Burosumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
X-linked hypophosphataemia
Adult: Initially, 1 mg/kg every 4 weeks, round dose to the nearest 10 mg. Max: 90 mg. Dose may be adjusted, interrupted, or maintained based on serum phosphorus level (refer to detailed product guideline).
Child: 1-17 years Initially, 0.8 mg/kg every 2 weeks, round dose to the nearest 10 mg. Max: 90 mg. Alternative dosage recommendation: 6 months to <18 years <10 kg: Initially, 1 mg/kg every 2 weeks, round dose to the nearest 1 mg; ≥10 kg: 0.8 mg/kg every 2 weeks, round dose to the nearest 10 mg; Max: 90 mg. All doses may be adjusted, interrupted, or maintained based on serum phosphorus level. Treatment or dosage recommendations may vary among countries. Refer to detailed product guideline.

Subcutaneous
Fibroblast growth factor 23 (FGF23)-related hypophosphataemia in tumour-induced osteomalacia
Adult: In cases associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised: Initially, 0.5 mg/kg every 4 weeks, round dose to the nearest 10 mg. Max: 2 mg/kg (not exceeding 180 mg) every 2 weeks. Dose may be adjusted, interrupted, or maintained based on serum phosphorus level (refer to detailed product guideline).
Child: In cases associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised: 2-17 years Initially, 0.4 mg/kg every 2 weeks, round dose to the nearest 10 mg. Max: 2 mg/kg (not exceeding 180 mg) every 2 weeks. Dose may be adjusted, interrupted, or maintained based on serum phosphorus level (refer to detailed product guideline).
Renal Impairment
Severe or ESRD: Contraindicated.
Contraindications
Serum phosphorus within or above normal range for age. Concomitant use with oral phosphate or active vitamin D analogues; discontinue oral phosphate and vitamin D analogues 1 week prior to initiation of therapy. Severe renal impairment or ESRD.
Special Precautions
Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hyperphosphataemia, hypersensitivity reactions (e.g. urticaria, rash), inj site reactions; restless leg syndrome (adults), decreased serum vitamin D, increased serum PTH.
Gastrointestinal disorders: Constipation; dental caries, vomiting, nausea, diarrhoea, toothache (children).
General disorders and administration site conditions: Fever (children).
Infections and infestations: Tooth abscess or infection.
Musculoskeletal and connective tissue disorders: Back pain, muscle spasm (adults); limb pain, myalgia (children).
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Cough (children).
Monitoring Parameters
Evaluate fasting serum phosphorus every 4 weeks for the 1st 12 weeks of therapy (measured 2 weeks post-dose [adults; children with tumour-induced osteomalacia]) or after any tumour-related treatment (in adults with tumour-induced osteomalacia), then as necessary thereafter (e.g. after dosage adjustment); recommended frequency of monitoring may vary among countries (refer to detailed product guidelines). Monitor for signs and symptoms of nephrocalcinosis at treatment initiation, every 6 months for the 1st 12 months, then annually thereafter; hypersensitivity or inj site reactions. Monitor plasma alkaline phosphatase, Ca, PTH, and creatinine every 6 months (every 3 months in children 1-2 years), or as clinically indicated; urine Ca and phosphate every 3 months; serum 25-hydroxyvitamin D levels.
Drug Interactions
May exacerbate hypocalcaemia with calcimimetic agents.
Potentially Fatal: May increase risk of hyperphosphataemia and hypercalcaemia with oral phosphate and active vitamin D analogues (e.g. calcitriol, calcifediol, doxercalciferol, paricalcitol).
Action
Description: Burosumab is a recombinant human monoclonal antibody (IgG1) which binds to and inhibits fibroblast growth factor 23 (FGF23) activity, thus restoring renal phosphate reabsorption and increasing serum concentration of 1,25-dihydroxyvitamin D.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 7-13 days.
Distribution: Volume of distribution: 8 L.
Metabolism: Expected to be degraded via catabolic pathways into small peptides and amino acids.
Excretion: Elimination half-life: Approx 19 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light. Do not shake.
MIMS Class
Other Drugs Acting on Musculo-Skeletal System / Targeted Cancer Therapy
ATC Classification
M05BX05 - burosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
References
Anon. Burosumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/07/2021.

Buckingham R (ed). Burosumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2021.

Crysvita 20 mg Solution for Injection (Kyowa Kirin Holdings B.V.). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2021.

Crysvita Injection (Kyowa Kirin Hong Kong Co., Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 18/08/2021.

Crysvita Injection (Ultragenyx Pharmaceutical Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2021.

Disclaimer: This information is independently developed by MIMS based on Burosumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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