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Frequently asked questions

Answers to your questions about CRYSVITA

What is CRYSVITA and how does it work?

CRYSVITA is the only FDA-approved treatment for FGF23-related hypophosphatemia in TIO when tumors are too small to find or cannot be removed. CRYSVITA is a TIO treatment that can raise the phosphorus levels in your body to a normal range and keep them there.

If you have TIO, your phosphorus levels are lower than they should be. Phosphorus is a mineral that is important for bone health. Low phosphorus levels can cause a weakening of your bones. CRYSVITA can help the body keep more of the phosphorus it needs.

Who should take 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.

Who should not take 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
How is CRYSVITA given?

CRYSVITA is given as an injection under the skin by a healthcare provider. They will inject you in one of 4 places (upper arm, upper thigh, buttocks, stomach) with the location being rotated at each visit.

  • When starting CRYSVITA, the recommended dose is once every 4 weeks for adults and once every 2 weeks for children
  • The dosage (the amount of CRYSVITA you take) is based on body weight and will be determined by your doctor. In some cases, this may require more than 1 injection
  • After initial treatment, your doctor may have to adjust your dose
How long do I need to take CRYSVITA for?

TIO is a progressive disease. It is important to continue taking CRYSVITA for as long as your doctor prescribes it.

How will CRYSVITA treatment affect my condition or symptoms?

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

  • Increasing and maintaining phosphorus levels in the blood
  • Helping to heal osteomalacia
How is CRYSVITA stored?

Instructions for storing and handling CRYSVITA:

  • CRYSVITA vials must be kept refrigerated at 36ºF to 46ºF (2ºC to 8ºC) in the original carton until it’s time to use it
  • Keep the CRYSVITA vial in the original carton to protect it from light until time of use
  • Do not freeze or shake CRYSVITA
  • Do not use CRYSVITA after the expiration date stamped on the carton
  • CRYSVITA vials are single dose only. Discard any unused product
What are the possible side effects of CRYSVITA?

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 abscess
  • Muscle spasms
  • Dizziness
  • Constipation
  • Injection site reaction
  • Rash
  • Headache
Can I take CRYSVITA if I am pregnant?

Currently, there are no studies that measure the risks and benefits of CRYSVITA in pregnant women. Talk to your doctor if you are considering CRYSVITA treatment and are, or plan to be, pregnant.

Glossary

These are some important terms that you might need to know about TIO and CRYSVITA.

Antibody

A protein that is made by the immune system to recognize and block a target.

Fibroblast growth factor 23 (FGF23)

A protein that plays a role balancing the amount of phosphorus in the body; in TIO, the activity of FGF23 is abnormally increased, causing the body to release excess phosphorus in the urine.

Hypophosphatemia

Low levels of phosphorus in the blood.

Mineralization

A process in which minerals like phosphorus are deposited in the bone, causing the bone to harden.

Oncogenic osteomalacia

A softening and weakening of the bones caused by tumors that prevent the body from absorbing enough phosphorus.

Osteoid

A starting component for building bone where minerals have not yet been deposited; an unmineralized component of bone.

Osteoid volume to bone volume (OV/BV)

A ratio of unmineralized bone to mineralized bone.

Osteomalacia

A softening and weakening of the bones in children and adults caused by deficiencies in vitamin D, calcium, or phosphorus.

Phosphorus

A mineral that is important for proper bone healing and growth.

Serum phosphorus

Amount of phosphorus in the blood.

Vitamin D

A nutrient used by the body to maintain strong bones.

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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.