What is CRYSVITA?
CRYSVITA is a prescription medicine used to treat adults and children 6 months of age and older with X-linked hypophosphatemia (XLH).
You should not take CRYSVITA if:
- You take an oral phosphate supplement and/or a specific form of vitamin D supplement (such as calcitriol, paricalcitol, doxercalciferol, calcifediol)
- Your phosphorus levels from a blood sample are within or above the normal range for your age
- You have kidney problems
What is the most important information I should know about CRYSVITA?
- Some patients developed allergic reactions (eg, rash or hives) while taking CRYSVITA. Your doctor will monitor you for symptoms of an allergic reaction while you are taking CRYSVITA. Your treatment may need to be discontinued for serious allergic reactions
- High levels of phosphorus in the blood have been reported in some patients taking CRYSVITA. This may be related to a risk of high calcium levels in the kidneys. Your doctor will collect blood samples to monitor your levels. If you are already taking CRYSVITA, dose interruption and/or dose reduction may be required based on your serum phosphorus levels
- High levels of calcium in the blood have been reported in patients taking CRYSVITA. The risk is greater in patients with pre-existing hyperparathyroidism (overactive parathyroid glands), for those who are unable to move for extended periods of time, become dehydrated, have high vitamin D levels, or have kidney issues. If you are at greater risk, your doctor will monitor your blood calcium and parathyroid hormone levels before you start and while taking CRYSVITA. If you develop high levels of blood calcium, your doctor may need to stop your treatment until it is adequately managed
- Administration of CRYSVITA may result in reactions at the injection site, such as hives, reddening of the skin, rash, swelling, bruising, pain, severe itching of the skin, and a collection of blood outside of a blood vessel (ie, hematoma). Call your doctor if you develop an injection site reaction. CRYSVITA may be discontinued if severe injection site reactions occur
What are the possible side effects of CRYSVITA in children?
The following side effects were observed in 10% or more of children who were treated with CRYSVITA* in Study 1:
- Fever
- Injection site reaction
- Cough
- Vomiting
- Pain in arms and legs
- Headache
- Tooth abscess
- Dental cavities
- Diarrhea
- Decreased vitamin D levels
- Constipation
- Rash
- Nausea
*More children in the CRYSVITA group experienced these reactions versus the conventional therapy group.
These are not all the possible side effects of CRYSVITA. Talk to your child’s doctor for medical advice about side effects.
Before taking CRYSVITA, tell your child’s doctor about all of their medications (including supplements) and medical conditions, including if they:
- Are taking oral phosphate and/or active vitamin D (such as calcitriol, paricalcitol, doxercalciferol, calcifediol)
While taking CRYSVITA, tell your child's doctor if they experience:
- An allergic reaction such as rash or hives
- A rash, swelling, bruising, or other reaction at the injection site
- New or worsening restless legs syndrome
These are not all the possible side effects of CRYSVITA. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.
Please see the full Prescribing Information for additional Important Safety Information.
Learn how CRYSVITA has helped others with XLH
“I've been on CRYSVITA for about 3 years now, and I feel it's working for me.”
Understand how CRYSVITA is dosed and given to children
Not actual size
