Voxzogo (vosoritide) is an innovative drug for achondroplasia in children. Its dosage and administration are crucial for ensuring therapeutic effects and patient safety. A correct and reasonable medication plan not only helps the effective absorption and action of the drug but also reduces the risk of unnecessary side effects.

Dosage and Administration of Voxzogo (vosoritide)

1.Instructions before Medication

To reduce the risk of hypotension and its related signs and symptoms, caregivers and patients should be instructed:

• Sufficient food should be taken before the injection of vosoritide.

• Drink about 240 to 300 ml of liquid within one hour before the injection of vosoritide.

2.Recommended Dosage and Administration Method

(1) General Recommended Dosage and Administration

The recommended dosage of vosoritide is based on the patient's actual body weight.

Vosoritide is administered subcutaneously once a day. If possible, inject vosoritide at approximately the same time every day. The dosage (injection volume) of vosoritide depends on the patient's actual body weight and the concentration of reconstituted vosoritide (0.8 mg/mL or 2 mg/mL). Vosoritide must be reconstituted before use.

(2) Missed Dose

If a dose of vosoritide is missed, it can be administered within 12 hours of the scheduled administration time. If more than 12 hours have passed, the missed dose should be skipped, and the next daily dose should be administered according to the usual dosage schedule.

3.Growth Monitoring

Regularly monitor and evaluate the patient's weight, growth, and physical development every 3-6 months. Adjust the dosage according to the patient's actual body weight.

Vosoritide can be permanently discontinued after epiphyseal closure when it is confirmed that there is no further growth potential.

4.Preparation before Medication and Medication Management

Before administration, reconstitute vosoritide using the provided dilution syringe containing sterile water for injection (USP).

Caregivers can administer vosoritide subcutaneously after receiving appropriate training from healthcare professionals on the preparation and administration of vosoritide.

(1) Reconstitution Instructions

Select the correct concentration of vosoritide vial (packaged with a pre-filled syringe of sterile water for injection diluent) according to the patient's actual body weight.

• Remove the vosoritide vial and the pre-filled diluent syringe from the refrigerator and allow the vial and pre-filled diluent syringe to reach room temperature before reconstituting vosoritide.

• Attach the diluent needle with auxiliary supplies to the pre-filled diluent syringe.

• Inject the entire volume of diluent from the pre-filled syringe into the vial.

• Gently rotate the diluent in the vial until the white powder is completely dissolved. Do not shake.

• Where solution and container permit, visually inspect for particulate matter and discoloration before administration. Vosoritide is a clear, colorless to yellow liquid. If the solution is discolored or turbid, or if particles are present, it should not be used. The concentration of the reconstituted solution is 0.8 mg/mL or 2.0 mg/mL.

• After reconstitution, vosoritide can be kept in the vial at room temperature (20°C to 25°C [68°F to 77°F]) for a maximum of 3 hours.

• For administration, extract the required dose from the vial using an administration syringe.

Discard any unused portion; do not retain the unused portion in the vial. Also, do not administer more than one dose from a single vial, and do not mix with other drugs.

(2) Subcutaneous Administration Instructions

• Ensure that the patient has taken sufficient food and liquid before receiving vosoritide. Slowly aspirate the reconstituted vosoritide solution from the single-dose vial into the syringe.

• Rotate the subcutaneous injection sites.

• The recommended injection sites for vosoritide are: the middle of the anterior thigh, the lower half of the abdomen at least 2 inches (5 cm) away from the navel, the top of the buttocks, or the back of the upper arm. The same injection site should not be used for two consecutive days.

Do not inject vosoritide into red, swollen, or tender areas.