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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Promacta
Generic Name
Eltrombopag Olamine
Active Ingredient
Eltrombopag OlamineCategory
Other
Variants
6
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Promacta, you must consult a qualified healthcare professional.
| 25 mg/1 | POWDER, FOR SUSPENSION | ORAL | 0078-0697 |
| 75 mg/1 | TABLET, FILM COATED | ORAL | 0078-0687 |
| 12.5 mg/1 | POWDER, FOR SUSPENSION | ORAL | 0078-0972 |
Detailed information about Promacta
Eltrombopag Olamine is a thrombopoietin receptor agonist used to increase platelet counts in patients with chronic immune thrombocytopenia, hepatitis C-associated thrombocytopenia, and severe aplastic anemia.
The dosage of Eltrombopag Olamine is highly individualized and depends on the specific condition being treated, the patient's baseline platelet count, and their ancestry.
Eltrombopag Olamine is approved for children with chronic ITP who are 1 year of age or older.
No specific dose adjustment is generally required for patients with renal impairment, though clinical monitoring should be more frequent as the drug's metabolites are partially cleared through the kidneys.
Because Eltrombopag is primarily metabolized and excreted via the liver, patients with hepatic impairment (Child-Pugh Class A, B, or C) are at a higher risk of toxicity. A lower starting dose (usually 25 mg) is mandatory, and liver function tests must be monitored weekly during the dose-adjustment phase.
Clinical trials did not show overall differences in safety or effectiveness between patients over 65 and younger patients. However, because elderly patients are more likely to have decreased hepatic or cardiac function, healthcare providers often start at the lower end of the dosing range.
Proper administration is critical for the efficacy of Eltrombopag Olamine.
If you miss a dose, skip the missed dose and take your next dose at the regularly scheduled time. Do not take two doses at once to make up for a missed one. Taking more than one dose in a 24-hour period increases the risk of serious side effects, including blood clots.
Signs of an Eltrombopag Olamine overdose may include an abnormally high platelet count, which significantly increases the risk of thromboembolic (clotting) events. Symptoms may include swelling in the legs, chest pain, or shortness of breath. In the event of a suspected overdose, seek emergency medical attention immediately. Healthcare providers will likely monitor platelet counts and may initiate treatment to prevent clotting.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking this medication without medical guidance, as your platelet counts may drop rapidly upon discontinuation.
Many patients taking Eltrombopag Olamine experience mild to moderate side effects as their body adjusts to the medication. According to clinical trial data, the most common side effects include:
Eltrombopag Olamine is a potent medication that requires careful clinical oversight. It is not a cure for ITP or aplastic anemia; rather, it is a management tool to keep platelet counts in a safe range. Patients must be aware that their platelet counts will likely drop back to baseline levels (or lower) within 1 to 2 weeks of stopping the medication, which can lead to a significant risk of bleeding.
Hepatotoxicity Risk: Eltrombopag Olamine can cause serious liver damage. Healthcare providers must perform liver function tests (ALT, AST, and bilirubin) prior to initiation, every 2 weeks during the dose titration phase, and monthly thereafter. If ALT levels increase to ≥3x the upper limit of normal (ULN), tests should be repeated within 3 to 5 days. If the levels remain high or continue to rise, the medication may need to be interrupted or permanently discontinued.
There is an increased risk of blood clots when taking Eltrombopag Olamine. This risk is not exclusively linked to high platelet counts; clots have occurred in patients with platelet counts within or even below the normal range. Patients with known risk factors for thromboembolism (e.g., Factor V Leiden, ATIII deficiency, or sedentary lifestyle) should be monitored with extreme caution.
There are no absolute drug-drug contraindications where the combination is strictly forbidden, but there are several that require such extreme caution that they are often avoided. The most significant concern is with Polyvalent Cation-containing products. While not a "combination" in the sense of two drugs interacting in the blood, taking Eltrombopag simultaneously with antacids (aluminum/magnesium), iron supplements, or calcium supplements will essentially neutralize the Eltrombopag, leading to treatment failure.
