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.
