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Generic Name
Eltrombopag
Brand Names
Alvaiz, Eltrombopag Olamine, Promacta
FDA approval date: April 01, 2016
Classification: Thrombopoietin Receptor Agonist
Form: Tablet, Powder
What is Alvaiz (Eltrombopag)?
ALVAIZ is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
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Related Clinical Trials
Efficacy and Safety of Multi-Target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia: A Prospective, Single-arm, Multicenter, Exploratory Trial
Summary: This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP). Patients will receive standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA) as initial therapy During the core treatment phase (Weeks 1-12). Corticosteroids will be tapered and discontinued within 8 weeks, whereas TPO-RA tre...
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Summary: To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.
Real-world Treatment Patterns and Outcomes of Eltrombopag in Patients With Primary Immune Thrombocytopenia
Summary: This study aims to describe the treatment patterns and clinical outcomes of treatment with eltrombopag in primary immune thrombocytopenia (ITP) patients treated with prior corticosteroid therapy. This study will use secondary data provided by health care professionals (HCPs) for a sample of primary ITP patients, and primary data from a structured HCP survey. Data will be collected from HCPs workin...
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Brand Information
ALVAIZ (Eltrombopag)
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTSWITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY
In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation
ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended
1
Warnings and Precautions, Laboratory Test Interference (5.6) 6/2025
2DOSAGE FORMS AND STRENGTHS
- 9 mg, round, biconvex, blue film-coated tablets, debossed with “TV” on one side and “Z9” on the other side.
- 18 mg, round, biconvex, off-white film-coated tablets debossed with “TV” on one side and “Z18” on the other side.
- 36 mg, round, biconvex, red film-coated tablets, debossed with “TV” on one side and “Z36” on the other side.
- 54 mg, round, biconvex, orange film-coated tablets, debossed with “TV” on one side and “Z54” on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions associated with ALVAIZ are described in other sections.
- Hepatic Decompensation in Patients with Chronic Hepatitis C
- Hepatotoxicity
- Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia
- Thrombotic/Thromboembolic Complications
- Cataracts
4.1Clinical 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.
The safety of ALVAIZ has been established based on adequate and well-controlled studies of eltrombopag olamine in adult and pediatric patients 6 years and older with persistent or chronic ITP, adult patients with chronic hepatitis C-associated thrombocytopenia, and adult patients with refractory severe aplastic anemia. Below is a display of the adverse reactions of eltrombopag olamine in these adequate and well-controlled studies.
Persistent or Chronic Immune 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 [see Warnings and Precautions (. The data described below reflect exposure of eltrombopag to patients with persistent or chronic ITP aged 18 to 85 years, of whom 66% were female, in three placebo-controlled trials and one open-label extension trial [see Clinical Studies (. 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.
In the three controlled clinical persistent or 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 persistent or 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.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
In the three controlled persistent or 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 persistent or chronic ITP trial, six additional patients had eltrombopag discontinued due to liver test abnormalities (less than or equal to Grade 3).
In the three controlled persistent or chronic ITP trials, cataracts developed or worsened in 7% of patients treated with eltrombopag and 7% of patients in the placebo group. All patients had documented, preexisting risk factors for cataractogenesis, including corticosteroid use. In the extension trial, cataracts developed or worsened in 11% of patients who underwent ocular examination prior to therapy with eltrombopag. Seventy-two percent of patients had preexisting risk factors, including corticosteroid use.
The safety of eltrombopag was also assessed in all patients treated in 7 adult persistent or chronic ITP clinical trials (N = 763 eltrombopag-treated patients and 179 placebo-treated patients). Thromboembolic events were reported in 6% of eltrombopag-treated patients versus 0% of placebo-treated patients and thrombotic microangiopathy with acute renal failure was reported in < 1% of eltrombopag-treated patients versus 0% of placebo-treated patients.
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 persistent or chronic ITP, of whom 53% were female, across the randomized phase of two placebo-controlled trials. ALVAIZ is not indicated for pediatric patients <6 years of age with persistent or chronic ITP.
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.
In the two controlled clinical persistent or chronic ITP trials, cataracts developed or worsened in 2 (1%) patients treated with eltrombopag. Both patients had received chronic oral corticosteroids, a risk factor for cataractogenesis.
