Drug
Burosumab-Twza
Pronounced
"bur-OH-sue-mab"
Side Effects
Injection site redness, pain, itching, or swelling may occur. Nausea, cough, dizziness, vomiting, headache, muscle pain, or diarrhea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of high phosphate levels (such as muscle cramps or numbness around the mouth), symptoms of tooth infections (such as tooth pain, swelling).
This medication may rarely cause high calcium levels in the blood. You may be at an increased risk for high calcium levels if you have a certain hormone problem (hyperparathyroidism), if you are immobile (such as on very long plane flights or being bedridden), are dehydrated, or have higher levels of vitamin D. Tell your doctor right away if you have symptoms of high calcium levels such as unusual tiredness, mental/mood changes, or constipation.
This medication can worsen or cause a certain medical condition (restless legs syndrome-RLS). Tell your doctor right away if you have symptoms of restless legs syndrome such as an unusual urge to move your legs or an uncomfortable/unpleasant feeling in the legs usually at night.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
See also Side Effects section.
Before using burosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, high levels of phosphate/calcium in your blood.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, burosumab should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.