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 Most common adverse reactions (≥ 5%): vomiting, injection-site reaction, pain in extremity, and nausea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascendis Pharma at 1-844-442-7236 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.
The safety of YUVIWEL was evaluated in pediatric patients with achondroplasia in two randomized, placebo-controlled trials of navepegritide.
Trial 1 included a 52-week, randomized, double-blind, placebo-controlled period, followed by a 52-week, single-arm, open-label extension (OLE) period.
In Trial 1, 84 pediatric participants with achondroplasia (mean age 5.7 years;
range: 2 to 12 years) were randomized to subcutaneous navepegritide 0.1 mg/kg/week (n = 57) or placebo (n = 27) [see Clinical Studies (14) ] .
Trial 2 included a randomized, double-blind, placebo-controlled dose-finding period.
In Trial 2, 57 pediatric participants with achondroplasia (mean age 5.9 years;
range: 2 to 10 years) were randomized 3:1 to subcutaneous navepegritide 0.006, 0.02, 0.05, or 0.1 mg/kg or placebo for 52 weeks.
5 WARNINGS AND PRECAUTIONS Risk of Low Blood Pressure : Transient decreases in blood pressure have been reported with a once daily CNP analog.
Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure while being treated with YUVIWEL.
( 5.1 ) 5.1 Risk of Low Blood Pressure Transient decreases in blood pressure have been reported with a once daily CNP analog.
Subjects with hemodynamically significant cardiovascular disease were excluded from participation in navepegritide clinical trials.
Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure (e.g., dizziness, fatigue and/or nausea) while being treated with YUVIWEL.
Like all medications, Yuviwel 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: