Voxzogo (vosoritide)
Bone Formation Stimulating Agents - Natriuretic Peptide Subcutaneous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Vosoritide is a human C-type natriuretic peptide (CNP) analog.
Vosoritide is a human C-type natriuretic peptide (CNP) analog. In patients with achondroplasia, endochondral bone growth is negatively regulated due to a gain of function mutation in fibroblast growth factor receptor 3 (FGFR3). Binding of vosoritide to natriuretic peptide receptor-B (NPR-B) antagonizes FGFR3 downstream signaling by inhibiting the extracellular signal-regulated kinases 1 and 2 (ERK1/2) in the mitogen-activated protein kinase (MAPK) pathway at the level of rapidly accelerating fibrosarcoma serine/threonine protein kinase (RAF-1).
As a result, vosoritide, like CNP, acts as a positive regulator of endochondral bone growth as it promotes chondrocyte proliferation and differentiation.
In animal models with open growth plates, vosoritide administration resulted in the promotion of chondrocyte proliferation and differentiation that led to a widening of the growth plate and subsequent increase in skeletal growth. In the mouse models of FGFR3-related chondrodysplasia, a partial or complete normalization of the dwarfism phenotype was observed.
Absolute bioavailability of vosoritide following subcutaneous injection has been not determined. Vosoritide was absorbed with a median time to peak concentration of 15 minutes after dosing. The mean half-life of vosoritide ranged from 21-27.9 minutes.
The mean apparent clearance of vosoritide across 52 weeks of subcutaneous administration of 15 mcg/kg once daily ranged from 79.4-104 mL/minute per kg. Vosoritide is expected to be metabolized via catabolic pathways with degradation into small peptide fragments and amino acids. Body weight is a significant covariate for vosoritide clearance and volume of distribution.
The apparent clearance and volume of distribution of vosoritide increased with increasing body weight in patients with achondroplasia (5-74.5 kg).
USES: This medication is used to treat children with achondroplasia. Achondroplasia is a condition that affects bone growth, making them shorter than usual, especially the arms and legs. Vosoritide works by promoting bone growth in children who are still growing.
Generic name: vosoritide
Pronunciation: (voe-SOR-i-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 Voxzogo
Indications
The following indications are listed for Voxzogo:
- 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.
Vosoritide is injected subcutaneously. Caregivers may inject vosoritide after proper training by a healthcare professional on preparation and administration. Rotate sites for subcutaneous injections. The recommended injection sites are: the front middle of the thighs, the lower part of the abdomen at least 2 inches (5 centimeters) away from the navel, top of the buttocks, or the back of the upper arms. Do not use the same injection area on 2 consecutive days. Do not inject vosoritide into sites that are red, swollen, or tender.
If a dose of vosoritide is missed, administer the missed dose within 12 hours of the scheduled time of administration. If the missed dose cannot be administered within 12 hours, skip the missed dose and administer the next daily dose according to the usual dosing schedule.
Refrigerate vosoritide vials and prefilled diluent syringes at 2-8degreesC in original containers and protect from light. Do not freeze. Vosoritide can be stored at a room temperature of 20-25degreesC (excursions permitted to 15-30degreesC) for 90 days. Do not return vosoritide to the refrigerator once stored at room temperature. After reconstitution, vosoritide can be held in the vial at a room temperature of 20-25degreesC for a maximum of 3 hours. Reconstituted vosoritide must be administered within 3 hours of reconstitution.
Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No clinical studies evaluating the drug-drug interaction potential of vosoritide have been conducted.
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 (>10%) are injection site erythema, injection site swelling, rash, vomiting, injection site urticaria, arthralgia, decreased blood pressure, and gastroenteritis.
More Frequent
- Gastroenteritis
- Hypotension
More Frequent
- Arthralgia
- Injection site erythema
- Injection site sequelae
- Localized edema
Less Frequent
- Diarrhea
- Dizziness
- Dry skin
- Earache
- Fatigue
- Induration of skin
- Influenza
- Seasonal allergic rhinitis
- Urticaria
Rare or Very Rare
- Hirsutism
Precautions
No enhanced messaging available.
The safety and effectiveness of vosoritide have been established in pediatric patients for the improvement in linear growth in patients with achondroplasia with open epiphyses. Use of vosoritide for this indication is supported by evidence from an adequate and well-controlled study in pediatric patients 5 to 15 years of age, pharmacokinetic data in pediatric patients 4.5 months to 15 years of age, and additional safety data in pediatric patients 4.4 months to <5 years of age.
There are no available data on vosoritide use 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, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at dosages equivalent to 14 times and 200 times, respectively, the exposure at the maximum recommended human dosage.
There is no information regarding the presence of vosoritide in human milk, the effects on the breast-fed infant, or the effects on milk production. Vosoritide is present in rat milk; therefore, it is likely that the drug will be present in human milk. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for vosoritide and any potential adverse effects on the breast-fed child from vosoritide 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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