Source: FDA, National Drug Code (US) Revision Year: 2020
DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
Begin DOPTELET dosing 10 to 13 days prior to the scheduled procedure. The recommended daily dose of DOPTELET is based on the patient’s platelet count prior to the scheduled procedure (see Table 1). Patients should undergo their procedure 5 to 8 days after the last dose of DOPTELET.
DOPTELET should be taken orally once daily for 5 consecutive days with food. In the case of a missed dose, patients should take the next dose of DOPTELET 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 at the usual time the next day; all 5 days of dosing should be completed.
Table 1. Recommended Dose and Duration in Patients with Chronic Liver Disease Scheduled to Undergo a Procedure:
| Platelet Count (x109/L) | Once Daily Dose | Duration |
|---|---|---|
| Less than 40 | 60 mg (3 tablets) | 5 days |
| 40 to less than 50 | 40 mg (2 tablets) | 5 days |
DOPTELET has been investigated only as a single 5-day once daily dosing regimen in clinical trials in patients with chronic liver disease [see Clinical Studies (14.1)]. DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
Monitoring: Obtain a platelet count prior to administration of DOPTELET therapy and on the day of a procedure to ensure an adequate increase in platelet count.
Use the lowest dose of DOPTELET needed to achieve and maintain a platelet count greater than or equal to 50 × 109/L as necessary to reduce the risk for bleeding. Dose adjustments are based on platelet count response. Do not use DOPTELET to normalize platelet counts.
Initial Dose Regimen: Begin DOPTELET at a starting dose of 20 mg (1 tablet) once daily with food.
Monitoring: After initiating therapy with DOPTELET, assess platelet counts weekly until a stable platelet count greater than or equal to 50 × 109/L has been achieved, and then obtain platelet counts monthly thereafter. Obtain platelet counts weekly for at least 4 weeks following discontinuation of DOPTELET.
Dose adjustments (see Table 2 and Table 3) are based on the platelet count response. Do not exceed a daily dose of 40 mg (2 tablets).
Table 2. DOPTELET Dose Adjustments for Patients with Chronic Immune Thrombocytopenia:
| Platelet Count (x109/L) | Dose Adjustment or Action |
|---|---|
| Less than 50 after at least 2 weeks of DOPTELET | • Increase One Dose Level per Table 3. • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments. |
| Between 200 and 400 | • Decrease One Dose Level per Table 3. • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments. |
| Greater than 400 | • Stop DOPTELET. • Increase platelet monitoring to twice weekly. • When platelet count is less than 150 x10 9/L, decrease One Dose Level per Table 3 and reinitiate therapy. |
| Less than 50 after 4 weeks of DOPTELET 40 mg once daily | • Discontinue DOPTELET. |
| Greater than 400 after 2 weeks of DOPTELET 20 mg weekly | • Discontinue DOPTELET. |
Table 3. DOPTELET Dose Levels for Titration in Patients with 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.
In the case of a missed dose, patients should take the missed dose of DOPTELET 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.
Discontinuation: Discontinue DOPTELET if the platelet count does not increase to greater than or equal to 50 × 109/L after 4 weeks of dosing at the maximum dose of 40 mg once daily. Discontinue DOPTELET if the platelet count is greater than 400 × 109/L after 2 weeks of dosing at 20 mg once weekly.
The recommended starting doses of DOPTELET in patients with chronic immune thrombocytopenia receiving concomitant medications are summarized in Table 4.
Table 4: DOPTELET Recommended Starting Dose for Patients with Chronic Immune Thrombocytopenia Based on Concomitant Medications
| Concomitant Medications | Recommended Starting Dose |
|---|---|
| Moderate or strong dual inhibitors of CYP2C9 and CYP3A4 | 20 mg (1 tablet) three times a week |
| Moderate or strong dual inducers of CYP2C9 and CYP3A4 | 40 mg (2 tablets) once daily |
In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications. Closely monitor the patient and platelet count. Treat thrombotic complications in accordance with standard of care.
No antidote for DOPTELET overdose is known.
Hemodialysis is not expected to enhance the elimination of DOPTELET because DOPTELET is only approximately 6% renally excreted and is highly bound to plasma proteins.
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). Store tablets in the original package.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
