Burosumab-twza (bur-OH-sue-mab - twza)

Treats low phosphate levels in the blood.

Brand Name(s):

Crysvita

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the upper arms, thighs, buttocks, or stomach.
• A nurse or other health provider will give you this medicine.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You should not receive this medicine together with an oral phosphate or an active vitamin D analog (including calcifediol, calcitriol, doxercalciferol, paricalcitol).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have restless leg syndrome.
• This medicine may increase the phosphate level in your blood, which may increase your risk for nephrocalcinosis (high calcium level in the kidneys).
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, cough (in children)
• Increased bone fractures, slowed growth
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Seizures, uneven heartbeat, mood or mental changes, muscle cramps, numbness and tingling around the mouth, fingertips, or feet

If you notice these less serious side effects, talk with your doctor:

• Aching or discomfort in the lower legs or sensation of crawling in the legs
• Back pain
• Constipation, diarrhea, nausea, vomiting
• Dizziness, headache
• Pain in the arms or legs (in children)
• Toothache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088