematologic response is achieved after 16 weeks at the maximum dose, treatment should be discontinued.
Adults with Hepatitis C-Associated Thrombocytopenia
Hepatitis C Thrombocytopenia Dosing
For patients with chronic hepatitis C infection, the recommended starting dose is 25 mg once daily. The dose may be increased in 25 mg increments every 2 weeks to a maximum of 100 mg once daily as necessary to achieve the target platelet count needed to initiate antiviral therapy. Platelet counts should be monitored weekly during antiviral treatment and the eltrombopag dose adjusted to avoid excessive platelet elevation. Once antiviral therapy is discontinued, eltrombopag should also be discontinued.
Children (1 Year and Older with Chronic ITP)
| Age Group | Starting Dose | Maximum Dose | Notes |
|---|---|---|---|
| 1–5 years | 25 mg once daily | 75 mg once daily | Titrate in 25 mg steps every 2 weeks |
| 6–17 years | 50 mg once daily | 75 mg once daily | 25 mg start for East Asian patients |
Elderly Patients
No specific dose adjustment is required for elderly patients (≥65 years) based on age alone. However, elderly patients may be more susceptible to certain adverse effects, particularly thromboembolic events, and may be more likely to have hepatic impairment or other comorbidities that warrant closer monitoring and potentially lower starting doses. The same dose titration principles apply: start at the recommended dose for the indication and adjust based on platelet count response and tolerability.
Patients with Hepatic Impairment
Patients with hepatic impairment have increased eltrombopag exposure and require dose reductions. For patients with ITP and hepatic impairment (Child-Pugh class A, B, or C), the starting dose should be reduced to 25 mg once daily, with cautious dose titration. Eltrombopag should not be used in patients with ITP who have moderate to severe hepatic impairment (Child-Pugh score ≥7) unless the expected benefit outweighs the identified risk of portal vein thrombosis.
Missed Dose
If you miss a dose of Eltrombopag Sandoz, take it as soon as you remember on the same day, provided you can still maintain the required separation from polyvalent cation-containing products. Do not take two doses at the same time or on the same day to make up for a missed dose. Simply resume your normal dosing schedule the next day. If you frequently forget to take your medication, discuss this with your doctor or pharmacist, who may suggest strategies to help you remember.
Overdose
In case of overdose, platelet counts may rise excessively, potentially increasing the risk of thromboembolic complications. There is no specific antidote for eltrombopag overdose. If overdose is suspected, seek immediate medical attention. Treatment is supportive and symptomatic. Close monitoring of platelet counts is essential, and standard medical interventions for thromboembolic events should be implemented if needed. Eltrombopag is not expected to be significantly removed by hemodialysis due to its high protein binding (>99%).
What Are the Side Effects of Eltrombopag Sandoz?
Like all medicines, Eltrombopag Sandoz can cause side effects, although not everybody gets them. The side effect profile has been characterized through extensive clinical trial programs involving thousands of patients across the approved indications, as well as post-marketing surveillance data accumulated since the originator product was first approved in 2008.
The frequency and type of side effects can vary depending on the indication being treated and the patient population. For example, patients with chronic hepatitis C who receive eltrombopag in combination with interferon and ribavirin may experience side effects attributable to the antiviral regimen rather than to eltrombopag itself. Similarly, patients with severe aplastic anemia may have a different adverse event profile due to their underlying condition and concomitant immunosuppressive therapy.
