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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 20.06.2022
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Treatment of Thrombocytopenia in Patients with Chronic ITP
Eltrombopag is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Treatment of Thrombocytopenia in Patients with Hepatitis C Infection
Eltrombopag is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
Treatment of Severe Aplastic Anemia
Eltrombopag is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Limitations of Use
Eltrombopag (Eltrombopag) is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body. Eltrombopag can lower the risk of bleeding by increasing platelets in your blood.
Eltrombopag is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. This medicine is for use in adults and children who are at least 1 year old, after other medicines have been tried without success.
Eltrombopag is also used to prevent bleeding in people with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).
Eltrombopag is also used to treat severe aplastic anemia in adults after other medicines have been tried without success.
Eltrombopag is not a cure for ITP and it will not make your platelet counts normal if you have this condition.
Chronic Immune (Idiopathic) Thrombocytopenia
Use the lowest dose of Eltrombopag to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use Eltrombopag to normalize platelet counts. In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting Eltrombopag and decreased within 1 to 2 weeks after discontinuing Eltrombopag.
Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).
For patients of East Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily.
For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A, B, C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily.
Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.
Monitoring and Dose Adjustment: After initiating Eltrombopag, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag and modify the dosage regimen of Eltrombopag based on platelet counts as outlined in Table 1. During therapy with Eltrombopag, assess CBCs with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter.
When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, and then follow standard monthly monitoring.
In patients with ITP and hepatic impairment (Child-Pugh Class A, B, C), after initiating Eltrombopag or after any subsequent dosing increase, wait 3 weeks before increasing the dose.
Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during therapy with Eltrombopag. Do not administer more than one dose of Eltrombopag within any 24-hour period.
Discontinuation: Discontinue Eltrombopag if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy with Eltrombopag at the maximum daily dose of 75 mg. Excessive platelet count responses, as outlined in Table 1, or important liver test abnormalities also necessitate discontinuation of Eltrombopag. Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation of Eltrombopag.
Chronic Hepatitis C-associated Thrombocytopenia
Use the lowest dose of Eltrombopag to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Dose adjustments are based upon the platelet count response. Do not use Eltrombopag to normalize platelet counts. In clinical trials, platelet counts generally began to rise within the first week of treatment with Eltrombopag.
Initial Dose Regimen: Initiate Eltrombopag at a dose of 25 mg once daily.
Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy.
During antiviral therapy, adjust the dose of Eltrombopag to avoid dose reductions of peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag.
For specific dosage instructions for peginterferon or ribavirin, refer to their respective prescribing information.
Discontinuation: The prescribing information for pegylated interferon and ribavirin include recommendations for antiviral treatment discontinuation for treatment futility. Refer to pegylated interferon and ribavirin prescribing information for discontinuation recommendations for antiviral treatment futility.
Eltrombopag should be discontinued when antiviral therapy is discontinued. Excessive platelet count responses, as outlined in Table 2, or important liver test abnormalities also necessitate discontinuation of Eltrombopag.
Severe Aplastic Anemia
Use the lowest dose of Eltrombopag to achieve and maintain a hematologic response. Dose adjustments are based upon the platelet count. Hematologic response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting Eltrombopag.
Initial Dose Regimen: Initiate Eltrombopag at a dose of 50 mg once daily.
For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate Eltrombopag at a reduced dose of 25 mg once daily.
Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 50-mg increments every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 109/L as necessary. Do not exceed a dose of 150 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag and modify the dosage regimen of Eltrombopag based on platelet counts as outlined in Table 3.
For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of Eltrombopag may be reduced by 50%. If counts remain stable after 8 weeks at the reduced dose, then discontinue Eltrombopag and monitor blood counts. If platelet counts drop to less than 30 x 109/L, hemoglobin to less than 9 g/dL, or ANC to less than 0.5 x 109/L, Eltrombopag may be reinitiated at the previous effective dose.
Discontinuation: If no hematologic response has occurred after 16 weeks of therapy with Eltrombopag, discontinue therapy. If new cytogenetic abnormalities are observed, consider discontinuation of Eltrombopag. Excessive platelet count responses (as outlined in Table 3) or important liver test abnormalities also necessitate discontinuation of Eltrombopag.
Administration
Preparation of the
Oral Suspension: Prior to use of the oral suspension, ensure patients or caregivers receive training on proper dosing, preparation, and administration of Eltrombopag for oral suspension.
Administer the oral suspension immediately after preparation. Discard any suspension not administered within 30 minutes after preparation.
