ELTROMBOPAG 25 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Thrombopoietin Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Eltrombopag is used to treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) and aplastic anemia (condition in which the body does not make enough new blood cells). Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
Read the full MedlinePlus article ↗- Eltrombopag has a unique quirk — it binds tightly to calcium and other minerals found in food and supplements, which can dramatically reduce how much of the medication actually get...
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- Eltrombopag carries a real risk of liver damage, and in some cases it can be serious. The reassuring thing is that when it's caught early through regular blood tests — before you e...
- Why does my doctor keep ordering liver blood tests while I'm on this medication?
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🧪 Inactive Ingredients / Excipients
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
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Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII VCQ006KQ1E
Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $65.88 | $1,976.34 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Eltrombopag 25 mg 00054-0963-13 | Hikma | 30 tablets | — | AB | FDA listed | — |
| Promacta 25 mg 00078-0685-15 | Novartis | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag 25 mg 31722-0842-30 | Camber | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag Olamine 25 mg 42291-0933-30 | AvKARE | 30 tablets | — | AB | FDA listed | — |
| eltrombopag 25 mg 43598-0730-30 | Dr. | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag Olamine 25 mg 60219-1416-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag Olamine 25 mg 69238-1416-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag olamine 25 mg 70069-0838-01 | Somerset | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag 25 mgthis 70710-1396-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag 25 mg 70771-1926-03 | Zydus | 30 tablets | — | AB | FDA listed | — |
| eltrombopag 25 mg 72205-0157-30 | Novadoz | 30 tablets | — | AB | FDA listed | — |
| Eltrombopag 25 mg 72865-0300-30 | XLCare | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70710-1396-03 You're viewing this | 30 TABLET in 1 BOTTLE (70710-1396-3) | 2026-01-14 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )]. Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions ( 5.2 )].
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity.
Monitor hepatic function and discontinue dosing as recommended. ( 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Eltrombopag is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Eltrombopag should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
Eltrombopag should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2 ) in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. ( 1.3 ) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
( 1.3 ) Limitations of Use: Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4 )
1.1Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia Eltrombopag tablets are indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
1.2Treatment of Thrombocytopenia in Patients With Hepatitis C Infection Eltrombopag tablets are indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
1.3Treatment of Severe Aplastic Anemia Eltrombopag tablets are indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. Eltrombopag tablets are indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
1.4Limitations of Use Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions ( 5.3 )]. Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Take eltrombopag without a meal or with a meal low in calcium (≤ 50 mg). Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods and mineral supplements. ( 2.4 , 7.1 , 12.3 ) Persistent or Chronic ITP: Initiate eltrombopag at 50 mg orally once daily for most adult and pediatric patients 6 years and older and at 25 mg orally once daily for pediatric patients aged 1 year to 5 years.
Dose reductions are needed for patients with hepatic impairment and some patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L. Do not exceed 75 mg per day.
( 2.1 , 8.6 , 8.7 ) Chronic Hepatitis C-associated Thrombocytopenia: Initiate eltrombopag at 25 mg orally once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.
( 2.2 ) First-line Severe Aplastic Anemia: Initiate eltrombopag orally once daily at 2.5 mg/kg (in pediatric patients aged 2 years to 5 years old), 75 mg (pediatric patients aged 6 years to 11 years old) or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of East-/Southeast-Asian ancestry. Modify dosage for toxicity or elevated platelet counts.
( 2.3 , 8.7 ) Refractory Severe Aplastic Anemia: Initiate eltrombopag orally at 50 mg once daily. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than 50 x 10 9 /L.
Do not exceed 150 mg per day. ( 2.3 , 8.6 , 8.7 )
2.1Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of eltrombopag to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /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 [see Warnings and Precautions ( 5.4 )].
In clinical trials, platelet counts generally increased within 1 week to 2 weeks after starting eltrombopag and decreased within 1 week to 2 weeks after discontinuing eltrombopag [see Clinical Studies ( 14.1 )]. Initial Dose Regimen Adult and Pediatric Patients 6 Years and Older with ITP Initiate eltrombopag at a dose of 50 mg orally once daily, except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh class A, B, C). For patients of East-/Southeast-Asian ancestry with ITP, initiate eltrombopag at a reduced dose of 25 mg orally once daily [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )].
