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Eltrombopag

Medically reviewed on Nov 15, 2018

Pronunciation

(el TROM boe pag)

Index Terms

  • Eltrombopag Olamine
  • Revolade
  • SB-497115
  • SB-497115-GR

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Promacta: 12.5 mg

Promacta: 25 mg [contains fd&c yellow #6 aluminum lake]

Promacta: 50 mg [contains fd&c blue #2 aluminum lake]

Promacta: 75 mg

Brand Names: U.S.

  • Promacta

Pharmacologic Category

  • Colony Stimulating Factor
  • Hematopoietic Agent
  • Thrombopoietic Agent
  • Thrombopoietin Receptor Agonist

Pharmacology

Eltrombopag is a thrombopoietin (TPO) nonpeptide agonist which increases platelet counts by binding to and activating the human TPO receptor. Activates intracellular signal transduction pathways to increase proliferation and differentiation of marrow progenitor cells.

Metabolism

Extensive hepatic metabolism; via CYP1A2, 2C8 oxidation and UGT1A1, 1A3 glucuronidation

Excretion

Feces (59%, ~20% as unchanged drug); urine (31%, as metabolites)

Onset of Action

Platelet count increase: Within 1 to 2 weeks

Time to Peak

2 to 6 hours

Duration of Action

Platelets return to baseline: 1 to 2 weeks after last dose

Half-Life Elimination

~21 to 32 hours in healthy individuals; ~26 to 35 hours in patients with ITP

Protein Binding

>99%

Special Populations: Renal Function Impairment

Following a single 50 mg dose, plasma AUC was 32% to 36% lower in subjects with mild-to-moderate renal impairment (estimated CrCl 30 to 80 mL/minute) and 60% lower in subjects with severe renal impairment (CrCl <30 mL/minute) compared with healthy subjects.

Special Populations: Hepatic Function Impairment

Following a single 50 mg dose, plasma AUC was 41% higher in patients with mild hepatic impairment (Child-Pugh class A) and approximately two-fold higher in patients with moderate-to-severe hepatic impairment (Child-Pugh class B and class C, respectively) when compared to patients with normal hepatic function. Following repeat doses of eltrombopag in thrombocytopenic patients with chronic liver disease, the AUC increased 87% to 110% in patients with mild hepatic impairment, and 141% to 240% in patients with moderate hepatic impairment. Half-life was prolonged 3- and 4-fold in mild and moderate hepatic impairment in thrombocytopenic patients with chronic liver disease, respectively. AUC increased with increasing Child-Pugh score in chronic hepatitis C patients; patients with chronic hepatitis C and mild impairment had ~100% to 144% higher plasma AUC than healthy subjects.

Special Populations: Children

Plasma eltrombopag apparent clearance following oral administration (CL/F) increased with increasing body weight. East Asian pediatric patients with ITP had approximately 43% higher plasma eltrombopag AUC(0-τ) values compared with non-East Asian patients.

Special Populations: Race

Eltrombopag exposure is 50% to 55% higher in Asian (eg, Chinese, Japanese, Korean, or Taiwanese) subjects with ITP compared with non-Asian subjects. An ~40% higher systemic exposure in healthy black subjects was found in 1 study, although 3 other studies found similar exposure.

Use: Labeled Indications

Aplastic anemia, severe: Treatment of severe 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 chronic hepatitis C (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).

Contraindications

There are no contraindications listed in the manufacturer’s US labeling.

Canadian labeling: Hypersensitivity to eltrombopag or any component of the formulation; severe hepatic impairment (Child-Pugh class C)

Dosing: Adult

Note: Do not use eltrombopag to normalize platelet counts.

Chronic immune thrombocytopenia (ITP): Oral: Note: Use the lowest dose to achieve and maintain platelet count ≥50,000/mm3 as needed to reduce the risk of bleeding. Discontinue if platelet count does not respond to a level that avoids clinically important bleeding after 4 weeks at the maximum of 75 mg/day.

Initial: 50 mg once daily (25 mg once daily for patients of Asian ethnicity [eg, Chinese, Japanese, Korean, Taiwanese]); dose should be titrated based on platelet response. Maximum dose: 75 mg/day.

