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This website is intended for use by US healthcare professionals only.

Prescribing Information location icon For US patients
CRYSVITA® (burosumab-twza) logo

Choose Indication

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Identifying, starting, or supporting patients on CRYSVITA? Here's what every provider should know.

Could CRYSVITA be the right treatment option for your patients?

From new diagnoses to long-term management of XLH, explore how CRYSVITA may meet your patients’ treatment needs using the information below.

Identify patients for CRYSVITA

Case studies

How CRYSVITA works

Mechanism of action

What to expect with CRYSVITA

Efficacy & safety in children Efficacy & safety in adults

Ready to start your patients on CRYSVITA?

Prescribing CRYSVITA marks an important milestone in your patient’s XLH care. Use the resources below to help them get started and access support through Kyowa Kirin Cares.

Initiate the CRYSVITA treatment journey

Starting patients on CRYSVITA

Discover Kyowa Kirin Cares

Patient access & support

Download the Enrollment Form

Enrollment Form (PDF) file download icon

Looking to support your patients through their CRYSVITA journey?

Ongoing, optimized therapy is key in XLH care. Use the resources below to help your patients stay on track with CRYSVITA and stay informed throughout treatment.

Adjust CRYSVITA dosing

Dosing for children Dosing for adults

Get ongoing support with Kyowa Kirin Cares

Patient access & support

Explore helpful CRYSVITA resources

Resources for patients

Identifying, starting, or supporting patients on CRYSVITA? Here's what every provider should know.

Could CRYSVITA be the right treatment option for your patients?

From new diagnoses to long-term management of XLH, explore how CRYSVITA may meet your patients’ treatment needs using the information below.

Identify patients for CRYSVITA

Case studies

How CRYSVITA works

Mechanism of action

What to expect with CRYSVITA

Efficacy & safety in children Efficacy & safety in adults

Ready to start your patients on CRYSVITA?

Prescribing CRYSVITA marks an important milestone in your patient’s XLH care. Use the resources below to help them get started and access support through Kyowa Kirin Cares.

Initiate the CRYSVITA treatment journey

Starting patients on CRYSVITA

Discover Kyowa Kirin Cares

Patient access & support

Download the Enrollment Form

Enrollment Form (PDF) file download icon

Ready to start your patients on CRYSVITA?

Prescribing CRYSVITA marks an important milestone in your patient’s XLH care. Use the resources below to help them get started and access support through Kyowa Kirin Cares.

Initiate the CRYSVITA treatment journey

Starting patients on CRYSVITA

Discover Kyowa Kirin Cares

Patient access & support

Download the Enrollment Form

Enrollment Form (PDF) file download icon

Help patients on their CRYSVITA treatment journey with
Kyowa Kirin Cares

Patient access & support

Kyowa Kirin Cares Co-pay Assistance Program

Eligible patients may pay as little as $0.2,*,†

95% of eligible commercially insured patients enrolled in the Kyowa Kirin Cares Co-Pay Assistance Program paid $0 for CRYSVITA®.† Financial assistance may be available for your patients through Kyowa Kirin Cares.2

The information provided on this page is intended for informational purposes, and should not be considered a guarantee of treatment or coverage. Restrictions apply. For additional information about eligibility, please see the below Program Terms & Conditions.

The Kyowa Kirin Cares Co-Pay Assistance Program for CRYSVITA helps commercially insured individuals who are residents of the United States (including the United States territories) and who are prescribed CRYSVITA for a use approved by the Food and Drug Administration (FDA) pay for their eligible out-of-pocket costs and cost-sharing for CRYSVITA and the associated cost-sharing for drug administration, up to a specified maximum benefit per calendar year. To learn the maximum benefit of financial assistance available to you under the Kyowa Kirin Cares Co-Pay Assistance Program, call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737). Depending on your commercial insurance plan and/or provider setting assistance under the Kyowa Kirin Cares Co-Pay Assistance Program may be provided via a pre-loaded debit card that can be utilized to pay your cost-sharing obligation for CRYSVITA and its administration or through a co-pay card that adjudicates as secondary insurance or a combination of both.

