IMPORTANT SAFETY INFORMATION
WARNINGS and PRECAUTIONS
Thrombotic/Thromboembolic Complications
DOPTELET has been associated with thrombotic and thromboembolic complications in patients with CLD or ITP. In patients with CLD, thromboembolic events (portal vein thrombosis) occurred in 0.4% (1/274) of patients receiving DOPTELET. In adult patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving DOPTELET.
Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions and acquired risk factors.
DOPTELET should not be administered to patients with CLD or ITP in an attempt to normalize platelet counts. Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts. Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and institute treatment promptly.
DRUG INTERACTIONS
Moderate or Strong Dual CYP2C9 and CYP3A4 Inducers or Inhibitors
Concomitant use of DOPTELET or DOPTELET Sprinkle with a moderate or strong dual inhibitor or inducer of CYP2C9 and CYP3A4 may increase the risk of DOPTELET or DOPTELET Sprinkle toxicities or reduce DOPTELET or DOPTELET Sprinkle efficacy.
ADVERSE REACTIONS
CLD
The most common serious adverse reaction was hyponatremia.
The most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.
Adult ITP
The most common serious adverse reaction was headache.
The most common adverse reactions (≥10%) were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Pediatric ITP
The most common serious adverse reactions were thrombocytosis and headache.
The most common adverse reactions (≥10%) were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain.
USE IN SPECIFIC POPULATIONS
DOPTELET or DOPTELET Sprinkle may cause fetal harm when administered to a pregnant woman.
Breastfeeding is not recommended during treatment with DOPTELET or DOPTELET Sprinkle and for at least 2 weeks after the last dose.
These are not all the possible risks associated with DOPTELET. Please see Full Prescribing Information for DOPTELET and DOPTELET Sprinkle.
To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088.
