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Crysvita Side Effects

Generic name: burosumab

Medically reviewed by Drugs.com. Last updated on Mar 27, 2021.

Note: This document contains side effect information about burosumab. Some of the dosage forms listed on this page may not apply to the brand name Crysvita.

For the Consumer

Applies to burosumab: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, burosumab (the active ingredient contained in Crysvita) 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

Side effects not requiring immediate medical attention

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

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%)

Frequently asked questions

References

1. "Product Information. Crysvita (burosumab)." Ultragenyx Pharmaceutical, Novato, CA.

Further information

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

Some side effects may not be reported. You may report them to the FDA.