Eltrombopag is an inhibitor of the OATP1B1 and BCRP transporters. This can lead to significantly increased plasma concentrations of certain statins, such as Rosuvastatin, Atorvastatin, and Simvastatin. Patients taking these combinations may have an increased risk of statin-induced myopathy and rhabdomyolysis (muscle breakdown). Healthcare providers may recommend reducing the statin dose by 50% when starting Eltrombopag.
Drugs like Methotrexate, Topotecan, and Irinotecan
Eltrombopag Olamine is absolutely contraindicated in patients with a known hypersensitivity to Eltrombopag or any of its excipients. An allergic reaction could manifest as anaphylaxis, angioedema (swelling of the face or throat), or severe skin rashes. If a patient has previously experienced a severe reaction to this medication, it must never be used again.
Relative contraindications are conditions where the drug should only be used if the potential benefits outweigh the significant risks.
Eltrombopag Olamine is classified as a medication that should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Animal studies have shown evidence of fetal toxicity, including reduced fetal body weight and an increased rate of cervical ribs at doses that were also toxic to the mother. There are no adequate and well-controlled studies in pregnant women.
Eltrombopag Olamine is a non-peptide thrombopoietin (TPO) receptor agonist. It targets the TPO receptor (c-Mpl), which is located on the surface of megakaryocytes and their progenitor cells. Unlike endogenous TPO, which binds to the extracellular domain of the receptor, Eltrombopag binds to the transmembrane domain. This binding triggers the activation of the Janus kinase (JAK) signaling pathway and the signal transducer and activator of transcription (STAT) pathway. The result is an increase in the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, ultimately leading to an increase in platelet production.
Common questions about Promacta
Eltrombopag Olamine is primarily used to treat low platelet counts (thrombocytopenia) in several specific medical conditions. It is FDA-approved for chronic immune thrombocytopenia (ITP) in adults and children who haven't responded to other treatments. It is also used for patients with chronic hepatitis C to increase platelets enough to allow for antiviral treatment. Additionally, it is a key therapy for severe aplastic anemia, both as a first-line treatment and for those who haven't responded to immunosuppression. Your doctor will determine if your specific type of low platelets is suitable for this medication.
The most common side effects reported by patients include nausea, diarrhea, headache, and muscle aches. Many people also experience symptoms similar to a common cold, such as a sore throat or cough. A significant number of patients may show an increase in liver enzymes on blood tests, which requires regular monitoring. Some patients also report feeling unusually tired or experiencing tingling sensations in their hands and feet. While many of these are mild, they should all be discussed with your healthcare provider during regular check-ups.
While there is no known direct interaction between alcohol and Eltrombopag Olamine, caution is strongly advised. Eltrombopag Olamine carries a serious warning regarding liver toxicity (hepatotoxicity), and alcohol is also known to stress the liver. Consuming alcohol while taking this medication could potentially increase the risk of liver damage or make it harder for your doctor to interpret your liver function tests. It is best to discuss your alcohol consumption habits with your doctor to ensure you are not putting unnecessary strain on your liver. Most healthcare providers recommend limiting or avoiding alcohol during treatment.
Eltrombopag Olamine is generally not recommended during pregnancy unless the potential benefits significantly outweigh the risks to the fetus. Animal studies have indicated that the drug can cause fetal harm, including lower birth weight and skeletal abnormalities. There is limited data on the effects of the drug in pregnant women, so it is classified as a medication to be used with extreme caution. If you are pregnant or planning to become pregnant, you must inform your hematologist immediately. They will likely explore alternative treatments to manage your platelet counts during your pregnancy.
Most patients begin to see an increase in their platelet counts within 1 to 2 weeks of starting Eltrombopag Olamine. However, the full effect may take several weeks as your doctor gradually adjusts the dose to find the amount that works best for you. It is important to attend all scheduled blood test appointments so your doctor can monitor this progress. If your platelet counts do not respond after several weeks at the maximum dose, your doctor may decide to discontinue the medication. Do not expect an immediate jump in platelets after the very first dose.
