Crysvita® (burosumab-twza)

The first and only therapy that addresses the underlying cause of X-linked hypophosphatemia.
 

INDICATION

Crysvita is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.


IMPORTANT SAFETY INFORMATION

Crysvita should not be taken if:

  • An oral phosphate supplement and a specific form of vitamin D supplement are taken
  • Phosphorus levels from a blood sample are within or above the normal range for age
  • Kidney problems are present

What is the most important information to know about Crysvita?

  • Some patients developed allergic reactions (rash and hives) while taking Crysvita. Doctors will monitor for symptoms of an allergic reaction while Crysvita is taken.
  • 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. Doctors will collect samples to monitor levels.
  • 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 collection of blood outside of a blood vessel (hematoma).

What are the possible side effects of Crysvita?

  • The most common adverse reactions that were seen in children with XLH are:
    • Headache
    • Injection site reaction
    • Vomiting
    • Fever
    • Pain in arms and legs
    • Decreased vitamin D levels
    • Rash
    • Toothache
    • Muscle pain
    • Tooth infection
    • Dizziness
  • The most common adverse reactions that were seen in adults with XLH are:
    • Back pain
    • Headache
    • Tooth infection
    • Restless leg syndrome
    • Decreased vitamin D levels
    • Dizziness
    • Constipation
    • Phosphorus levels increased in the blood
  • Narrowing of the spaces within the spine is common in adults with XLH and pressure on the spinal cord has been reported in adults taking Crysvita. It is not known if taking Crysvita worsens the narrowing of the spaces within the spine or the pressure on the spinal cord.

Before taking Crysvita, doctors should be informed about all medical conditions, including if:

  • One is pregnant, thinks she may be pregnant, or plans to become pregnant. There is not enough experience to know if Crysvita may harm an unborn baby. Report pregnancies to the Ultragenyx Adverse Event reporting line at 1-888-756-8657.
  • One is breastfeeding or plans to breastfeed. There is not enough experience to know if Crysvita passes into breast milk. Women should talk with their doctors about the best way to feed their babies while taking Crysvita.

While taking Crysvita, doctors should be informed if one experiences:

  • An allergic reaction such as rash or hives
  • A rash, swelling, bruising or other reaction at the injection site
  • New or worsening restless leg syndrome

These are not all the possible side effects of Crysvita. Doctors should be contacted for medical advice about side effects.

Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Side effects may also be reported to Ultragenyx at 1-888-756-8657.

Full U.S. Prescribing Information for Crysvita >

The product information in this site is intended only for residents of the U.S. The products discussed herein may have different product labeling in different countries.

More information available at www.crysvita.com >