Dosage adjustment based on platelet response:

Platelet count <50,000/mm3 (≥2 weeks after treatment initiation or a dose increase): Increase daily dose by 25 mg (if taking 12.5 mg once daily, increase dose to 25 mg once daily prior to increasing the dose amount by 25 mg daily); maximum: 75 mg/day

Platelet count ≥200,000/mm3 and ≤400,000/mm3 (at any time): Reduce daily dose by 25 mg (if taking 25 mg once daily, decrease dose to 12.5 mg once daily); reassess in 2 weeks

Platelet count >400,000/mm3: Withhold dose; assess platelet count twice weekly; when platelet count <150,000/mm3, resume with the daily dose reduced by 25 mg (if taking 25 mg once daily, resume with 12.5 mg once daily)

Platelet count >400,000/mm3 after 2 weeks at the lowest dose: Discontinue treatment

Chronic hepatitis C-associated thrombocytopenia: Oral: Note: Use the lowest dose to achieve the target platelet count necessary to initiate antiviral therapy (peginterferon and ribavirin) or to avoid dose reductions of peginterferon during antiviral therapy. Discontinue when antiviral therapy is stopped.

Initial: 25 mg once daily; dose should be titrated based on platelet response. Maximum dose: 100 mg/day

Dosage adjustment based on platelet response:

Platelet count <50,000/mm3 (after at least 2 weeks): Increase daily dose by 25 mg every 2 weeks; maximum dose: 100 mg/day

Platelet count ≥200,000/mm3 and ≤400,000/mm3 (at any time): Reduce daily dose by 25 mg; reassess in 2 weeks

Platelet count >400,000/mm3: Withhold dose; assess platelet count twice weekly; when platelet count <150,000/mm3, resume with the daily dose reduced by 25 mg (if taking 25 mg once daily, resume with 12.5 mg once daily)

Platelet count >400,000/mm3 after 2 weeks at the lowest dose: Discontinue treatment

Severe aplastic anemia: Oral: Note: Use the lowest dose to achieve and maintain hematologic response. Hematologic response may take up to 16 weeks and requires dose titration. Discontinue therapy if hematologic response is not achieved after 16 weeks of treatment, for excessive platelet responses or for liver function abnormalities. Consider discontinuing if new cytogenetic abnormalities are observed.

Initial: 50 mg once daily (25 mg once daily for patients of Asian ethnicity); dose should be titrated based on platelet response. Maximum dose: 150 mg/day.

Dosage adjustment based on platelet response:

Platelet count <50,000/mm3 (≥2 weeks after treatment initiation or a dose increase): Increase daily dose by 50 mg (if taking 25 mg once daily, increase dose to 50 mg once daily prior to increasing the dose amount by 50 mg daily); maximum: 150 mg/day

Platelet count ≥200,000/mm3 and ≤400,000/mm3 (at any time): Reduce daily dose by 50 mg; reassess in 2 weeks

Platelet count >400,000/mm3: Withhold dose for 1 week; when platelet count <150,000/mm3, resume with the daily dose reduced by 50 mg

Platelet count >400,000/mm3 after 2 weeks at the lowest dose: Discontinue treatment

For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks, may reduce the dose by 50%. If counts remain stable after 8 weeks at the reduced dose, discontinue and monitor blood counts. If platelets counts drop to <30,000/mm3, hemoglobin to <9 g/dL, or ANC to <500/mm3, may reinitiate at the prior effective dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Do not use eltrombopag to normalize platelet counts.

Chronic immune thrombocytopenia (ITP): Note: Use the lowest dose to achieve and maintain platelet count ≥50,000/mm3 as needed to reduce the risk of bleeding. Discontinue if platelet count does not respond to a level that avoids clinically important bleeding after 4 weeks at the maximum of 75 mg/day.

Children 1 to 5 years: Oral: Initial: 25 mg once daily; dose should be titrated based on platelet response (no dosage adjustment required for patients of Asian ancestry). Maximum dose: 75 mg/day.

Children ≥6 years of age and Adolescents: Oral: Refer to adult dosing

Dosing: Renal Impairment

No dosage adjustment is necessary.

Dosing: Hepatic Impairment

Adjustment for hepatic impairment prior to initiating treatment:

Chronic ITP: Note: In patients with ITP and hepatic impairment, wait 3 weeks (instead of 2 weeks) after therapy initiation or subsequent dosage changes prior to increasing dose.

Mild, moderate, or severe impairment (Child-Pugh classes A, B, or C): Initial: 25 mg once daily

Patients of East-Asian ethnicity with hepatic impairment (Child-Pugh classes A, B, or C): Initial: Consider 12.5 mg once daily

Chronic hepatitis C-associated thrombocytopenia:

Initial: No dosage adjustment is necessary

Severe aplastic anemia:

Mild, moderate, or severe impairment (Child-Pugh classes A, B, or C): Initial: 25 mg once daily

Adjustment for hepatic impairment during treatment:

ALT levels ≥3 times the upper limit of normal (ULN) in patients with normal hepatic function or ≥3 times baseline in those with preexisting transaminase elevations and which are progressive, persistent (≥4 weeks), accompanied by increased direct bilirubin, or accompanied by clinical signs of liver injury or evidence of hepatic decompensation: Discontinue treatment. Hepatotoxicity may recur with re-treatment after therapy interruption, but if determined to be clinically beneficial, may cautiously resume treatment; monitor ALT weekly during dosage titration; permanently discontinue if liver function test elevations persist, worsen, or recur.

