Eltrombopag Accord: Uses, Dosage & Side Effects
An oral thrombopoietin receptor agonist that stimulates platelet production for the treatment of chronic immune thrombocytopenia, severe aplastic anemia, and hepatitis C-associated thrombocytopenia
Eltrombopag Accord is a prescription oral thrombopoietin receptor agonist (TPO-RA) used to stimulate the production of platelets in the bone marrow. It is indicated for the treatment of chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; as part of first-line immunosuppressive therapy for severe aplastic anemia (SAA); and for thrombocytopenia in adults with chronic hepatitis C virus (HCV) infection where low platelet counts interfere with the initiation or maintenance of interferon-based antiviral therapy. Eltrombopag works by binding to the transmembrane domain of the thrombopoietin receptor (c-Mpl), activating intracellular signaling pathways that promote megakaryocyte proliferation and differentiation, ultimately leading to increased platelet production.
Quick Facts: Eltrombopag Accord
Key Takeaways
- Eltrombopag Accord is an oral thrombopoietin receptor agonist (TPO-RA) that stimulates the bone marrow to produce more platelets, used primarily for chronic immune thrombocytopenia (ITP) in adults and children aged 1 year and older who have not responded adequately to other treatments.
- The medication is also approved for first-line treatment of severe aplastic anemia (in combination with immunosuppressive therapy) and for thrombocytopenia in chronic hepatitis C patients requiring interferon-based antiviral treatment.
- Eltrombopag must be taken on an empty stomach or with a low-calcium meal, at least 2 hours before or 4 hours after consuming dairy products, calcium supplements, or antacids, as polyvalent cations significantly reduce its absorption.
- Regular monitoring of liver function tests, complete blood counts, and peripheral blood smears is essential during treatment, as eltrombopag carries risks of hepatotoxicity, thromboembolic events, and bone marrow reticulin fiber deposition.
- Treatment should be initiated and supervised by a physician experienced in the management of hematological conditions, with dose adjustments guided by platelet count response to achieve counts sufficient to prevent bleeding rather than normalize platelet levels.
What Is Eltrombopag Accord and What Is It Used For?
Eltrombopag Accord contains the active substance eltrombopag (as eltrombopag olamine), a small-molecule, non-peptide thrombopoietin receptor agonist. Unlike biological thrombopoietin-based agents, eltrombopag is a synthetic compound that can be taken orally as a film-coated tablet. It belongs to the pharmacological class known as thrombopoietin receptor agonists (TPO-RAs), which represent a significant advancement in the treatment of conditions characterized by low platelet counts (thrombocytopenia).
Platelets (thrombocytes) are small, disc-shaped cell fragments produced in the bone marrow by large precursor cells called megakaryocytes. They play a critical role in hemostasis – the process by which the body stops bleeding. Normal platelet counts range from approximately 150,000 to 400,000 per microliter of blood. When platelet counts fall below safe thresholds, patients become vulnerable to spontaneous bleeding, bruising, and in severe cases, life-threatening hemorrhage. The primary signal for platelet production is thrombopoietin (TPO), a glycoprotein hormone produced mainly by the liver that binds to the TPO receptor (c-Mpl) on the surface of megakaryocyte precursors and megakaryocytes in the bone marrow.
Eltrombopag works by binding to the transmembrane domain of the human TPO receptor at a site that is distinct from the binding site of endogenous thrombopoietin. This unique binding mechanism means that eltrombopag does not compete with the body's own thrombopoietin but instead works synergistically with it. When eltrombopag binds to c-Mpl, it activates intracellular signaling cascades, primarily the Janus kinase–signal transducer and activator of transcription (JAK-STAT) pathway and the mitogen-activated protein kinase (MAPK) pathway. These signaling pathways promote the proliferation and differentiation of megakaryocyte progenitor cells in the bone marrow, leading to the production of mature megakaryocytes that release functional platelets into the bloodstream.
