burosumab

Contraindicated in:

Hypersensitivity;
Concurrent use with oral phosphate and active vitamin D analogs;
Serum phosphorus concentrations within or above the normal range for age;
Severe renal impairment or end-stage renal disease.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 mo (safety and effectiveness not established);
Geri: Choose dose carefully, considering concurrent disease states, drug therapy, and age-related ↓ in hepatic and renal function.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

Endo: ↓vitamin D concentrations

F and E: hyperphosphatemia

GI: tooth abscess, toothache, vomiting, constipation

GU: nephrocalcinosis

Local: injection site reactions

MS: musculoskeletal pain, restless leg syndrome

Neuro: dizziness, headache

Misc: fever, hypersensitivity reactions (rash, urticaria)

Interactions ⬆ ⬇

Drug-drug:

None known.

Availability ⬆ ⬇

Solution for injection: 10 mg/mL; 20 mg/mL; 30 mg/mL

Route/Dosage ⬆ ⬇

X-Linked Hypophosphatemia

SC (Adults ): 1 mg/kg (rounded up to nearest 10 mg) every 4 wk (min dose = 10 mg; max dose = 90 mg). May adjust dose based on fasting serum phosphorus concentrations measured on monthly basis 2 wk after dose for 1st 3 mo of therapy, and thereafter as appropriate (not to be adjusted more frequently than every 4 wk).
SC (Children ≥6 mo and ≥10 kg): 0.8 mg/kg (rounded up to nearest 10 mg) every 2 wk (max dose = 90 mg). May adjust dose based on fasting serum phosphorus concentrations measured every 4 wk for 1st 3 mo of therapy, and thereafter as appropriate (not to be adjusted more frequently than every 4 wk).
SC (Children ≥6 mo and <10 kg): 1 mg/kg (rounded up to nearest 1 mg) every 2 wk. May adjust dose based on fasting serum phosphorus concentrations measured every 4 wk for 1st 3 mo of therapy, and thereafter as appropriate (not to be adjusted more frequently than every 4 wk).

Tumor-Induced Osteomalacia

SC (Adults ): 0.5 mg/kg (rounded up to nearest 10 mg) every 4 wk. May adjust dose based on fasting serum phosphorus concentrations measured on monthly basis 2 wk after dose for 1st 3 mo of therapy, and thereafter as appropriate (not to be adjusted more frequently than every 4 wk).
SC (Children ≥2 yr): 0.4 mg/kg (rounded up to nearest 10 mg) every 2 wk. May adjust dose based on fasting serum phosphorus concentrations measured on monthly basis 2 wk after dose for 1st 3 mo of therapy, and thereafter as appropriate (not to be adjusted more frequently than every 4 wk).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to and inhibits the activity of FGF23. Excess levels of FGF23 are present in X-linked hypophosphatemia which leads to inhibition of the reabsorption of phosphate by the renal tubules and the production of 1,25 dihydroxy vitamin D by the kidneys.

Therapeutic effects:

Increased serum phosphorus and 1,25 dihydroxy vitamin D concentrations.
Healed osteomalacia.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ injection unknown.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Broken down by catabolic processes into peptides and amino acids.

Half-Life: 19 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	8–11 days	14 days

Patient/Family Teaching ⬆ ⬇

Explain purpose of injections to patient and family.
Advise patient to notify health care professional if signs and symptoms of hypersensitivity or injection site reactions occur.
Instruct patient to avoid any oral phosphate and/or active vitamin D analog products during therapy.
May cause or worsen restless leg syndrome. Advise patient to notify health care professional if restless leg syndrome occurs or worsens.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Serum phosphorus levels should be monitored throughout pregnancy. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-888-756-8657.

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Indications ⬇

Contraind./Precautions ⬆ ⬇