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Identifying appropriate patients with TIO and initiating or supporting CRYSVITA® (burosumab-twza) treatment? Here’s what every provider should know

Could CRYSVITA be the right treatment option for your patients?

TIO is an acquired and often misdiagnosed form of hypophosphatemia.1,2 Discover the importance of treatment and how and when CRYSVITA may support your patients’ needs.

Gilberto, a patient currently on CRYSVITA, smiling
Silhouettes of three people

Understanding
TIO

About TIO

How CRYSVITA works

Mechanism of action

What to expect with CRYSVITA

Efficacy & safety

Ready to start your patients with non-resectable TIO on CRYSVITA?

Starting CRYSVITA marks a new chapter in your patient’s care. Help get them started and access support through Kyowa Kirin Cares using the resources below.

Gilberto, a patient currently on CRYSVITA, smiling
A prescription pad

Initiate the treatment journey with CRYSVITA

Starting patients on CRYSVITA
A syringe

Learn about dosage and administration

Dosage for children Dosage for adults
A heart with a plus sign in the middle

Discover Kyowa Kirin Cares

Patient access & support

Looking to support your patients on CRYSVITA through their treatment journey?

Use the resources below to help your patients stay on track with CRYSVITA and stay informed throughout treatment.

Gilberto, a patient currently on CRYSVITA, smiling
A document

Enroll patients in Kyowa Kirin Cares

Enrollment Form (PDF) file download icon
A heart with a plus sign in the middle

Get ongoing support with Kyowa Kirin Cares

Patient access & support
A book

Explore helpful resources for CRYSVITA

Resources for patients

Identifying appropriate patients with TIO and initiating or supporting CRYSVITA® (burosumab-twza) treatment? Here’s what every provider should know

Gilberto, a patient currently on CRYSVITA, smiling
Gilberto, a patient currently on CRYSVITA, smiling
Gilberto, a patient currently on CRYSVITA, smiling
Identifying patients

Could CRYSVITA be the right treatment option for your patients?

TIO is an acquired and often misdiagnosed form of hypophosphatemia.1,2 Discover the importance of treatment and how and when CRYSVITA may support your patients’ needs.

Ready to start your patients with non-resectable TIO on CRYSVITA?

Starting CRYSVITA marks a new chapter in your patient’s care. Help get them started and access support through Kyowa Kirin Cares using the resources below.

Looking to support your patients on CRYSVITA through their treatment journey?

Use the resources below to help your patients stay on track with CRYSVITA and stay informed throughout treatment.

Kyowa Kirin Cares

Help patients with TIO prescribed CRYSVITA get access and support with Kyowa Kirin Cares

$0

Kyowa Kirin Cares Co-Pay Assistance Program

Eligible patients may pay as little as $0.3*

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.

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.

Kyowa Kirin Cares Co-Pay Assistance Program Terms and Conditions

Patients who are enrolled in any federal or state healthcare program, including, without limitation, Medicaid, Managed Medicaid, Medicare, Medicare Advantage, Medigap, CHAMPVA, TriCare, Veterans Affairs (VA), or Department of Defense (DoD), or any state or patient assistance program are not eligible for Kyowa Kirin Cares Co-Pay Assistance Program. 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). Either the patient, or the patient's legal guardian or representative, must personally enroll in the Kyowa Kirin Cares Co-Pay Assistance Program. Health insurance plans, pharmacy benefit managers, employers, payors, or any of their representatives or agents are prohibited from enrolling patients or assisting patients with enrolling in the Kyowa Kirin Cares Co-Pay Assistance Program.

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. Individuals may not seek reimbursement from any health savings, flexible savings, or other healthcare reimbursement account for any amounts received from the Co-Pay Assistance Program. Claims accrued 90 days prior to enrollment in Kyowa Kirin Cares will not be eligible for Co-Pay Assistance. 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).

The above set of Terms and Conditions are subject to change at any time without prior notification. Kyowa Kirin reserves the right to make eligibility determinations, to set parameters for its Programs, to monitor participation, and to change, modify, or discontinue its Programs at any time without notice.

*Data on File, May 2024.

