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Voxzogo 0.4mg Injection
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Indications & Clinical Uses
- Voxzogo 0.4 mg (vosoritide) is a once-daily injection given under the skin (subcutaneous) to increase linear growth in children with achondroplasia who still have open growth plates (epiphyses).
- In the US it is approved under accelerated approval based on improvement in growth velocity, with the main trials in children aged 5 to 15 years and safety data from as young as 4.4 months.
- In the EU it is authorised for achondroplasia in patients aged 4 months and older.
- It is supplied as a kit containing a vial of powder, a prefilled syringe of sterile water diluent, needles and syringes, and is mixed just before use.
- Three vial strengths exist (0.4 mg, 0.56 mg and 1.2 mg), and the dose is set by the child's current body weight, so always use the vial and volume your healthcare provider specifies.
- A trained caregiver can give the injection.
Side Effects
- The most common side effects (more than 1 in 10 people) are injection site reactions such as redness, swelling and hives (seen in about 85% of treated children), rash, vomiting, joint pain (arthralgia), decreased blood pressure and gastroenteritis.
- Transient drops in blood pressure can occur, and symptoms such as dizziness, tiredness or nausea should be reported; being well hydrated with adequate food intake before the injection helps reduce the risk.
- Voxzogo has no boxed warning.
- Rotate injection sites each day and contact your healthcare provider if injection site reactions are severe or persistent, or if your child has fainting or repeated vomiting after injections.
Precautions & Warnings
- Give Voxzogo at about the same time each day after adequate food intake and 240 to 300 mL of fluid within one hour before the injection, to reduce the risk of low blood pressure.
- The vial is mixed with sterile water diluent and must be used within 3 hours if kept at room temperature after mixing.
- Your child's weight, growth and development are assessed every 3 to 6 months and the dose is adjusted to current weight.
- Treatment is stopped permanently once the growth plates close.
- There are no human pregnancy data; animal studies at up to 200 times the human dose showed no fetal harm.
- Store unopened kits at 2°C to 8°C and do not freeze; they may be kept at 20°C to 25°C for up to 90 days in total and not returned to the refrigerator afterwards.
Avoid Interactions
- No clinically significant drug-drug interactions were identified in the US label, and laboratory studies showed that vosoritide does not inhibit or induce cytochrome P450 enzymes.
- Medicines that increase its effect or toxicity: none identified in the label.
- Medicines that reduce efficacy: none identified in the label.
- Use only the diluent and supplies provided in the kit.
- Make sure your child is well hydrated and has eaten before each injection, as advised for the low blood pressure risk, and ask your provider before starting any new medicine, including over-the-counter products.
- Tell your healthcare provider about all medicines, herbal products and supplements your child takes.
References
Frequently Asked Questions
Voxzogo (vosoritide) is a daily injection that increases linear growth in children with achondroplasia whose growth plates are still open. In the EU it is authorised from 4 months of age. It works only while the growth plates are open, and treatment stops once they close.
Voxzogo (vosoritide) is injected under the skin once daily at about the same time each day, after your child has eaten and drunk 240 to 300 mL of fluid within the hour before. A trained caregiver can give it. The dose depends on body weight, and the powder is mixed with sterile water first.
Common Voxzogo side effects are injection site redness, swelling and hives, rash, vomiting, joint pain, gastroenteritis and low blood pressure. Voxzogo (vosoritide) can cause a temporary drop in blood pressure, so report dizziness, tiredness or nausea after an injection. There is no boxed warning.
Avoid injecting Voxzogo (vosoritide) on an empty stomach or without extra fluids, because this raises the risk of low blood pressure. No clinically significant drug interactions were found. Do not freeze the kit, and do not put it back in the refrigerator once it has been kept at room temperature.
If a dose of Voxzogo (vosoritide) is missed, give it within 12 hours of the scheduled time. Beyond 12 hours, skip the missed dose and give the next daily dose at the usual time. Do not give two doses to make up for a missed one.
Store Voxzogo (vosoritide) kits in the refrigerator at 2°C to 8°C and do not freeze them. You may keep them at 20°C to 25°C for up to 90 days in total, but they cannot go back in the refrigerator afterwards. Use the mixed solution within 3 hours at room temperature.
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