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Eltrombopag Dosage

Applies to the following strength(s): 25 mg ; 50 mg ; 75 mg ; 12.5 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Aplastic Anemia

Initial dose: 50 mg orally once a day; increase daily dose if necessary in increments of 50 mg every two weeks

Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean):
Initial dose: 25 mg orally once a day; increase to 50 mg once a day after 2 weeks if necessary, then increase daily dose in increments of 50 mg every 2 weeks

Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary
Maximum dose: 150 mg orally once a day

Duration:
-Patients who achieve trilineage response, including transfusion independence lasting at least 8 weeks: Eltrombopag dose may be reduced by 50% and discontinued if counts remain stable after 8 weeks at the reduced dose.
-Treatment should be discontinued if no hematologic response is observed after 16 weeks of therapy.
-Consider treatment discontinuation if new cytogenetic abnormalities are observed.

Comments:
-Treatment should be restarted at the previous effective dose if platelet counts fall to below 30 x 10(9)/L, hemoglobin falls to less than 9 g/dL, or ANC falls to less than 0.5 x 10(9)/L.

Use: Treatment of severe aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Initial dose: 50 mg orally once a day

Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean):
Initial dose: 25 mg orally once a day

Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary to reduce the risk of bleeding.
Maximum dose: 75 mg orally once a day

Duration: Treatment should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum daily dose.

Comments:
-Monitor CBC with differentials, including platelet counts, every week until the platelet count is stable, followed by monthly thereafter. They should also be monitored every week for at least 4 weeks following treatment discontinuation.
-Platelet counts generally increase within 1 to 2 weeks after starting therapy and decrease within 1 to 2 weeks after treatment discontinuation.

Use: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Usual Adult Dose for Thrombocytopenia

Initial dose: 25 mg orally once a day
Maintenance dose: The lowest dose to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin.
Maximum dose: 100 mg orally once a day
Duration: Treatment should be discontinued when concomitant antiviral therapy is discontinued

Comments:
-Adjust the daily dose by increments of 25 mg every two weeks as necessary according to platelet count response.
-Monitor platelet counts every week prior to starting antiviral therapy.
-During antiviral therapy, monitor CBC with differentials, including platelet counts, every week until the platelet count is stable. Monitor platelet counts monthly thereafter.
-Platelet counts generally began to rise within the first week of treatment with eltrombopag.

Use: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura

1 TO 5 YEARS:
Initial dose: 25 mg orally once a day

6 YEARS OR OLDER:
Initial dose: 50 mg orally once a day

Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean):
Initial dose: 25 mg orally once a day

Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary to reduce the risk of bleeding.
Maximum dose: 75 mg orally once a day

Duration: Treatment should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum daily dose.

Comments:
-Monitor CBC with differentials, including platelet counts, every week until the platelet count is stable, followed by monthly thereafter. They should also be monitored every week for at least 4 weeks following treatment discontinuation.
-Platelet counts generally increase within 1 to 2 weeks after starting therapy and decrease within 1 to 2 weeks after treatment discontinuation.

Use: Treatment of thrombocytopenia in patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Renal Dose Adjustments

No dose adjustment recommended; use with caution and close monitoring.

Liver Dose Adjustments

Thrombocytopenia in patients with chronic ITP:
-Mild to severe liver dysfunction (Child-Pugh A, B, or C): Initiate dose at 25 mg orally once a day
-Mild to severe liver dysfunction with East Asian ancestry: Initiate dose at 12.5 mg orally once a day
-In patients with liver dysfunction (Child-Pugh Class A, B, C), after initiating eltrombopag or after any subsequent dosing increase, wait 3 weeks before increasing the dose.

Thrombocytopenia in patients with hepatitis C:
Liver dysfunction: No dosage adjustment recommended

Severe aplastic anemia:
Liver dysfunction:
Initial dose: 25 mg orally once a day; increase to 50 mg once a day after 2 weeks if necessary according to platelet counts, then increase daily dose in increments of 50 mg every 2 weeks.