Eltrombopag Accord is a generic version of the originator product and is approved for three distinct clinical indications:
Chronic Immune Thrombocytopenia (ITP)
Immune thrombocytopenia (ITP), formerly known as idiopathic thrombocytopenic purpura, is an autoimmune disorder in which the immune system produces antibodies that target and destroy the patient's own platelets. This accelerated platelet destruction, combined with impaired platelet production due to immune-mediated damage to megakaryocytes, results in persistently low platelet counts. Chronic ITP is defined as ITP lasting more than 12 months. Eltrombopag is indicated for the treatment of chronic ITP in adults and children aged 1 year and older who have had an insufficient response to other treatments, including corticosteroids, immunoglobulins, or splenectomy.
The efficacy of eltrombopag in ITP has been demonstrated in multiple randomized controlled trials. In the pivotal RAISE trial, a phase III double-blind, placebo-controlled study involving 197 patients with chronic ITP, eltrombopag significantly increased platelet counts compared with placebo. Over the 6-month study period, patients receiving eltrombopag had a median platelet count above 50,000 per microliter for 8 times as many days as placebo-treated patients. The odds of achieving a platelet count of 50,000 or higher were 8.2 times greater with eltrombopag than with placebo. Furthermore, patients receiving eltrombopag had significantly less bleeding and a reduced need for rescue medications compared with the placebo group.
Long-term extension studies (the EXTEND study) followed patients receiving eltrombopag for up to 8.2 years, demonstrating sustained platelet count responses with a manageable safety profile over prolonged treatment. Approximately 85% of patients achieved a platelet count of at least 50,000 per microliter at some point during treatment, and the median duration of platelet response was sustained.
Severe Aplastic Anemia (SAA)
Severe aplastic anemia is a rare but life-threatening bone marrow failure disorder characterized by pancytopenia (deficiency of all three blood cell types: red blood cells, white blood cells, and platelets) and a hypocellular bone marrow. The standard first-line treatment for patients who are not candidates for bone marrow transplantation is immunosuppressive therapy (IST) with horse anti-thymocyte globulin (ATG) and ciclosporin. Eltrombopag is approved for use in combination with standard IST as first-line treatment for adult patients with SAA.
This indication is based on results from a landmark study conducted by the National Institutes of Health (NIH), which demonstrated that adding eltrombopag to standard IST significantly improved overall response rates compared with historical controls receiving IST alone. The overall hematologic response rate at 6 months was approximately 94% in patients receiving the combination of eltrombopag plus IST, compared with approximately 66% for IST alone in historical comparisons. Complete response rates were also substantially higher. These results represented one of the most significant therapeutic advances in aplastic anemia in decades.
Hepatitis C-Associated Thrombocytopenia
Chronic hepatitis C virus (HCV) infection can cause thrombocytopenia through multiple mechanisms, including splenic sequestration, decreased thrombopoietin production by the damaged liver, and direct viral suppression of megakaryopoiesis. Low platelet counts in HCV patients can prevent the initiation or continuation of interferon-based antiviral therapy, which itself causes further myelosuppression. Eltrombopag is indicated for the treatment of thrombocytopenia in adult patients with chronic HCV infection to allow the initiation and maintenance of interferon-based therapy.
In the ENABLE 1 and ENABLE 2 trials, eltrombopag significantly increased the proportion of patients who were able to initiate and complete interferon-based antiviral treatment. While the treatment landscape for HCV has evolved significantly with the introduction of direct-acting antivirals (DAAs), this indication remains relevant in settings where interferon-based therapy may still be used.
The goal of eltrombopag treatment in ITP is not to normalize platelet counts, but rather to achieve and maintain a platelet count sufficient to reduce the risk of clinically significant bleeding. The target platelet count is typically above 50,000 per microliter, but treatment should be individualized based on the patient's clinical situation, bleeding risk, and response to therapy. Excessively high platelet counts can increase the risk of thromboembolic events.
What Should You Know Before Taking Eltrombopag Accord?
Contraindications
The primary contraindication to Eltrombopag Accord is hypersensitivity (allergy) to eltrombopag or to any of the other ingredients in the formulation. If you have experienced a previous allergic reaction to eltrombopag or any product containing it, you must not use Eltrombopag Accord. Signs of a serious allergic reaction may include skin rash, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or anaphylaxis.
