Doptelet Dosage

Important Use and Administration Instructions

• ​Select the recommended product (DOPTELET tablets or DOPTELET SPRINKLE) based on the indication and patient’s age.
• ​Administer DOPTELET tablets and DOPTELET SPRINKLE with food.
• ​DOPTELET tablets and DOPTELET SPRINKLE are not substitutable on a mg-to-mg basis.
• ​The mixture prepared from the granules in DOPTELET SPRINKLE capsules is more bioavailable than DOPTELET tablets. There is no experience from clinical trials in switching between dosing with the granules and the tablet. If the formulation is switched, monitor platelet counts weekly until stable platelet counts are obtained and adjust dosing as needed before resuming monthly monitoring.

Recommended Dosage of DOPTELET Tablets for Patients with Chronic Liver Disease

Begin DOPTELET tablets dosing 10 days 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 days to 8 days after the last dose of DOPTELET.

DOPTELET tablets should be taken orally once daily for 5 consecutive days with food. All 5 days of dosing should be completed.

Table 1: Recommended DOPTELET Tablets Dosage and Duration in Patients with Chronic Liver Disease Scheduled to Undergo a Procedure

DOPTELET tablets have been investigated only as a single 5-day once daily dosing regimen in clinical trials in patients with chronic liver disease. 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.

Recommended Dosage of DOPTELET Tablets for Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or 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 Dosage:

• Begin DOPTELET tablets at an initial dosage of 20 mg (1 tablet) orally once daily with food (see Table 3).
• The recommended initial dosages of DOPTELET tablets are different for patients receiving certain concomitant medications (see Table 4).

​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:

DOPTELET tablet dose adjustments (see Table 2 and Table 3) are based on the platelet count response. Do not exceed a DOPTELET daily dose of 40 mg (2 tablets).

​Table 2: DOPTELET Tablets Recommended Dose Adjustments for Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia

​Table 3: DOPTELET Tablet Dose Levels for Titration in Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia

*Initial dosage regimen for all patients except those taking Moderate or Strong Dual Inducers or Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4.

​Discontinuation:

• Discontinue DOPTELET tablets 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 (2 tablets) once daily.
• Discontinue DOPTELET tablets if the platelet count is greater than 400×109/L after 2 weeks of dosing at 20 mg (1 tablet) once weekly.

Recommended Initial Dosage of DOPTELET Tablets with Concomitant Moderate or Strong Dual Inducers or Inhibitors of CYP2C9 and CYP3A4

​The recommended initial dosages of DOPTELET tablets with concomitant moderate or strong dual inducers or inhibitors of CYP2C9 and CYP3A4 in adult patients with chronic immune thrombocytopenia and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia are summarized in Table 4.

​Table 4: DOPTELET Tablets Recommended Initial Dosage with Concomitant Moderate or Strong Dual Inducers or Inhibitors of CYP2C9 and CYP3A4 for Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia

Recommended Dosage of DOPTELET SPRINKLE for Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia

​Use the lowest dose of DOPTELET SPRINKLE 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 SPRINKLE to normalize platelet counts.

​Initial Dosage:

• Begin DOPTELET SPRINKLE at an initial dosage of 10 mg (content of 1 capsule) orally once daily with food (see Table 6).
• The recommended initial dosages of DOPTELET SPRINKLE are different for patients receiving certain concomitant medications (see Table 7).

​Monitoring:

After initiating therapy with DOPTELET SPRINKLE, 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 SPRINKLE.

​Dose Adjustments:

DOPTELET SPRINKLE dose adjustments (see Table 5 and Table 6) are based on the platelet count response. Do not exceed a DOPTELET SPRINKLE daily dose of 20 mg (content of 2 capsules).

​Table 5: DOPTELET SPRINKLE Dose Adjustments for Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia

​Table 6: DOPTELET SPRINKLE Dose Levels for Titration in Pediatric Patients 1 Year to Less than 6 Years with Persistent or 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.

​Discontinuation:

• Discontinue DOPTELET SPRINKLE 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 20 mg (content of 2 capsules) once daily.
• Discontinue DOPTELET SPRINKLE if the platelet count is greater than 400×109/L after 2 weeks of dosing at 10 mg (content of 1 capsule) once weekly.

Recommended Initial Dosage of DOPTELET SPRINKLE with Concomitant Moderate or Strong Dual Inducers or Inhibitors of CYP2C9 and CYP3A4

​The recommended initial dosages of DOPTELET SPRINKLE with concomitant moderate or strong dual inducers or inhibitors of CYP2C9 and CYP3A4 in pediatric patients 1 year to less than 6 years with persistent or chronic immune thrombocytopenia are summarized in Table 7.

​Table 7: DOPTELET SPRINKLE Recommended Initial Dosage with Concomitant Moderate or Strong Dual Inducers or Inhibitors of CYP2C9 and CYP3A4 for Pediatric Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia

Important Preparation and Administration Instructions for DOPTELET SPRINKLE

• ​Open the capsules and sprinkle the granules onto a small amount of a soft food or liquid in a spoon or cup.
• ​Do not swallow the capsules whole. Do not chew or crush the granules.
• Use the entire contents of the capsules to achieve the dose.
  • The following soft foods and liquids are suitable:
    • Soft foods: applesauce; strawberry jelly; yogurt (plain)
    • Liquids: milk (whole or skim); orange juice; pediatric electrolyte solution (unflavored); water
• ​Mix the granules into the soft food or liquid; the granules will not dissolve.
• ​Consume the mixture immediately after preparation; it should not be saved for future use.
• ​Rinse the spoon or cup with the soft food or liquid to ensure that the full dose is administered.

Missed Dose

​In the case of a missed dose of DOPTELET tablets or DOPTELET SPRINKLE, patients should take the missed dose 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.