Applies to burosumab: subcutaneous solution.
Serious side effects of Burosumab
Along with its needed effects, burosumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking burosumab:
More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bone malformations
- confusion
- cough or hoarseness
- fast or irregular heartbeat
- fever
- frequent bone fractures
- hives, itching, skin rash
- irritation
- joint pain, stiffness, or swelling
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- pain in the arm or leg
- redness of the skin
- seizures
- slowed growth
- stomach cramps
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- tremor
- troubled breathing or swallowing
Other side effects of Burosumab
Some side effects of burosumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Aching or discomfort in the lower legs or sensation of crawling in the legs
- back pain
- constipation
- diarrhea
- difficulty with moving
- dizziness
- headache
- muscle ache, pain, spasm, or stiffness
- nausea
- toothache
- vomiting
For Healthcare Professionals
Applies to burosumab: subcutaneous solution.
General
The more commonly reported adverse reactions have included injection site reactions, muscle spasms, back pain, tooth infections, restless leg syndrome, dizziness, headache, decreased vitamin D, and constipation.[Ref]
Metabolic
Very common (10% or more): Vitamin D decreased (up to 37%)
Common (1% to 10%): Blood phosphorus increased
Increased blood phosphorus was reported in 6% of adult patients during clinical trials. There were no reports of increased blood phosphorus in pediatric clinical trials.
Gastrointestinal
Very common (10% or more): Vomiting (up to 48%), toothache (up to 23%), tooth abscess (up to 34%), dental caries (up to 31%), diarrhea (up to 24%), constipation (up to 17%)
Common (1% to 10%): Nausea
Hypersensitivity
In pediatric patients, the more frequent events that were considered potential hypersensitivity events included rash (22%), injection site rash (6%), and urticaria (5%). In adult patients approximately 6% of patients in both the study group and placebo group experience mild or moderate hypersensitivity reactions that did not require drug discontinuation.
Frequency not reported: Hypersensitivity reactions
Dermatologic
Rash includes pruritic, maculopapular, and pustular rashes
Very common (10% or more): Rash (up to 27%)
Musculoskeletal
Spinal stenosis is common in adults with X-linked hypophosphatemia (XLH). In phase 2/3 studies, 6 patients (n=176) underwent spinal surgery for what appeared to involve progression of a preexisting spinal stenosis. It is unknown if therapy exacerbates spinal stenosis or spinal cord compression.
Very common (10% or more): Extremity pain (up to 46%), myalgia (up to 17%), back pain (15%); muscle spasm (up to 19%)
Common (1% to 10%): Spinal surgery
Other
Very common (10% or more): Pyrexia (up to 55%)
Local
Very common (10% or more): Injection site reaction (up to 67%)
Injection site reactions have included erythema, pruritus, swelling, pain, rash, bruising, discoloration, discomfort, hematoma, hemorrhage, induration, macule, and urticaria at the injection site
Nervous system
Very common (10% or more): Headache (up to 73%), dizziness (up to 15%), restless leg syndrome (12%)
Respiratory
Very common (10% or more): Cough (up to 52%)
