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Voxzogo Generic Name & Formulations
Legal Class
Rx
General Description
Vosoritide 0.4mg, 0.56mg, 1.2mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free; contains trehalose dihydrate, mannitol.
Pharmacological Class
Human C type natriuretic peptide (CNP) analog.
How Supplied
Single-dose vials (2mL)—10 (w. prefilled diluent syringes, needles, syringes)
Manufacturer
Generic Availability
NO
Mechanism of Action
Vosoritide binds to natriuretic peptide receptor-B (NPR-B), which antagonizes fibroblast growth factor receptor 3 downstream signaling by inhibiting the extracellular signal-regulated kinases 1 and 2 (ERK1/2) in the mitogen-activated protein kinase 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.
Voxzogo Indications
Indications
To increase linear growth in children with achondroplasia and open epiphyses.
Voxzogo Dosage and Administration
Adult
Not applicable.
Children
Give by SC inj once daily (at same time each day) into middle of thighs, lower abdominal area, buttocks, or upper arms; rotate inj sites. Base dose on actual body weight. 3kg: 0.096mg; 4kg: 0.12mg; 5kg: 0.16mg; 6–7kg: 0.2mg; 8–11kg: 0.24mg; 12–16kg: 0.28mg; 17–21kg: 0.32mg; 22–32kg: 0.4mg; 33–43kg: 0.5mg; 44–59kg: 0.6mg; 60–89kg: 0.7mg; ≥90kg: 0.8mg.
Voxzogo Contraindications
Not Applicable
Voxzogo Boxed Warnings
Not Applicable
Voxzogo Warnings/Precautions
Warnings/Precautions
Risk of transient decreases in BP. Ensure adequate food and fluid intake (~240–300mL) prior to initiation. Monitor body weight, growth, physical development regularly every 3–6 months. Permanently discontinue if no further growth potential due to closure of epiphyses. Renal impairment (eGFR <60mL/min/1.73m2): not recommended. Pregnancy. Nursing mothers.
Voxzogo Pharmacokinetics
Absorption
Absolute bioavailability: not determined. Median Tmax: 15 minutes after dosing.
Distribution
Mean apparent volume of distribution: 2880 (±2450) to 3020 (±1980) mL/kg.
Elimination
Half-life: 21.0 (±4.7) to 27.9 (±9.9) minutes. Mean apparent clearance: 79.4 (±53.0) to 104 (±98.8) mL/min/kg.
Voxzogo Interactions
Not Applicable
Voxzogo Adverse Reactions
Adverse Reactions
Inj site reactions (erythema, swelling, urticaria), vomiting, arthralgia, decreased BP, gastroenteritis, diarrhea, dizziness, ear pain, influenza.
Voxzogo Clinical Trials
See Literature
Voxzogo Note
Not Applicable
Voxzogo Patient Counseling
See Literature
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