Crysvita

You should not use Crysvita if you are allergic to it, or if you have:

• severe or end-stage kidney disease; or

• if you currently take phosphate or vitamin D by mouth.

Tell your doctor if you have ever had:

• kidney disease; or

• restless leg syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using Crysvita.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Crysvita is not approved for use by anyone younger than 1 year old.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Crysvita.

At least 1 week before your first injection, stop using oral phosphate and vitamin D medications.

Crysvita is injected under the skin, once every 2 weeks in children and once every 4 weeks in adults.

A healthcare provider will give you this injection.

Crysvita doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Call your doctor for instructions if you miss an appointment for your Crysvita injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Headache.
• Throwing up.
• Fever.
• Pain in arms or legs.
• Tooth pain.
• Muscle pain.
• Dizziness.
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There is no available data to inform a drug-associated risk.

Comments:
-Serum phosphate levels should be monitored throughout pregnancy
-Pregnancies should be reported to Ultragenyx Adverse Event reporting line at 1-888-756-8657.

Studies in cynomolgus monkeys without X-linked hypophosphatemia (XLH) found no evidence of teratogenic effects in fetuses or offspring when dosed at 1-, 7-, and 64-fold expected human exposure. Maternal hyperphosphatemia and placental mineralization were observed along with increased late fetal loss, a shortened gestation period, and an increased incidence of preterm births at doses of 64-fold the expected human exposure. This drug appears to cross the placenta as it has been detected in the serum of fetuses and offspring of dams exposed to 64-fold human dose. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of burosumab-twza injection in children younger than 1 year of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of burosumab-twza injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose in patients receiving burosumab-twza.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Calcifediol
• Calcitriol
• Cholecalciferol
• Dihydrotachysterol
• Doxercalciferol
• Ergocalciferol
• Paricalcitol
• Potassium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease, severe (eg, end-stage kidney disease)—Should not be used in patients with this condition.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect burosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.