Active Ingredient: Vosoritide
Vosoritide is indicated for the treatment of achondroplasia in patients 4 months 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:
For:
Regimen A: In case that patient age in months is ≥ 4 and patient weight is ≥ 4 kg and patient weight is < 5 kg, subcutaneous, 0.12 milligrams vosoritide, once daily.
Regimen B: In case that patient age in months is ≥ 4 and patient weight is ≥ 5 kg and patient weight is < 6 kg, subcutaneous, 0.16 milligrams vosoritide, once daily.
Regimen C: In case that patient age in months is ≥ 4 and patient weight is ≥ 6 kg and patient weight is < 8 kg, subcutaneous, 0.2 milligrams vosoritide, once daily.
Regimen D: In case that patient age in months is ≥ 4 and patient weight is ≥ 8 kg and patient weight is < 12 kg, subcutaneous, 0.24 milligrams vosoritide, once daily.
Regimen E: In case that patient age in months is ≥ 4 and patient weight is ≥ 12 kg and patient weight is < 17 kg, subcutaneous, 0.28 milligrams vosoritide, once daily.
Regimen F: In case that patient age in months is ≥ 4 and patient weight is ≥ 17 kg and patient weight is < 22 kg, subcutaneous, 0.32 milligrams vosoritide, once daily.
Regimen G: In case that patient age in months is ≥ 4 and patient weight is ≥ 22 kg and patient weight is < 33 kg, subcutaneous, 0.4 milligrams vosoritide, once daily.
Regimen H: In case that patient age in months is ≥ 4 and patient weight is ≥ 33 kg and patient weight is < 44 kg, subcutaneous, 0.5 milligrams vosoritide, once daily.
Regimen I: In case that patient age in months is ≥ 4 and patient weight is ≥ 44 kg and patient weight is < 60 kg, subcutaneous, 0.6 milligrams vosoritide, once daily.
Regimen J: In case that patient age in months is ≥ 4 and patient weight is ≥ 60 kg and patient weight is < 90 kg, subcutaneous, 0.7 milligrams vosoritide, once daily.
Regimen K: In case that patient age in months is ≥ 4 and patient weight is ≥ 90 kg, subcutaneous, 0.8 milligrams vosoritide, once daily.
Vosoritide is given as a daily subcutaneous injection. The recommended dose is based on the patient’s weight and is approximately between 15-30 μg/kg, where the higher dose is given to smallest children, see Table 1.
The dose can be administered using either mL graduated syringes or Unit (U) graduated syringes (see Table 1). The measurements for the Unit graduated syringes are equivalent to mL as follows: 0.1 mL = 10 Units. For practicality reasons and to account for weight-related PK changes, the following dosing is recommended.
Table 1. Single dose volumes by body weight in mL and Units (U) volumes:
| Body weight (kg) | Dose (mg) | 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 | Units | mL | Units | mL | Units | ||
| 4 | 0.12 mg | 0.15 mL | 15 U | ||||
| 5 | 0.16 mg | 0.20 mL | 20 U | ||||
| 6-7 | 0.20 mg | 0.25 mL | 25 U | ||||
| 8-11 | 0.24 mg | 0.30 mL | 30 U | ||||
| 12-16 | 0.28 mg | 0.35 mL | 35 U | ||||
| 17-21 | 0.32 mg | 0.40 mL | 40 U | ||||
| 22-32 | 0.40 mg | 0.50 mL | 50 U | ||||
| 33-43 | 0.50 mg | 0.25 mL | 25 U | ||||
| 44-59 | 0.60 mg | 0.30 mL | 30 U | ||||
| 60-89 | 0.70 mg | 0.35 mL | 35 U | ||||
| ≥90 | 0.80 mg | 0.40 mL | 40 U | ||||
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).
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 an adequate amount 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).
If possible, this medicinal product should be injected at approximately the same time each day.
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