Yuviwel

navepegritide

Drug Monograph

Black Box Warnings
Adult Dosing
Peds Dosing
Contraindications/Cautions
Drug Interactions
Adverse Reactions
Safety/Monitoring
Pregnancy/Lactation
Pharmacology
Formulary
Manufacturer/Pricing
Patient Education
Pill Pictures
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Dosing Calculator

Adult Dosing .

Adult dosing is currently unavailable or not applicable for this drug.

Peds Dosing .

Dosage forms: INJ: 1.3 mg per vial, 2.8 mg per vial, 5.5 mg per vial

achondroplasia

[2 yo and older, 8-9.9 kg]: Dose: 0.88 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 10-13.4 kg]: Dose: 1.2 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 13.5-17.5 kg]: Dose: 1.6 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 17.6-23 kg]: Dose: 2.1 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 23.1-30.5 kg]: Dose: 2.8 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 30.6-41.2 kg]: Dose: 3.6 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 41.3-55.9 kg]: Dose: 5 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 56-73.5 kg]: Dose: 6.6 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

[2 yo and older, 73.6-90 kg]: Dose: 8.8 mg SC qwk; Info: give doses >5 days apart; D/C when epiphyses close

renal dosing

[see below]: eGFR >60: no adjustment; eGFR <60: not defined

HD/PD: not defined

hepatic dosing

[not defined]

Contraindications / Cautions .

hypersensitivity to drug or ingredient
caution: hypotension risk

Drug Interactions .

Overview

navepegritide

C-type natriuretic peptide (CNP) analog

Interaction Characteristics:

None

No significant interactions known or found for this drug. Caution always advised with multiple medications.

Adverse Reactions .

Serious Reactions

hypotension risk

Common Reactions

vomiting
injection site reaction
extremity pain
nausea
hypertrichosis

Safety/Monitoring .

Monitoring Parameters
no routine tests recommended

Pregnancy/Lactation .

Pregnancy

Clinical Summary

weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at up to 10x MRHD

Lactation

Clinical Summary

weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production

Pharmacology .

Metabolism: for navepegritide: proteolytic degradation; CYP450: unknown

Excretion: for navepegritide: unknown; Half-life: 5.3 days

Subclass: Skeletal Dysplasias

Mechanism of Action
for navepegritide: prodrug converted to C-type natriuretic peptide, which binds natriuretic peptide receptor-B (NPR-B) to block fibroblast growth factor receptor 3 (FGFR3) downstream signaling, resulting in endochondral bone growth

Formulary .

No Formulary Selected

Manufacturer/Pricing .

Manufacturer: Ascendis Pharma, Inc.

DEA/FDA: Rx

Retail Price

This information is currently not available for this drug.

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