Active Ingredient: Vosoritide
Vosoritide is indicated for the treatment of achondroplasia in patients 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
15 - 15 ug per kg of body weight
From 15 To 15 ug per kg of body weight once every day
It is important to initiate treatment in children as young as possible.
The volume of vosoritide to be administered at the recommended dose is based on the patient’s weight and the vosoritide concentration (see Table 1). The usual dose is 15 µg/kg body weight. For practicality reasons and to account for weight-related PK changes, the following dosing is recommended.
Table 1. Single dose volumes by body weight:
| Body weight (kg | Vosoritide 0.4 mg solvent (water for injections): 0.5 mL concentration: 0.8 mg/mL | Vosoritide 0.56 mg solvent (water for injections): 0.7 mL concentration: 0.8 mg/mL | Vosoritide 1.2 mg solvent (water for injections): 0.6 mL concentration: 2 mg/mL |
|---|---|---|---|
| Daily injection volume (mL) | |||
| 10-11 | 0.30 ml | ||
| 12-16 | 0.35 ml | ||
| 17-21 | 0.40 ml | ||
| 22-32 | 0.50 ml | ||
| 33-43 | 0.25 ml | ||
| 44-59 | 0.30 ml | ||
| 60-89 | 0.35 ml | ||
| ≥90 | 0.40 ml | ||
Treatment with this medicinal product should be stopped upon confirmation of no further growth potential, indicated by a growth velocity of <1.5 cm/year and closure of epiphyses.
If a dose of vosoritide is missed, it can be administered within 12 hours. If more than 12 hours have passed since the original dosing schedule, the missed dose should NOT be administered. Patients/caregivers should be advised to continue with the next scheduled dose the following day.
Patients should be monitored and assessed regularly every 3-6 months to check body weight, growth and physical development. Dose should be adjusted according to the patient’s body weight (see Table 1).
Vosoritide is for subcutaneous single use only and must be administered within 3 hours of reconstitution.
Patients and caregivers should be instructed to rotate sites for subcutaneous injections. Recommended injection sites on the body include the front middle of the thighs, the lower part of the abdomen except for 5 cm directly around the navel, top of the buttocks or the back of the upper arms. The same injection area should not be used on two consecutive days. Vosoritide should not be injected into sites that are red, swollen, or tender.
Patients should be well hydrated at the time of injection. It is recommended patients eat a light snack and drink a glass of fluid (e.g., water, milk, juice, etc.) about 30 minutes before injecting. This is to reduce the signs and symptoms of potential decreases in blood pressure (dizziness, fatigue and/or nausea) occurring.
If possible, this medicinal product should be injected at approximately the same time each day.
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