Patient Medication Information: uses, side effects, how to take - Crysvita
What CRYSVITA is used for:
- CRYSVITA contains the active substance burosumab. This is a type of medicine called a human monoclonal antibody.
CRYSVITA is used to treat X-linked hypophosphatemia (XLH). It is used in children 6 months of age and older and adults.
- 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 cannot grow and harden properly.
- CRYSVITA is used to treat tumor-induced osteomalacia (TIO) in adults.
- TIO is caused by a tumor that produces high amounts of fibroblast growth factor 23 (FGF23). FGF23 cause decreased amount of phosphate in the blood. The low level of phosphate may lead to weakened bones and muscles.
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.
The ingredients in CRYSVITA are:
Medicinal ingredients: Burosumab
Non-medicinal ingredients: D-sorbitol, L-histidine, L-methionine, polysorbate 80, water for injection (USP), and hydrochloric acid may be used to adjust pH.
CRYSVITA comes in the following dosage form(s):
10 mg, 20 mg and 30 mg solution for injection
Do not use CRYSVITA if:
- You are allergic to burosumab or any of the other ingredients in this medication
- You are taking any phosphate or active vitamin D
- You already have a high level of phosphate in your blood (“hyperphosphatemia”)
- You have severe kidney disease or kidney failure
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CRYSVITA. Talk about any health conditions or problems you may have, including if you:
- Are taking phosphates or active vitamin D, such as those with the active ingredient calcitriol or alfacalcidol. There are some non-active vitamin D supplements you can use and your healthcare professional will advise which ones these are.
- Have a problem with your parathyroid glands.
Other warnings you should know about:
Skin reactions
You may get skin reactions where the injection is given. If these reactions are severe, you should contact your healthcare professional right away.
Children with XLH under 6 months
CRYSVITA should not be given to children with XLH under 6 months of age because the safety and effects of the medicine have not been studied in this age group.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your healthcare professional or pharmacist for advice before taking this medicine. This is because it is not known if CRYSVITA will affect the baby.
Females who are able to become pregnant should use an effective method of birth control during treatment with CRYSVITA and for at least 14 weeks after stopping treatment. Talk to your healthcare professional about birth control methods that you can use during this time. Tell your healthcare professional right away if you become pregnant during treatment with CRYSVITA.
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 healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Studies to test how CRYSVITA interacts with other medicines have not been done.
How to take CRYSVITA:
CRYSVITA should be given by injection under the skin in the arm, abdomen, buttock or thigh by your healthcare professional or a trained healthcare provider.
Usual dose:
The dose is based on your body weight. Your healthcare professional will work out the right dose for you. CRYSVITA will be injected every two weeks in children and every four weeks in adults.
Tests and Checks
Your healthcare professional will sometimes check the phosphate level in your blood and your urine in order to reduce the risk of hyperphosphatemia (too much phosphate in the blood).
Your healthcare professional will perform these checks to make sure that you are getting the right dose and may change your dose if needed.
Your healthcare professional may check the calcium and parathyroid hormone levels in your blood before and during treatment in order to reduce the risk of hypercalcemia (too much calcium in the blood) and hyperparathyroidism (too much parathyroid hormone in the blood).
Overdose:
CRYSVITA is administered under the supervision of a healthcare professional, who will check that the correct dose has been given and treat any overdose.
Missed Dose:
If a dose is missed, talk to your healthcare professional right away. The missed dose should be given as soon as possible, and your healthcare professional will re-arrange future doses accordingly.
Possible side effects from using CRYSVITA:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are possible side effects you may feel when taking CRYSVITA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects in children with XLH may include:
- Tooth abscess (infection)
- Toothache
- 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:
- Redness or rash
- Pain or itching
- Swelling
- 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
- Dizziness
Side effects in adults may include:
- Back pain
- Headache
- Tooth infection
- Restless leg syndrome
- Constipation
- Low vitamin D
- Dizziness
- Muscle spasm
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
VERY COMMON Skin reactions | √ | ||
| Dizziness | √ | ||
RARE Allergic reactions shortly after being given CRYSVITA: rash and itching all over the body, severe swelling of eyelids, mouth or lips, shortness of breath, rapid heartbeat, sweating | √ | ||
If you have a troublesome symptom or that is not listed here or becomes bad enough to interfere with your daily activities, talk to 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:
CRYSVITA vials must be stored in the original carton until the time of use under refrigerated conditions at 36°F to 46°F (2°C to 8°C). Keep CRYSVITA vial in the original carton to protect from light until time of use.
Do not freeze or shake CRYSVITA.
Keep out of reach and sight of children.
If you want more information about CRYSVITA:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://kkna.kyowakirin.com/canada-en, or by calling 1-866-590-9508.