Voxzogo

What is Voxzogo?

Voxzogo is a prescription medicine used to increase linear growth in children with achondroplasia who are 5 years of age and older with open bone growth plates (epiphyses).
It is not known if Voxzogo is safe and effective in children with achondroplasia under 5 years of age.

What should I tell my healthcare provider before using Voxzogo?

Before you give your child Voxzogo, tell your child's healthcare provider about all your child's medical conditions, including if they:

• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if Voxzogo will harm your child's unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Voxzogo passes into your child's breast milk. Talk to your child's healthcare provider about the best way to feed your child's baby if your child takes Voxzogo.

Tell your child's healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines your child takes. Keep a list of them to show your child's healthcare provider and pharmacist when your child gets a new medicine.

How should I use Voxzogo?

• See the detailed Instructions for use that comes with this Patient Information leaflet for instructions about the right way to store, prepare, and give Voxzogo injections at home.
• Voxzogo is given as an injection under the skin (subcutaneous or SC). Inject Voxzogo 1 time every day, at about the same time each day.
• If your child's healthcare provider decides a caregiver can give the injections of Voxzogo at home, your child's caregiver should receive training on the right way to prepare and inject Voxzogo. Do not try to inject Voxzogo until you have been shown the right way by your child's healthcare provider or nurse.
• Your child's healthcare provider will tell you how often you should give Voxzogo. If your child misses a dose of Voxzogo, it can be given within 12 hours of the scheduled time of injection. If more than 12 hours have passed, do not give the missed dose. Give the next daily dose according to your child's usual schedule.
• Your child should eat a meal and drink about 8 to 10 ounces of fluid within 1 hour before injection.
• In case you are not sure when to inject Voxzogo, call your child's healthcare provider or pharmacist. Do not give Voxzogo more often than as directed by your child's healthcare provider.
• Your child's dose of Voxzogo depends on his or her body weight. Your child's healthcare provider will tell you which strength of Voxzogo to use and how much to give your child.
• Your child's healthcare provider will monitor your child's growth and instruct you on when your child should stop Voxzogo if they determine that your child is no longer able to grow. Stop giving Voxzogo to your child if instructed by your child's healthcare provider.

What are the possible side effects of Voxzogo?

Voxzogo may cause serious side effects, including:

• risk of low blood pressure. Voxzogo may temporarily lower blood pressure in some people. To help reduce the risk of low blood pressure and its symptoms (dizziness, feeling tired, or nausea), your child should eat a meal and drink about 8 to 10 ounces of fluid within 1 hour before receiving Voxzogo.

The most common side effects of Voxzogo include:

• injection site reactions (redness, itching, swelling, bruising, rash, hives, pain)
• vomiting
• joint pain
• decreased blood pressure
• stomach ache

These are not all the possible side effects of Voxzogo. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Voxzogo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Voxzogo for a condition for which it was not prescribed. Do not give Voxzogo to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Voxzogo that is written for health professionals.

How should I store Voxzogo?

• Store the Voxzogo vial and prefilled diluent syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
• You may store Voxzogo (before mixing) at room temperature between 68°F to 77°F (20°C to 25°C) for 90 days.
• Record the date you started storing Voxzogo at room temperature on the carton to keep track of the 90 days.
• Do not return Voxzogo to the refrigerator after it has been stored at room temperature. Throw Voxzogo away if unused within 90 days of storing at room temperature.
• Do not use Voxzogo past the expiration date.
• Do not freeze Voxzogo.
• Store Voxzogo out of direct sunlight.

Keep Voxzogo and all medicines out of the reach of children.

What are the ingredients in Voxzogo?

Active ingredient: vosoritide

Inactive ingredients: trehalose dihydrate, mannitol, sodium citrate dihydrate, methionine, citric acid monohydrate, and polysorbate 80.

For more information, go to www.VOXZOGO.com or call 1-877-695-8826.

Instructions for use for Voxzogo

[Vox zoe' goe']
(Vosoritide)
For injection, for subcutaneous use
Single-use

This Instructions for Use contains information for caregivers on how to inject Voxzogo.

Read this Instructions for Use before you start using Voxzogo and each time you get a refill. There may be new information. This information does not take the place of talking to your child's healthcare provider about your child's medical condition and their treatment. Before you use Voxzogo for the first time, make sure your child's healthcare provider shows you the right way to use it. Contact your child's healthcare provider if you or your child have any questions.