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 orally once daily [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. For patients of East-/Southeast-Asian ancestry with ITP and hepatic impairment (Child-Pugh class A, B, C), consider initiating eltrombopag at a reduced dose of 12.5 mg orally once daily [see Clinical Pharmacology ( 12.3 )]. Pediatric Patients with ITP Aged 1 Year to 5 Years Initiate eltrombopag at a dose of 25 mg orally once daily [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )].
Monitoring and Dose Adjustment After initiating eltrombopag, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /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 complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been ac…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Eltrombopag tablets, 12.5 mg are white to light blue, round, biconvex, film-coated tablets debossed with "I" on one side and plain on the other. Eltrombopag tablets, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with "I7" on one side and plain on the other. Eltrombopag tablets, 50 mg are light blue, round, biconvex, film-coated tablets debossed with "" on one side and plain on the other.
Eltrombopag tablets, 75 mg are light purple, round, biconvex, film-coated tablets debossed with " " on one side and plain on the other. Tablets: 12.5 mg, 25 mg, 50 mg and 75 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor liver function before and during therapy. ( 5.2 ) Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia. ( 5.3 ) Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving eltrombopag. Monitor platelet counts regularly. ( 5.4 )
5.1Hepatic Decompensation in Patients With Chronic Hepatitis C In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. In two controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, ascites and encephalopathy occurred more frequently on the arm receiving treatment with eltrombopag plus antivirals (7%) than the placebo plus antivirals arm (4%). Patients with low albumin levels (less than 3.5 g/dL) or Model for End-Stage Liver Disease (MELD) score greater than or equal to 10 at baseline had a greater risk for hepatic decompensation on the arm receiving treatment with eltrombopag plus antivirals.
Discontinue eltrombopag if antiviral therapy is discontinued.
5.2Hepatotoxicity Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity [see Adverse Reactions ( 6.1 )]. One patient (< 1%) with ITP treated with eltrombopag in clinical trials experienced drug-induced liver injury. Eleven patients (1%) with chronic hepatitis C treated with eltrombopag in clinical trials experienced drug-induced liver injury.
Treatment of ITP, Chronic Hepatitis C-associated Thrombocytopenia and Refractory Severe Aplastic Anemia Measure serum ALT, AST and bilirubin prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose [see Drug Interactions ( 7.5 )] . Eltrombopag inhibits UDP-glucuronosyltransferase (UGT)1A1 and organic anion-transporting polypeptide (OATP)1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform fractionation.
Evaluate abnormal serum liver tests with repeat testing within 3 days to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized. Discontinue eltrombopag if ALT levels increase to greater than or equal to 3 x ULN in patients with normal liver function or greater than or equal to 3 x baseline (or greater than 5 x ULN, whichever is the lower) in patients with pre-treatment elevations in transaminases and are: progressively increasing or persistent for greater than or equal to 4 weeks or accompanied by increased direct bilirubin or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
If the potential benefit for reinitiating treatment with eltrombopag is considered to outweigh the risk for hepatotoxicity, then consider cautiously reintroducing eltrombopag and measure serum liver tests weekly during the dose adjustment phase. Hepatotoxicity may reoccur if eltrombopag is reinitiated. If liver test abnormalities persist, worsen or recur, then permanently discontinue eltrombopag.
First-Line Treatment of Severe Aplastic Anemia Measure ALT, AST and bilirubin prior to initiation of eltrombopag, every other day while hospitalized for h-ATG therapy and then every 2 weeks during treatment. During treatment, manage increases in ALT or AST levels as recommended in Table 6.
5.3Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia A randomized, double-blind, placebo-controlled, multicenter trial in patients with International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high risk MDS with thrombocytopenia, receiving azacitidine in combination with either eltrombopag (n=179) or placebo (n=177) was terminated due to lack of efficacy and safety reasons, including increased progression to acute myeloid leukemia (AML). Patients received eltrombopag or placebo at a…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions associated with eltrombopag are described in other sections. Hepatic Decompensation in Patients with Chronic Hepatitis C [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia [see Warnings and Precautions ( 5.3 )] Thrombotic/Thromboembolic Complications [see Warnings and Precautions ( 5.4 )] Cataracts [see Warnings and Precautions ( 5.5 )] Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase increased, cough, fatigue, headache and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. 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 ( 5.4 )].