You should never stop taking Eltrombopag Olamine suddenly without consulting your healthcare provider. When the medication is stopped, your platelet counts will likely drop back to their previous low levels within 1 to 2 weeks. In some cases, the counts can drop even lower than they were before you started the drug, which significantly increases your risk of serious bleeding. If the drug needs to be stopped, your doctor will provide a plan to monitor your blood counts closely for several weeks afterward. Always follow your medical team's instructions regarding discontinuation.
If you miss a dose of Eltrombopag Olamine, you should skip the missed dose and simply take your next scheduled dose at the usual time. Do not take two doses at once or "double up" to make up for the one you missed. Taking too much of the medication in a short period can cause your platelet counts to rise too high, increasing the risk of dangerous blood clots. To help remember your doses, try using a pill organizer or setting a daily alarm on your phone. If you frequently miss doses, talk to your doctor about strategies to stay on track.
Weight gain is not a commonly reported side effect of Eltrombopag Olamine in clinical trials. Unlike corticosteroids (such as prednisone), which are often used for ITP and are well-known for causing weight gain and fluid retention, Eltrombopag works through a different mechanism that does not typically affect metabolism or appetite in that way. If you notice sudden or unusual weight gain while taking this medication, it could be due to other factors or a different health issue. You should discuss any significant changes in your weight with your healthcare provider to determine the underlying cause.
Eltrombopag Olamine has several important drug interactions that require careful management. It can increase the levels of certain cholesterol-lowering medications (statins) in your blood, which may require a dose reduction of the statin. Most importantly, it must not be taken within 4 hours of any supplements or medications containing calcium, magnesium, aluminum, iron, or zinc, as these will prevent the drug from being absorbed. Always provide your doctor and pharmacist with a complete list of all medications, vitamins, and herbal supplements you are taking. This allows them to check for safety and adjust your treatment plan accordingly.
As of 2024 and 2025, generic versions of Eltrombopag Olamine have begun to enter the market in various regions following the expiration of certain patent protections for the brand-name drug, Promacta (or Revolade outside the US). The availability of a generic can significantly reduce the cost of treatment for many patients. However, availability depends on your specific country and insurance provider. When a generic is used, it must meet the same strict standards for safety and effectiveness as the original brand-name medication. Ask your pharmacist or insurance company if a generic version is available for your prescription.
Other drugs with the same active ingredient (Eltrombopag Olamine)
> Warning: Stop taking Eltrombopag Olamine and call your doctor immediately if you experience any of the following symptoms of serious complications:
With prolonged use, the primary concerns are the development of cataracts and potential changes to the bone marrow architecture. Long-term data from the EXTEND trial suggested that while most patients tolerate the drug well for years, the risk of liver enzyme elevations persists throughout the duration of therapy. Additionally, there is a risk that the underlying disease (such as Myelodysplastic Syndrome) could progress to Acute Myeloid Leukemia (AML) if the drug is used in patients with pre-existing marrow abnormalities.
Eltrombopag Olamine carries a Black Box Warning for Hepatotoxicity. The drug may cause severe liver injury that can be fatal. In clinical trials, significant elevations in serum transaminases and bilirubin were observed. Healthcare providers must measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin before starting Eltrombopag, every 2 weeks during the dose adjustment phase, and monthly once a stable dose is reached. If levels are significantly elevated, the drug must be discontinued.
Report any unusual symptoms, especially those involving your vision, liver, or circulation, to your healthcare provider immediately.
Eltrombopag Olamine is not indicated for the treatment of Myelodysplastic Syndrome (MDS). There is a concern that TPO receptor agonists could stimulate the proliferation of malignant cells. In clinical trials of patients with MDS, Eltrombopag was associated with an increased risk of progression to Acute Myeloid Leukemia (AML).
As noted in animal studies and confirmed in human clinical trials, Eltrombopag is associated with the development and progression of cataracts. Baseline and regular ophthalmic examinations are recommended for all patients.
Patients on Eltrombopag Olamine must commit to a rigorous monitoring schedule:
While Eltrombopag Olamine does not typically cause sedation, side effects like headaches or vision changes (cataracts) could potentially impair your ability to drive or operate heavy machinery safely. Assess your reaction to the medication before engaging in these activities.
