Promacta Dosage
Generic name: eltrombopag olamine
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Promacta safely and effectively. See full prescribing information for Promacta.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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 (5.3)]. 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 (14)].
Take PROMACTA on an empty stomach (1 hour before or 2 hours after a meal) [see Clinical Pharmacology (12.3)]. 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 (7.4)].
Initial Dose Regimen
Initiate PROMACTA at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).
For patients of East Asian ancestry, initiate PROMACTA at a reduced dose of 25 mg once daily [see Clinical Pharmacology (12.3)].
For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate PROMACTA at a reduced dose of 25 mg once daily [see Use in Specific Populations (8.6)].
​For patients of East Asian ancestry with hepatic impairment (Child-Pugh Class A, B, C), consider initiating PROMACTA at a reduced dose of 12.5 mg once daily [see Clinical Pharmacology (12.3)].
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 with differentials (including platelet count) weekly until a stable platelet count has been achieved. Obtain CBCs with differentials (including platelet counts) monthly thereafter.
| 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. For patients taking 12.5 mg once daily, increase the dose to 25 mg daily before increasing the dose amount by 25 mg. |
| ≥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. ​For patients taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg. |
| >400 x 109/L after 2 weeks of therapy at lowest dose of PROMACTA | Discontinue PROMACTA. |
In patients with hepatic impairment (Child-Pugh Class A, B, C), after initiating PROMACTA or after any subsequent dosing increase wait 3 weeks before increasing the dose.
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 (5.1)].
