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 6 months of age and older.

CRYSVITA is used to treat Tumour-induced Osteomalacia (TIO) where the tumour causing this condition cannot be successfully removed or found, in patients aged 2 years and older.

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

What is Tumour-induced osteomalacia (TIO)

·                People with TIO have higher levels of a hormone called FGF23 produced by certain types of tumours.

·                FGF23 lowers the amount of phosphate in the blood.

·                The low level of phosphate may lead to softening of the bones, muscle weakness, tiredness, bone pain and fractures.

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.

1.              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, paricalcitol, doxercalciferol, calcifediol)

·         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 6 months

Crysvita should not be given to children under 6 months 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, paricalcitol, doxercalciferol, calcifediol). 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 breast-feeding and fertility

If you are pregnant or breast-feeding, think you may 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 and using machines

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

CRYSVITA should be given by injection under the skin in the arm, abdomen, buttock, or thigh by a trained healthcare provider.

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 6 months to less than 18 years of age

-          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 or frequency of dose if needed.

The maximum dose you will be given for the treatment of XLH is 90 mg. The maximum dose you will be given for the treatment of TIO is 180 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.

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

Possible side effects for XLH

Side effects in children and adolescents

Very common (may affect more than 1 in 10 children and adolescents)

·                Tooth abscess (infection)

·                Cough

·                Headache

·                Vomiting

·                Nausea

·                Diarrhoea

·                Constipation

·                Tooth decay or cavities

·                Rash

·                Pain in muscles (myalgia) and hands and feet

·                Reactions where the injection was given, which may include:

o      redness or rash

o      pain or itching

o      swelling

o      bleeding or bruising

These injection site reactions are usually mild and occur within a day after the injection and usually get better in around 1 to 3 days.

·                Fever

·                Low vitamin D in your blood

Common (may affect up to 1 in 10 children and adolescents)

·                Dizziness

Not known (frequency cannot be estimated from the available data)

·         Increased phosphate in your blood

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

Possible side effects for TIO

Side effects in adults

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

·                Tooth abscess (infection)

·                Headache

·                Dizziness

·                Constipation

·                Rash

·                Muscle spasm

·                Reactions where the injection was given, which may include pain or swelling.

These injection site reactions are usually mild and occur within a day after the injection and usually get better in around 1 to 3 days.

Common (may affect up to 1 in 10 adults)

·                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)

·                Low vitamin D in your blood

·                Increased phosphate in your blood

Side effects in children and adolescents

Side effects in children and adolescents are not known but are expected to be similar to those seen in patients with XLH.

Reporting of side effects

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse, or pharmacist.

Keep CRYSVITA out of the sight and reach of children.

Do not use CRYSVITA after the expiry date which is stated on the carton label. Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not use CRYSVITA if it contains visible particles.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.