Important Information You Need to Know Before Injecting Voxzogo

• Wash your hands with soap and water.
• Do not drop Voxzogo or put opened items down on surfaces that are not clean.
• Voxzogo is available in more than 1 strength. Make sure the strength matches your prescription strength. Do not open packaging until ready to use.
• Take the Voxzogo vial and prefilled diluent syringe out of the refrigerator and allow them to reach room temperature before mixing.
• Inspect the vial and supplies for any signs of damage or contamination. Do not use if damaged or contaminated.
• Check the expiration date. The expiration date can be found on the carton, vial and prefilled diluent syringe. Do not use if expired.
• Your child should eat a meal and drink a glass (about 8 to 10 ounces) of fluid (such as water, milk, or juice) within 1 hour before injection.
• Voxzogo should be given at about the same time every day.
• Do not mix Voxzogo with other medicines.
• After mixing the Voxzogo, use it right away. Do not use the mixed Voxzogo if it has been sitting at room temperature for more than 3 hours. Throw it away (dispose of) in a sharps container. See Step 18 and "How to throw away (dispose of) Voxzogo" for more information.
• Do not reuse any of the supplies. After the injection, throw away (dispose of) the used vial even if there is Voxzogo remaining. See Step 18 and "HOW TO THROW AWAY (DISPOSE OF) Voxzogo" for more information.

How to Store Voxzogo

• Store the Voxzogo vial and prefilled diluent syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
• You may store Voxzogo (before mixing) at room temperature between 68°F to 77°F (20°C to 25°C) for 90 days. Record the date you started storing Voxzogo at room temperature on the carton to keep track of the 90 days. Do not return Voxzogo to the refrigerator after it has been stored at room temperature. Throw Voxzogo away if unused within 90 days of storing at room temperature.
• Do not freeze Voxzogo.
• Store Voxzogo out of direct sunlight.

Keep Voxzogo and all other medicines out of the reach of children.

Supplies Needed to Inject Voxzogo

Gather all of these supplies on a clean, flat surface before injecting.

Items supplied

Voxzogo

Items not supplied If you do not have these items, ask your pharmacist.

Preparing Voxzogo for Injection

• Step 1. On a clean flat surface, flip off the vial cap and wipe the top with an alcohol pad.

• Step 2. Gently bend to snap off the cap from the prefilled diluent syringe.

• Step 3. Twist the diluent needle onto the prefilled diluent syringe until you can no longer twist it. Do not use the prefilled diluent syringe to give the injection.

• Step 4. Pull off the needle cap and insert the needle through the middle of the vial stopper. Slowly push the plunger rod down to inject all of the liquid.

• Step 5. Remove the needle from the vial, then press the blue tab for the needle to pull back (retract). Throw away the needle and syringe in a sharps container. See Step 18 and "How to throw away (dispose of) Voxzogo." Do not use the prefilled diluent syringe to give the injection.

• Step 6. Gently swirl the vial until the powder has completely dissolved and the solution is clear. Do not shake.

• Step 7. Take the injection syringe out of the carton. Pull off the needle cap from the injection syringe and insert the needle straight through the middle of the vial stopper. Be careful not to bend the needle.

• Step 8. Carefully hold the vial and syringe and turn the vial upside down with the needle still inserted. The vial should be on top. Be careful not to bend the needle.

• Step 9. Keep the needle tip in the medicine and slowly pull the plunger rod back to draw up the prescribed dose in the syringe. Check the prescription label for how much to draw up.

• Step 10. Remove large air bubbles in the syringe by gently tapping the syringe. Then push the bubbles back into the vial.

• Step 11. Repeat Steps 9 and 10 until you have the correct prescribed dose in the syringe and no large bubbles.

• Step 12. Make sure you have the prescribed dose in the syringe, then remove the vial and prepare to give the dose.

Select and Prepare Injection Site

• Step 13. Voxzogo should be injected into the fatty layer under the skin (subcutaneous) only.
  Do not inject into the same site 2 times in a row

• Step 14. Wipe the injection site with an alcohol pad and let the skin air dry.

Giving Voxzogo Injection

• Step 15. After wiping the site with an alcohol pad, pinch the skin up around the selected injection site.

• Step 16. Quickly insert the needle all the way into the skin at a 45-degree angle.

• Step 17. Release the pinch and slowly push the plunger rod all the way down.

Continue pressing the plunger rod until the needle retracts into the syringe.

• Step 18. Throw away the used vial, syringes and needles in a sharps container. See "How to throw away (dispose of) Voxzogo" for more information.

How to Throw Away (Dispose of) Voxzogo

Put your used or expired vials, needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the vials, loose needles and syringes in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that:

• is made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out,
• is upright and stable during use,
• is leak-resistant, and
• is properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

After the Injection

• Inspect the injection site. If a small amount of bleeding occurs from the injection site, gently press a gauze pad on it for a few seconds or apply a bandage. Do not rub the injection site.
• Monitor for signs of low blood pressure, such as dizziness, tiredness, and nausea. If your child experiences these symptoms you should call your child's healthcare provider, then get your child to lay back with legs raised.

For Help or More Information

• Call your healthcare provider
• Call BioMarin at 1-800-123-4567
• Visit www.Voxzogo.com

Instructions for use approved 11/2021.