Voxzogo

Dosage and administration of Voxzogo

The recommended dosage of Vosoritide is based on the patient’s actual body weight. Vosoritide is administered by subcutaneous injection once daily.
One should have adequate food intake before the administration of Vosoritide.
Drink approximately 240-300 mL of fluid in the hour prior to Voxzogo administration.
Inject Voxzogo at approximately the same time each day, if possible.

Reconstitution instructions

• Select the correct strength of /Voxzogo and prefilled diluent syringe co-pack based on the patient’s actual body weight.
• Remove Voxzogo vial and prefilled diluent syringe (Sterile Water for Injection) from the refrigerator and allow the vial and prefilled diluent syringe to reach room temperature before reconstituting Voxzogo.
• Attach the diluent needle provided with ancillary supplies to the diluent prefilled syringe.
• Inject the entire diluent prefilled syringe volume into the vial.
• Gently swirl the diluent in the vial until the white powder is completely dissolved. Do not shake.
• Parenteral drug products should be inspected visually for particulate matter and discolouration before administration whenever solution and container permit. Once reconstituted, Voxzogo is a clear, colourless to yellow liquid. The solution should not be used if discoloured, cloudy, or if particles are present. The concentration of reconstituted solution is 0.8 mg/mL or 2.0 mg/mL.
• After reconstitution, Voxzogo can be held in the vial at a room temperature of 20°C to 25°C (68°F to 77°F) for a maximum of 3 hours.
• Extract the required dose volume from the vial using the supplied administration syringe.
  Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.

Instructions for Subcutaneous Administration

• Ensure patients have had adequate food and fluid intake before Voxzogo administration. Slowly withdraw the dosing volume of the reconstituted VOXZOGO solution from the single-dose vial into a syringe.
• Rotate sites for subcutaneous injections.
• The recommended injection sites for Voxzogo are the front middle of the thighs, the lower part of the abdomen at least 2 inches (5 centimetres) away from 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. Do not inject Voxzogo into red, swollen, or tender sites.

Side effects of Voxzogo

The common side-effects of Vosoritide are injection site reactions, vomiting, joint pain, decreased blood pressure, and stomach aches.

These are not all the possible side effects of Vosoritide. For more information, ask your healthcare provider or pharmacist.

Warnings and Precautions

In clinical studies, it was observed that patients receiving Vosoritide risk a decrease in blood pressure. To reduce the risk of a decrease in blood pressure and associated symptoms (dizziness, fatigue, and nausea), one should instruct patients to be well hydrated and have adequate food intake before administering Vosoritide.

Handling and storage of Voxzogo

• One should refrigerate Vosoritide vials and prefilled diluent syringes at 2°C to 8°C (36°F to 46°F). One should not freeze this drug.
• Vosoritide can be stored at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for 90 days. Do not return Vosoritide to the refrigerator once stored at room temperature.
• After reconstitution, one could store Vosoritide in the vial at room temperature 20°C to 25°C (68°F to 77°F) for a maximum of 3 hours.