The data described below reflect exposure of eltrombopag to patients with persistent or chronic ITP aged 18 years to 85 years, of whom 66% were female, in three placebo-controlled trials and one open-label extension trial [see Clinical Studies ( 14.1 )]. Eltrombopag was administered to 330 patients for at least 6 months and 218 patients for at least 1 year. Table 8 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 8 Adverse Reactions (≥ 3%) From Three Placebo-controlled Trials in Adults With Persistent or Chronic Immune Thrombocytopenia Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase. a Includes PTs of urinary tract infection, cystitis, urinary tract infection bacterial and bacteriuria. 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 Urinary tract infection a 5 4 Increased ALT 5 3 Myalgia 5 2 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 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 9 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 9 Treatment-related Adverse Reactions (≥ 3%) From Extension Trial in Adults With Persistent or Chronic Immune Thrombocytopenia Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
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 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 pat…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Polyvalent Cations (Chelation) Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium and zinc) in foods, mineral supplements and antacids. Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, dairy products and mineral supplements to avoid significant reduction in absorption of eltrombopag due to chelation [see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 )].
7.2Transporters Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 or BCRP and consider reduction of the dose of these drugs, if appropriate.
In clinical trials with eltrombopag, a dose reduction of rosuvastatin by 50% was recommended.
7.3Protease Inhibitors HIV Protease Inhibitors No dose adjustment is recommended when eltrombopag is coadministered with lopinavir/ritonavir (LPV/RTV). Drug interactions with other HIV protease inhibitors have not been evaluated. Hepatitis C Virus Protease Inhibitors No dose adjustments are recommended when eltrombopag is coadministered with boceprevir or telaprevir.
Drug interactions with other hepatitis C virus (HCV) protease inhibitors have not been evaluated.
7.4Peginterferon Alfa-2a/b Therapy No dose adjustments are recommended when eltrombopag is coadministered with peginterferon alfa-2a (PEGASYS ® ) or -2b (PEGINTRON ® ).
7.5Interference with Clinical Laboratory Tests Eltrombopag is highly colored and can cause patient sample discoloration, which is reported to interfere with some clinical laboratory tests, including, but not limited to bilirubin and creatinine. Bilirubin Testing: Eltrombopag can cause both positive and negative interference with bilirubin assays. If the laboratory results for bilirubin are inconsistent with clinical observations, further evaluation of liver function should be performed to clarify the clinical status of the patient.
Evaluating contemporaneous aminotransferase values (AST, ALT) may help determine the validity of normal total bilirubin levels in the presence of clinical jaundice. Creatinine Testing: Eltrombopag can cause positive interference with creatinine measurements, leading to falsely elevated creatinine levels. In the event of an unexpected serum creatinine test result, further evaluation of renal function should be performed.
Blood urea should be evaluated if serum creatinine is unexpectedly high. Communicate to the lab conducting testing if the patient is taking eltrombopag. Re-testing using other methods may also help in determining the validity of the test results.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed during treatment. ( 8.2 )
8.1Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with eltrombopag use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. These effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (AUC) in patients with persistent or chronic ITP at 75 mg/day and three times the AUC in patients with chronic hepatitis C at 100 mg/day (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In an early embryonic development study, female rats received oral eltrombopag at doses of 10 mg/kg/day, 20 mg/kg/day or 60 mg/kg/day (0.8 times, 2 times and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3 times, 1 time and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity.
In an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10 mg/kg/day, 20 mg/kg/day or 60 mg/kg/day (0.8 times, 2 times and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3 times, 1 time and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity.
However, no evidence of major structural malformations was observed. In an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30 mg/kg/day, 80 mg/kg/day or 150 mg/kg/day (0.04 times, 0.3 times and 0.5 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.02 times, 0.1 times and 0.3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).
No evidence of fetotoxicity, embryolethality or teratogenicity was observed. In a pre- and post-natal developmental toxicity study in pregnant rats (F0), oral eltrombopag was administered from gestation Day 6 through lactation Day 20. No adverse effects on maternal reproductive function or on the development of the offspring (F1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).
Eltrombopag was detected in the plasma of offspring (F1). The plasma concentrations in pups increased with dose following administration of drug to the F0 dams.
8.2Lactation Risk Summary There are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. However, eltrombopag was detected in the pups of lactating rats 10 days postpartum suggesting the potential for transfer during lact…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with eltrombopag use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. These effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (AUC) in patients with persistent or chronic ITP at 75 mg/day and three times the AUC in patients with chronic hepatitis C at 100 mg/day (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In an early embryonic development study, female rats received oral eltrombopag at doses of 10 mg/kg/day, 20 mg/kg/day or 60 mg/kg/day (0.8 times, 2 times and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3 times, 1 time and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity.
