Active Ingredient: Avatrombopag
Avatrombopag is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
20 - 20 mg
From 20 To 20 mg once every day
Use the lowest dose of avatrombopag needed to achieve and maintain a platelet count ≥ 50 × 109/L as necessary to reduce the risk for bleeding. Do not use avatrombopag to normalise platelet counts. In clinical studies, platelet counts generally increased within 1 week after starting avatrombopag and decreased within 1 to 2 weeks after discontinuation.
The recommended starting dose of avatrombopag is 20 mg once daily with food.
After initiating therapy, assess platelet counts at least once weekly until a stable platelet count ≥50 × 109/L and ≤150 × 109/L has been achieved. Twice weekly platelet count monitoring should be conducted during the first weeks of therapy in patients receiving avatrombopag only once or twice weekly. Twice weekly monitoring should also be conducted after dose adjustments during the treatment.
Due to the potential risk of platelet counts above 400 × 109/L within the first weeks of treatment patients should be carefully monitored for any signs or symptoms of thrombocytosis. After a stable platelet count has been achieved, obtain platelet counts at least monthly. After discontinuation of avatrombopag, platelet counts should be obtained weekly for at least 4 weeks.
Dose adjustments (see Table 2 and Table 3) are based on the platelet count response. Do not exceed a daily dose of 40 mg.
Table 2. Avatrombopag dose adjustments for patients with primary chronic immune thrombocytopenia:
| Platelet count (x 109/L) | Dose adjustment or action |
|---|---|
| <50 after at least 2 weeks of avatrombopag treatment | • Increase One Dose Level per Table 3. • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments. |
| >150 and ≤250 | • Decrease One Dose Level per Table 3. • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments. |
| >250 | • Stop avatrombopag. • Increase platelet monitoring to twice weekly. • When platelet count is less than 100 × 109/L, decrease One Dose Level per Table 3 and reinitiate therapy. |
| <50 after 4 weeks of avatrombopag 40 mg once daily | • Discontinue avatrombopag. |
| >250 after 2 weeks of avatrombopag 20 mg weekly | • Discontinue avatrombopag. |
Table 3. Avatrombopag dose levels for titration in patients with primary chronic immune thrombocytopenia:
| Dose≠ | Dose Level |
|---|---|
| 40 mg once daily | 6 |
| 40 mg three times a week AND 20 mg on the four remaining days of each week | 5 |
| 20 mg once daily* | 4 |
| 20 mg three times a week | 3 |
| 20 mg twice a week OR 40 mg once weekly | 2 |
| 20 mg once weekly | 1 |
* Initial dose regimen for all patients except those taking moderate or strong dual inducers or moderate or strong dual inhibitors of CYP2C9 and CYP3A4/5, or of CYP2C9 alone.
≠ Patients taking avatrombopag less frequently than once daily should take the medication in a consistent manner from week to week.
Dose Level 3: Three non-consecutive days a week, e.g. Monday, Wednesday and Friday
Dose Level 2: Two non-consecutive days a week, e.g. Monday and Friday
Dose Level 1: The same day each week, e.g. Monday
In the case of a missed dose, patients should take the missed dose of avatrombopag as soon as they remember. Patients should not take two doses at one time to make up for a missed dose, and should take the next dose per the current regimen.
Avatrombopag can be administered in addition to other ITP medicinal products. Platelet counts should be monitored when combining avatrombopag with other medicinal products for the treatment of primary ITP in order to avoid platelet counts outside of the recommended range, and to determine whether the dose of either medication should be reduced.
Discontinue avatrombopag if the platelet count does not increase to ≥50 × 109/L after 4 weeks of dosing at the maximum dose of 40 mg once daily. Discontinue avatrombopag if the platelet count is greater than 250 × 109/L after 2 weeks of dosing at 20 mg once weekly.
Avatrombopag is for oral use, and the tablets should be taken with food.
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