Among those subjects treated with idarucizumab, adverse reactions reported in ≥5% of subjects was headache (12/224, 5%).
In these trials, during the treatment period, the overall frequency of adverse events was similar between idarucizumab-treated subjects (55/224, 25%) and placebo-treated subjects (26/105, 25%). In three healthy volunteer clinical trials, 224 subjects were treated with idarucizumab. SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.īecause 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 clinical practice. Intolerance due to Sorbitol Excipient 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW Of Serious Adverse Reactions in Patients with Hereditary Fructose Of Coagulation Parameters 5.3 Hypersensitivity Tell your doctor if have hereditary fructose intolerance.ĭo not take Praxbind if you are allergic to Praxbind or to any of its ingredients.FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose 2.2 Preparation 2.3 Administration 2.4 RestartingĪntithrombotic Therapy 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Thromboembolic Patients with hereditary fructose intolerance may be at risk of adverse reactions such as low blood sugar, low phosphate, metabolic acidosis, increase in uric acid, and acute liver failure. Hereditary Fructose Intolerance to Sorbitol Excipient. Praxbind contains sorbitol.These may include fever, difficulty breathing due to tightening of the airways, hyperventilation, rash, and itching, Your doctor will discontinue Praxbind if this occurs. Hypersensitivity reactions (serious allergic reaction).
Some patients may require an additional dose of Praxbind.
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