The following side effects have been reported in clinical trials and post-marketing experience, organized by frequency according to the standard MedDRA convention:
Very Common
Affects more than 1 in 10 patients
- Headache
- Nausea
- Diarrhea
- Elevated liver enzymes (ALT, AST increases)
- Upper respiratory tract infection (nasopharyngitis, pharyngitis)
- Fatigue
Common
Affects 1 in 10 to 1 in 100 patients
- Vomiting
- Abdominal pain (upper abdominal pain, abdominal distension)
- Oral discomfort (oropharyngeal pain, mouth ulceration)
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Back pain, pain in extremities
- Muscle spasms
- Rash, skin eruptions, alopecia (hair loss)
- Pruritus (itching)
- Dizziness
- Paresthesia (tingling or numbness)
- Insomnia
- Cough
- Urinary tract infection
- Influenza-like illness
- Pyrexia (fever)
- Decreased appetite
- Hyperbilirubinemia (elevated bilirubin)
- Dry eye, blurred vision
- Peripheral edema
Uncommon
Affects 1 in 100 to 1 in 1,000 patients
- Thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Hepatotoxicity (drug-induced liver injury)
- Jaundice (yellowing of skin or eyes)
- Reticulin deposition in bone marrow
- Cataracts, lens opacities
- Palpitations, tachycardia
- Renal impairment
- Hyperuricemia (elevated uric acid)
- Tremor
- Menorrhagia (heavy menstrual bleeding)
Rare
Affects fewer than 1 in 1,000 patients
- Myocardial infarction (heart attack)
- Stroke, transient ischemic attack
- Portal vein thrombosis (particularly in patients with liver disease)
- Bone marrow fibrosis (collagen fibrosis)
- Severe skin reactions
- Hemolytic anemia
Not Known
Frequency cannot be estimated from available data
- Thrombotic microangiopathy with renal failure
- Severe hypersensitivity reactions (anaphylaxis)
- Skin discoloration (hyperpigmentation)
Hepatotoxicity in Detail
Hepatotoxicity is one of the most clinically significant adverse effects of eltrombopag. In clinical trials, elevations of serum alanine aminotransferase (ALT) to 3 times the upper limit of normal or greater were observed in approximately 10–11% of patients with chronic ITP and in up to 43% of patients with hepatitis C (where liver disease is already present). Most ALT elevations were transient, resolved spontaneously or with dose reduction, and did not require permanent discontinuation of treatment. However, cases of serious hepatotoxicity with clinical symptoms including jaundice, significantly elevated bilirubin, and liver failure have been reported, particularly in patients with pre-existing liver disease.
To minimize the risk of hepatotoxicity, liver function tests (ALT, AST, total and direct bilirubin) should be performed before starting treatment, every 2 weeks during the dose adjustment phase, and monthly once a stable dose is achieved. If ALT levels increase to ≥3 times the upper limit of normal and are progressive, persistent for ≥4 weeks, accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence of hepatic decompensation, eltrombopag should be discontinued.
Thromboembolic Events
Thromboembolic events have been reported in patients receiving eltrombopag, including deep vein thrombosis, pulmonary embolism, transient ischemic attacks, myocardial infarction, and ischemic stroke. These events have occurred both at elevated platelet counts and at normal or even low platelet counts, suggesting that factors beyond platelet count elevation may contribute to the thrombotic risk. Patients with known risk factors for thromboembolism (advanced age, prolonged immobilization, concurrent malignancy, hormonal therapy, previous thrombotic events, inherited thrombophilia) may be at increased risk and require careful monitoring.
Contact your doctor immediately or go to the nearest emergency department if you experience any of the following: sudden severe headache, visual disturbances, weakness on one side of the body, chest pain, shortness of breath, leg swelling or pain, yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness, right upper abdominal pain, or severe or unexpected bleeding.
How Should You Store Eltrombopag Sandoz?
Proper storage of Eltrombopag Sandoz is important to ensure the medication retains its full potency and safety throughout its shelf life. The film-coated tablets should be stored in the original blister packaging to protect them from moisture and light. No special temperature storage conditions are required beyond avoiding excessive heat—the tablets should be stored below 30°C (86°F). Do not refrigerate or freeze the tablets.
Keep this medicine out of the sight and reach of children. Children in the household should not have access to this medication, as accidental ingestion could cause a dangerous increase in platelet counts. Store the medication in a secure location, ideally in a locked medicine cabinet or on a high shelf out of children's reach.
Do not use Eltrombopag Sandoz after the expiry date which is printed on the carton and blister packaging after "EXP." The expiry date refers to the last day of that month. If the tablets appear damaged, discolored, or otherwise changed in appearance, do not take them and consult your pharmacist.
When disposing of unused or expired medication, do not throw it in household waste or flush it down the toilet. Ask your pharmacist about local take-back programs or approved disposal methods in your area. Proper disposal of pharmaceuticals helps protect the environment from potential contamination.
What Does Eltrombopag Sandoz Contain?
Active Ingredient
The active substance is eltrombopag, present in each film-coated tablet as eltrombopag olamine (the olamine salt). Each tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag free acid. Eltrombopag olamine is a small-molecule, non-peptide compound with the chemical formula C25H22N4O4 · C2H7NO (as the olamine salt) and a molecular weight of approximately 564.6 g/mol (salt form). It is a biphenyl hydrazone compound with a distinctive orange-brown color.
Inactive Ingredients (Excipients)
The excipients in Eltrombopag Sandoz 25 mg film-coated tablets serve various pharmaceutical functions to ensure tablet integrity, stability, and appropriate dissolution characteristics:
- Tablet core: Magnesium stearate (lubricant), mannitol (diluent/filler), microcrystalline cellulose (binder/filler), povidone (binder), sodium starch glycolate (disintegrant)
- Film coating: Hypromellose (film-forming agent), titanium dioxide E171 (opacifier/colorant), macrogol/polyethylene glycol (plasticizer), iron oxide yellow E172 and iron oxide red E172 (colorants)
Patients with known allergies or intolerances to any of these excipients should inform their healthcare provider before starting treatment. The tablets do not contain lactose, gluten, or sucrose. Each tablet contains less than 1 mmol (23 mg) of sodium and is therefore essentially sodium-free.