Prepare the suspension with water only. NOTE: Do not use hot water to prepare the suspension.
For details on preparation and administration of the suspension, see Instructions for Use.
Administration of Tablets and
Oral Suspension: Take Eltrombopag on an empty stomach (1 hour before or 2 hours after a meal).
Take Eltrombopag at least 2 hours before or 4 hours after other medications (e.g., antacids), calcium-rich foods (e.g., dairy products and calcium-fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.
Do not crush tablets and mix with food or liquids.
Prepare the oral suspension with water only.
See also:
What is the most important information I should know about Eltrombopag?
Before you take Eltrombopag tell your doctor if you have kidney disease, blood cancer, a bone marrow disorder, high platelet levels, liver problems (if you are not being treated for hepatitis C), a history of cataracts or blood clot, if your spleen has been removed, or if you are of East Asian descent. Also tell your doctor about all other medications you use.
Take Eltrombopag on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Eltrombopag.
Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take Eltrombopag.
While using Eltrombopag, you may need frequent blood tests at your doctor's office.
Eltrombopag may cause liver damage. Stop using Eltrombopag and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
After you stop taking Eltrombopag, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking Eltrombopag. Your blood will need to be tested weekly during this time.
Use Eltrombopag as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Eltrombopag comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Eltrombopag refilled.
- Take Eltrombopag by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
- Take Eltrombopag at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium-fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc.
- Do not suddenly stop taking Eltrombopag. You may have an increased risk of severe low platelets and bleeding. If you need to stop Eltrombopag, your doctor will need to monitor your condition.
- If you miss a dose of Eltrombopag, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.
Ask your health care provider any questions you may have about how to use Eltrombopag.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Aplastic anemia, severe: First-line treatment (in combination with standard immunosuppressive therapy) of severe aplastic anemia in patients ≥2 years of age; treatment of severe (refractory) aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy
Chronic hepatitis C infection-associated thrombocytopenia: Treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) to allow the initiation and maintenance of interferon-based therapy.
Chronic immune thrombocytopenia: Treatment of thrombocytopenia in adult and pediatric patients ≥1 year of age with chronic immune thrombocytopenia (ITP) who have had insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Limitations of use: For ITP, Eltrombopag should only be used if the degree of thrombocytopenia and clinical condition increase the risk for bleeding. For CHC, Eltrombopag should only be used if the degree of thrombocytopenia prevents initiation of or limits the ability to maintain interferon-based therapy. Safety and efficacy have not been established when used in combination with direct-acting antiviral agents without interferon for treatment of CHC infection. Eltrombopag is not indicated for the treatment of myelodysplastic syndromes (MDS).
See also:
What other drugs will affect Eltrombopag?
Rosuvastatin: In vitro studies demonstrated that Eltrombopag is not a substrate for the organic anion transporter polypeptide, OATP1B1, but is an inhibitor of this transporter. In vitro studies also demonstrated that Eltrombopag is a BCRP substrate and inhibitor. When Eltrombopag and rosuvastatin were co-administered in a clinical drug interaction study, there was increased plasma rosuvastatin exposure. When co-administered with Eltrombopag, a reduced dose of rosuvastatin should be considered and careful monitoring should be undertaken. In clinical trials with Eltrombopag, a dose reduction of rosuvastatin by 50% was recommended for co-administration of rosuvastatin and Eltrombopag. Concomitant administration of Eltrombopag and other OATP1B1 and BCRP substrates should be undertaken with caution.
Polyvalent Cations (Chelation): Eltrombopag chelates with polyvalent cations eg, aluminum, calcium, iron, magnesium, selenium and zinc. Antacids, dairy products and other products containing polyvalent cations eg, mineral supplements, should be administered at least 4 hrs apart from Eltrombopag dosing to avoid significant reduction in Eltrombopag absorption.
Food Interaction: Administration of a single Eltrombopag 50-mg dose with a standard high-calorie, high-fat breakfast that included dairy products reduced plasma Eltrombopag AUC0-∞ by 59% (90% CI: 54%, 64%) and Cmax by 65% (90% CI: 59%, 70%). Food low in calcium (calcium <50 mg) including fruit, lean ham, beef and unfortified (no added calcium, magnesium, iron) fruit juice, unfortified soy milk and unfortified grain did not significantly impact plasma Eltrombopag exposure, regardless of calorie and fat content.
