doptelet

DOPTELET tablets and DOPTELET SPRINKLE are not substitutable on a mg-to-mg basis. DOPTELET SPRINKLE capsules should be opened, and the contents (oral granules) mixed with a soft food or liquid. Administer immediately after mixing. Do not swallow the capsules whole. Administer DOPTELET tablets and DOPTELET SPRINKLE with food. ( 2.1 , 2.3 , 2.5 ) Chronic Liver Disease : Dose DOPTELET tablets based upon platelet count prior to procedure, orally for 5 days beginning 10 days to 13 days before procedure. For platelet count less than 40×10 9 /L, the dose is 60 mg (3 tablets) orally once daily; for platelet count 40 to less than 50×10 9 /L the dose is 40 mg (2 tablets) orally once daily. ( 2.2 ) Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia : Initiate DOPTELET tablets at 20 mg (1 tablet) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10 9 /L. Do not exceed 40 mg (2 tablets) per day. Pediatric Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia : Initiate DOPTELET SPRINKLE oral granules at 10 mg (content of 1 capsule) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10 9 /L. Do not exceed 20 mg (content of 2 capsules) per day.…

The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Thrombotic/Thromboembolic Complications [ see Warnings and Precautions ( 5.1 ) ] In adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. ( 6.1 ) In adult patients with chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis. ( 6.1 ) In pediatric patients with persistent or chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sobi, Inc. at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Patients with Chronic Liver Disease The safety of DOPTELET was evaluated in two international, identically designed, randomized, double-blind,…

None. None. ( 4 )

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 avatrombopag is only approximately 6% renally excreted and is highly bound to plasma proteins. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Moderate or Strong Dual CYP2C9 and CYP3A4 Inducers or Inhibitors: Dose adjustments are recommended for patients with persistent or chronic immune thrombocytopenia. ( 7.1 ) 7.1 Effect of Other Drugs on DOPTELET in Patients with Persistent or Chronic Immune Thrombocytopenia Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 increases avatrombopag AUC [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of DOPTELET toxicities. Reduce the starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 (see Table 4 and Table 7) [ see Dosage and Administration ( 2.4 and 2.6 )] . In patients starting moderate or strong dual inhibitors of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 2 and Table 3; and Table 5 and Table 6) [ see Dosage and Administration ( 2.3 and 2.5 )] . Moderate or Strong Dual Inducers of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inducer of CYP2C9 and CYP3A4 decreases avatrombopag AUC [ see Clinical Pharmacology ( 12.3 )] , which may reduce DOPTELET efficacy. Increase the recommended starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4 (see Table 4 and Table 7) [ see Dosage and Administration ( 2.4 and 2.6 )] . In patients starting moderate or strong dual inducers of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 2 and Table 3; and Table 5 and Table 6) [ see Dosage and Administration ( 2.3 and 2.5 )] . Patients with Chronic Liver Disease No dosage adjustments are required for patients with chronic liver disease.