Although not an absolute contraindication, eltrombopag should be used with extreme caution in patients with moderate to severe hepatic impairment (Child-Pugh class B or C). The liver is the primary organ responsible for metabolizing eltrombopag, and impaired liver function can lead to significantly increased drug exposure, raising the risk of adverse effects including hepatotoxicity. Dose reductions are required in patients with hepatic impairment.
Warnings and Precautions
Eltrombopag can cause serious liver damage (hepatotoxicity). Liver function tests (serum ALT, AST, and bilirubin) must be measured before starting treatment, every 2 weeks during dose adjustment, and monthly once a stable dose is established. If liver function test abnormalities are detected, treatment may need to be interrupted or discontinued. Seek immediate medical attention if you experience symptoms such as yellowing of the skin or eyes (jaundice), unusually dark urine, unusual tiredness, or right upper abdominal pain.
Before starting Eltrombopag Accord, discuss the following important safety considerations with your healthcare provider:
- Hepatotoxicity: Eltrombopag can cause elevations in liver enzymes (ALT, AST) and bilirubin. In clinical trials, hepatobiliary laboratory abnormalities were reported in approximately 10-11% of ITP patients and up to 30% of HCV patients receiving eltrombopag. Severe hepatotoxicity leading to treatment discontinuation has been reported. Regular monitoring of liver function is mandatory.
- Thromboembolic events: Increasing platelet counts with TPO receptor agonists may increase the risk of blood clots (thromboembolism), including deep vein thrombosis (DVT), pulmonary embolism (PE), transient ischemic attack (TIA), and stroke. This risk is particularly relevant in patients with pre-existing risk factors for thromboembolism, such as Factor V Leiden mutation, antiphospholipid syndrome, chronic liver disease, advanced age, prolonged immobilization, or use of oral contraceptives. The platelet count target should not exceed the level needed to prevent bleeding.
- Bone marrow reticulin fiber deposition: TPO receptor agonists, including eltrombopag, may increase the deposition of reticulin fibers in the bone marrow. This is a form of bone marrow fibrosis that can potentially progress and lead to bone marrow failure. Peripheral blood smears should be examined before starting treatment and regularly during treatment to look for morphological abnormalities such as teardrop-shaped red blood cells and nucleated red blood cells. If such abnormalities are detected, bone marrow biopsy with staining for reticulin fibers should be considered.
- Rebound thrombocytopenia: In ITP patients, platelet counts may drop to levels lower than baseline after discontinuation of eltrombopag. This rebound thrombocytopenia typically occurs within 2 weeks of stopping treatment and can increase the risk of bleeding. Platelet counts should be monitored weekly for at least 4 weeks after discontinuation.
- Cataracts: In preclinical studies, cataracts were observed in rodents and dogs receiving eltrombopag. In clinical trials, new or worsening cataracts were reported in some patients, although a definitive causal relationship was not established. Regular ophthalmological examinations are recommended before and during treatment.
- Malignancy risk in aplastic anemia: In patients with aplastic anemia, the condition itself carries an increased risk of transformation to myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The potential contribution of eltrombopag to this risk has not been fully determined. Cytogenetic abnormalities, including monosomy 7, have been observed in some patients with aplastic anemia receiving eltrombopag.
Pregnancy and Breastfeeding
Eltrombopag Accord should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of eltrombopag in pregnant women. Animal reproductive studies have shown adverse effects on embryo-fetal development, including reduced fetal body weight and increased pre- and post-implantation loss at maternally toxic doses. The relevance of these findings to humans is uncertain, but as a precaution, 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. 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 discontinue treatment with Eltrombopag Accord, taking into account the importance of the medicine to the mother.
Children and Adolescents
Eltrombopag is approved for use in children aged 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments. The safety and efficacy in pediatric ITP patients have been established through the PETIT and PETIT-2 clinical trials. Eltrombopag is not approved for use in children with aplastic anemia or hepatitis C-associated thrombocytopenia. The safety and efficacy in children under 1 year of age have not been established.