Reconstitution

The oral suspension must be reconstituted with cool or cold water only (do not use hot water). Fill the provided single-use oral syringe with 20 mL of drinking water and empty into the mixing bottle; use a new single-use oral dosing syringe to prepare each dose. Add the appropriate eltrombopag dose to the mixing bottle; gently and slowly shake the bottle for at least 20 seconds to mix. If not used immediately, suspension may be stored for up to 30 minutes at room temperature; discard any solution if not used within 30 minutes. Following administration, discard the used oral dosing syringe and any suspension remaining in bottle in trash (do not dispose of in drain); clean supplies by rinsing the bottle and lid under running water and air-dry (bottle may stain, this is normal); wash hands with soap and water. If powder or suspension spills during preparation or administration, consider wearing disposable gloves during spill clean-up to avoid staining skin.

Administration

Oral: Administer on an empty stomach, 1 hour before or 2 hours after a meal. Swallow tablets whole; do not split, chew, or crush and mix with food or liquids. Prepare the suspension with cool or cold water only (do not use hot water); discard any suspension not administered within 30 minutes after reconstitution. Do not reuse oral dosing syringes; use a new single-use syringe to prepare and administer each dose. If powder or suspension spills during preparation or administration, consider wearing disposable gloves during spill clean-up to avoid staining skin. Administer eltrompobag at least 2 hours before or 4 hours after antacids, foods high in calcium (eg, dairy products and calcium-fortified juices), or supplements containing polyvalent cations (eg, iron, calcium, aluminum, magnesium, selenium, zinc). Do not administer more than one dose within 24 hours.

Dietary Considerations

Food, especially dairy products, may decrease the absorption of eltrombopag.

Storage

Oral suspension: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Once reconstituted (if not used immediately), the suspension may be stored for a maximum of 30 minutes between 20°C and 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Discard the mixture if not used within 30 minutes.

Tablets: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Dispense in original bottle.

Drug Interactions

Aluminum Hydroxide: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any aluminum-containing product. Consider therapy modification

Asunaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Asunaprevir. Avoid combination

BCRP/ABCG2 Substrates: Eltrombopag may increase the serum concentration of BCRP/ABCG2 Substrates. Monitor therapy

Calcium Salts: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any calcium-containing product. Consider therapy modification

CycloSPORINE (Systemic): May decrease the serum concentration of Eltrombopag. Monitor therapy

Deferiprone: UGT1A6 Inhibitors may increase the serum concentration of Deferiprone. Monitor therapy

Elagolix: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Elagolix. Avoid combination

Eluxadoline: Eltrombopag may increase the serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with eltrombopag and monitor patients for increased eluxadoline effects/toxicities. Consider therapy modification

Grazoprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Grazoprevir. Avoid combination

Irinotecan Products: UGT1A1 Inhibitors may increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be increased. UGT1A1 Inhibitors may increase the serum concentration of Irinotecan Products. Avoid combination

Iron Salts: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any iron-containing product. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Consider therapy modification

Magnesium Salts: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any magnesium-containing product. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any multivitamin containing polyvalent cations. Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any multivitamin containing polyvalent cations. Consider therapy modification

OATP1B1/SLCO1B1 Substrates: Eltrombopag may increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy

PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Avoid combination

Rosuvastatin: Eltrombopag may increase the serum concentration of Rosuvastatin. Management: Consideration a preventive 50% reduction in rosuvastatin adult dose when starting this combination; Canadian labeling recommends limiting rosuvastatin to a maximum of 20 mg/day. Consider therapy modification

Selenium: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any selenium-containing product. Consider therapy modification

Sucralfate: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of sucralfate. Consider therapy modification

Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Monitor therapy

Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Avoid combination

Voxilaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Voxilaprevir. Avoid combination

Zinc Salts: May decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any zinc-containing product. Consider therapy modification

Adverse Reactions

>10%:

Central nervous system: Fatigue (adults: 28%), headache (adults: 21%), insomnia (adults: 16%), chills (adults: 14%)

Dermatologic: Pruritus (adults: 15%)

Gastrointestinal: Diarrhea (adults: 9% to 19%; children and adolescents: 9%), nausea (adults: 9% to 19%), decreased appetite (adults: 18%)

