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VOXZOGO (vosoritide)
Achondroplasia patients with open epiphyses.(191-193)
Vosoritide increased annualized growth velocity to 1.87 cm/year.
|
Actual Body Weight |
Vial Strength for Reconstitution* |
Dose |
Injection Volume |
Injection Units
|
|
10-11 kg |
0.4 mg |
0.24 mg |
0.3 mL |
30 U |
|
12-16 kg |
0.56 mg |
0.28 mg |
0.35 mL |
35 U |
|
17-21 kg |
0.56 mg |
0.32 mg |
0.4 mL |
40 U |
|
22-32 kg |
0.56 mg |
0.4 mg |
0.5 mL |
50 U |
|
33-43 kg |
1.2 mg |
0.5 mg |
0.25 mL |
25 U |
|
44-59 kg |
1.2 mg |
0.6 mg |
0.3 mL |
30 U |
|
60-89 kg |
1.2 mg |
0.7 mg |
0.35 mL |
35 U |
|
≥90 kg |
1.2 mg |
0.8 mg |
0.4 mL |
40 U |
For injection: 0.4 mg, 0.56 mg, or 1.2 mg lyophilized powder in a single-dose vial for reconstitution.
Subcutaneous(SC).
Injection site erythema, injection site swelling, vomiting, injection site urticaria, arthralgia, decreased blood pressure, and gastroenteritis.
4
191. Ravi Savarirayan, Louise Tofts, Melita Irving, William R Wilcox, Carlos A Bacino, Julie Hoover-Fong et al., Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study. Clinical Trial Genet Med . 2021 Dec;23(12):2443-2447. doi: 10.1038/s41436-021-01287-7.
192. Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N. C-type natriuretic peptide analogue therapy in children with achondroplasia. New England Journal of Medicine. 2019 Jul 4;381(1):25-35.
193. Chan ML, Qi Y, Larimore K, Cherukuri A, Seid L, Jayaram K, Jeha G, Fisheleva E, Day J, Huntsman-Labed A, Savarirayan R. Pharmacokinetics and Exposure–Response of Vosoritide in Children with Achondroplasia. Clinical pharmacokinetics. 2022 Feb;61(2):263-80.
