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CLD=chronic liver disease; ITP=immune thrombocytopenia.
CLD=chronic liver disease; ITP=immune thrombocytopenia.
Indication & Important Safety Information
DOPTELET is indicated for the treatment of:
IMPORTANT SAFETY INFORMATION
WARNINGS and PRECAUTIONS
Thrombotic/Thromboembolic Complications
DOPTELET has been associated with thrombotic and thromboembolic complications in patients with ITP.
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 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 with a moderate or strong dual inhibitor or inducer of CYP2C9 and CYP3A4 may increase the risk of DOPTELET toxicities or reduce DOPTELET efficacy.
ADVERSE REACTIONS
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 the 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.