cookie policy

INDICATION AND USAGE

YUVIWEL is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk of Low Blood Pressure

Transient decreases in blood pressure have been reported with a once-daily C-type natriuretic peptide (CNP) analog. Subjects with hemodynamically significant cardiovascular disease were excluded from participation in YUVIWEL clinical trials. Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure (eg, dizziness, fatigue, and/or nausea) while being treated with YUVIWEL.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) are vomiting, injection site reaction, pain in extremity, and nausea.

SPECIFIC POPULATIONS

Pregnancy and Lactation

There are no available data on the use of YUVIWEL in pregnant women, or data on the presence of YUVIWEL in human milk, the potential effects on milk production or the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for YUVIWEL and any potential adverse effects on the breastfed infant from YUVIWEL or from the underlying maternal condition.

Renal Impairment

YUVIWEL is not recommended for patients with moderate or severe renal impairment.

You are encouraged to report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Update Cookie Preference