In an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10 mg/kg/day, 20 mg/kg/day or 60 mg/kg/day (0.8 times, 2 times and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3 times, 1 time and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity.
However, no evidence of major structural malformations was observed. In an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30 mg/kg/day, 80 mg/kg/day or 150 mg/kg/day (0.04 times, 0.3 times and 0.5 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.02 times, 0.1 times and 0.3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).
No evidence of fetotoxicity, embryolethality or teratogenicity was observed. In a pre- and post-natal developmental toxicity study in pregnant rats (F0), oral eltrombopag was administered from gestation Day 6 through lactation Day 20. No adverse effects on maternal reproductive function or on the development of the offspring (F1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).
Eltrombopag was detected in the plasma of offspring (F1). The plasma concentrations in pups increased with dose following administration of drug to the F0 dams.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of eltrombopag have been established in pediatric patients 1 year and older with persistent or chronic ITP and in pediatric patients 2 years and older with IST-naïve severe aplastic anemia (in combination with h-ATG and cyclosporine). Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established. Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.
The safety and efficacy of eltrombopag in pediatric patients 1 year and older with persistent or chronic ITP were evaluated in two double-blind, placebo-controlled trials [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )]. The pharmacokinetics of eltrombopag have been evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily [see Clinical Pharmacology ( 12.3 )]. See Dosage and Administration ( 2.1 ) for dosing recommendations for pediatric patients 1 year and older.
The safety and efficacy of eltrombopag in combination with h-ATG and cyclosporine for the first-line treatment of severe aplastic anemia in pediatric patients 2 years and older were evaluated in a single-arm, open-label trial [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.3 )]. A total of 26 pediatric patients (ages 2 years to < 17 years) were evaluated; 12 children (aged 2 years to < 12 years) and 14 adolescents (aged 12 years to < 17 years). See Dosage and Administration ( 2.3 ) for dosing recommendations for pediatric patients 2 years and older.
The safety and efficacy of eltrombopag in combination with h-ATG and cyclosporine in pediatric patients younger than 2 years for the first-line treatment of severe aplastic anemia have not yet been established. In patients 2 years to 16 years of age, 69% of patients experienced serious adverse events compared to 42% in patients 17 years and older. Among the 12 patients who were 2 years to 11 years of age in the eltrombopag D1 to M6 cohort and reached the 6 month assessment or withdrew earlier, the complete response rate at Month 6 was 8% versus 46% in patients age 12 years to 16 years and 50% in patients 17 years of age and older.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 106 patients in two randomized clinical trials of eltrombopag 50 mg in persistent or chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. Of the 1,439 patients in two randomized clinical trials of eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while < 1% were 75 years of age and over. Of the 196 patients who received eltrombopag for the treatment of severe aplastic anemia, 18% were 65 years of age and over, while 3% were 75 years of age and over.
No overall differences in safety or effectiveness were observed between these patients and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In one report, a subject who ingested 5,000 mg of eltrombopag had a platelet count increase to a maximum of 929 x 10 9 /L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue.
The patient was treated with gastric lavage, oral lactulose, intravenous fluids, omeprazole, atropine, furosemide, calcium, dexamethasone and plasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months' follow-up, all events had resolved without sequelae. 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 [see Dosage and Administration ( 2.1 , 2.2 )]. Consider contacting the Poison Help line (1800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Eltrombopag is a TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
12.2Pharmacodynamics In clinical trials, treatment with eltrombopag resulted in dose-dependent increases in platelet counts following repeated (daily) dosing. The increase in platelet counts reached a maximum approximately two weeks after the initiation of dosing and returned to baseline within approximately two weeks after the last dose of eltrombopag. Cardiac Electrophysiology At doses up to 150 mg (the maximum recommended dose) daily for 5 days, eltrombopag did not prolong the QT/QTc interval to any relevant extent.
12.3Pharmacokinetics Eltrombopag demonstrated a dose-proportional increase in exposure between doses of 50 mg/day to 150 mg/day in healthy adult subjects. Eltrombopag AUC was approximately 1.7 fold higher in patients with persistent or chronic ITP and approximately 2.8 fold higher in patients with HCV compared to healthy subjects. Steady-state was achieved after approximately 1 week of once daily treatment, with geometric mean accumulation ratio of 1.56 (90% confidence interval 1.20, 1.63) at 75 mg/day.