There is no direct chemical interaction between alcohol and Eltrombopag. However, because both alcohol and Eltrombopag can stress the liver, patients are generally advised to limit alcohol consumption to avoid exacerbating potential hepatotoxicity.
If Eltrombopag Olamine is discontinued, the risk of bleeding is significantly increased because platelet counts will fall. This "rebound thrombocytopenia" can result in counts lower than the patient's original baseline. Healthcare providers will typically monitor CBCs weekly for at least 4 weeks after stopping the drug.
> Important: Discuss all your medical conditions, especially any history of liver disease or blood clots, with your healthcare provider before starting Eltrombopag Olamine.
While Eltrombopag is metabolized by these enzymes, clinical studies suggest that inhibitors (like ciprofloxacin) or inducers (like rifampin) have a modest effect on Eltrombopag levels. However, caution is still advised, and platelet counts should be monitored more frequently if these drugs are started or stopped.
Consuming Eltrombopag with dairy products (milk, yogurt, cheese) or calcium-fortified foods can reduce the drug's absorption by over 70%. This interaction occurs in the digestive tract where calcium binds to the Eltrombopag molecule, creating a complex that the body cannot absorb.
While the primary restriction is on minerals, a very high-fat meal can also slightly alter the absorption profile, though the effect is less dramatic than the mineral interaction. The recommendation remains to take the drug on an empty stomach.
Eltrombopag is highly colored (reddish-brown). In some instances, it may interfere with certain laboratory tests that use colorimetric methods, such as serum bilirubin tests or creatinine tests. If lab results seem inconsistent with clinical findings, the laboratory should be notified that the patient is taking Eltrombopag.
For each major interaction, the management strategy usually involves either spacing the doses (for minerals) or reducing the dose of the interacting drug (for statins).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter antacids and multivitamins.
There is no known cross-sensitivity between Eltrombopag Olamine and other TPO receptor agonists like Romiplostim or Avatrombopag, as their chemical structures are distinct. However, if a patient has a history of severe immune-mediated reactions to other non-peptide drugs, they should be monitored closely for the first several doses.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of liver disease, blood clots, or cancer, before prescribing Eltrombopag Olamine.
Eltrombopag is FDA-approved for the treatment of chronic ITP in children 1 year and older and for SAA in children 2 years and older. In pediatric clinical trials, the safety profile was generally similar to that in adults, though the incidence of upper respiratory tract infections and fever was higher in children. Long-term effects on growth and development have not been fully established, though no major signals have emerged in the years since its approval.
Clinical studies included a significant number of patients aged 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger subjects. However, because older adults often have reduced hepatic, renal, or cardiac function and are frequently taking multiple other medications (polypharmacy), healthcare providers usually start at the lower end of the dosing range and monitor more frequently for interactions, particularly with statins.
Eltrombopag is not significantly cleared by the kidneys; therefore, no dose adjustment is required for patients with renal impairment. However, because some metabolites are excreted in the urine, patients with severe renal disease or those on dialysis should be monitored closely for any signs of unexpected toxicity.
This is a critical area for Eltrombopag. For patients with any degree of hepatic impairment (Child-Pugh Class A, B, or C), the starting dose must be reduced to 25 mg once daily. These patients are at a significantly higher risk for liver injury and must have their liver enzymes monitored weekly during the dose titration phase. If liver function worsens, the drug must be stopped.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
| Parameter | Value |
|---|---|
| Bioavailability | ≥52% (decreased by food/minerals) |
| Protein Binding | >99% (primarily to albumin) |
| Half-life | 21–32 hours |
| Tmax | 2–6 hours |
| Metabolism | CYP1A2, CYP2C8, UGT1A1, UGT1A3 |
| Excretion | Fecal 59%, Renal 31% |
Eltrombopag Olamine is classified as a Thrombopoietin (TPO) Receptor Agonist. It is part of a small group of medications that includes Romiplostim (an injectable peptide) and Avatrombopag (another oral non-peptide). These drugs are distinct from other hematologic agents like erythropoiesis-stimulating agents (ESAs) or colony-stimulating factors (CSFs), as they specifically target the platelet lineage.