Appearance
Eltrombopag Sandoz 25 mg film-coated tablets are round, biconvex tablets with a characteristic color determined by the film-coating pigments. The tablets are packaged in blister packs within a cardboard carton. The pack size and exact tablet appearance may vary depending on the market and specific formulation approved in your country. Always check that the tablets match the description in the patient information leaflet provided with your medication.
Frequently Asked Questions About Eltrombopag Sandoz
Eltrombopag Sandoz is used to treat low platelet counts (thrombocytopenia) in three main conditions: (1) chronic immune thrombocytopenia (ITP) in patients aged 1 year and older who have not responded adequately to other treatments such as corticosteroids or immunoglobulins; (2) severe aplastic anemia in adults who have had an insufficient response to immunosuppressive therapy; and (3) chronic hepatitis C infection where thrombocytopenia prevents the initiation or continuation of interferon-based antiviral therapy. The medication works by stimulating the body's own platelet production in the bone marrow.
Unlike corticosteroids and immunoglobulins, which work by suppressing the immune system's destruction of platelets, Eltrombopag Sandoz takes a fundamentally different approach by stimulating the production of new platelets in the bone marrow. It activates the thrombopoietin receptor on megakaryocytes, promoting their growth and maturation. This means it addresses the production side of the platelet balance rather than just the destruction side. Additionally, eltrombopag is taken orally as a tablet, unlike romiplostim (another TPO receptor agonist) which requires weekly subcutaneous injections. This oral administration makes it a convenient option for long-term use.
Eltrombopag forms insoluble complexes (chelates) with polyvalent metal cations, including the calcium found abundantly in dairy products. When eltrombopag chelates with calcium in your stomach and intestines, it cannot be absorbed into your bloodstream, reducing its effectiveness by up to 70%. This is why you must take the tablet at least 2 hours before or 4 hours after consuming dairy products, calcium-fortified foods, antacids, or mineral supplements. This timing restriction also applies to iron supplements and multivitamins containing minerals.
Stopping eltrombopag suddenly can cause a rebound drop in platelet counts, potentially to levels lower than before treatment started. This rebound thrombocytopenia typically occurs within 2 weeks of stopping and usually resolves within 4 weeks, but it can temporarily increase your risk of bleeding. For this reason, your doctor will monitor your platelet counts weekly for at least 4 weeks after discontinuation. Never stop taking Eltrombopag Sandoz without consulting your doctor first, even if you feel well. If treatment needs to be stopped, your doctor will plan an appropriate monitoring schedule.
Eltrombopag Sandoz is a generic version containing the same active substance (eltrombopag) as the originator products Revolade (marketed in the EU and many other countries) and Promacta (marketed in the United States). Generic medications approved by regulatory authorities must demonstrate bioequivalence to the originator product, meaning they deliver the same amount of active substance at the same rate. The therapeutic effects and safety profile are therefore expected to be equivalent. The main differences between the products may include tablet appearance, excipients used in the formulation, and price.
Regular blood monitoring is essential during Eltrombopag Sandoz treatment. Liver function tests (ALT, AST, bilirubin) should be performed before starting treatment, every 2 weeks during the dose adjustment phase, and monthly once a stable dose is established. Complete blood counts with platelet counts should be checked weekly during dose adjustment, then monthly on a stable dose. A peripheral blood smear should be examined before treatment and periodically during treatment to check for morphological abnormalities. Your doctor will determine the exact monitoring schedule based on your clinical situation.
References
- European Medicines Agency (EMA). Revolade (eltrombopag) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR Revolade.
- U.S. Food and Drug Administration (FDA). Promacta (eltrombopag) Prescribing Information. Novartis Pharmaceuticals Corporation. Last revised 2024.
- 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.
- Saleh MN, Bussel JB, Cheng G, et al. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013;121(3):537-545. doi:10.1182/blood-2012-04-425512.
- 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.
- Afdhal NH, Dusheiko GM, Giannini EG, et al. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014;146(2):442-452.e1. doi:10.1053/j.gastro.2013.10.012.
- 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.
- Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. doi:10.1182/bloodadvances.2019000812.
- National Institute for Health and Care Excellence (NICE). Eltrombopag for treating chronic immune (idiopathic) thrombocytopenic purpura. Technology appraisal guidance [TA293]. 2013. Reviewed 2023.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
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