Patients of East Asian Descent
Pharmacokinetic studies have demonstrated that patients of East Asian ancestry (including Japanese, Chinese, Korean, and Taiwanese heritage) have approximately 50% higher exposure to eltrombopag compared with non-East Asian patients at the same dose. This is likely related to genetic polymorphisms in drug-metabolizing enzymes and transporters. Consequently, a lower starting dose of 25 mg once daily (rather than 50 mg) is recommended for adult patients of East Asian descent with ITP. For East Asian children aged 1 to 5 years, the recommended starting dose is 12.5 mg, and for those aged 6 to 17 years, the starting dose is also reduced. Close monitoring and careful dose titration are particularly important in this population.
Before starting Eltrombopag Accord, your doctor should perform: (1) complete blood count with differential and peripheral blood smear, (2) liver function tests (ALT, AST, bilirubin), (3) baseline ophthalmological examination, (4) assessment for risk factors for thromboembolism, and (5) in aplastic anemia patients, bone marrow biopsy with cytogenetic analysis. These baseline assessments help guide safe dosing and monitoring during treatment.
How Does Eltrombopag Accord Interact with Other Drugs?
Eltrombopag has several important drug interactions that require careful management. Unlike many drugs where interactions occur through cytochrome P450 (CYP) enzyme inhibition or induction, the most significant interactions with eltrombopag involve chelation (binding to metal ions that reduces absorption) and inhibition of drug transport proteins.
Major Interactions
The most critical interaction affecting eltrombopag is with polyvalent cations. Eltrombopag chelates (binds to) polyvalent metal cations such as aluminum, calcium, iron, magnesium, selenium, and zinc. When taken with products containing these minerals, eltrombopag forms insoluble complexes in the gastrointestinal tract that cannot be absorbed, leading to dramatically reduced bioavailability. In pharmacokinetic studies, co-administration of eltrombopag with a polyvalent cation-containing antacid reduced eltrombopag exposure by approximately 70%, rendering it essentially ineffective.
This interaction has profound practical implications for patients:
- Dairy products (milk, cheese, yogurt, butter, ice cream) contain high levels of calcium and must be avoided within the dosing window
- Calcium-fortified foods and beverages (fortified orange juice, fortified plant milks, fortified cereals) should be avoided
- Mineral supplements containing calcium, iron, magnesium, zinc, or selenium must be separated from eltrombopag
- Antacids containing aluminum hydroxide, magnesium hydroxide, or calcium carbonate (e.g., Maalox, Gaviscon, Tums, Rennie) must be separated
The recommended approach is to take eltrombopag at least 2 hours before or 4 hours after consuming any polyvalent cation-containing products. Many physicians recommend taking eltrombopag in the evening on an empty stomach, at least 2 hours after the last meal, to minimize the risk of interaction with dietary cations.
| Interacting Substance | Mechanism | Effect | Management |
|---|---|---|---|
| Polyvalent cation antacids (Al, Ca, Mg) | Chelation in GI tract | ~70% reduction in eltrombopag absorption | Take eltrombopag 2h before or 4h after |
| Dairy products & calcium foods | Chelation with calcium | Significantly reduced absorption | Avoid within 2h before/4h after dosing |
| Iron supplements | Chelation with iron | Reduced eltrombopag absorption | Take eltrombopag 2h before or 4h after |
| Rosuvastatin | OATP1B1 and BCRP inhibition | ~55% increase in rosuvastatin levels | Consider rosuvastatin dose reduction; monitor for myopathy |
| Other statins (atorvastatin, fluvastatin, pravastatin) | Potential OATP1B1/BCRP inhibition | Possible increased statin levels | Monitor for statin-related side effects |
| Ciclosporin | CYP2C8/OATP1B1 interaction | Possible altered exposure of both drugs | Monitor ciclosporin levels; adjust if needed |
| Lopinavir/ritonavir | OATP1B1/CYP interaction | Reduced eltrombopag exposure | Monitor platelet response closely |
| Methotrexate, topotecan | BCRP substrate | Possible increased substrate levels | Monitor for toxicity of co-administered drug |
Minor Interactions and Metabolic Pathways
Eltrombopag is metabolized primarily through CYP1A2 and CYP2C8 oxidation, as well as UGT1A1 and UGT1A3 glucuronidation. Drugs that strongly induce or inhibit these enzymes may alter eltrombopag exposure, although formal interaction studies with specific CYP inhibitors or inducers have not identified clinically significant changes. Smoking, which induces CYP1A2, may potentially reduce eltrombopag exposure, although this has not been systematically studied. Patients who start or stop smoking during eltrombopag treatment should be monitored for changes in platelet response.