Eltrombopag AUC was approximately 3.2-fold higher in patients with definitive immunosuppressive therapy-naïve severe aplastic anemia compared to healthy subjects suggesting higher relative exposure compared to healthy subjects or patients with ITP and similar exposure compared to patients with chronic hepatitis C. Eltrombopag for oral suspension delivered 22% higher plasma AUC 0-INF than the tablet formulation. Absorption Eltrombopag is absorbed with a peak concentration occurring 2 hours to 6 hours after oral administration.
Oral absorption of drug-related material following administration of a single 75 mg solution dose was estimated to be at least 52%. Effect of Food A standard high-fat breakfast (876 calories, 52 g fat, 71 g carbohydrate, 34 g protein and 427 mg calcium) significantly decreased plasma eltrombopag AUC 0-INF by approximately 59% and C max by 65% and delayed T max by 1 hour. The decrease in exposure is primarily due to the high calcium content.
A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content. The effect of administration of a single 25 mg dose of eltrombopag for oral suspension with a high-calcium, moderate-fat, moderate calorie meal on AUC 0-INF and C max in healthy adult subjects is presented in Table 14. Table 14 Effect on Plasma Eltrombopag Pharmacokinetic Parameters After Administration of a Single 25 mg Dose of Eltrombopag for Oral Suspension With a High Calcium Meal a in Healthy Adult Subjects a 372 calories, 9 g fat and 448 mg calcium.
Timing of eltrombopag for oral suspension dose Mean (90% CI) reduction in plasma eltrombopag AUC 0-INF Mean (90% CI) reduction in plasma eltrombopag C max With a high-calcium, moderate-fat, moderate-calorie meal 75% (71%, 88%) 79% (76%, 82%) 2 hours after the high-calcium, moderate-fat, moderate-calorie meal 47% (40%, 53%) 48% (40%, 54%) 2 hours before the high-calcium, moderate-fat, moderate-calorie meal 20% (9%, 29%) 14% (2%, 25%) Distribution The concentration of eltrombopag in blood cells is approximately 50% to 79% of plasma concentrations based on a radiolabel study.
In vitro studies suggest that eltrombopag is highly bound to human plasma proteins (greater than 99%). Eltrombopag is a substrate of BCRP, but is not a substrate for P-glycoprotein (P-gp) or OATP1B1. Elimination The plasma elimination half-life of eltrombopag is approximately 21 hours to 32 hours in healthy subjects and 26 hours to 35 hours in patients with ITP.
Metabolism Absorbed eltrombopag is extensively metabolized, predominantly through pathways, including cleavage, oxidation and…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Eltrombopag is a TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1Tablets Eltrombopag tablets, 12.5 mg are white to light blue, round, biconvex, film-coated tablets debossed with "I" on one side and plain on the other and are supplied as follows: NDC 70710-1395-3 in bottle of 30 tablets with child-resistant closure Eltrombopag tablets, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with "I7" on one side and plain on the other and are supplied as follows: NDC 70710-1396-3 in bottle of 30 tablets with child-resistant closure Eltrombopag tablets, 50 mg are light blue, round, biconvex, film-coated tablets debossed with " " on one side and plain on the other and are supplied as follows: NDC 70710-1397-7 in bottle of 14 tablets with child-resistant closure NDC 70710-1397-3 in bottle of 30 tablets with child-resistant closure Eltrombopag tablets, 75 mg are light purple, round, biconvex, film-coated tablets debossed with " " on one side and plain on the other and are supplied as follows: NDC 70710-1398-3 in bottle of 30 tablets with child-resistant closure Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
Dispense in original bottle. Image Image
📋 Description ▾
11 DESCRIPTION Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2).
It has the molecular formula C 25 H 22 N 4 O 4 .2(C 2 H 7 NO). The molecular weight is 564.64 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.5, very slightly soluble in water, slightly soluble in methanol and ethanol.
Each film-coated tablets contain eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid and contains the following inactive ingredients: hypromellose, microcrystalline cellulose, polyethylene glycol, povidone (k-30), sodium starch glycolate, sodium stearyl fumarate, titanium dioxide and xylitol. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow, each 50 mg tablet contains FD&C blue #2 Aluminum Lake and each 75 mg tablet contains ferrosoferric oxide and iron oxide red.
