Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials 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.
Adult and Pediatric Patients 12 Years of Age and Older The safety of TAKHZYRO is primarily based on a 26-week, randomized, double-blind, parallel-group and placebo-controlled study (Trial 1) in 125 patients with Type I or II HAE.
Eligible patients were also able to participate in an open-label extension study (Trial 2) up to 130 weeks.
In Trial 1, a total of 84 patients with HAE aged 12 years and older received at least one dose of TAKHZYRO.
Overall, 70% of patients were female and 90% of patients were Caucasian with a mean age of 41 years.
The proportion of patients who discontinued study drug prematurely due to adverse events was 1.2% for TAKHZYRO-treated patients and 4.9% for placebo-treated patients.
No deaths occurred in the trial.
The safety profile of TAKHZYRO was generally similar across all subgroups of patients, including analysis by age, sex, and geographic region.
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions have been observed.
In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been observed.
In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
Like all medications, Takhzyro can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: