DOSAGE AND ADMINISTRATION
Only prescribers enrolled in PROMACTA CARES may prescribe PROMACTA [see Warnings and Precautions].
Monitor liver tests (ALT, AST, and bilirubin) and complete blood counts (CBCs), including platelet counts and peripheral blood smears, prior to initiation of PROMACTA and throughout therapy with PROMACTA. If bilirubin is elevated, perform fractionation. Monitor CBCs, including platelet counts, for at least 4 weeks following discontinuation of PROMACTA [see Warnings and Precautions]. In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting PROMACTA and decreased within 1 to 2 weeks after discontinuing PROMACTA [see Clinical Studies].
Use the lowest dose of PROMACTA to achieve and maintain a platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use PROMACTA in an attempt to normalize platelet counts [see Warnings and Precautions].
Take PROMACTA on an empty stomach (1 hour before or 2 hours after a meal) [see Clinical Pharmacology]. Allow at least a 4-hour interval between PROMACTA and other medications (e.g., antacids), calcium-rich foods (e.g., dairy products and calcium fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc [see Drug Interactions and Clinical Pharmacology].
Initial Dose Regimen
Initiate PROMACTA at a dose of 50 mg once daily except in patients who are of East Asian ancestry or who have moderate to severe hepatic impairment.
For patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean), initiate PROMACTA at a reduced dose of 25 mg once daily [see Clinical Pharmacology].
For patients with moderate or severe hepatic impairment, initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations].
Monitoring and Dose Adjustment
After initiating PROMACTA, adjust the dose to achieve and maintain a platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts as outlined in Table 1. During therapy with PROMACTA, assess CBCs, including platelet count and peripheral blood smears, weekly until a stable platelet count has been achieved. Obtain CBCs including platelet counts and peripheral blood smears, monthly thereafter.
Table 1. Dose Adjustments of PROMACTA
|
Platelet Count Result
|
Dose Adjustment or Response
|
| <50 x 109/L following at least 2 weeks of PROMACTA |
Increase daily dose by 25 mg to a maximum of 75 mg/day. |
| ≥200 x 109/L to ≤400 x 109/L at any time |
Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments. |
| >400 x 109/L |
Stop PROMACTA; increase the frequency of platelet monitoring to twice weekly.
Once the platelet count is <150 x 109/L, reinitiate therapy at a daily dose reduced by 25 mg. |
| >400 x 109/L after 2 weeks of therapy at lowest dose of PROMACTA |
Permanently discontinue PROMACTA. |
Modify the dosage regimen of concomitant ITP medications, as medically appropriate, to avoid excessive increases in platelet counts during therapy with PROMACTA. Do not administer more than one dose of PROMACTA within any 24-hour period.
Discontinuation
Discontinue PROMACTA if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy with PROMACTA at the maximum daily dose of 75 mg. Excessive platelet count responses, as outlined in Table 1, or important liver test abnormalities also necessitate discontinuation of PROMACTA [see Warnings and Precautions].
DOSAGE FORMS AND STRENGTHS
25 mg tablets — round, biconvex, orange, film-coated tablets debossed with GS NX3 and 25 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.
50 mg tablets — round, biconvex, blue, film-coated tablets debossed with GS UFU and 50 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 50 mg of eltrombopag free acid.
75 mg tablets — round, biconvex, pink, film-coated tablets debossed with GS FSS and 75 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 75 mg of eltrombopag free acid.
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