Patient Medication Information: uses, side effects, how to take - Voxzogo

What VOXZOGO is used for:

For the following indication(s) VOXZOGO has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

VOXZOGO (vosoritide for injection) is indicated to increase linear growth in patients with achondroplasia who are 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How VOXZOGO works:

Individuals with achondroplasia usually have a genetic change that makes a protein called FGFR3 overactive. This protein limits bone growth. VOXZOGO contains vosoritide, which blocks FGFR3’s effect and helps bones grow more normally.

The ingredients in VOXZOGO are:

Medicinal ingredient: vosoritide

Non-medicinal ingredients: citric acid monohydrate, mannitol, methionine, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate.

VOXZOGO comes in the following dosage form:

Powder and diluent for injection

White flip cap: 0.4 milligrams (mg)/0.5 milliliter (mL) per vial
Magenta flip cap: 0.56 mg/0.7 mL per vial
Gray flip cap: 1.2 mg/0.6 mL per vial.

Do not use VOXZOGO if:

You or your child are allergic (hypersensitive) to vosoritide or any of the other ingredients of this medicine.

To help avoid side effects and ensure proper use, talk to a healthcare professional about any health conditions or problems, including if you or your child:

have significant heart disease or blood pressure problems.
are taking or have recently taken medicines that lower blood pressure.
are pregnant or plan to become pregnant. It is not known if VOXZOGO will harm an unborn baby.
are breastfeeding or plan to breastfeed. It is not known if VOXZOGO passes into breast milk. A healthcare professional can advise on the best way to feed a baby if the breastfeeding parent is taking VOXZOGO.
have severe vitamin D deficiency.

Other warnings you should know about:

VOXZOGO can lower blood pressure. As a result, you or your child may feel dizzy, tired, or nauseous. Blood pressure usually returns to normal within 90 minutes of VOXZOGO injection. If these effects occur and are severe, tell your doctor.

Drinking plenty of fluids at the time of injection may reduce the likelihood of these effects. It is recommended that patients eat a light snack and drink a glass of fluid (e.g., water, milk, juice, or baby formula) about 30 minutes before injection.

If the patient experiences side effects of low blood pressure, they should avoid driving, riding a bicycle, doing physical activities or using machines for about an hour after injection or until they feel better.

Your doctor will test if you or your child have low vitamin D levels prior to treatment with VOXZOGO and will continue to test for low vitamin D levels throughout treatment. Your doctor may require that vitamin D deficiency be managed prior to initiating treatment with VOXZOGO.

Tell your healthcare professional about all the medicines you or your child are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take VOXZOGO:

See the detailed Instructions for Use, that comes with this Patient Medical Information leaflet, for instructions about the right way to store, prepare, and give VOXZOGO injections at home.
A caregiver should give the VOXZOGO injection to younger children. Do not inject yourself or your child with VOXZOGO until you have received proper training from a healthcare professional on how to prepare and inject VOXZOGO.
VOXZOGO is given as an injection under the skin (subcutaneous injection). Inject VOXZOGO once a day, at about the same time each day.
Patients should eat a light snack and drink an adequate amount of fluid (e.g., water, milk, juice, or baby formula) about 1 hour before the injection. This can reduce side effects such as dizziness, tiredness or nausea (feeling sick).
It is recommended that you give the injection in a different place each day and do not use the same site 2 days in a row. Do not inject this medicine into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard.

Usual dose:

Your healthcare professional will choose the correct dose depending on your or your child’s bodyweight. The doctor will tell you how much of the injection solution to inject. If you are not sure, ask your doctor or pharmacist.

Table 1 shows the dose of VOXZOGO (volume) to be injected daily, based on the actual body weight of the patient.

Table 1: Single dose volumes by body weight in mL

		VOXZOGO 0.4 mg Diluent (water for injection): 0.5 mL Concentration: 0.8 mg/mL		VOXZOGO 0.56 mg Diluent (water for injection): 0.7 mL Concentration: 0.8 mg/mL
			Daily Injection Volume (mL)
			5	0.16 mg		0.20 mL
			6-7		0.20 mg		0.25 mL
			8-11		0.24 mg		0.30 mL
12-16	0.28 mg				0.35 mL
17-21	0.32 mg				0.40 mL
22-32	0.40 mg				0.50 mL
33-43	0.50 mg					0.25 mL
44-59	0.60 mg					0.30 mL
60-89	0.70 mg					0.35 mL
60-89	≥ 90	0.80 mg						0.40 mL

^aBody weights that fall within these weight bands should be rounded to the nearest whole number

Overdose:

If you think you, or a person you are caring for, have taken too much VOXZOGO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you or your child miss a dose, the injection should still be given if it is within 12 hours of the scheduled time. If more than 12 hours have passed since the scheduled dose time, do not inject the missed dose. Wait until the next day and continue with the usual dose at the usual time.

Possible side effects from using VOXZOGO:

These are not all the possible side effects you may have when taking VOXZOGO. If you experience any side effects not listed here, tell your healthcare professional.

