YUVIWEL Powder for solution for injection Ref.[116347] Active ingredients:

Source: FDA, National Drug Code (US) Revision Year: 2026

Product description

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 C₂₃₁H₃₈₆N₆₄O₆₇S₅ + 4 × (C₂H₄O)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)*	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

^* An overfill is included in the vial to compensate for loss in the vial and during transfer.

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.

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.

Manufactured for: Ascendis Pharma Growth Disorders A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark

Drugs

Drug	Countries
YUVIWEL	United States

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