Lopinavir/Ritonavir: Co-administration of Eltrombopag with lopinavir/ritonavir (LPV/RTV) may cause a decrease in the concentration of Eltrombopag. A study in 40 healthy volunteers showed that the co-administration of single dose Eltrombopag 100 mg with repeat dose LPV/RTV 400/100 mg twice daily resulted in a reduction in Eltrombopag plasma AUC(0-∞) by 17% (90% CI:6.6%, 26.6%). Therefore, caution should be observed when co-administration of Eltrombopag with LPV/RTV takes place. Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of Eltrombopag when LPV/RTV therapy is initiated or discontinued.
Incompatibilities: No known incompatibilities.
See also:
What are the possible side effects of Eltrombopag?
The following serious adverse reactions associated with Eltrombopag are described in other sections.
- Hepatic Decompensation in Patients with Chronic Hepatitis C
- Hepatotoxicity
- Thrombotic/Thromboembolic Complications
- Cataracts
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Chronic Immune (Idiopathic) Thrombocytopenia
Adults
In clinical trials, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of Eltrombopag. Other serious adverse reactions included thrombotic/thromboembolic complications. The data described below reflect exposure of Eltrombopag to patients with chronic ITP aged 18 to 85 years, of whom 66% were female, in three placebo-controlled trials and one open-label extension trial. Eltrombopag was administered to 330 patients for at least 6 months and 218 patients for at least 1 year.
Table 4 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of patients receiving Eltrombopag) from the three placebo-controlled trials, with a higher incidence in Eltrombopag versus placebo.
Table 4. Adverse Reactions (≥3%) from Three Placebo-controlled Trials in Adults with Chronic Immune (Idiopathic) Thrombocytopenia
| Adverse Reaction | Eltrombopag 50 mg n = 241 (%) | Placebo n = 128 (%) |
| Nausea | 9 | 3 |
| Diarrhea | 9 | 7 |
| Upper respiratory tract infection | 7 | 6 |
| Vomiting | 6 | <1 |
| Increased ALT | 5 | 3 |
| Myalgia | 5 | 2 |
| Urinary tract infection | 5 | 3 |
| Oropharyngeal pain | 4 | 3 |
| Increased AST | 4 | 2 |
| Pharyngitis | 4 | 2 |
| Back pain | 3 | 2 |
| Influenza | 3 | 2 |
| Paresthesia | 3 | 2 |
| Rash | 3 | 2 |
In the three controlled clinical chronic ITP trials, alopecia, musculoskeletal pain, blood alkaline phosphatase increased, and dry mouth were the adverse reactions reported in 2% of patients treated with Eltrombopag and in no patients who received placebo.
Among 302 patients with chronic ITP who received Eltrombopag in the single-arm extension trial, the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled trials. Table 5 presents the most common treatment-related adverse reactions (experienced by greater than or equal to 3% of patients receiving Eltrombopag) from the extension trial.
Table 5. Treatment-related Adverse Reactions (3%) from Extension Trial in Adults with Chronic Immune (Idiopathic) Thrombocytopenia
| Adverse Reaction | Eltrombopag 50 mg n = 302 (%) |
| Headache | 10 |
| ALT increased | 5 |
| AST increased | 5 |
| Cataract | 5 |
| Fatigue | 5 |
| Blood bilirubin increased | 4 |
| Nausea | 4 |
| Hyperbilirubinemia | 3 |
| Diarrhea | 3 |
In the three controlled chronic ITP trials, serum liver test abnormalities (predominantly Grade 2 or less in severity) were reported in 11% and 7% of patients for Eltrombopag and placebo, respectively. Four patients (1%) treated with Eltrombopag and three patients in the placebo group (2%) discontinued treatment due to hepatobiliary laboratory abnormalities. Seventeen of the patients treated with Eltrombopag in the controlled trials with hepatobiliary laboratory abnormalities were re-exposed to Eltrombopag in the extension trial. Eight of these patients again experienced liver test abnormalities (less than or equal to Grade 3) resulting in discontinuation of Eltrombopag in one patient. In the extension chronic ITP trial, six additional patients had Eltrombopag discontinued due to liver test abnormalities (less than or equal to Grade 3).
In clinical trials in patients with chronic ITP, one patient treated with Eltrombopag (<1%) experienced drug-induced liver injury.
In a placebo-controlled trial of Eltrombopag in patients with chronic liver disease and thrombocytopenia not related to ITP, six patients treated with Eltrombopag and one patient in the placebo group developed portal vein thromboses.
