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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?

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.
High levels of calcium in the blood have been reported in patients taking CRYSVITA. The risk is greater in patients with pre-existing hyperparathyroidism (overactive parathyroid glands), for those who are unable to move for extended periods of time, become dehydrated, have high vitamin D levels, or have kidney issues. If you are at greater risk, your doctor will monitor your blood calcium and parathyroid hormone levels before you start and while taking CRYSVITA. If you develop high levels of blood calcium, your doctor may need to stop your treatment until it is adequately managed.
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
- 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.
- High levels of calcium in the blood have been reported in patients taking CRYSVITA. The risk is greater in patients with pre-existing hyperparathyroidism (overactive parathyroid glands), for those who are unable to move for extended periods of time, become dehydrated, have high vitamin D levels, or have kidney issues. If you are at greater risk, your doctor will monitor your blood calcium and parathyroid hormone levels before you start and while taking CRYSVITA. If you develop high levels of blood calcium, your doctor may need to stop your treatment until it is adequately managed.
- 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 for CRYSVITA.

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 for CRYSVITA.

What is CRYSVITA?

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.
High levels of calcium in the blood have been reported in patients taking CRYSVITA. The risk is greater in patients with pre-existing hyperparathyroidism (overactive parathyroid glands), for those who are unable to move for extended periods of time, become dehydrated, have high vitamin D levels, or have kidney issues. If you are at greater risk, your doctor will monitor your blood calcium and parathyroid hormone levels before you start and while taking CRYSVITA. If you develop high levels of blood calcium, your doctor may need to stop your treatment until it is adequately managed.
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
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 for CRYSVITA.

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.

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

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

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