Crysvita 30 mg solution for injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

What CRYSVITA is

CRYSVITA contains the active substance burosumab. This is a type of medicine called a human monoclonal antibody.

What is CRYSVITA used for

CRYSVITA is used to treat X-linked hypophosphataemia (XLH). It is used in children and adolescents aged 1 to 17 years, and in adults.

What is X-Linked Hypophosphataemia (XLH)

X-Linked Hypophosphataemia (XLH) is a genetic disease.

• People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
• FGF23 lowers the amount of phosphate in the blood.
• The low level of phosphate may:
  • lead to bones that may not harden properly and, in children and adolescents, cannot grow properly
  • result in pain and stiffness in bones and joints

How CRYSVITA works

CRYSVITA attaches to FGF23 in the blood which stops FGF23 from working and increases the phosphate levels in the blood so that normal levels of phosphate can be achieved.

Do not use CRYSVITA if

• you are allergic to burosumab or any of the other ingredients of this medicine (listed in section 6)
• you are taking any phosphate supplements or certain vitamin D supplements (that contain so called active vitamin D, e.g. calcitriol)
• you already have a high level of phosphate in your blood (“hyper-phosphataemia”)
• you have severe kidney disease or kidney failure.

Allergic reactions

Stop taking CRYSVITA and tell your doctor straight away if you have any of the following side effects, as they could be signs of an allergic reaction:

• rash and itching all over the body
• severe swelling of eyelids, mouth or lips (angio-oedema)
• shortness of breath
• rapid heartbeat
• sweating.

Do not take CRYSVITA if any of the above apply to you. If you are not sure, talk to your doctor before using CRYSVITA.

Warnings and precautions

Skin reactions

You may get skin reactions where the injection is given, see section 4 for more information. If these reactions are severe, tell your doctor.

Tests and checks

Your doctor will check the phosphate and calcium levels in your blood and urine and may also do a renal ultrasound during your treatment in order to reduce the risk of hyperphosphataemia (too much phosphate in the blood) and ectopic mineralisation (a build-up of calcium in tissues such as the kidneys). Your serum parathyroid hormone level will also be checked from time to time.

Children under 1 year

Crysvita should not be given to children under 1 year of age because the safety and effects of the medicine have not been studied in this age group.

Other medicines and CRYSVITA

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

Do not take CRYSVITA and tell your doctor if you are taking:

• phosphate supplements
• certain vitamin D supplements (that contain so called active vitamin D, e.g. calcitriol). There are some vitamin D supplements you can continue or start to use and your doctor will advise which ones these are.

Talk to your doctor before taking CRYSVITA if you are taking:

• medicines that work in the same way as calcium in the body (“calcimimetics”). If used together they may lower blood calcium.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This is because it is not known if CRYSVITA will affect the baby.

CRYSVITA is not recommended in pregnancy.

If you could get pregnant, you must use an effective method of contraception (birth control) while using CRYSVITA. You should discuss this with your doctor.

It is not known if CRYSVITA passes into breast milk, and a risk to newborns or infants cannot be ruled out. You should discuss this with your doctor.

Driving, riding a bike and using machines

It is possible that CRYSVITA could cause dizziness and affect you being able to ride a bike, use any tools or machines or to drive. If you think you are affected, do not ride a bike, use any tools or machines or drive, and tell your doctor.

CRYSVITA contains sorbitol

This medicine contains 45.91 mg of sorbitol in each vial which is equivalent to 45.91 mg/ml.

How much CRYSVITA you will be given

The dose is based on your body weight. Your doctor will work out the right dose for you.

CRYSVITA will be injected:

• every two weeks in children and adolescents aged 1 - 17 years
• every four weeks in adults

Your doctor will perform checks to make sure that you are getting the right dose and may change your dose if needed.

The maximum dose you will be given is 90 mg.

If you have been given more CRYSVITA than you should

If you think that you have been given too much CRYSVITA, tell your doctor straight away.

If you miss a dose of CRYSVITA

If a dose is missed, talk to your doctor straight away. The missed dose should be given as soon as possible and your doctor will re-arrange future doses accordingly.

If you have any further questions on the use of this medicine, ask your doctor.

Side effects in adults

Very common (may affect more than 1 in 10 adults)

• Tooth abscess (infection)
• Headache
• Dizziness
• Restless legs syndrome (irresistible urge to move your legs to stop uncomfortable, painful or odd sensations in the legs especially prior to sleep or at night time)
• Pain in back
• Muscle spasm
• Low vitamin D in your blood

Common (may affect up to 1 in 10 adults)

• Constipation
• Increased phosphate in your blood

Reporting of side effects

If you 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What CRYSVITA contains

The active substance is burosumab. Each vial contains either 10, 20 or 30 mg of burosumab.

The other ingredients are L-histidine, D-sorbitol (E420), polysorbate 80, L-methionine, 10%, hydrochloric acid, and water for injections. (See “CRYSVITA contains sorbitol” in section 2 for more information).

What CRYSVITA looks like and contents of the pack

CRYSVITA comes as a clear to slightly opalescent, colourless to pale yellow/brown solution for injection in a small glass vial. Each pack contains 1 vial.

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