Important safety information related to taking CRYSVITA® (burosumab-twza)

CRYSVITA® for TIO—side effects

Learn about the potential side effects related to taking CRYSVITA

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 age
  • You have kidney problems

What is the most important information I should know about CRYSVITA?

  • Some patients developed allergic reactions (e.g., rash and hives) while taking CRYSVITA. Your doctor will monitor you for symptoms of an allergic reaction while you are taking CRYSVITA
  • 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 samples to monitor your 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 (i.e., hematoma)
CRYSVITA® for TIO—side effects in adults

What are the possible side effects of CRYSVITA in adults?

The following side effects were observed in more than 10% of adults who were treated with CRYSVITA every 4 weeks in Studies 6 and 7

Possible side effects in adults with TIO who were treated with CRYSVITA were:

  • Tooth infection
  • Muscle spasms
  • Dizziness
  • Constipation
  • Injection site reaction
  • Rash
  • Headache

Before taking CRYSVITA, tell your doctor about all of your medications (including supplements) and medical conditions, including if you:

  • are taking oral phosphate and/or active vitamin D (such as calcitriol, paricalcitol, doxercalciferol, calcifediol)
  • are pregnant, think you may be pregnant, or plan to become pregnant. There is not enough experience to know if CRYSVITA may harm your unborn baby. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-888-756-8657
  • are breastfeeding or plan to breastfeed. There is not enough experience to know if CRYSVITA passes into your breast milk. Talk with your doctor about the best way to feed your baby while you receive CRYSVITA