10 mg, 20 mg, and 30 mg, injection, solution 
burosumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

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

1. What CRYSVITA is and what it is used for

What CRYSVITA is

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

What CRYSVITA is used for

CRYSVITA is used to treat x-chromosome- bound hypophosphatemia (XLH). It is used for children and adolescents aged 1 to 17 years, and adults.

What is x-chromosome- bound hypophosphatemia (XLH)

X-chromosome- bound hypophosphatemia (XLH) is an inherited disease.

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

How CRYSVITA works

CRYSVITA attaches to FGF23 in the blood, which prevents FGF23 from working. This increases the phosphate levels in the blood and normal phosphate levels can be achieved.

2. What you need to know before using CRYSVITA

Do not use CRYSVITA

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 a phosphate supplement or certain vitamin D supplements (which contain so-called active vitamin D, eg calcitriol)
  • you already have high levels of phosphate in your blood ( hyperphosphatemia )
  • you have severe kidney disease or kidney failure.

Allergic reactions

Stop taking CRYSVITA and talk to your doctor immediately if you get any of the following side effects, as it may be a sign of an allergic reaction:

  • skin rash and itching all over the body
  • severe swelling of the eyelids, mouth, and lips ( angioedema )
  • respiratory distress
  • palpitation
  • 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 cautions

Skin reactions

You may get skin reactions at the injection site. See section 4 for more information. Tell your doctor if these reactions become severe.

Sampling and inspections

Your doctor will check the phosphate and calcium levels in your blood and urine and may also perform an ultrasound of your kidneys during treatment to reduce the risk of hyperphosphatemia (too much phosphate in your blood) and ectopic mineralization (an accumulation of calcium in tissues such as your kidneys). Your serum thyroid hormone levels will also be checked occasionally.

Children under 1 year

Crysvita should not be given to children under 1 year of age as the safety and efficacy of the drug 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 (which contain so-called active vitamin D, eg calcitriol). There are some vitamin D supplements that you can start with or continue to use. The doctor will inform you about who they are.

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

  • drugs that act in the same way as calcium in the body (calcimimetic). They can lower the level of calcium in the blood is used at the same time.

Pregnancy, breastfeeding, 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 affects the baby.

CRYSVITA is not recommended during pregnancy.

Women of childbearing potential should use effective contraception during treatment with CRYSVITA. You should discuss this with your doctor.

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

Driving and using machines

CRYSVITA may cause dizziness and prevent you from cycling, using tools or machines, or driving vehicles. If you think you are affected, tell your doctor and do not cycle, use tools or machines, or drive vehicles

CRYSVITA contains excipients

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

3. How to use CRYSVITA

CRYSVITA should be given by injection under the skin of the abdomen, an arm, buttock, or thigh by a healthcare professional.

How much CRYSVITA you get

Dose one is based on your body weight. Your doctor will calculate the correct dose for you.

CRYSVITA is 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 you are getting the right dose and can change your dose as needed.

The maximum dose is 90 mg.

If you use more CRYSVITA then you should 

Talk to your doctor immediately if you think you have received too much CRYSVITA.

If you forget to use CRYSVITA

Talk to your doctor immediately if a dose is missed. The missed dose should be given as soon as possible and the doctor will also decide how the next doses should be given.

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

4. Possible side effects

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

Side effects in children and adolescents

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

  • Dental abscess ( infection )
  • Cough
  • Headache
  • Vomiting
  • Nausea
  • Diarrhea
  • Constipation
  • Caries (holes in the teeth)
  • Rash
  • Pain in muscles ( myalgia ) and hands and feet
  • Injection site reactions, which may include:
    • redness or rash
    • pain or itching
    • swelling
    • bleeding or bruisingThese injection site reactions are usually mild and occur within one day after injection and usually resolve within about 1 to 3 days.
  • Fever
  • Low vitamin D in the blood

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

  • Dizziness

Has been reported (occurs in an unknown number of users)

  • Increased phosphate content in the blood

Side effects are in adults

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

  • Dental abscess ( infection )
  • Headache
  • Dizziness
  • Restless legs syndrome (very strong drive to move the legs to get rid of discomfort, pain, or strange feelings in the legs, especially before falling asleep and at night)
  • Back pain
  • Muscle spasms
  • Low vitamin D in the blood

Common (may affect more than 1 in 10 adults)

  • Constipation
  • Increased phosphate content in the blood

5. How to store CRYSVITA

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Keep the vial in the outer carton. Sensitive to light. Do not use CRYSVITA if it contains visible particles.

Any unused product or waste material should be disposed of by local requirements.

6. Contents of the packaging and other information

Content declaration

The active substance is burosumab. Each vial contains 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 the medicine looks like and the contents of the pack

CRYSVITA is a clear to slightly opalescent, colorless to slightly brownish/yellowish solution for injection in a small glass vial. Each pack contains 1 vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Kyowa Kirin Holdings BV

Bloemlaan 2

2132NP Hoofddorp

Netherlands

medinfo@kyowakirin.com

Manufacturer

Piramal Healthcare UK Limited Whalton Road

Morpeth NE61 3YA

UK

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 10-12

37081 Göttingen

Germany

Muhammad Nadeem

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