Frequently asked questions about CRYSVITA and TIO

CRYSVITA is the only FDA-approved treatment for FGF23-related hypophosphatemia in TIO when tumors are too small to find or cannot be removed. In TIO, tumors cause the body to lose too much phosphorus. CRYSVITA does not treat the tumor itself, but can increase and maintain the phosphorus levels in your blood.

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

CRYSVITA is a prescription medicine used to treat adults and children 2 years of age and older with FGF23-related hypophosphatemia in TIO when the tumor, which makes the body lose too much phosphate, cannot be located or removed.

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

CRYSVITA is given as an injection under the skin by a healthcare provider. They will inject you in 1 of 4 places (upper arm, upper thigh, buttocks, stomach) with the location being rotated at each visit.

• The starting schedule for CRYSVITA is once every 4 weeks for adults and once every 2 weeks for children
• The starting dose (the amount of CRYSVITA you receive) is based on body weight and will be determined by your doctor. In some cases, this may require more than 1 injection
• Your doctor will check your phosphorus levels every month for the first 3 months, measured 2 weeks after you receive CRYSVITA, and as needed after that.

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

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

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 them
• 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

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

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