General:
Discontinue eltrombopag if ALT levels increase by at least 3 x ULN in patients with normal liver function or transaminases increase by at least 3 x baseline levels in patients with elevated transaminases pretreatment and where transaminases are:
-Progressively increasing,
-Persistent for at least 4 weeks,
-Accompanied by increased direct bilirubin, or
-Accompanied by clinical symptoms of liver injury or evidence of hepatic decompensation

Treatment may be cautiously restarted if the benefits outweigh the risks, with weekly LFT monitoring during the dose adjustment phase; however, it should be permanently discontinued if LFT abnormalities remain, worsen, or reoccur.

Dose Adjustments

General:
-A period of at least 2 weeks is recommended between dose adjustments in order to see the effect on the platelet count.
-Excessive platelet count responses necessitate eltrombopag treatment discontinuation.

Thrombocytopenia in patients with chronic ITP:
General: Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during eltrombopag therapy.
Platelet count:
-Less than 50 x 10(9)/L following at least 2 weeks of eltrombopag therapy: Increase daily dose by 25 mg to a maximum of 75 mg per day. For patients taking 12.5 mg once a day, increase the dose to 25 mg once a day before increasing the dose amount by 25 mg.
-Greater than or equal to 200 x 10(9)/L to less than or equal to 400 x 10(9)/L at any time: Decrease the daily dose by 25 mg. For patients taking 25 mg once a day, decrease dose to 12.5 mg once a day.
-Greater than 400 x 10(9)/L: Stop eltrombopag; increase platelet monitoring to twice weekly. Once the platelet count is less than 150 x 10(9)/L, restart eltrombopag at a daily dose reduced by 25 mg. For patients taking 25 mg once a day, restart therapy at 12.5 mg once a day.
-Greater than 400 x 10(9)/L after 2 weeks of therapy at the lowest dose of eltrombopag: Discontinue eltrombopag

Thrombocytopenia in patients with chronic hepatitis C:
General:
-During antiviral therapy, the dose of eltrombopag should be adjusted to avoid dose reductions of peginterferon.
-Eltrombopag should be discontinued when antiviral therapy is discontinued.
Platelet count:
-Less than 50 x 10(9)/L following at least 2 weeks of eltrombopag therapy: Increase daily dose by 25 mg to a maximum of 100 mg per day
-Greater than or equal to 200 x 10(9)/L to less than or equal to 400 x 10(9)/L at any time: Decrease the daily dose by 25 mg
-Greater than 400 x 10(9)/L: Stop eltrombopag; increase platelet monitoring to twice weekly. Once the platelet count is less than 150 x 10(9)/L, restart eltrombopag at a daily dose reduced by 25 mg. For patients taking 25 mg once a day, restart therapy at 12.5 mg once a day.
-Greater than 400 x 10(9)/L after 2 weeks of therapy at lowest dose of eltrombopag: Discontinue eltrombopag

Severe aplastic anemia:
Platelet count:
-Less than 50 x 10(9)/L following at least 2 weeks of eltrombopag therapy: Increase daily dose by 50 mg to a maximum of 150 mg per day. For patients taking 25 mg once a day, increase the dose to 50 mg once a day before increasing the dose amount by 50 mg.
-Greater than or equal to 200 x 10(9)/L to less than or equal to 400 x 10(9)/L at any time: Decrease the daily dose by 50 mg
-Greater than 400 x 10(9)/L: Stop eltrombopag for 1 week. Restart therapy at 50 mg once a day when the platelet count is less than 150 x 10(9)/L.
-Greater than 400 x 10(9)/L after 2 weeks of therapy at the lowest dose of eltrombopag: Discontinue eltrombopag

Precautions

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

Safety and efficacy have not been established in patients younger than 1 year with ITP. Safety and efficacy have not been established in patients younger than 18 years with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take eltrombopag on an empty stomach (1 hour before or 2 hours after a meal).
-Allow at least 4 hours between eltrombopag and other medications (e.g., antacids), calcium-rich foods, or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.
-Do not administer more than one dose of eltrombopag within any 24 hour period.

Monitoring:
-Cardiovascular: Thrombotic/thromboembolic events
-Hematologic: CBC with differentials, including platelet counts
-Hepatic: Hepatic function

General:
-Eltrombopag should not be used in an attempt to normalize platelet counts.
-The prescribing information for concomitant pegylated interferon and ribavirin therapy should be consulted for further information regarding these medicines.

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