Hematologic & oncologic: Anemia (adults: 40%)

Hepatic: Abnormal hepatic function tests (adults: 11%)

Neuromuscular & skeletal: Asthenia (adults: 16%), myalgia (adults: 5% to 12%)

Respiratory: Flu-like symptoms (adults: 18%), upper respiratory tract infection (children and adolescents: 17%; adults: 7%), cough (9% to 15%), nasopharyngitis (children and adolescents: 12%)

Miscellaneous: Fever (adults: 30%; children and adolescents: 9%)

1% to 10%:

Cardiovascular: Peripheral edema (adults: 10%), thromboembolic disease (6%), thrombosis (adults: 3%), portal vein thrombosis (2%)

Central nervous system: Encephalopathy (adults: ≤7%)

Dermatologic: Alopecia (adults: 2% to 10%), skin rash (3% to 9%)

Gastrointestinal: Abdominal pain (children and adolescents: 8%), toothache (children and adolescents: 6%), vomiting (adults: 6%), xerostomia (adults: 2%)

Genitourinary: Urinary tract infection (adults: 5%)

Hepatic: Hyperbilirubinemia (adults: 8%), ascites (adults: ≤7%), increased serum alanine aminotransferase (6%), increased serum aspartate aminotransferase (4% to 5%), increased serum alkaline phosphatase (adults: 2%)

Infection: Influenza (adults: 3%)

Neuromuscular & skeletal: Back pain (adults: 3%), paresthesia (adults: 3%), musculoskeletal pain (adults: 2%)

Ophthalmic: Cataract (adults: 8%; children and adolescents: 1%)

Respiratory: Rhinitis (children and adolescents: 9%), oropharyngeal pain (4% to 8%), pharyngitis (adults: 4%), rhinorrhea (children and adolescents: 4%)

<1%, postmarketing, and/or case reports: Hemorrhage, skin discoloration (including hyperpigmentation and skin yellowing), thrombotic microangiopathy (with acute renal failure)

ALERT: U.S. Boxed Warning

Hepatotoxicity

In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation.

Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.

Warnings/Precautions

Concerns related to adverse effects:

• Cataract formation: Cataract formation or worsening was observed in clinical trials. Monitor regularly for signs and symptoms of cataracts; obtain ophthalmic exam at baseline and during therapy. Use with caution in patients at risk for cataracts (eg, advanced age, long-term glucocorticoid use).

• Hepatotoxicity: [US Boxed Warning]: Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. Liver enzyme elevations may occur; obtain ALT, AST, and bilirubin prior to treatment initiation, every 2 weeks during adjustment phase, then monthly (after stable dose established). Eltrombopag inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia; obtain fractionation for elevated bilirubin levels. Repeat abnormal liver function tests within 3 to 5 days; if confirmed abnormal, monitor weekly until resolves, stabilizes, or returns to baseline. Discontinue treatment for ALT levels ≥3 times the ULN in patients with normal hepatic function, or ≥3 times baseline (or >5 times ULN; whichever is lower) in those with preexisting transaminase elevations and which are progressively increasing, or persistent (≥4 weeks), or accompanied by increased direct bilirubin, or accompanied by clinical signs of liver injury or evidence of hepatic decompensation. Hepatotoxicity may recur with re-treatment after therapy interruption; however, if the benefit of treatment outweighs the hepatotoxicity risk, initiate carefully, and monitor liver function tests weekly during the dose adjustment phase. Permanently discontinue if liver test abnormalities persist, worsen, or recur with rechallenge. In clinical trials, isolated cases of severe liver injury occurred, liver function test abnormalities usually occurred ~3 months after initiation of eltrombopag and resolved with discontinuation.

• Thromboembolism: Thromboembolism (venous or arterial) may occur with excessive increases in platelet levels. Use with caution in patients with known risk factors for thromboembolism (eg, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, chronic liver disease). Thrombotic events, primarily involving the portal venous system, were more commonly seen in eltrombopag-treated chronic hepatitis C patients with thrombocytopenia (when compared to placebo). Thrombotic events (including portal venous thrombosis) were also reported in a study of non-immune thrombocytopenia (ITP) thrombocytopenic patients with chronic liver disease undergoing elective invasive procedures receiving eltrombopag 75 mg once daily. Symptoms of portal vein thrombosis include abdominal pain, nausea, vomiting, and diarrhea. The risk for portal venous thrombosis is increased in thrombocytopenic patients with chronic liver disease receiving 75 mg once daily for 2 weeks as preparation for invasive procedures.

