Burosumab Injection

What is this medication?

BUROSUMAB (bur OH sue mab) treats low phosphorus levels caused by a tumor or genetic condition. It works increasing levels of phosphorus in your body. This makes your bones stronger and less likely to break (fracture). It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CRYSViTA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• An unusual or allergic reaction to burosumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Ibritumomab tiuxetan
• Oral phosphate
• Vitamin D supplements, including calcitriol, calcifediol, doxercalciferol, paricalcitol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse. Your condition will be monitored carefully while you are receiving this medication. You will need blood work done while you are taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
• High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth
• Restless leg syndrome—tingling, crawling, pulling, or other unusual feelings in the legs, restlessness, uncontrolled urge to move

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Fever
• Headache
• Pain, redness, or irritation at injection site
• Pain in the hands, arms, legs, or feet
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.