Phosphate element, as shown in the periodic table

Learn about two phase 2 studies that demonstrated how CRYSVITA helped increase serum phosphorus levels and helped heal osteomalacia1,4,5

Efficacy & safety
Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.


Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years 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.
  • Patients who undergo treatment of the underlying tumor should have dosing interrupted and adjusted to prevent hyperphosphatemia.

Hypercalcemia

  • Increases in serum calcium have been reported in patients treated with CRYSVITA. Patients with risk factors such as pre-existing hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment, are at higher risk of hypercalcemia. Monitor these patients for serum calcium and parathyroid hormone levels before and during CRYSVITA treatment for moderate to severe hypercalcemia. In patients with moderate to severe hypercalcemia, CRYSVITA should not be administered until hypercalcemia is adequately managed.

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

Adult Patients

  • Adverse reactions reported in more than 10% of CRYSVITA-treated adult TIO patients in two studies are: tooth abscess (19%), muscle spasms (19%), dizziness (15%), constipation (15%), injection site reaction (15%), rash (15%), and headache (11%).

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 COUNSELING 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.

References:

  • 1. CRYSVITA (burosumab-twza). US Prescribing Information. Kyowa Kirin, Inc.; April 2026. 2. Minisola S, Peacock M, Fukumoto S, et al. Tumour-induced osteomalacia. Nat Rev Dis Primers. 2017;3:17044. doi:10.1038/nrdp.2017.44 3. Data on file. Kyowa Kirin Cares Copay Utilization. Kyowa Kirin, Inc.; 2024. 4. Jan de Beur SM, Miller PD, Weber TJ, et al. Burosumab for the treatment of tumor-induced osteomalacia. J Bone Miner Res. 2021;36(4):627-635. doi:10.1002/jbmr.4233 5. Imanishi Y, Ito N, Rhee Y, Takeuchi Y, Shin CS, Takahashi Y, et al. Interim analysis of a phase 2 open-label trial assessing burosumab efficacy and safety in patients with tumor-induced osteomalacia. J Bone Miner Res. 2021;36(2):262-270. doi:10.1002/jbmr.4184
Indication

CRYSVITA® (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years 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.
  • Patients who undergo treatment of the underlying tumor should have dosing interrupted and adjusted to prevent hyperphosphatemia.

Hypercalcemia

  • Increases in serum calcium have been reported in patients treated with CRYSVITA. Patients with risk factors such as pre-existing hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment, are at higher risk of hypercalcemia. Monitor these patients for serum calcium and parathyroid hormone levels before and during CRYSVITA treatment for moderate to severe hypercalcemia. In patients with moderate to severe hypercalcemia, CRYSVITA should not be administered until hypercalcemia is adequately managed.

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

Adult Patients

  • Adverse reactions reported in more than 10% of CRYSVITA-treated adult TIO patients in two studies are: tooth abscess (19%), muscle spasms (19%), dizziness (15%), constipation (15%), injection site reaction (15%), rash (15%), and headache (11%).

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 COUNSELING 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.

References:

  • 1. CRYSVITA (burosumab-twza). US Prescribing Information. Kyowa Kirin, Inc.; April 2026. 2. Minisola S, Peacock M, Fukumoto S, et al. Tumour-induced osteomalacia. Nat Rev Dis Primers. 2017;3:17044. doi:10.1038/nrdp.2017.44 3. Data on file. Kyowa Kirin Cares Copay Utilization. Kyowa Kirin, Inc.; 2024. 4. Jan de Beur SM, Miller PD, Weber TJ, et al. Burosumab for the treatment of tumor-induced osteomalacia. J Bone Miner Res. 2021;36(4):627-635. doi:10.1002/jbmr.4233 5. Imanishi Y, Ito N, Rhee Y, Takeuchi Y, Shin CS, Takahashi Y, et al. Interim analysis of a phase 2 open-label trial assessing burosumab efficacy and safety in patients with tumor-induced osteomalacia. J Bone Miner Res. 2021;36(2):262-270. doi:10.1002/jbmr.4184

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COMM-US-CRY-0996 June 2026