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).
Rash was reported in 9% and 7% of patients receiving eltrombopag and placebo, respectively.
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 the two controlled clinical trials in patients with chronic hepatitis C, cataracts developed or worsened in 8% of patients treated with eltrombopag and 5% of patients treated with placebo.
The safety of eltrombopag was also assessed in all patients treated with eltrombopag in the two controlled trials, including patients who initially received eltrombopag in the pre-antiviral treatment phase of the trial and were later randomized to the placebo arm (N = 1520 eltrombopag-treated patients). Hepatic failure was reported in 0.8% of eltrombopag-treated patients and 0.4% of placebo-treated patients.
Severe Aplastic Anemia:
Refractory Severe Aplastic Anemia
In the single-arm, open-label trial, 43 patients with refractory 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.
Rash and hyperbilirubinemia were reported in 7% of patients; cataract was reported in 2% of patients.
In this trial, concurrent ALT or AST greater than 3 x ULN with total bilirubin greater than 1.5 x ULN were reported in 5% of patients. Total bilirubin greater than 1.5 x ULN occurred in 14% of patients.
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.
4.2Postmarketing 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.
Skin and Subcutaneous Tissue Disorders: Skin discoloration, including hyperpigmentation and skin yellowing.
5OVERDOSAGE
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.
In one report, a subject who ingested 5000 mg of eltrombopag had a platelet count increase to a maximum of 929 x 10
In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate eltrombopag and thus limit absorption. Closely monitor platelet counts. Reinitiate treatment with eltrombopag in accordance with dosing and administration recommendations
6DESCRIPTION
ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration.
Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C
Eltrombopag choline has the following structural formula:
Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8.
ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are:
Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide.
Coating:
7CLINICAL STUDIES
The effectiveness of ALVAIZ has been established based on adequate and well-controlled studies of eltrombopag olamine in adult and pediatric patients 6 years and older with persistent or chronic ITP, adult patients with chronic hepatitis C-associated thrombocytopenia, and adult patients with refractory severe aplastic anemia. Below is a display of the efficacy information for eltrombopag olamine in these adequate and well-controlled studies.
7.1Persistent or Chronic ITP
Adults: The efficacy and safety of eltrombopag in adult patients with persistent or chronic ITP were evaluated in three randomized, double-blind, placebo-controlled trials and in an open-label extension trial.
In Study TRA100773B and Study TRA100773A (referred to as Study 773B and Study 773A, respectively [NCT00102739]), patients who had completed at least one prior ITP therapy and who had a platelet count less than 30 x 10
The median age of the patients was 50 years and 60% were female. Approximately 70% of the patients had received at least 2 prior ITP therapies (predominantly corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine) and 40% of the patients had undergone splenectomy. The median baseline platelet counts (approximately 18 x 10
Study 773B randomized 114 patients (2:1) to eltrombopag 50 mg or placebo. Of 60 patients with documented time since diagnosis, approximately 17% met the definition of persistent ITP with time since diagnosis of 3 to 12 months. Study 773A randomized 117 patients (1:1:1:1) among placebo or 1 of 3 dose regimens of eltrombopag , 30 mg, 50 mg, or 75 mg each administered daily. Of 51 patients with documented time since diagnosis, approximately 14% met the definition of persistent ITP.
The efficacy of eltrombopag in this trial was evaluated by response rate, defined as a shift from a baseline platelet count of less than 30 x 10
The platelet count response to eltrombopag was similar among patients who had or had not undergone splenectomy. In general, increases in platelet counts were detected 1 week following initiation of eltrombopag and the maximum response was observed after 2 weeks of therapy. In the placebo and 50-mg dose groups of eltrombopag, the trial drug was discontinued due to an increase in platelet counts to greater than 200 x 10
Of 7 patients who underwent hemostatic challenges, additional ITP medications were required in 3 of 3 placebo group patients and 0 of 4 patients treated with eltrombopag. Surgical procedures accounted for most of the hemostatic challenges. Hemorrhage requiring transfusion occurred in one placebo group patient and no patients treated with eltrombopag.
