Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - voxzogo

Document Subject

Generated Narrative: MedicinalProductDefinition mpe6fbce999498edd4c95f0774e58fd4a0

identifier: http://ema.europa.eu/identifier/EU/1/21/1577/001 10 x 0.4 mg Powder and solvent for solution for injection

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Voxzogo 0.4 mg powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e6fbce999498edd4c95f0774e58fd4a0

identifier: http://ema.europa.eu/identifier/EU/1/21/1577/001 10 x 0.4 mg Powder and solvent for solution for injection

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - voxzogo

Attesters

What is in this leaflet

1. What Voxzogo is and what it is used for
2. What you need to know before you use Voxzogo
3. How to use Voxzogo
4. Possible side effects
5. How to store Voxzogo
6. Contents of the pack and other information

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 made by recombinant technology involving bacteria that have been modified to include the gene for producing the protein.

What Voxzogo is used for This medicine is used for the treatment of achondroplasia in patients 4 months of age and older whose bones are still growing. Achondroplasia is a genetic condition that affects growth of almost all bones in the body including the skull, spine, arms and legs resulting in very short stature with a characteristic appearance.

The product is indicated only in achondroplasia which is caused by mutations in the FGFR3-gene as confirmed by genetic testing.

How does Voxzogo work The active substance in Voxzogo works directly on the growth points of your bones to promote new bone growth.

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 significant heart disease or blood pressure problems.
• If you or your child are taking or have recently taken medicines that lower blood pressure. If any of these applies to you or your child or you are unsure, talk to the doctor before using Voxzogo.

Blood pressure effects Voxzogo can lower blood pressure. As a result, you may feel dizzy, nauseous, or tired. 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 patients eat a light snack and drink enough fluid (e.g. water, milk or juice) about 30 minutes before injection.

Children and adolescents There is not enough information on the use of this medicine in children under 4 months old and therefore it is not recommended.

Other medicines and Voxzogo Tell your doctor if you or your child are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding If you or your child are being treated with this medicine and are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

The use of this medicine is not recommended during pregnancy and breast-feeding.

Driving, cycling and using machines
This medicine may cause you to feel dizzy, light-headed, tired or you may feel sick shortly after your injection. If this happens, you should not drive, ride a bicycle, do physical activities or use machines for around an hour after injection or until you feel better.

Voxzogo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

A caregiver should give the Voxzogo injection. Do not inject your child with Voxzogo until you have had proper training from a healthcare professional.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose Your doctor 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 you or your child will need to inject daily based on bodyweight. The amount to inject may be presented as different volumes based on the type of syringe included in your pack (millilitres (mL) or Units (U)). Please check that you have the correct dose for the syringe you are using.

Table 1: Single dose volumes by body weight in mL and Units (U) volumes

Body weight (kg) Dose (mg) Vosoritide 0.4 mg solvent (water for injections): 0.5 mL concentration: 0.8 mg/mL Vosoritide 0.56 mg solvent (water for injections): 0.7 mL concentration: 0.8 mg/mL Vosoritide 1.2 mg solvent (water for injections): 0.6 mL concentration: 2 mg/mL

Daily injection volume

mL Units mL Units mL Units 4 0.12 mg 0.15 mL 15 U

5 0.16 mg 0.20 mL 20 U

6-7 0.20 mg 0.25 mL 25 U

8-0.24 mg 0.30 mL 30 U

12-0.28 mg

0.35 mL 35 U

17-0.32 mg

0.40 mL 40 U

22-0.40 mg

0.50 mL 50 U

33-0.50 mg

0.25 mL 25 U 44-0.60 mg

0.30 mL 30 U 60-0.70 mg

0.35 mL 35 U 0.80 mg

0.40 mL 40 U

You or your child should eat a light snack and drink enough water, milk or juice about 30 minutes before the injection. This can reduce side effects such as dizziness, tiredness or nausea (feeling sick).

How to use Voxzogo Inject Voxzogo slowly under the skin (subcutaneous injection).

The injection should be given at around the same time each day.

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.

If you use more Voxzogo than you should If you inject more Voxzogo than you should, contact your doctor straight away.

If you forget to use Voxzogo
If your child misses 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.

If you stop using Voxzogo
Always talk to your child s doctor before deciding to stop your child s treatment. If you or your child have any further questions on the use of this medicine, ask your doctor or pharmacist

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects
These may affect more than 1 in 10 people:

• Vomiting
• Low blood pressure (temporary effects include dizziness, feeling tired or feeling sick shortly after an injection)
• Injection site reactions: redness, itching, inflammation, swelling, bruising, rash, hives, pain. Injection site reactions are usually minor and resolve on their own within a few hours
• High levels of blood alkaline phosphatase (shown in blood tests)

Common side effects
These may affect up to 1 in 10 people:

• Nausea
• Feeling faint or light-headed and passing out
• Dizziness
• Tiredness

Reporting of side effects
If you or your child get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP . The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze. Store in the original package in order to protect from light.

Voxzogo may be stored at room temperature (below 30 C) for up to 90 days, but not beyond the expiry date. Do not return Voxzogo to refrigerator after storage at room temperature. Record on the carton the date you remove Voxzogo from the refrigerator to store at room temperature.

Use Voxzogo as soon as it has been made up as a solution. In any case it must be given within 3 hours of making it up. Do not use this medicine if the solution for injection is cloudy or contains any particles.

Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Voxzogo contains

• The active substance is vosoritide.

• Each vial of 0.4 mg powder reconstituted in a solution of 0.5 mL solvent, corresponds to a concentration of 0.8 mg/mL.
• Each vial 0.56 mg powder reconstituted in a solution of 0.7 mL solvent, corresponds to a concentration of 0.8 mg/mL.
• Each vial of 1.2 mg powder reconstituted in a solution of 0.6 mL solvent, corresponds to a concentration of 2 mg/mL.

• The other ingredients are citric acid (E 330), sodium citrate (E 331), trehalose dihydrate, mannitol (E 421), methionine, polysorbate 80 (E 433).
• The solvent is water for injections.

What Voxzogo looks like and contents of the pack

Voxzogo powder and solvent for solution for injection is provided as:

• a white to yellow powder for solution for injection in a glass vial, and
• a clear and colourless solvent (water for injections) to dissolve the powder.

After dissolving the powder in the solvent the solution is a clear, colourless to yellow liquid.

Each carton contains:

• 10 vials of Voxzogo
• 10 pre-filled syringes of water for injections
• 10 individual single use needles
• 10 individual single use syringes

Marketing Authorisation Holder and Manufacturer BioMarin International Limited Shanbally, Ringaskiddy County Cork Ireland P43 RThis leaflet was last revised in MM/YYYY.

Detailed information on this medicine is available on the European Medicines Agency web site: