CRYSVITA (burosumab-twza) for patients with X-linked hypophosphatemia CRYSVITA (burosumab-twza) for patients with X-linked hypophosphatemia

UltraCare: Assistance in Gaining Access to Crysvita (BUROSUMAB-TWZA)

CRYSVITA is a treatment that targets FGF23, the underlying cause of X-linked hypophosphatemia (XLH) and hypophosphatemia in tumor-induced osteomalacia (TIO)

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LESS

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)
  • Adults and children 2 years of age and older with fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be located or removed

IMPORTANT SAFETY INFORMATION

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 you 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 blood 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).

What are the possible side effects of CRYSVITA?

  • Adverse reactions that were seen in children with XLH are:
    • Fever
    • Injection site reaction
    • Cough
    • Vomiting
    • Pain in arms and legs
    • Headache
    • Tooth infection
    • Dental cavities
    • Diarrhea
    • Decreased vitamin D levels
    • Toothache
    • Constipation
    • Muscle pain
    • Rash
    • Dizziness
    • Nausea
  • Adverse reactions that were seen in adults with XLH are:
    • Back pain
    • Headache
    • Tooth infection
    • Restless legs syndrome
    • Decreased vitamin D levels
    • Dizziness
    • Constipation
    • Muscle spasms
    • Phosphorus levels increased in the blood
  • Adverse reactions that were seen in adults with TIO are:
    • Tooth infection
    • Muscle spasms
    • Dizziness
    • Constipation
    • Injection site reaction
    • Rash
    • Headache
  • 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, 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 1-888-756-86571-888-756-8657.
  • 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.

While taking CRYSVITA, tell your doctor if you 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(800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-888-756-86571-888-756-8657.

Please see full Prescribing Information for additional Important Safety Information.

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)
  • Adults and children 2 years of age and older with fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be located or removed

IMPORTANT SAFETY INFORMATION

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 you 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 blood 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).

What are the possible side effects of CRYSVITA?

  • Adverse reactions that were seen in children with XLH are:
    • Fever
    • Injection site reaction
    • Cough
    • Vomiting
    • Pain in arms and legs
    • Headache
    • Tooth infection
    • Dental cavities
    • Diarrhea
    • Decreased vitamin D levels
    • Toothache
    • Constipation
    • Muscle pain
    • Rash
    • Dizziness
    • Nausea
  • Adverse reactions that were seen in adults with XLH are:
    • Back pain
    • Headache
    • Tooth infection
    • Restless legs syndrome
    • Decreased vitamin D levels
    • Dizziness
    • Constipation
    • Muscle spasms
    • Phosphorus levels increased in the blood
  • Adverse reactions that were seen in adults with TIO are:
    • Tooth infection
    • Muscle spasms
    • Dizziness
    • Constipation
    • Injection site reaction
    • Rash
    • Headache
  • 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, 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 1-888-756-86571-888-756-8657.
  • 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.

While taking CRYSVITA, tell your doctor if you 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(800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-888-756-86571-888-756-8657.

Please see full Prescribing Information for additional Important Safety Information.

For additional information and questions about medical information or medical affairs, please contact Ultragenyx Medical Affairs at 1-888-756-8657.