Yuviwel (navepegritide)
Bone Formation Stimulating Agents - Natriuretic Peptide Subcutaneous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Navepegritide, a C-type natriuretic peptide (CNP) analog, is a prodrug of active CNP consisting of a CNP moiety conjugated to methoxypolyethylene glycol (mPEG).
USES: This medication is used to treat achondroplasia. Achondroplasia is a condition that affects bone growth, making them shorter than usual, especially the arms and legs. Navepegritide works by promoting bone growth in children who are still growing.
Generic name: navepegritide
Pronunciation: (NAV-eh-PEG-rih-tide)
Drug class: Bone Formation Stimulating Agents - Natriuretic Peptide
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Yuviwel
Indications
The following indications are listed for Yuviwel:
- Growth Failure Due To Achondroplasia
Also known as: Growth Failure Due To Achondroplastic Dwarfism, Growth Failure In Child With Achondroplasia, Short Stature In Pediatric Patient With Achondroplasia.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Hypotension
Adverse reactions
Most common adverse reactions (>= 5%): vomiting, injection-site reaction, pain in extremity, and nausea.
There are no severe adverse reactions for this drug.
More Frequent
- Injection site sequelae
- Pain in extremities
- Vomiting
Less Frequent
- Hirsutism
- Nausea
Precautions
No enhanced messaging available.
The safety and effectiveness of navepegritide to increase linear growth have been established in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. Use of navepegritide for this indication is supported by evidence from a 52-week, randomized, placebo-controlled trial in 84 pediatric patients with achondroplasia. The safety and effectiveness of navepegritide in pediatric patients less than 2 years of age have not been established.
There are no available data on the use of navepegritide 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). 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.
There is no information available regarding the presence of navepegritide in human milk or regarding the potential effects on milk production or on the breastfed newborn/infant. High molecular weight therapeutic compounds, including navepegritide, are expected to have low passage into human milk. Further, no or low anticipated oral absorption of navepegritide will limit any systemic bioavailability in the breastfed newborn/infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for navepegritide and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Growth failure due to achondroplasia | ||
| Q77.4 | ICD10CM | Achondroplasia |
| R62.52 | ICD10CM | Short stature (child) |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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