In the RAISE study (NCT00370331), 197 patients were randomized (2:1) to receive either eltrombopag 50 mg once daily (n = 135) or placebo (n = 62) for 6 months, during which time the dose of eltrombopag could be adjusted based on individual platelet counts. Of 145 patients with documented time since diagnosis, 19% met the definition of persistent ITP. Patients were allowed to taper or discontinue concomitant ITP medications after being treated with eltrombopag for 6 weeks. Patients were permitted to receive rescue treatments at any time during the trial as clinically indicated.
The median ages of the patients treated with eltrombopag and placebo were 47 years and 52.5 years, respectively. Approximately half of the patients treated with eltrombopag and placebo (47% and 50%, respectively) were receiving concomitant ITP medication (predominantly corticosteroids) at randomization and had baseline platelet counts less than or equal to 15 x 10
The efficacy of eltrombopag in this trial was evaluated by the odds of achieving a platelet count greater than or equal to 50 x 10
Outcomes of treatment are presented in Table 11 for all patients enrolled in the trial.
Among 94 patients receiving other ITP therapy at baseline, 37 (59%) of 63 patients treated with eltrombopag and 10 (32%) of 31 patients in the placebo group discontinued concomitant therapy at some time during the trial.
In the EXTEND study (NCT00351468), patients who completed any prior clinical trial with eltrombopag were enrolled in an open-label, single-arm trial in which attempts were made to decrease the dose or eliminate the need for any concomitant ITP medications. Eltrombopag was administered to 302 patients in EXTEND; 218 patients completed 1 year, 180 patients completed 2 years, 107 patients completed 3 years, 75 patients completed 4 years, 34 patients completed 5 years, and 18 patients completed 6 years of therapy. The median baseline platelet count was 19 x 10
Pediatric Patients: The efficacy and safety of eltrombopag in pediatric patients 1 year and older with persistent or chronic ITP were evaluated in two double-blind, placebo-controlled trials. ALVAIZ is not indicated for pediatric patients less than 6 years of age with persistent or chronic ITP. The trials differed in time since ITP diagnosis: at least 6 months versus at least 12 months. During the trials, doses could be increased every 2 weeks to a maximum of 75 mg once daily. The dose of eltrombopag was reduced if the platelet count exceeded 200 x 109/L and interrupted and reduced if it exceeded 400 x 109/L.
In the PETIT2 study (NCT01520909), patients refractory or relapsed to at least one prior ITP therapy with a platelet count less than 30 x 10
The 13-week, randomized, double-blind period was followed by a 24-week, open-label period where patients from both arms were eligible to receive eltrombopag.
The median age of the patients was 9 years and 48% were female. Approximately 62% of patients had a baseline platelet count less than or equal to 15 x 10
The efficacy of eltrombopag in this trial was evaluated by the proportion of subjects on eltrombopag achieving platelet counts ≥ 50 x 10
More pediatric patients treated with eltrombopag (75%) compared with placebo (21%) had at least one platelet count greater than or equal to 50 x 10
Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the trial. Among 15 patients receiving other ITP therapy at baseline, 53% (8/15) reduced (n = 1) or discontinued (n = 7) concomitant therapy, mainly corticosteroids, without needing rescue therapy.
In the PETIT study (NCT00908037), patients refractory or relapsed to at least one prior ITP therapy with a platelet count less than 30 x 10
The 7-week, randomized, double-blind period was followed by an open-label period of up to 24 weeks where patients from both arms were eligible to receive eltrombopag.
The median age of the patients was 10 years and 60% were female. Approximately 51% of patients had a baseline platelet count less than or equal to 15 x 10
The efficacy of eltrombopag in this trial was evaluated by the proportion of patients achieving platelet counts greater than or equal to 50 x 10
Fewer pediatric patients treated with eltrombopag required rescue treatment during the randomized, double-blind period compared with placebo-treated patients (13% [6/45] versus 50% [11/22]).
Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the trial. Among 13 patients receiving other ITP therapy at baseline, 46% (6/13) reduced (n = 3) or discontinued (n = 3) concomitant therapy, mainly corticosteroids, without needing rescue therapy.
