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Powder and Diluent for Solution for Injection 10 X 0.4 mg/ 0.5 ml |
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Powder and Diluent for Solution for Injection 10 X 0.56 mg/ 0.7 ml |
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Powder and Diluent for Solution for Injection 10 X 1.2 mg/ 0.6 ml |
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Related information
Dosage
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. Given as a daily subcutaneous injection.
For full details see prescribing information.
Indications
Treatment of achondroplasia in pediatric patients whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
Contra-Indications
Hypersensitivity to the active substance(s) or to any of the excipients
Special Precautions
Blood pressure effects
To reduce the risk of a potential decrease in blood pressure and associated symptoms (dizziness, fatigue and/or nausea), patients should be well hydrated and have adequate food intake at the time of injection.
For full details see prescribing information.
Side Effects
Very common: Hypotension, Vomiting, Injection site reaction, Increased alkaline phosphatase.
Common: Syncope, Pre-syncope, Dizziness, Nausea, Fatigue.
Drug interactions
Because it is a recombinant human protein, vosoritide is an unlikely candidate for drug-drug interactions.
For full details see prescribing information.
Pregnancy and Lactation
Pregnancy: There are no or limited amount of data from the use of vosoritide in pregnant women.
Lactation: A risk to newborns/infants cannot be excluded. Vosoritide should not be used during breast-feeding.
For full details see prescribing information.
Overdose
In clinical trials, doses of vosoritide were explored up to 30 μg/kg/day. Two patients received up to 3 times the recommended daily dose of 15 μg/kg/day for up to 5-weeks. No signs, symptoms or adverse reactions associated with the higher than intended dose were observed.
