Yuviwel (navepegritide) is filed as C-type natriuretic peptide analog. The sections below restate public label fields stored for this profile.
1 INDICATIONS 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 [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) 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). ( 1 )
12.1 Mechanism of Action CNP released from navepegritide has the same receptor binding affinity and activity as endogenous CNP. CNP binds to natriuretic peptide receptor-B (NPR-B), which inhibits the mitogen activated protein kinase signaling (MAPK) pathway. Achondroplasia is caused by a gain-of-function variant in the fibroblast growth factor receptor 3 (FGFR3) leading to overactive downstream signaling. The overly active FGFR3 inhibits endochondral ossification leading to short stature and skeletal dysplasia. Like endogenous CNP, CNP released from navepegritide binds to NPR-B, stimulating an
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.
4 CONTRAINDICATIONS None. None. ( 4 )
Vomiting (≥5%); Injection-site reaction (≥5%); Pain in extremity (≥5%); Nausea (≥5%)
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. At Week 52, all participants transitioned to an OLE period during which they received navepegritide 0.1 mg/kg/week for 104 weeks. The adverse reaction rates for navepegritide were derived from pediatric participants with achondroplasia who received navepegritide 0.1 mg/kg/week or placebo during the double-blind period of Trials 1 and 2. Of the dosages evaluated in Trials 1 and 2, 0.1 mg/kg/week is most similar to the approved weight-based dosage listed in Table 1. Adverse reactions reported in the placebo-controlled pooled periods of Trials 1 and 2 in ≥ 5% of navepegritide-treated patients and at an incidence at least 2% greater than with placebo are presented in Table 2. Table 2: Adverse Reactions Reported in ≥ 5% of Participants Treated with Navepegritide 0.1 mg/kg/week and ≥ 2% Higher Than Placebo During the Placebo-Controlled Period of Trials 1 and 2 Adverse Reaction NAVEPEGRITIDE 0.1 mg /kg/week N = 68 n (%) Placebo N = 42 n (%) Vomiting 14 (21) 6 (14) Injection-site reaction Includes injection-site swelling, injection-site erythema, injection-site bruising, injection-site reaction, injection-site pruritus, injection-site discoloration, injection-site hemorrhage, injection-site pain, injection-site vesicles, and injection-site edema . 13 (19) 6 (14) Pain in extremity 8 (12) 3 (7) Nausea 4 (6) 0 Injection-Site Reactions During the 52-week double-blind period of Trials 1 and 2, 13 of 68 (19%) participants receiving navepegritide 0.1 mg/kg/week experienced a total of 25 events of injection-site reactions, while 6 of 42 (14%) participants receiving placebo experienced a total of 6 events of injection site reactions, corresponding to 0.4 events per person year exposure and 0.2 events per person year exposure, respectively. Other Adverse Reactions from Trials 1 and 2 (Pooled) Hypertrichosis Hypertrichosis was reported in 2 of 68 patients (3%) receiving navepegritide 0.1 mg/kg/week compared to none receiving placebo in the double-blind periods of Trials 1 and 2. Cases presented as localized hair growth at injection sites or generalized increased body hair growth affecting limbs, back, or shoulders. To reduce the risk of local skin changes, rotate the site of injection with each dose.
2 DOSAGE AND ADMINISTRATION Administer once-weekly by subcutaneous injection. Dosage is based on body weight. ( 2.1 ) Periodically monitor growth and adjust dose according to body weight. Discontinue when no further growth potential, as indicated by epiphyseal closure. ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.3 , 2.4 ) 2.1 Recommended Dosage and Administration The recommended once-weekly dosage of YUVIWEL is based on the patient´s body weight (see Table 1 ). YUVIWEL is administered by subcutaneous injection. YUVIWEL must be reconstituted prior to use [see Dosage and Administration (2.3) ]. Table 1: Recommended YUVIWEL Weekly Dosage and Injection Volume Patient Body weight Weekly Dose Injection Volume Vial Strength for Reconstitution The concentration of navepegritide is 2.2 mg/mL in a reconstituted 1.3 mg vial; 4.6 mg/mL in a reconstituted 2.8 mg vial; and 5.5 mg/mL in a reconstituted 5.5 mg vial. 8 to 9.9 kg 0.88 mg 0.4 mL 1.3 mg 10 to 13.4 kg 1.2 mg 0.55 mL 13.5 to 17.5 kg 1.6 mg 0.35 mL 2.8 mg 17.6 to 23 kg 2.1 mg 0.45 mL 23.1 to 30.5 kg 2.8 mg 0.6 mL 30.6 to 41.2 kg 3.6 mg 0.65 mL 5.5 mg 41.3 to 55.9 kg 5 mg 0.9 mL 56 to 73.5 kg 6.6 mg 1.2 mL (use 2 Kits) Administer 0.6 mL from each Kit 73.6 to 90 kg 8.8 mg 1.6 mL (use 2 Kits) Administer 0.8 mL from each Kit Switching from Daily C-type Natriuretic Peptide (CNP) Analog Start once-weekly YUVIWEL on the day after completing the last dose of daily CNP therapy. 2.2 Monitor Growth Periodically monitor the patient's growth and adjust the dosage according to the actual body weight [see Dosage and Administration (2.1) ] . Discontinue YUVIWEL upon confirmation of no further growth potential, indicated by closure of the epiphyses. 