0.4 mg; 0.56 mg and 1.2 mg respectively powder and liquid for injection, solution
What Voxzogo is and what it is used for
What Voxzogo is
Voxzogo contains the active substance vosoritide. It is similar to a protein in the body called C-type natriuretic peptide (CNP). Vosoritide is produced using recombinant technology, which involves bacteria that have been modified to contain the gene that produces the protein et.
What Voxzogo is used for
This medicine is used to treat achondroplasia in patients aged 2 years and older, whose bones are still growing. Achondroplasia is a genetic condition that affects the growth of almost all bones in the body, including the skull, spine, arms, and legs, leading to short stature with a characteristic appearance.
The medicine is only intended for use in achondroplasia caused by mutations in the FGFR3 gene that have been confirmed via genetic testing.
How Voxzogo works
What you need to know before using Voxzogo
Do not use Voxzogo
- if you or your child are allergic to vosoritide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Voxzogo
- if you or your child have heart disease or blood pressure problems
- if you or your child are taking or have recently taken medicines that lower blood pressure etc.
If any of this applies to you or your child, or if you are not sure, talk to your doctor before using Voxzogo.
Effects on blood pressure et
Voxzogo can lower blood pressure et. It can make you feel dizzy, nauseous, or tired. Blood pressure usually returns to normal within 90 minutes after injection with Voxzogo. If these effects occur and are severe, talk to a doctor.
If you drink plenty of fluids at the time of injection, the likelihood of these effects may decrease. You or your child are advised to eat a light snack and drink a glass of liquid (eg water, milk, or juice) about 30 minutes before injection one.
Children and young people
Other medicines and Voxzogo
Tell the doctor if you or your child are taking, have recently taken, or might be taking other medicines.
Pregnancy and breastfeeding
If you or your child are being treated with this medicine and are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a doctor before using this medicine.
Ability to drive, cycle and use machines
This medicine may make you feel dizzy, tired, or nauseous soon after the injection. If this happens, you should not drive, cycle, do physical activity, or use machinery for about an hour after the injection or until you feel better.
Voxzogo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use Voxzogo
A healthcare provider should give an injection with Voxzogo. Do not give your child an injection of Voxzogo until you have received appropriate training from a healthcare professional.
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor will choose the right dose depending on your or your child’s body weight. The doctor will tell you how much of the solution for injection to inject. Ask your doctor or pharmacist if you are unsure.
You or your child should eat a light snack and drink a glass of water, milk, or juice about 30 minutes before injection one. This can reduce side effects such as dizziness, fatigue, or nausea.
How to use Voxzogo
Inject Voxzogo slowly under the skin ( subcutaneous injection ).
Injection one should be given at approximately the same time each day.
It would help if you gave the injection at a different site each day and not use the same place two days in a row. Do not inject this medicine into skin blemishes, scars, birthmarks, or areas where the skin is tender, red, stiff, or bruised.
If you have used too much Voxzogo
If you forget to use Voxzogo
If you or your child miss a dose, the injection must still be given if it is within 12 hours of the scheduled time. If more than 12 hours have passed since dose one should have been given, the missed dose one should not be injected. Wait until the next day and continue with the usual dose at the usual time.
If you stop using Voxzogo
Always talk to your or your child’s doctor before deciding to stop your or your child’s treatment. If you or your child have any further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects are
May affect more than 1 in 10 users:
- low blood pressure (temporary symptoms, including dizziness, tiredness, or nausea, soon after an injection )
- reactions at the injection site: redness, itching, inflammation, swelling, bruising, rash, hives, pain. Injection site reactions are usually mild and resolve on their own within a few hours.
Common side effects may
affect up to 1 in 10 users:
- feeling faint or dizzy and fainting
- high levels of alkaline phosphatase in the blood (detected by a blood test).
How to store Voxzogo
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after “Expiry Date”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C–8 °C). Must not be frozen. Store in the original packaging. Light sensitive.
Voxzogo can be stored at room temperature (below 30 °C) for up to 90 days, but not after the expiry date. Do not return Voxzogo to the refrigerator after storage at room temperature. Record the date Voxzogo is taken out of the refrigerator and placed at room temperature on the carton.
Use Voxzogo as soon as it has been prepared into a solution. It must always be given within 3 hours of being prepared. Do not use this medicine if the solution for injection is cloudy or contains particles.
Contents of the packaging and other information
- The active substance is vosoritide.
- Each vial of 0.4 mg powder prepared in a solution with 0.5 ml liquid corresponds to a concentration of 0.8 mg/ml.
- Each vial of 0.56 mg powder prepared in a solution with 0.7 ml liquid corresponds to a concentration of 0.8 mg/ml.
- Each vial of 1.2 mg powder prepared in a solution with 0.6 ml liquid corresponds to a concentration of 2 mg/ml.
- Other ingredients are citric acid (E 330), sodium citrate (E 331), trehalose dihydrate, mannitol (E 421), methionine, and polysorbate 80 (E 433).
- The liquid is water for injections.
Appearance and package sizes of the medicine
Voxzogo powder and solution for injection are supplied as
- a white to yellow powder for injection, a solution in a glass vial, and
- a clear and colorless liquid (water for injections ) to dissolve the powder.
When the powder has dissolved in the liquid, the solution is a clear, colorless yellow liquid.
Each carton contains
- 10 vials of Voxzogo
- 10 pre-filled syringes with water for injections
- 10 individually wrapped disposable needles
- 10 individually wrapped disposable syringes.
BioMarin International Limited