Eltrombopag is a potent inhibitor of the organic anion transporting polypeptide 1B1 (OATP1B1) and the breast cancer resistance protein (BCRP). OATP1B1 is a hepatic uptake transporter that facilitates the entry of many drugs into liver cells. BCRP is an efflux transporter expressed in the intestine, liver, and kidneys. By inhibiting these transporters, eltrombopag can increase the systemic exposure of drugs that are substrates of OATP1B1 or BCRP. The most clinically significant example is rosuvastatin, which showed approximately 55% higher plasma levels when co-administered with eltrombopag. This interaction may increase the risk of rosuvastatin-related adverse effects, including myopathy and rhabdomyolysis. Dose adjustment of rosuvastatin and close monitoring for muscle-related symptoms are recommended.
The most practical way to avoid the critical chelation interaction is to take Eltrombopag Accord in the evening on an empty stomach, at least 2 hours after your last meal. Wait at least 4 hours before eating dairy products or taking mineral supplements in the morning. This timing strategy maximizes drug absorption while minimizing inconvenience.
What Is the Correct Dosage of Eltrombopag Accord?
Dosing of Eltrombopag Accord must be individualized based on the patient's clinical indication, baseline platelet count, response to treatment, and any dose-modifying factors such as hepatic impairment or ethnic background. Treatment should be initiated and supervised by a physician experienced in the management of hematological conditions. The tablets should be swallowed whole and taken on an empty stomach or with a meal low in calcium content, observing the required separation from polyvalent cation-containing products.
Adults with Chronic ITP
Standard Dosing – Adult ITP
Starting dose: 50 mg once daily orally
Starting dose (East Asian patients): 25 mg once daily orally
Dose range: 12.5 mg to 75 mg once daily
Maximum dose: 75 mg once daily
Dose adjustment interval: Every 2 weeks based on platelet count
Target: Platelet count ≥ 50,000/μL, sufficient to reduce bleeding risk
After initiating eltrombopag at 50 mg once daily, the dose should be adjusted to achieve and maintain a platelet count of 50,000 per microliter or above as needed to reduce the risk of bleeding. Platelet counts should be assessed weekly until a stable platelet count has been achieved, and then monitored at least monthly. The dose adjustment guidelines are as follows:
| Platelet Count | Action |
|---|---|
| < 50,000/μL after at least 2 weeks | Increase dose by 25 mg daily (max 75 mg/day) |
| 50,000–150,000/μL | Maintain current dose |
| 150,000–250,000/μL | Decrease dose by 25 mg daily (allow 2 weeks to assess) |
| > 250,000/μL | Stop treatment; resume at reduced dose when < 100,000/μL |
If the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the maximum dose of 75 mg once daily, eltrombopag should be discontinued. Excessive platelet count elevation (>250,000/μL) must be avoided to reduce the risk of thromboembolic complications.
Children with Chronic ITP (Aged 1–17 Years)
Pediatric Dosing – ITP
Children 1–5 years: Starting dose 25 mg once daily
Children 6–17 years: Starting dose 50 mg once daily (25 mg for East Asian descent)
Dose range: 12.5 mg to 75 mg once daily
Maximum dose: 75 mg once daily
For children aged 1 to 5 years, the recommended starting dose is 25 mg once daily. For children aged 6 to 17 years, the recommended starting dose is 50 mg once daily (or 25 mg for children of East Asian descent). Dose adjustments follow the same platelet count-based algorithm as for adults. Platelet counts should be monitored weekly during dose adjustment and monthly once a stable dose is achieved.
Adults with Severe Aplastic Anemia
Dosing – Severe Aplastic Anemia (First-Line)
Starting dose: 150 mg once daily from day 1 of IST
Duration: For 6 months concurrently with IST
Assessment: Evaluate hematologic response at 6 months
Note: Dose reduction to 75 mg for East Asian patients may be considered
In the first-line treatment of severe aplastic anemia, eltrombopag is administered at 150 mg once daily starting on day 1 of standard immunosuppressive therapy (horse ATG plus ciclosporin). This higher starting dose reflects the different pathophysiology of aplastic anemia compared with ITP – in SAA, the bone marrow is severely hypocellular, and higher doses of eltrombopag are needed to stimulate the residual stem cells and progenitor cells. Treatment is continued for 6 months, at which point the hematologic response is assessed. If a response is achieved, eltrombopag can be tapered gradually under close monitoring.