Pediatric Patients: The data described below reflect median exposure to Eltrombopag of 91 days for 107 pediatric patients (aged 1 to 17 years) with chronic ITP, of whom 53% were female, across the randomized phase of two placebo-controlled trials.
Table 6 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of pediatric patients 1 year and older receiving Eltrombopag) across the two placebo-controlled trials, with a higher incidence for Eltrombopag versus placebo.
Table 6. Adverse Reactions (≥3%) with a Higher Incidence for Eltrombopag versus Placebo from Two Placebo-controlled Trials in Pediatric Patients 1 Year and Older with Chronic Immune (Idiopathic) Thrombocytopenia
| Adverse Reaction | Eltrombopag n = 107 (%) | Placebo n = 50 (%) |
| Upper respiratory tract infection | 17 | 6 |
| Nasopharyngitis | 12 | 4 |
| Cough | 9 | 0 |
| Diarrhea | 9 | 2 |
| Pyrexia | 9 | 8 |
| Rhinitis | 9 | 6 |
| Abdominal pain | 8 | 4 |
| Oropharyngeal pain | 8 | 2 |
| Toothache | 6 | 0 |
| ALT increased Includes adverse reactions or laboratory abnormalities >3 x ULN. |
Chronic Hepatitis C-Associated Thrombocytopenia
In the two placebo-controlled trials, 955 patients with chronic hepatitis C-associated thrombocytopenia received Eltrombopag. Table 7 presents the most common adverse drug reactions (experienced by greater than or equal to 10% of patients receiving Eltrombopag compared with placebo).
Table 7. Adverse Reactions (≥10% and Greater than Placebo) from Two Placebo-controlled Trials in Adults with Chronic Hepatitis C
| Adverse Reaction | Eltrombopag + Peginterferon/ Ribavirin n = 955 (%) | Placebo + Peginterferon/ Ribavirin n = 484 (%) |
| Anemia | 40 | 35 |
| Pyrexia | 30 | 24 |
| Fatigue | 28 | 23 |
| Headache | 21 | 20 |
| Nausea | 19 | 14 |
| Diarrhea | 19 | 11 |
| Decreased appetite | 18 | 14 |
| Influenza-like illness | 18 | 16 |
| Asthenia | 16 | 13 |
| Insomnia | 16 | 15 |
| Cough | 15 | 12 |
| Pruritus | 15 | 13 |
| Chills | 14 | 19 |
| Myalgia | 12 | 10 |
| Alopecia | 10 | 6 |
| Peripheral edema | 10 | 5 |
In the two controlled clinical trials in patients with chronic hepatitis C, hyperbilirubinemia was reported in 8% of patients receiving Eltrombopag compared with 3% for placebo. Total bilirubin greater than or equal to 1.5 x ULN was reported in 76% and 50% of patients receiving Eltrombopag and placebo, respectively. ALT or AST greater than or equal to 3 x ULN was reported in 34% and 38% of patients for Eltrombopag and placebo, respectively.
In clinical trials in patients with chronic hepatitis C, 11 patients treated with Eltrombopag (1%) experienced drug-induced liver injury.
Severe Aplastic Anemia
In the single-arm, open-label trial, 43 patients with severe aplastic anemia received Eltrombopag. Eleven patients (26%) were treated for greater than 6 months and 7 patients (16%) were treated for greater than 1 year. The most common adverse reactions (greater than or equal to 20%) were nausea, fatigue, cough, diarrhea, and headache.
Table 8. Adverse Reactions (≥10%) from One Open-label Trial in Adults with Severe Aplastic Anemia
| Adverse Reaction | Eltrombopag (n = 43) (%) |
| Nausea | 33 |
| Fatigue | 28 |
| Cough | 23 |
| Diarrhea | 21 |
| Headache | 21 |
| Pain in extremity | 19 |
| Dyspnea | 14 |
| Pyrexia | 14 |
| Dizziness | 14 |
| Oropharyngeal pain | 14 |
| Febrile neutropenia | 14 |
| Abdominal pain | 12 |
| Ecchymosis | 12 |
| Muscle spasms | 12 |
| Transaminases increased | 12 |
| Arthralgia | 12 |
| Rhinorrhea | 12 |
In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported on therapy, including 5 patients who had complex changes in chromosome 7.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Eltrombopag. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Vascular Disorders
Thrombotic microangiopathy with acute renal failure.
Eltrombopag is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Eltrombopag has also been recently approved (late 2012) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.