Disease-related concerns:

• Chronic hepatitis C infection: [US Boxed Warning]: May increase risk of hepatic decompensation when used in combination with interferon and ribavirin in patients with chronic hepatitis C. In clinical trials, patients with low albumin (<3.5 g/dL) or a Model for End-Stage Liver Disease (MELD) score ≥10 at baseline had an increased risk of hepatic decompensation; closely monitor these patients during therapy. If antiviral therapy is discontinued for hepatic decompensation according to interferon/ribavirin recommendations, eltrombopag should also be discontinued. Indirect hyperbilirubinemia is commonly observed with eltrombopag when used in combination with peginterferon and ribavirin. In addition, ascites, encephalopathy, and thrombotic events were reported more frequently than placebo in chronic hepatitis C trials.

• Hepatic impairment: Clearance may be reduced in patients with hepatic impairment; use with caution; reduced starting doses are recommended in patients with ITP (except children 1 to 5 years) and severe aplastic anemia who have hepatic impairment (no initial dose reductions are necessary in patients with chronic hepatitis C-related thrombocytopenia).

• Myelodysplastic syndromes: Eltrombopag is not indicated for the treatment of myelodysplastic syndromes (MDS). A clinical trial comparing the combination of azacitidine plus eltrombopag to azacitidine alone in patients with intermediate-1, intermediate-2, or high-risk MDS was terminated due to lack of efficacy and safety concerns (including increased progression to AML). Increased relative risks of death and progression to AML in the eltrombopag arm compared to placebo were observed in the study.

• Renal impairment: Use with caution with renal impairment (any degree) and monitor closely; initial dosage adjustment is not necessary.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian ethnicity (eg, Chinese, Japanese, Korean, Taiwanese): May have greater drug exposure (compared to non-Asians); therapy should be initiated with lower starting doses in ITP and severe aplastic anemia patients.

Other warnings/precautions:

• Appropriate use: Do not use to normalize platelet counts. ITP: Indicated only when the degree of thrombocytopenia and clinical conditions increase the risk for bleeding in patients with chronic ITP; use the lowest dose necessary to achieve and maintain platelet count ≥50,000/mm3. Discontinue if platelet count does not respond to a level to avoid clinically important bleeding after 4 weeks at the maximum recommended dose. Chronic hepatitis C-associated thrombocytopenia: Use only when thrombocytopenia prevents the initiation and maintenance of interferon-based therapy; discontinue if antiviral therapy is discontinued. Safety and efficacy have not been established when combined with direct acting antiviral medications approved for chronic hepatitis C genotype 1 infection therapy. Severe aplastic anemia: Use the lowest dose to achieve and maintain hematologic response. Discontinue if no hematologic response has occurred after 16 weeks of therapy, excessive platelet count responses or important liver test abnormalities. Consider discontinuation if new cytogenetic abnormalities are observed.

Monitoring Parameters

Monitor liver function tests, including ALT, AST, and bilirubin (baseline, every 2 weeks during dosage titration, then monthly after a stable dose is achieved; evaluate abnormal liver function tests within 3 to 5 days; monitor weekly until abnormalities resolve, stabilize, or return to baseline or if re-treating [not recommended] after therapy interruption for hepatotoxicity); bilirubin fractionation (for elevated bilirubin); ophthalmic exam (baseline and during treatment).

Thrombocytopenia due to CHC and chronic ITP: CBC with differential and platelet count (weekly at initiation and during dosage titration, then monthly when stable; after cessation, monitor weekly for ≥4 weeks; when switching between the oral suspension and tablet, monitor platelet counts weekly for 2 weeks, then monthly when stable).

Severe aplastic anemia: CBC with differential and platelets (regularly throughout therapy)

Monitor adherence.

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies.

Information related to the use of eltrombopag for the treatment of thrombocytopenia in pregnancy is limited (Favier 2017; Purushothaman 2016; Suzuki 2017).

Females of reproductive potential should use effective contraception during eltrombopag therapy and for at least 7 days after the last eltrombopag dose.

If used in combination with ribavirin, all warnings related to the use of ribavirin and pregnancy and/or contraception should be followed. Refer to the ribavirin monograph for additional information.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, insomnia, itching, lack of appetite, flu-like symptoms, cough, muscle pain, joint pain, rhinorrhea, rhinitis, sneezing, back pain, dizziness, pharyngitis, tooth pain, muscle spasms, or hair loss. Have patient report immediately to prescriber signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood), severe loss of strength and energy, severe abdominal vision changes, eye pain, severe eye irritation, burning or numbness feeling, severe nausea, vomiting, severe diarrhea, bruising, bleeding, mouth sores, mouth irritation, confusion, swelling of arms or legs, chills, or abdominal edema (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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