Very common: may affect more than 1 in 10 people

Low blood pressure (dizziness, feeling tired or feeling sick shortly after an injection)
Injection site reactions: redness, itching, inflammation, swelling, bruising, rash, hives, pain
High levels of blood alkaline phosphatase (shown in blood tests)
Vomiting
Redness, swelling or pain of the skin (rash)
Flu-like symptoms (fever, chills, cough, headache, muscle aches, and tiredness)
Joint pain
Ear pain
Diarrhea
Dizziness, feeling faint or lightheaded

Common: may affect up to 1 in 10 people

Stomach flu
Seasonal allergy
Nausea
Tiredness
Dry skin

Uncommon: may affect up to 1 in 100 people

Passing out

Frequency not known:

Broken thigh bone (fracture of the femur) which may occur as a result of a fall or injury
Abnormal hair growth

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep this medicine out of reach and sight of children.
Do not use this medicine past the expiration date.
Store the VOXZOGO vial and prefilled diluent syringe in the refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
VOXZOGO may be stored (before mixing) at room temperature (below 30°C) for up to 90 days. Do not return VOXZOGO to refrigerator after storage at room temperature. Throw VOXZOGO away if unused within 90 days of storing at room temperature.
Record on the carton the date you started storing VOXZOGO at room temperature.
Use VOXZOGO as soon as it has been made up as a solution. If not used immediately, VOXZOGO must be administered within 3 hours of reconstitution. Do not use this medicine if the solution for injection is cloudy or contains any particles.

If you want more information about VOXZOGO:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.biomarin.ca, or by calling 1-800-983-4587.

Last Revised: 2026-10-02

Instructions for Use

VOXZOGO (vosoritide for injection)

Single-Use

Instructions for Use of the syringe graduated in milliliters (mL)

Please read these Instructions for Use before using VOXZOGO and each time you get a refill. There may be new information. Before you use VOXZOGO for the first time, make sure your healthcare provider shows you the right way to use it. Contact a healthcare provider if you 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 light meal and an adequate amount of fluid (such as water, milk, juice, or baby formula) 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 19 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 19 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 2°C to 8°C.
You may store VOXZOGO (before mixing) at room temperature (below 30°C) for up to 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 provided

VOXZOGO Vial

Diluent Needle

(blue tab retracts needle)

Prefilled Diluent Syringe

(Contains water for injection for reconstitution of VOXZOGO)

A close-up of a bottle

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A black and white drawing of a knife

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Injection Syringe

Please speak to your doctor or healthcare professional if you are unsure of your recommended dose or how to use the diluent needle and injection syringe.

Items needed but not provided in the pack

If you don’t have these items, ask your pharmacist.

Alcohol Pads

Sharps Container

Gauze or Bandage

A black and white biohazard symbol

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PREPARING FOR INJECTION

Step 1: On a clean flat surface, flip off the vial cap and wipe the top with an alcohol pad. ATTENTION: Do not touch the vial stopper with your fingers after wiping it with an alcohol pad.
Step 2: Gently bend to snap off the cap from the diluent syringe.
Step 3: Twist the diluent needle onto the prefilled diluent syringe until you can no longer twist it.
Step 4: Pull off the needle cap and insert the needle into the vial through the middle of the vial stopper. Slowly push the plunger rod down to inject all of the liquid. ATTENTION: Be careful not to push the blue tab until Step 5.
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 into a sharps container. See step 19 and “How to throw away (dispose of) VOXZOGO.” Do not use the prefilled diluent syringe to give the injection. ATTENTION: Be careful not to touch the needle tip.
Step 6: Gently swirl the vial until the powder has completely dissolved and the solution is clear. Do not shake. Make sure medicine is clear to yellow, not cloudy and does not have particles.
Step 7: Take the injection syringe out of the carton. Pull off the needle cap from the injection syringe and insert the needle into the vial straight through the middle of the vial stopper. Be careful not to bend the needle. ATTENTION: Do not place the cap back on 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. ATTENTION: 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. ATTENTION: Draw up the prescribed dose.
Step 10: Remove large air bubbles in the syringe by gently tapping the syringe. Then slowly 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. Make sure the dose in the syringe matches the prescribed dose. Measure from the base of the plunger as shown. ATTENTION: Remove any large bubbles. 1 or 2 small bubbles are acceptable.
Step 12: Make sure you have the prescribed dose in the syringe, then remove the vial and prepare to give the dose. ATTENTION: Confirm that the dose in the syringe matches the prescribed dose before removing vial.

SELECTING AND PREPARING INJECTION SITE

Step 13: VOXZOGO should be injected into the fatty layer under the skin (subcutaneous) only.

Do not inject through clothes.
Do not inject in the same site 2 times in a row.
Do not inject into skin that is swollen, sore, bruised, red, hard, or scarred.

The following sites are recommended for injection:

Thighs or
Abdomen (5 centimeters from belly button) or
Buttocks
Healthcare providers and caregivers may also inject VOXZOGO into the back of upper arms

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

ATTENTION: Do not touch the area again before injecting.

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.




Step 18: Continue pressing the plunger rod until the needle retracts into the syringe.
Step 19: Throw away the used vial, syringes and needles in a sharps container. See “How to Throw Away (Dispose of) VOXZOGO” for more information.

After injecting VOXZOGO

Check the injection site. If there is a small amount of blood at 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, or nausea (feeling sick). If the patient has these symptoms call your doctor or healthcare provider, then lie the patient down on their back and place cushions under their legs to raise them.

How to throw away (dispose of) VOXZOGO

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

If you do not have a 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 labelled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

For Help or More Information

Call your healthcare provider
Call BioMarin at 1-800-983-4587
Visit www.biomarin.ca
Instructions for Use
VOXZOGO (vosoritide for injection)
Single-Use
Instructions for Use of the syringe graduated in Units (U)

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 light meal and an adequate amount of fluid (such as water, milk, juice, or baby formula) 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.