2.1 Recommended Dosage for Patients with Chronic Liver Disease

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

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.

2.2 Recommended Dosage for Patients with Chronic Immune Thrombocytopenia

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

Table 3: DOPTELET Dose Levels for Titration in Patients with Chronic Immune Thrombocytopenia

*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.

2.3 Recommended Dosage with Concomitant Moderate or Strong Dual Inducers or Inhibitors of CYP2C9 and CYP3A4 in Patients with Chronic Immune Thrombocytopenia

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