Hepatic Impairment
Patients with hepatic impairment have increased exposure to eltrombopag due to reduced hepatic metabolism. For ITP patients with hepatic impairment (Child-Pugh class A, B, or C), eltrombopag should not be initiated unless the expected benefit outweighs the identified risk of portal vein thrombosis. If treatment is considered necessary, the starting dose should be reduced to 25 mg once daily, and liver function should be monitored very closely.
Missed Dose
If you miss a dose of Eltrombopag Accord, do not take a double dose to make up for it. Take your next dose at the usual scheduled time. If you regularly miss doses, the platelet count may decrease, increasing the risk of bleeding. Set a daily reminder to help maintain consistent dosing. If you have difficulty remembering to take your medication, discuss this with your healthcare provider or pharmacist.
Overdose
In the event of an overdose with eltrombopag, platelet counts may increase excessively, which can increase the risk of thromboembolic events. There is no specific antidote for eltrombopag overdose. Since eltrombopag is extensively bound to plasma proteins, hemodialysis is not expected to be effective in removing the drug from the body. Contact your local poison control center or seek emergency medical attention immediately. Platelet counts should be monitored closely, and appropriate supportive measures should be instituted. The clinical effects of an overdose may be delayed due to the time required for platelet production (typically several days).
What Are the Side Effects of Eltrombopag Accord?
Like all medicines, Eltrombopag Accord can cause side effects, although not everybody gets them. The side effect profile differs somewhat depending on the indication (ITP, aplastic anemia, or hepatitis C) and is influenced by the underlying disease and concomitant medications. The following information is based on data from clinical trials and post-marketing surveillance. Side effects are organized below by frequency, as defined by the Medical Dictionary for Regulatory Activities (MedDRA) convention.
Very Common (affects more than 1 in 10 people)
- Headache
- Nausea
- Diarrhea
- Elevated liver enzymes (ALT, AST elevations)
- Anemia (particularly in HCV patients on interferon)
- Decreased appetite (particularly in HCV patients)
- Insomnia (particularly in aplastic anemia patients)
- Cough
- Fatigue
Common (affects 1 to 10 in 100 people)
- Upper respiratory tract infection (nasopharyngitis, pharyngitis)
- Urinary tract infection
- Influenza
- Oral herpes
- Pneumonia
- Abdominal pain, vomiting, flatulence
- Elevated bilirubin (hyperbilirubinemia)
- Rash, pruritus (itching), alopecia (hair loss)
- Myalgia (muscle pain), arthralgia (joint pain), back pain
- Paresthesia (tingling or numbness)
- Cataracts
- Dry eye
- Dizziness
- Fever (pyrexia)
- Peripheral edema (swelling)
- Hyperbilirubinemia
- Ecchymosis (bruising)
Uncommon (affects 1 to 10 in 1,000 people)
- Thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Myocardial infarction (heart attack)
- Increased reticulin in bone marrow
- Hepatotoxicity (severe liver injury)
- Skin discoloration (yellowing)
- Renal failure
- Transient ischemic attack (TIA)
- Menorrhagia (heavy menstrual bleeding)
- Glossodynia (tongue pain)
Rare (affects fewer than 1 in 1,000 people)
- Severe hepatotoxicity with jaundice
- Portal vein thrombosis (especially with liver disease)
- Cerebrovascular events (stroke)
- Bone marrow fibrosis (myelofibrosis)
- Severe skin reactions
- Thrombotic microangiopathy
The hepatotoxicity risk associated with eltrombopag deserves particular attention. In clinical trials for ITP, approximately 10-11% of patients experienced ALT elevations of grade 3 or higher (more than 5 times the upper limit of normal). In HCV patients, this rate was higher, reflecting the combined hepatotoxic potential of eltrombopag, interferon, and the underlying liver disease. Most ALT elevations were reversible upon dose reduction or discontinuation, but severe and potentially life-threatening liver injury has been reported. The mechanism is not fully understood but may involve direct hepatotoxic effects or idiosyncratic drug reaction.
