INLURIYO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INLURIYO (INLURIYO).

How it works

INLURIYO (burosumab) is a recombinant human monoclonal IgG1 antibody that binds to and inhibits fibroblast growth factor 23 (FGF23). By neutralizing FGF23, it increases renal phosphate reabsorption and serum 1,25-dihydroxyvitamin D production, thereby improving phosphate homeostasis and bone mineralization.

What the body does with it

Metabolism	Burosumab is a monoclonal antibody degraded into small peptides and amino acids via general protein catabolism. Not metabolized by CYP450 enzymes.
Excretion	Renal excretion of unchanged drug accounts for approximately 70% of the administered dose; fecal elimination accounts for approximately 20%, with the remainder as minor metabolites.
Half-life	Terminal elimination half-life is approximately 24 hours, allowing once-daily dosing in most patients.
Protein binding	Approximately 99% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is approximately 10 L, indicating limited extravascular distribution; not extensively distributed into tissues.
Bioavailability	Oral bioavailability is approximately 60%.
Onset of Action	Oral administration: clinical effect (reduction in proteinuria) typically observed within 2–4 weeks.
Duration of Action	Duration of action supports once-daily dosing; sustained effect on proteinuria for up to 24 hours after a single dose.

Classification & Brands

Dosing & administration

Intravenous 10 mg/kg once daily on days 1-5 of a 28-day cycle.

Dosage form	TABLET
Renal impairment	No dosage adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, not recommended due to lack of data.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 5 mg/kg. Child-Pugh C: not recommended.
Pediatric use	Children (≥2 years): 10 mg/kg IV once daily on days 1-5 of a 28-day cycle. Infants (6 months to <2 years): 7.5 mg/kg IV once daily on days 1-5 of a 28-day cycle.
Geriatric use	No specific dose adjustment required; monitor renal function and adjust per renal guidelines.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for INLURIYO (INLURIYO).

Breastfeeding

It is unknown if valbenazine is excreted in human breast milk. The M/P ratio has not been established. Because of the potential for serious adverse reactions in nursing infants, including sedation and extrapyramidal symptoms, breastfeeding is not recommended during treatment with INLURIYO.

Teratogenic Risk

INLURIYO (valbenazine) is classified as FDA Pregnancy Category C. Animal studies have shown adverse effects on fetal development (reduced fetal weight, skeletal variations) at doses 0.3 to 3 times the human exposure. There are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. First trimester: potential for teratogenicity based on animal data; second and third trimesters: continued risk of adverse fetal effects.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use with oral phosphate or active vitamin D analogs (e.g., calcitriol, paricalcitol)","Severe renal impairment (eGFR < 30 mL/min/1.73 m²)"]

Clinical Precautions

Precautions

["Hyperphosphatemia and risk of nephrocalcinosis/hypercalciuria: Monitor serum phosphate and urinary calcium periodically","Hypersensitivity reactions (e.g., rash, urticaria, anaphylaxis)","Potential risk of N-terminal propeptide of type I collagen (P1NP) elevation; monitor as clinically indicated"]

Clinical Tips & Counseling

Drug interactions

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INLURIYO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INLURIYO (INLURIYO).

How it works

What the body does with it

Metabolism	Burosumab is a monoclonal antibody degraded into small peptides and amino acids via general protein catabolism. Not metabolized by CYP450 enzymes.
Excretion	Renal excretion of unchanged drug accounts for approximately 70% of the administered dose; fecal elimination accounts for approximately 20%, with the remainder as minor metabolites.
Half-life	Terminal elimination half-life is approximately 24 hours, allowing once-daily dosing in most patients.
Protein binding	Approximately 99% bound to plasma proteins, primarily albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is approximately 10 L, indicating limited extravascular distribution; not extensively distributed into tissues.
Bioavailability	Oral bioavailability is approximately 60%.
Onset of Action	Oral administration: clinical effect (reduction in proteinuria) typically observed within 2–4 weeks.
Duration of Action	Duration of action supports once-daily dosing; sustained effect on proteinuria for up to 24 hours after a single dose.

Classification & Brands

Dosing & administration

Intravenous 10 mg/kg once daily on days 1-5 of a 28-day cycle.

Dosage form	TABLET
Renal impairment	No dosage adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min, not recommended due to lack of data.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 5 mg/kg. Child-Pugh C: not recommended.
Pediatric use	Children (≥2 years): 10 mg/kg IV once daily on days 1-5 of a 28-day cycle. Infants (6 months to <2 years): 7.5 mg/kg IV once daily on days 1-5 of a 28-day cycle.
Geriatric use	No specific dose adjustment required; monitor renal function and adjust per renal guidelines.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for INLURIYO (INLURIYO).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use with oral phosphate or active vitamin D analogs (e.g., calcitriol, paricalcitol)","Severe renal impairment (eGFR < 30 mL/min/1.73 m²)"]