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💬 Information for Patients ▾
17 PATIENT 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 eltrombopag: Risks Hepatotoxicity Therapy with eltrombopag may be associated with hepatobiliary laboratory abnormalities [see Warnings and Precautions ( 5.2 )]. Advise patients with chronic hepatitis C and cirrhosis that they may be at risk for hepatic decompensation when receiving eltrombopag with alfa interferon therapy [see Warnings and Precautions ( 5.1 )].
Advise patients that they should report any of the following signs and symptoms of liver problems to their healthcare provider right away [see Warnings and Precautions ( 5.2 )]. yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area pain confusion swelling of the stomach area (abdomen) Risk of Bleeding Upon Eltrombopag Discontinuation Advise patients that thrombocytopenia and risk of bleeding may reoccur upon discontinuing eltrombopag, particularly if eltrombopag is discontinued while the patient is on anticoagulants or antiplatelet agents.
Advise patients that during therapy with eltrombopag, they should continue to avoid situations or medications that may increase the risk for bleeding. Thrombotic/Thromboembolic Complications Advise patients that too much eltrombopag may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications [see Warnings and Precautions ( 5.4 )]. Cataracts Advise patients to have a baseline ocular examination prior to administration of eltrombopag and be monitored for signs and symptoms of cataracts during therapy [see Warnings and Precautions ( 5.5 )].
Drug Interactions Advise patients to take eltrombopag 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 [see Dosage and Administration ( 2.4 ), Drug Interactions ( 7.1 )]. Lactation Advise women not to breastfeed during treatment with eltrombopag [see Use in Specific Populations ( 8.2 )]. Administration of Eltrombopag For patients with persistent or chronic ITP, therapy with eltrombopag is administered to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding [see Indications and Usage ( 1.1 )].
For patients with chronic hepatitis C, therapy with eltrombopag is administered to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin [see Indications and Usage ( 1.2 )]. Advise patients to take eltrombopag 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 [see Dosage and Administration ( 2.4 )]. The brands listed are the registered trademarks of their respective owners.
💬 Medication Guide ▾
MEDICATION GUIDE Eltrombopag (el trom' boe pag) Tablets What is the most important information I should know about eltrombopag tablets? Eltrombopag tablets can cause serious side effects, including: Liver problems: If you have chronic hepatitis C virus and take eltrombopag tablets with interferon and ribavirin treatment, eltrombopag tablets may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking eltrombopag tablets.
Eltrombopag tablets may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking eltrombopag tablets and during your treatment. Your healthcare provider may stop your treatment with eltrombopag tablets if you have changes in your liver function blood tests.
Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice) right upper stomach area (abdomen) pain unusual darkening of the urine confusion unusual tiredness swelling of the stomach area (abdomen) See "What are the possible side effects of eltrombopag tablets?" for other side effects of eltrombopag tablets. What are eltrombopag tablets? Eltrombopag tablets are a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to persistent or chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough.
Eltrombopag tablets are also used to treat people with: low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon. severe aplastic anemia (SAA) in combination with other medicines to treat SAA, as the first treatment for adults and children 2 years of age and older. severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough. Eltrombopag tablets are used to try to raise platelet counts in order to lower your risk for bleeding.
Eltrombopag tablets are not used to make platelet counts normal. Eltrombopag tablets are not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS) or in people with low platelet counts caused by certain other medical conditions or diseases. It is not known if eltrombopag tablets are safe and effective when used with other antiviral medicines to treat chronic hepatitis C.
It is not known if eltrombopag tablets are safe and effective in children: younger than 1 year with ITP with low blood platelet counts due to chronic hepatitis C whose severe aplastic anemia (SAA) has not improved after previous treatments. younger than 2 years when used in combination with other medicines to treat SAA as the first treatment for SAA. Before you take eltrombopag tablets, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have a precancerous condition called MDS or a blood cancer have or had a blood clot have a history of cataracts have had surgery to remove your spleen (splenectomy) have bleeding problems are of East-/Southeast-Asian ancestry.
You may need a lower dose of eltrombopag tablets. are pregnant or plan to become pregnant. It is not known if eltrombopag tablets will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with eltrombopag tablets.
Females who are able to become pregnant, should use effective birth control (contraception) during treatment with eltrombopag tablets and for at least 7 days after stopping treatment with eltrombopag tablets. Talk to your healthcare provider about birth control methods that may be right for you during this time. are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with eltro…