Yuviwel

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

• The safety and effectiveness of YUVIWEL to increase linear growth have been established in pediatric patients aged 2 years and older with achondroplasia with open epiphyses.
• Use of YUVIWEL for this indication is supported by evidence from a 52-week, randomized, placebo-controlled trial in 84 pediatric patients with achondroplasia [see Adverse Reactions (6.1) , Clinical Studies (14) ] .
• The safety and effectiveness of YUVIWEL in pediatric patients less than 2 years of age have not been established.

Quoted from the official label, section “Pediatric Use”.

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 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied YUVIWEL (navepegritide) for injection is supplied as a lyophilized white to off-white powder in a vial, in three strengths:
• 1.3 mg, 2.8 mg, and 5.5 mg (see Table 5 ).
• Each YUVIWEL carton contains 4 Kits with 1 Prescribing Information, and 1 Instructions for Use.
• Table 5:
• YUVIWEL Strengths and Contents of Each Kit Strength Contents of Each Kit (4 Kits in each carton) Carton NDC 1.3 mg vial One 1.3 mg single-dose vial of YUVIWEL for injection with yellow cap One 0.8 mL Sterile Water for Injection, USP (clear, colorless prefilled diluent syringe) 2 single use preparation needles (21 gauge) 1 single use injection syringe 1 single use injection needle (30 gauge) 73362-201-01 2.8 mg vial One 2.8 mg single-dose vial of YUVIWEL for injection with blue cap One 0.8 mL Sterile Water for Injection, USP (clear, colorless prefilled diluent syringe) 2 single use preparation needles (21 gauge) 1 single use injection syringe 1 single use injection needle (30 gauge) 73362-202-01 5.5 mg vial One 5.5 mg single-dose vial of YUVIWEL for injection with violet cap One 1.1 mL Sterile Water for Injection, USP (clear, colorless prefilled diluent syringe) 2 single use preparation needles (21 gauge) 1 single use injection syringe 1 single use injection needle (30 gauge) 73362-203-01 Only use the vial, needles, and syringes that are in the Kits for handling of YUVIWEL [see Dosage and Administration (2.3) ] and
• do not use the components for other medicinal products.
• 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 to 30°C (86°F) for up to 6 months and can be returned to refrigeration within the 6 months.
• Do not use YUVIWEL beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
• Reconstituted YUVIWEL can be stored at room temperature up to 30°C (86°F) for up to 4 hours.
• Discard unused reconstituted solution.

Quoted from the official label, section “How Supplied”.

How to store it

• 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 to 30°C (86°F) for up to 6 months and can be returned to refrigeration within the 6 months.
• Do not use YUVIWEL beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).
• Reconstituted YUVIWEL can be stored at room temperature up to 30°C (86°F) for up to 4 hours.
• Discard unused reconstituted solution.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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 (1.0 mg), trehalose dihydrate (66.7 mg), tromethamine and hydrochloric acid (q.s. for adjustment to pH 5.0) 4.6 mg/mL 5.5 mg/vial Navepegritide equivalent to 6.9 mg CNP(89-126), succinic acid (1.5 mg), trehalose dihydrate (91.9 mg), tromethamine and hydrochloric acid (q.s. for adjustment to pH 5.0) 5.5 mg/mL Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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