Thromboembolic events have been reported across all clinical indications, occurring in approximately 2-6% of patients in clinical trials. These events include deep vein thrombosis, pulmonary embolism, transient ischemic attack, myocardial infarction, stroke, and portal vein thrombosis (particularly in patients with chronic liver disease). The risk of thromboembolism appears to correlate with platelet count elevation, emphasizing the importance of using the lowest dose that maintains a safe platelet count rather than attempting to normalize platelet counts.
In patients with aplastic anemia, cytogenetic abnormalities (particularly monosomy 7) and progression to myelodysplastic syndrome have been reported. Whether this represents a direct effect of eltrombopag or reflects the natural history of aplastic anemia is still under investigation. Regular monitoring with bone marrow biopsies and cytogenetic analysis is recommended in SAA patients receiving eltrombopag.
Contact your doctor or emergency services immediately if you experience: yellowing of skin or eyes (jaundice), unusually dark urine, severe abdominal pain (especially right upper quadrant), sudden severe headache, visual disturbances, chest pain, difficulty breathing, leg swelling or pain, or sudden numbness or weakness on one side of the body. These may indicate serious complications requiring urgent medical evaluation.
How Should You Store Eltrombopag Accord?
Eltrombopag Accord film-coated tablets should be stored at temperatures not exceeding 30°C (86°F). Keep the tablets in the original blister packaging to protect them from moisture. As with all medicines, Eltrombopag Accord should be stored in a safe location that is out of sight and out of reach of children and pets. Do not use the tablets after the expiry date which is printed on the blister and carton after “EXP.” The expiry date refers to the last day of that month.
Do not dispose of unused or expired Eltrombopag Accord tablets in household waste or through the water system (toilet or drain). Ask your pharmacist about proper disposal procedures for medicines you no longer need. Proper disposal helps protect the environment and prevents accidental exposure to children, animals, or other individuals. Many pharmacies and healthcare facilities accept returned medications for safe disposal.
If the tablets appear damaged, discolored, or the blister packaging is torn or shows signs of tampering, do not use the medication. Contact your pharmacist or the manufacturer for guidance. Do not transfer the tablets to a different container, as this may expose them to moisture and light, potentially affecting their stability and effectiveness.
What Does Eltrombopag Accord Contain?
Each Eltrombopag Accord 12.5 mg film-coated tablet contains 12.5 mg of eltrombopag as eltrombopag olamine. Eltrombopag olamine is the olamine salt form of eltrombopag, which enhances the drug's solubility and oral bioavailability. The molecular formula of eltrombopag olamine is C25H22N4O4·C2H7NO, and it has a molecular weight of 564.6 daltons. Eltrombopag olamine is a yellow to orange powder that is practically insoluble in aqueous solutions at pH 1-5 and slightly soluble at pH 7.
The inactive ingredients (excipients) in the tablet core include magnesium stearate (a lubricant that aids manufacturing), mannitol (a sugar alcohol used as a filler), microcrystalline cellulose (a binding agent that provides structural integrity), povidone (a binder), and sodium starch glycolate (a disintegrant that helps the tablet break apart in the gastrointestinal tract). The film coating contains hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene glycol), polysorbate 80 (an emulsifier), and titanium dioxide (a white colorant).
Patients with known allergies or intolerances to any of these excipients should inform their healthcare provider before starting treatment. Eltrombopag Accord does not contain lactose, gluten, or gelatin. The medication is suitable for patients with lactose intolerance or celiac disease from an excipient perspective, although the clinical decision to use the medication must be based on the patient's hematological condition.
Frequently Asked Questions About Eltrombopag Accord
Eltrombopag Accord is a generic (biosimilar) version of the originator product marketed as Revolade in Europe and Promacta in the United States. Both contain the same active ingredient (eltrombopag olamine) in the same dose and have been demonstrated to be bioequivalent, meaning they achieve the same blood levels of the drug and are expected to have the same clinical efficacy and safety profile. The primary difference is in the manufacturer and potentially the inactive ingredients (excipients), although these differences do not affect the therapeutic action of the medication. Generic medications undergo rigorous regulatory review to ensure they meet the same quality standards as the originator product.
