Navepegritide
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment YUVIWEL is not recommended for patients with moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m 2 ). The recommended dosage for patients with mild renal impairment (eGFR ≥ 60 mL/min/1.73 m 2 ) is the same as the recommended dosage for patients with normal renal function [see Clinical Pharmacology ] .
Preparation and administration
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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 ]. [See table below.] 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.
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.
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.
| Patient Body weight | Weekly Dose | Injection Volume | Vial Strength for ReconstitutionThe 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 |
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on the use of YUVIWEL in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of navepegritide during the period of organogenesis in pregnant rats and rabbits resulted in no impact on embryo-fetal survival or congenital malformations at doses up to 10- and 7-fold, respectively, the exposure at the maximum recommended human dose (MRHD) (see Data ) . Achondroplasia is an autosomal dominant genetic disorder with 100% penetrance.
Therefore, there is a 50% risk for a parent with achondroplasia to have a child with achondroplasia. The estimated background risk of birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal developmental toxicity study in pregnant rats, navepegritide was administered subcutaneously during the period of organogenesis (gestation day 6 to 20) at doses from 0.45 to 1.3 mg/kg/day.
There was no effect on embryo-fetal survival, fetal toxicity, or embryo-fetal development up to the highest dose tested, corresponding to 10-fold the exposure at the MRHD [based on area under the curve (AUC)]. In an embryo-fetal developmental toxicity study in pregnant rabbits, navepegritide was administered subcutaneously during the period of organogenesis (gestation day 7 to 27) at doses from 0.3 to 0.9 mg/kg/every fourth day. There was no effect on embryo-fetal survival, fetal toxicity, or congenital malformations up to the highest dose tested, corresponding to 7-fold the exposure at the MRHD (based on AUC).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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