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

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:

^* 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.

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.

• 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.