7.2Chronic HepatitisC-associated Thrombocytopenia
The efficacy and safety of eltrombopag for the treatment of thrombocytopenia in adult patients with chronic hepatitis C were evaluated in two randomized, double-blind, placebo-controlled trials. The ENABLE1 study (NCT00516321) utilized peginterferon alfa-2a (PEGASYS
The efficacy of eltrombopag for both trials was evaluated by sustained virologic response (SVR) defined as the percentage of patients with undetectable HCV-RNA at 24 weeks after completion of antiviral treatment. The median time to achieve the target platelet count greater than or equal to 90 x 10
In both trials, a significantly greater proportion of patients treated with eltrombopag achieved SVR (see Table 14). The improvement in the proportion of patients who achieved SVR was consistent across subgroups based on baseline platelet count (less than 50 x 10
The majority of patients treated with eltrombopag (76%) maintained a platelet count greater than or equal to 50 x 10
7.3Severe Aplastic Anemia
Refractory Severe Aplastic Anemia
Eltrombopag was studied in a single-arm, single-center, open-label trial (Study ETB115AUS28T, referred to as Study US28T [NCT00922883]) in 43 patients with severe aplastic anemia who had an insufficient response to at least one prior immunosuppressive therapy and who had a platelet count less than or equal to 30 x 10
The treated population had median age of 45 years (range, 17 to 77 years) and 56% were male. At baseline, the median platelet count was 20 x 10
Table 15 presents the efficacy results.
In the 17 responders, the platelet transfusion-free period ranged from 8 to 1096 days with a median of 200 days, and the RBC transfusion-free period ranged from 15 to 1082 days with a median of 208 days.
In the extension phase, 8 patients achieved a multi-lineage response; 4 of these patients subsequently tapered off treatment with eltrombopag and maintained the response (median follow-up: 8.1 months, range, 7.2 to 10.6 months).
8PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).
Prior to treatment, patients should fully understand and be informed of the following risks and considerations for ALVAIZ:
Risks
Hepatotoxicity
- Therapy with ALVAIZ may be associated with hepatobiliary laboratory abnormalities
- Advise patients with chronic hepatitis C and cirrhosis that they may be at risk for hepatic decompensation when receiving ALVAIZ with alfa interferon therapy
- Advise patients that they should report any of the following signs and symptoms of liver problems to their healthcare provider right away
Risk of Bleeding Upon ALVAIZ Discontinuation
- Advise patients that thrombocytopenia and risk of bleeding may reoccur upon discontinuing ALVAIZ, particularly if ALVAIZ is discontinued while the patient is on anticoagulants or antiplatelet agents. Advise patients that during therapy with ALVAIZ, they should continue to avoid situations or medications that may increase the risk for bleeding.
Thrombotic/Thromboembolic Complications
- Advise patients that too much ALVAIZ may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications
Cataracts
- Advise patients to have a baseline ocular examination prior to administration of ALVAIZ and be monitored for signs and symptoms of cataracts during therapy
Drug Interactions
- Advise patients to take ALVAIZ at least 2 hours before or 4 hours after calcium-rich foods, mineral supplements, and antacids which contain polyvalent cations, such as iron, calcium, aluminum, magnesium, selenium, and zinc
Lactation
- Advise women not to breastfeed during treatment with ALVAIZ
Administration of ALVAIZ
- For patients with persistent or chronic ITP, therapy with ALVAIZ is administered to achieve and maintain a platelet count greater than or equal to 50 x 10
- For patients with chronic hepatitis C, therapy with ALVAIZ is administered to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin
- Advise patients to take ALVAIZ without a meal or with a meal low in calcium (≤ 50 mg) and at least 2 hours before or 4 hours after other medications (e.g., antacids) and calcium-rich foods
Brands listed are the trademarks of their respective owners.
Manufactured For:
Rev. C 1/2026
9PACKAGE.LABEL.PRINCIPAL DISPLAY PANEL
NDC 0480-3273-56
Rx only
Alvaiz
9 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis.
30 Tablets
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0480-3274-56
Rx only
Alvaiz
18 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis.
30 Tablets
11PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0480-3275-56
Rx only
Alvaiz
36 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis.
30 Tablets
12PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0480-3276-56
Rx only
Alvaiz
54 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis.
30 Tablets
