yuviwel
Yuviwel (Navepegritide) is a medication used to treat Achondroplasia.
Navepegritide · by Ascendis
Key facts
- Active ingredient
- Navepegritide
- Form
- Kit
- Strength
- Navepegritide 1.3MG/VIAL · Navepegritide 2.8MG/VIAL · Navepegritide 5.5MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- achondroplasia
- Manufacturer
- Ascendis
- FDA application
- NDA219164
What is Yuviwel?
From the FDA label:YUVIWEL for injection contains navepegritide, a C-type natriuretic peptide (CNP) analog. Navepegritide is a prodrug of active CNP consisting of a CNP moiety transiently conjugated to two branched 20 kDa methoxy polyethylene glycol (mPEG) moieties via a proprietary TransCon ® Linker. The amino acid sequence of the CNP moiety is identical to the 38 amino acid sequence of residues 89-126 of human CNP. The structural formula of navepegritide is as follows: The molecular formula is C 231 H 386 N 64 O 67 S 5 + 4 × (C 2 H 4 O)n, where n is between 200 and 250. The average molecular weight is approximately 45 kDa. YUVIWEL is provided as a sterile, lyophilized white to off-white powder for reconstitution to a colorless solution with Sterile Water for Injection, USP (diluent). The diluent for reconstitution of YUVIWEL is provided in a prefilled syringe. The compositions of YUVIWEL are shown in Table 3. Table 3: Content of YUVIWEL Strength Composition of YUVIWEL (gross content per vial) An overfill is included in the vial to compensate for loss in the vial and during transfer. CNP(89-126) Concentration After Reconstitution 1.3 mg/vial Navepegritide equivalent to 1.9 mg CNP(89-126), succinic acid (1.0 mg), trehalose dihydrate (72.2 mg), tromethamine and hydrochloric acid (q.s. for adjustment to pH 5.0) 2.2 mg/mL 2.8 mg/vial Navepegritide equivalent to 4.0 mg CNP(89-126), succinic acid…
How to use
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…
Side effects
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…
Warnings
Important safety information
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.
Who should not take Yuviwel
None. None. ( 4 )
Storing Yuviwel, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store YUVIWEL refrigerated between 2°C to 8°C (36°F to 46°F).”
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Yuviwel treat?
- Yuviwel (Navepegritide) may be used to treat achondroplasia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Yuviwel?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Yuviwel. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Yuviwel?
- Yuviwel is marketed by Ascendis. You can see Ascendis's full profile, rating, and other products on pharmaranks.
- Is Yuviwel a brand-name or generic drug?
- Yuviwel is a brand-name product with the active ingredient Navepegritide.
- Is Yuviwel available over the counter?
- No. Yuviwel is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Yuviwel come in?
- Yuviwel is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Yuviwel FDA-registered?
- Yuviwel is on record with the U.S. FDA under application number NDA219164. You can verify this on its official FDA label.
- Is Yuviwel safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Yuviwel. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Yuviwel?
- Yuviwel's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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