burosumab at a glance
Medicine class
Human monoclonal antibody targeting FGF23
Licensed use
X-linked hypophosphataemia in adults and in children and adolescents with radiographic bone disease
Administration
Subcutaneous injection, sometimes given at home after suitable training
Key monitoring
Blood phosphate and mineral metabolism, with kidney assessment for nephrocalcinosis
What is burosumab used for?
Burosumab is licensed for:
X-linked hypophosphataemia in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease.
X-linked hypophosphataemia in adults.
How does burosumab work?
FGF23 reduces phosphate reabsorption by the kidneys and lowers production of active vitamin D. Burosumab blocks FGF23, increasing kidney phosphate reabsorption, blood phosphate and active vitamin D.
burosumab preparations and strengths
Injection
Route: Parenteral
Strengths: 10 mg, 20 mg, 30 mg
How to take burosumab
Burosumab is injected under the skin by a healthcare professional or, when approved by the specialist team, a suitably trained patient or carer using a pre-filled syringe.
Use the upper arm, abdomen, buttock or thigh and rotate injection sites.
The first self-administered injection after starting treatment or a treatment adjustment should be supervised by a healthcare professional.
Follow the product-specific instructions. Do not use a pre-filled syringe if the liquid is cloudy, discoloured or contains particles.
Allow a refrigerated pre-filled syringe to reach room temperature for 45 minutes; do not warm it another way.
burosumab side effects
Common or expected effects
- Injection-site redness, pain, itching, swelling or bruising
- Headache or dizziness
- Low vitamin D
- Dental infection or tooth abscess
- Back pain, muscle spasms or restless legs in adults
- Fever, cough, vomiting, diarrhoea or limb pain in children and adolescents
Get urgent medical advice
- Severe allergic reaction, including widespread itching or rash, facial or mouth swelling, breathlessness, rapid heartbeat or collapse
- A severe or worsening injection-site reaction requiring prompt clinical assessment
burosumab in pregnancy
Human pregnancy information is limited, and burosumab is not recommended during pregnancy. Anyone who could become pregnant should discuss contraception with the specialist team; the product information advises effective contraception during treatment and for at least 14 weeks after stopping.
burosumab while breastfeeding
It is unknown whether burosumab enters human milk, and risk to a breastfed infant cannot be excluded. The prescriber and parent should weigh the benefits of breastfeeding against the benefits of continuing treatment.
burosumab interactions
Tell the specialist team about prescribed, over-the-counter and nutritional products before treatment.
Oral phosphate supplements
Concurrent use is contraindicated because it may increase blood phosphate and calcium excessively.
Active vitamin D analogues, such as calcitriol
Concurrent use is contraindicated because it may increase blood phosphate and calcium excessively.
Common questions about burosumab
Answers are fully visible for fast scanning and source review.
Does burosumab treat every cause of low phosphate?
No. It is licensed specifically for X-linked hypophosphataemia, not low phosphate from unrelated causes.
Is burosumab suitable for children under 1 year?
Its safety and effectiveness have not been established in children under 1 year, and the licensed indication starts at age 1.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.