Note that individuals residing in Massachusetts or Rhode Island (or elsewhere as prohibited by law) may not be eligible for financial assistance related to the administration/injection of CRYSVITA. In order to be eligible for the Program, individuals must provide a signed authorization compliant with the Health Insurance Portability and Accountability Act of 1996 and the regulations thereunder (collectively “HIPAA”). The Program does not cover the costs of physician office visits or evaluations, blood work or other testing, or transportation or other related services. The Program is NOT insurance.

Void if copied, transferred, purchased, altered, or traded, and where prohibited and restricted by law. For additional terms and conditions, call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737).

†Data on File, May 2024.

Access helpful resources to support your patient’s treatment journey with CRYSVITA

Resources for your practice & patients
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Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Important Safety Information

CONTRAINDICATIONS

CRYSVITA is contraindicated:

  • In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.
  • When serum phosphorus is within or above the normal range for age.
  • In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.

WARNINGS AND PRECAUTIONS

Hypersensitivity

  • Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment.

Hyperphosphatemia and Risk of Nephrocalcinosis

  • Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels.

Injection Site Reactions

  • Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.

ADVERSE REACTIONS

Pediatric Patients

  • Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%).
  • Postmarketing experience reported in CRYSVITA-treated pediatric XLH patients: blood phosphorus increased.

Adult Patients

  • Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%).
  • Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression.

USE IN SPECIFIC POPULATIONS

  • There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
  • There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition.

PATIENT COUNSELLING INFORMATION

  • Advise patients not to use any oral phosphate and/or active vitamin D analog products.
  • Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.

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.

Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Important Safety Information

CONTRAINDICATIONS

CRYSVITA is contraindicated:

  • In concomitant use with oral phosphate and/or active vitamin D analogs (e.g., calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.
  • When serum phosphorus is within or above the normal range for age.
  • In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.

WARNINGS AND PRECAUTIONS

Hypersensitivity

  • Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment.

Hyperphosphatemia and Risk of Nephrocalcinosis

  • Increases in serum phosphorus to above the upper limit of normal may be associated with an increased risk of nephrocalcinosis. For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels.

Injection Site Reactions

  • Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.

ADVERSE REACTIONS

Pediatric Patients

  • Adverse reactions reported in 10% or more of CRYSVITA-treated pediatric XLH patients across three studies are: pyrexia (55%, 44%, and 62%), injection site reaction (52%, 67%, and 23%), cough (52%), vomiting (41%, 48%, and 46%), pain in extremity (38%, 46%, and 23%), headache (34% and 73%), tooth abscess (34%, 15%, and 23%), dental caries (31%), diarrhea (24%), vitamin D decreased (24%, 37%, and 15%), toothache (23% and 15%), constipation (17%), myalgia (17%), rash (14% and 27%), dizziness (15%), and nausea (10%).
  • Postmarketing experience reported in CRYSVITA-treated pediatric XLH patients: blood phosphorus increased.

Adult Patients

  • Adverse reactions reported in more than 5% of CRYSVITA-treated adult XLH patients and in at least 2 patients more than placebo in one study are: back pain (15%), headache (13%), tooth infection (13%), restless legs syndrome (12%), vitamin D decreased (12%), dizziness (10%), constipation (9%), muscle spasms (7%), and blood phosphorus increased (6%).
  • Spinal stenosis is prevalent in adults with XLH, and spinal cord compression has been reported. It is unknown if CRYSVITA therapy exacerbates spinal stenosis or spinal cord compression.

USE IN SPECIFIC POPULATIONS

  • There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
  • There is no information regarding the presence of CRYSVITA in human milk or the effects of CRYSVITA on milk production or the breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CRYSVITA and any potential adverse effects on the breastfed infant from CRYSVITA or from the underlying maternal condition.

PATIENT COUNSELLING INFORMATION

  • Advise patients not to use any oral phosphate and/or active vitamin D analog products.
  • Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.

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.

Reference:

  • 1. CRYSVITA (burosumab-twza). US Prescribing Information. Kyowa Kirin, Inc.; March 2023. 2. Data on file. Kyowa Kirin Cares Copay Utilization. Kyowa Kirin, Inc., 2024.

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COMM-US-CRY-0076 | March 2025