It depends on what your breakfast includes. Black coffee (without milk or cream) does not significantly affect eltrombopag absorption and can be consumed with the medication. However, if your breakfast includes dairy products (milk, yogurt, cheese), calcium-fortified foods, or mineral supplements, you should not take eltrombopag at that time. Many physicians recommend taking eltrombopag in the evening on an empty stomach, at least 2 hours after dinner, to maximize absorption and minimize dietary interactions. A light breakfast without dairy or mineral-fortified products can be consumed with eltrombopag, but most patients find the evening dosing schedule more practical.
The duration of treatment depends on your clinical indication and response to therapy. For chronic ITP, treatment is typically long-term and ongoing, as the medication manages (but does not cure) the condition. However, some ITP patients may achieve sustained platelet responses even after discontinuation, allowing eltrombopag to be stopped. Your hematologist will periodically attempt dose reduction to find the lowest effective dose. For severe aplastic anemia, the initial course is typically 6 months in combination with immunosuppressive therapy, after which the need for continuation is assessed. For hepatitis C-associated thrombocytopenia, treatment is given during the period of antiviral therapy. In all cases, your doctor will regularly reassess whether continued treatment is necessary and beneficial.
If you stop taking Eltrombopag Accord abruptly (particularly in ITP), your platelet count is likely to return to pre-treatment levels within 1-2 weeks. In some cases, platelet counts may fall below baseline levels temporarily (rebound thrombocytopenia), increasing the risk of bleeding. This is why eltrombopag should never be stopped without medical supervision. Your doctor will monitor your platelet counts weekly for at least 4 weeks after discontinuation and may adjust other ITP treatments accordingly. If your platelet count drops dangerously low after stopping, your doctor may restart eltrombopag or initiate alternative treatments to prevent bleeding complications.
There are limited data on the effect of eltrombopag on human fertility. In animal studies, eltrombopag did not impair fertility in male or female rats at clinically relevant doses. However, as with any medication, if you are planning to conceive, discuss this with your healthcare provider. They can help weigh the risks and benefits of continuing treatment during the preconception period. Women of childbearing potential are advised to use effective contraception during treatment with Eltrombopag Accord due to the potential risks to fetal development observed in animal studies.
While there is no direct pharmacological interaction between eltrombopag and alcohol, caution is advised. Both eltrombopag and alcohol can affect the liver, and the combination may increase the risk of hepatotoxicity. If you have underlying liver disease (particularly chronic hepatitis C), alcohol consumption is strongly discouraged. Even without liver disease, it is prudent to limit alcohol intake during eltrombopag treatment and to discuss your alcohol consumption with your doctor, especially given the requirement for regular liver function monitoring.
References
This article is based on evidence from the following peer-reviewed sources and authoritative medical guidelines:
- European Medicines Agency (EMA). Revolade (eltrombopag) – Summary of Product Characteristics. Last updated 2025. Available from: EMA – Revolade EPAR.
- U.S. Food and Drug Administration (FDA). Promacta (eltrombopag) – Prescribing Information. Revised 2024. Available from: FDA – Promacta Label.
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Editorial Team
This article has been researched, written, and reviewed by the iMedic Medical Editorial Team. Our team consists of licensed physicians, pharmacists, and medical researchers with specialized expertise in hematology, internal medicine, and clinical pharmacology.
Written by physicians with expertise in hematology and platelet disorders. All clinical information is sourced from peer-reviewed literature, regulatory documents (EMA SmPC, FDA prescribing information), and international treatment guidelines (ASH, BSH).
Independently reviewed by the iMedic Medical Review Board. All facts have been verified against primary sources. Evidence level: 1A (based on systematic reviews and randomized controlled trials including RAISE, EXTEND, PETIT, and NIH aplastic anemia studies).
Content follows the GRADE evidence framework and adheres to iMedic editorial standards. No pharmaceutical company involvement in content creation or review. All potential conflicts of interest are disclosed. Content is updated regularly to reflect the latest evidence.
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