2.3 Preparation of YUVIWEL for Administration Patients and caregivers who will administer YUVIWEL should receive appropriate training by a healthcare provider prior to use. Refer to the Instructions for Use for complete preparation and administration instructions with illustrations. Before administration, reconstitute YUVIWEL using the provided prefilled diluent syringe containing Sterile Water for Injection as described below. Needles and syringes supplied with YUVIWEL are for single use only. If the product was refrigerated, allow the YUVIWEL vial and the prefilled diluent syringe to reach room temperature (about 30 minutes) before reconstitution. Screw a preparation needle onto the prefilled diluent syringe and inject the entire diluent volume into the vial. Shake the vial up and down for 15 seconds. Do not swirl or roll. The reconstituted YUVIWEL vial should stand at room temperature for 5 minutes after shaking. Dispose the diluent syringe with attached preparation needle immediately after injecting the diluent into the vial. YUVIWEL should be visually inspected for particles or discoloration prior to administration, whenever solution and container permit. Once reconstituted, YUVIWEL is a clear and colorless solution. Do not use the solution if it is discolored, cloudy or contains visible particles. Air bubbles may be seen, and this is normal. Screw a new preparation needle onto the injection syringe and withdraw the prescribed injection volume from the reconstituted vial. Remove air from the withdrawn dose volume before continuing and ensure the withdrawn dose volume is correct after removing any air. Remove and dispose the preparation needle from the injection syringe. Screw the injection needle onto the injection syringe before administration. Two Kits are needed to achieve a complete dose for patients with body weight 56 kg or greater, where the prescribed injection volume is greater than 1 mL. Reconstituted YUVIWEL can be stored at room temperature up to 30°C (86°F) for up to 4 hours. 2.4 Administration Instructions Refer to the Instructions for Use for complete administration instructions with illustrations. Using the prepared syringe, administer the prescribed injection volume [see Dosage and Administration (2.1 , 2.3) ] . Administer YUVIWEL subcutaneously in the abdominal region (2 inches from the belly button) or thighs. If a caregiver is administering YUVIWEL, subcutaneous injection in the buttocks or back of the upper arm is also acceptable. Rotate injection sites. Do not give an injection into sites other than described above. Avoid injecting where the skin is red, swollen, or scarred. Administer YUVIWEL once weekly on the dosing day, at any time of day. All YUVIWEL components are for single use only. Do not draw up more than one injection volume, as specified in Table 1, from a vial. For injection volumes greater than 1 mL, use two Kits to achieve a complete dose. The two injections must be given one after the other, using different injection sites. Discard the unused reconstituted solution. 2.5 Missed Dose If a dose of YUVIWEL is missed, administer the missed dose as soon as possible but not more than 2 days after the missed dosing day. To avoid missed doses, YUVIWEL can be taken up to 2 days before or 2 days after the scheduled dosing day. Resume once-weekly dosing for the next dose at the previously scheduled dosing day. If more than 2 days have passed from the dosing day, skip the missed dose and administer the dose on the next regularly scheduled day. At least 5 days should elapse between doses.
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Provide appropriate instructions for injection to the patient/caregiver based on the YUVIWEL Instructions for Use (available at www.Yuviwel.com). Patients/caregivers and healthcare providers may also call the Ascendis Pharma Customer Support toll-free number at 1-844-442-7236 (1-844-44ASCENDIS) for assistance or additional training, if needed. Advise patients/caregivers to refer to the Instructions for Use that accompanies YUVIWEL for complete reconstitution and administration instructions with illustrations [see Dosage and Administration (2.3 , 2.4) ] . Advise patients/caregivers to administer YUVIWEL once weekly on the dosing day, at any time of day. Advise patients and caregivers to rotate the site of injection to reduce the risk of injection site reactions [see Dosage and Administration (2.4) ]. Missed Dose [see Dosage and Administration (2.5) ] Advise patients/caregivers that to avoid missed doses, YUVIWEL can be taken up to 2 days before or 2 days after the scheduled dosing day. If a dose is missed and more than 2 days have passed from the scheduled day, advise patients/caregivers to skip the missed dose and administer the next dose on the regularly scheduled day. To change the regular dosing day to a different day of the week, advise patients/caregivers to ensure that at least 5 days will elapse between the last dose and the newly established regular dosing day. Risk of Low Blood Pressure Advise patients and/or caregivers 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 [see Warnings and Precautions (5.1) ] .
According to its FDA label, Yuviwel (navepegritide) is approved for: 1 INDICATIONS 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 [see Clini… For medical advice, please talk to your prescriber or pharmacist.
Yuviwel (navepegritide) belongs to the C-type natriuretic peptide analog class of medications.
The FDA label lists Yuviwel (navepegritide) as: 3 DOSAGE FORMS AND STRENGTHS For injection: 1.3 mg, 2.8 mg, and 5.5 mg of CNP(89-126) as a white to off-white lyophilized powder in a single-dose vial for reconstitution. For injection: 1.3 mg, 2.8 mg, and 5.5 mg as a lyophilized powder in single-dose vial for reconstitution. ( 3 ). Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Yuviwel. Availability changes as patents expire.
Our ingest of the FDA label for Yuviwel (navepegritide) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Yuviwel (navepegritide) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Yuviwel (navepegritide) as 2026-02-27.
The FDA label lists Ascendis Pharma Endocrinology, Inc. as a labeler/manufacturer of Yuviwel (navepegritide). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling Store YUVIWEL refrigerated between 2°C to 8°C (36°F to 46°F). Store in the original packaging until time of use to protect from light. Do not freeze. YUVIWEL can also be stored at room temperature up…" Follow the packaging insert for the authoritative guidance.
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