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CRYSVITA was effective in adults with TIO

Actor portrayal

Two clinical studies of adults with TIO have shown that
CRYSVITA can help by:

Periodic table abbreviation of phosphorus

Increasing and maintaining phosphorus levels in the blood

Leg with cast

Helping to heal osteomalacia

(weak or softened mature bone)

Study designs

The benefits and risks of treatment with CRYSVITA were studied in a total of 27 adults with TIO

Study 6

  • Number of patients: 14
  • Patient ages: 33 to 68 years
  • Length of treatment: 144 weeks

Study 7

  • Number of patients: 13
  • Patient ages: 41 to 73 years
  • Length of treatment: 88 weeks

INCREASING PHOSPHORUS

CRYSVITA increased phosphorus levels in the blood

In CRYSVITA clinical studies, adults with TIO had the level of phosphorus in their blood measured through week 144 (Study 6) and week 88 (Study 7).

Study 6

(Ages 33 to 68 years)

Line graph of increase in phosphorus serum levels

This chart shows the increase in phosphorus levels in the blood for people in Study 6 (14 adults, ages 33-68 years).

Phosphorus levels in the blood increased from 1.6 mg/dL at baseline to 2.64 mg/dL averaged across the midpoint of dose intervals through week 24 and were sustained through week 144.

For people receiving CRYSVITA in Study 7, serum phosphorus increased from 1.62 mg/dL at baseline to 2.63 mg/dL averaged across the midpoint of dose intervals through week 24. This increase was sustained through week 88 with CRYSVITA.

Study 6: 7 out of 14 people (50%) had serum phosphorus levels in the normal range averaged across the midpoint of dose intervals through week 24.

Study 7: 9 out of 13 people (69%) had serum phosphorus levels in the normal range averaged across the midpoint of dose intervals through week 24.

HEALING OSTEOMALACIA

CRYSVITA helped heal osteomalacia

Under normal circumstances, minerals like phosphorus are continuously added to bones. This process, called mineralization, helps keep bones hard. People with TIO don’t have enough phosphorus for bones to properly mineralize, which causes some parts of the bone to become “soft” and more likely to break.

In Study 6, a study of adults with TIO aged 33 to 68 years, small samples of bone were taken and examined for signs of healing of osteomalacia. Bone samples were taken before patients started treatment with CRYSVITA and then again after the patients were treated with CRYSVITA every 4 weeks for 48 weeks.

CRYSVITA helped improve bone mineralization in people with TIO.

Study 6
(14 adults, ages 33 to 68 years)

34%

Reduction in unmineralized or soft bone with CRYSVITA

Bone scans taken during Study 6 showed that some people receiving CRYSVITA saw healing in their bone abnormalities at week 48 through week 144.

In Studies 6 and 7, patients receiving CRYSVITA had a 34% reduction in unmineralized bone at week 48. Their bone biopsies showed a decrease in osteoid volume to bone volume (OV/BV), which is a measurement of unmineralized bone.

CRYSVITA reduced the bone damage caused by osteomalacia.

Learn about the possible side effects of CRYSVITA

CRYSVITA SAFETY

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What is CRYSVITA?

CRYSVITA is a prescription medicine used to treat 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.


What is CRYSVITA?

CRYSVITA is a prescription medicine used to treat 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).
  • If you are taking CRYSVITA for TIO, your doctor will have you stop your CRYSVITA treatment temporarily if you are undergoing treatment for your tumor (e.g., surgical removal of the tumor or radiation therapy).

What are the possible side effects of CRYSVITA?

  • Adverse reactions that were seen in adults with TIO are:

    • Tooth abscess
    • 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 1-844-768-3544.
  • 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 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.

For important risk and use information, please see the full Prescribing Information.

What is CRYSVITA?

CRYSVITA is a prescription medicine used to treat 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).
  • If you are taking CRYSVITA for TIO, your doctor will have you stop your CRYSVITA treatment temporarily if you are undergoing treatment for your tumor (e.g., surgical removal of the tumor or radiation therapy).

What are the possible side effects of CRYSVITA?

  • Adverse reactions that were seen in adults with TIO are:

    • Tooth abscess
    • 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 1-844-768-3544.
  • 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 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.

For important risk and use information, please see the full Prescribing Information.