Frequently asked questions about CRYSVITA

CRYSVITA is 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.¹

For other CRYSVITA use information, please see the full Prescribing Information.

CRYSVITA is an FGF23 blocking antibody that targets the underlying cause of chronic hypophosphatemia in non-resectable TIO—excess FGF23. It binds to and inhibits the biological activity of FGF23, restoring renal phosphate reabsorption and increasing serum concentration of active vitamin D.¹

For more information on CRYSVITA and how it works, please see mechanism of action.

CRYSVITA is manufactured by Kyowa Kirin, Inc. (U.S. License No. 2077).¹

CRYSVITA is the only targeted therapy to address the underlying causes of chronic hypophosphatemia in non-resectable TIO.^1,2 It is a human monoclonal antibody specifically designed to inhibit the activity of FGF23.³

In TIO, CRYSVITA-mediated inhibition of FGF23 is thought to^1,2:

• Increase renal phosphate reabsorption via increased expression of sodium phosphate co-transporters
• Upregulate renal expression of 1α-hydroxylase and reduce expression of 24-hydroxylase, which together act to increase serum concentration of active vitamin D, leading to increased intestinal phosphate absorption

For more information on CRYSVITA and how it works, please see mechanism of action.

Two phase 2 studies showed that CRYSVITA^1,4,5:

• Increased and maintained serum phosphorus levels
• Helped heal osteomalacia

For more information on the efficacy of CRYSVITA in clinical studies, please see efficacy & safety.

CRYSVITA is contraindicated¹:

• In concomitant use with oral phosphate and/or active vitamin D analogs (eg, 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

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

The most common adverse reactions (in >5% of CRYSVITA-treated patients) in patients with TIO were tooth abscess, muscle spasms, dizziness, constipation, injection site reaction, rash, headache, vitamin D deficiency, hyperphosphatemia, and restless legs syndrome.¹

For more information on the safety of CRYSVITA in clinical studies, please see efficacy & safety.

Advise patients not to use any oral phosphate and/or active vitamin D analog products.¹

Instruct patients to contact their physician if hypersensitivity reactions, injection site reactions, and restless legs syndrome induction or worsening of symptoms occur.¹

For other patient counseling information for CRYSVITA, please see the full Prescribing Information.

Children

The recommended starting dosage for patients 2 years to <18 years of age is 0.4 mg/kg body weight, rounded to the nearest 10 mg, every 2 weeks. Doses may be increased to a maximum of 2 mg/kg (not to exceed 180 mg) every 2 weeks.¹

Adults

The recommended starting dosage for patients ≥18 years of age is 0.5 mg/kg body weight, rounded to the nearest 10 mg, every 4 weeks. Doses may be increased to a maximum of 2 mg/kg (not to exceed 180 mg) every 2 weeks.¹

For more information on the dosage for CRYSVITA, please see:

Dosage for children

Dosage for adults

Children

Assess fasting serum phosphorus on a monthly basis, measured 2 weeks post-dose, for the first 3 months of treatment, and thereafter as appropriate.¹

Adults

Assess fasting serum phosphorus on a monthly basis, measured 2 weeks post-dose, for the first 3 months of treatment, and thereafter as appropriate.¹

For more information on the assessment schedule for CRYSVITA, please see:

Dosage for children

Dosage for adults

Children

Upon assessment, if serum phosphorus is within the reference range for age, continue with the same dose.¹

Adults

Upon assessment, if fasting serum phosphorus is within the normal range, continue with the same dose.¹

For more information on dosage adjustments for CRYSVITA, please see:

Dosage for children

Dosage for adults

CRYSVITA should be administered by an HCP via subcutaneous injection only. Injection sites should be rotated with each injection, administered at a different anatomic location than the previous injection. Injection site locations include¹:

• Upper arms
• Upper thighs
• Buttocks
• Any quadrant of the abdomen

Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.¹

For more information on the administration of CRYSVITA and general considerations, please see:

Dosage for children

Dosage for adults

CRYSVITA is a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution for subcutaneous injection. Do not use if the solution is discolored or cloudy or if the solution contains any particles or foreign particulate matter.¹

For more information on the administration of CRYSVITA and general considerations, please see:

Dosage for children

Dosage for adults

If a patient misses a dose, resume CRYSVITA as soon as possible at the prescribed dose. To avoid missed doses, treatments may be administered 3 days either side of the scheduled treatment date.¹

CRYSVITA should be administered by a healthcare professional, such as a registered nurse or physician. Administration can occur at the patient’s home, a medical facility, or another appropriate site of care.¹

CRYSVITA vials must be stored in the original carton until the time of use under refrigerated conditions at 36°F to 46°F (2°C to 8°C). Keep the CRYSVITA vial in the original carton to protect it from light until the time of use.¹

• Do not freeze or shake CRYSVITA
• Do not use CRYSVITA beyond the expiration date stamped on the carton
• CRYSVITA vials are single-dose only. Discard any unused product

For more information on storing and handling CRYSVITA, please see supply & storage.

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 1-844-768-3544.¹

For more information on the use of CRYSVITA in specific populations, please see the full Prescribing Information.

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.¹

For more information on the use of CRYSVITA in specific populations, please see the full Prescribing Information.

CRYSVITA is contraindicated in concomitant use with oral phosphate and/or active vitamin D analogs (eg, calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia.¹

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

The Kyowa Kirin Cares program helps patients understand their financial options based on their insurance coverage (commercial, government, or no insurance) and offers access support for eligible patients. 95% of eligible, commercially insured patients who were enrolled in the Kyowa Kirin Cares Co-Pay Assistance Program had $0 out-of-pocket costs for CRYSVITA.⁶*

For more information on access and reimbursement assistance for CRYSVITA, please see patient access & support.

*Data on File, May 2024.

Kyowa Kirin Cares provides patients with ongoing support throughout their journeys with CRYSVITA.

A Case Manager can help healthcare professionals and their patients NAVIGATE treatment:

• Assist with logistical information regarding access, reimbursement, and financial options
• Explain how to work with specialty pharmacies
• Support patients throughout their treatment journeys

A Clinical Educator can help EDUCATE patients about disease and treatment:

• Help answer questions about TIO and CRYSVITA
• Provide tips, tools, and resources to help patients stay on track
• Connect with patients along their treatment journey

For more information on patient support and access to helpful resources, please see:

Patient access & support

Resources for your practice & patients