STATOBEX-G

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STATOBEX-G (STATOBEX-G).

How it works

STATOBEX-G is a monoclonal antibody that binds to and inhibits the activity of granulocyte-macrophage colony-stimulating factor (GM-CSF), thereby reducing inflammation and joint damage in autoimmune diseases.

What the body does with it

Metabolism	STATOBEX-G is metabolized via peptide hydrolysis into small amino acids and peptides; not dependent on hepatic CYP450 enzymes.
Excretion	Renal excretion accounts for 70% (30% unchanged), biliary/fecal elimination for 30% (15% unchanged and 15% as glucuronide conjugates).
Half-life	Terminal elimination half-life is 18-22 hours in healthy adults; prolonged to 30-40 hours in hepatic impairment and 24-30 hours in moderate renal impairment (CrCl 30-50 mL/min).
Protein binding	99.5% bound, primarily to albumin.
Volume of Distribution	0.15-0.20 L/kg, indicating extensive tissue distribution, especially to synovial fluid and inflamed tissues.
Bioavailability	Oral: 80-90% (first-pass metabolism limited); Intramuscular: 100% (complete absorption).
Onset of Action	Oral: 30-60 minutes; Intravenous: 2-5 minutes; Intramuscular: 10-15 minutes.
Duration of Action	6-8 hours for analgesic effect; up to 12 hours for anti-inflammatory effect (due to active metabolite).

Classification & Brands

Dosing & administration

STATOBEX-G 200 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR ≥50 mL/min: no adjustment; GFR 30-49 mL/min: 200 mg once daily; GFR <30 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 200 mg once daily; Child-Pugh C: contraindicated.
Pediatric use	Weight <20 kg: 5 mg/kg orally twice daily; 20-40 kg: 100 mg orally twice daily; >40 kg: adult dose.
Geriatric use	Start at 200 mg once daily; titrate to twice daily based on renal function and tolerability.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for STATOBEX-G (STATOBEX-G).

Breastfeeding	No data on excretion in human milk; however, due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during therapy and for at least 2 weeks after last dose. M/P ratio unknown.
Teratogenic Risk	STATOBEX-G is contraindicated in pregnancy. First trimester exposure carries high risk of major congenital malformations including neural tube defects, cardiovascular anomalies, and oral clefts. Second and third trimester exposure is associated with fetal growth restriction, oligohydramnios, and neonatal renal impairment. Teratogenicity is dose-dependent and considered a Class X risk.

Warnings & precautions

■ FDA Black Box Warning

WARNING: SERIOUS INFECTIONS - Patients treated with STATOBEX-G are at increased risk for developing serious infections, including tuberculosis, invasive fungal infections, and bacterial or viral infections. Discontinue therapy if a serious infection develops.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Active serious infections","Known hypersensitivity to STATOBEX-G or any of its excipients","History of recurrent or chronic infections","Concurrent use with other immunosuppressive agents"]

Clinical Precautions

Precautions

["Risk of serious infections","Hypersensitivity reactions including anaphylaxis","Potential for immunogenicity","May cause elevations in liver enzymes","Avoid use with live vaccines","Monitor for signs of infection during treatment"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

STATOBEX-G

Clinical safety rating: caution

Comprehensive clinical and safety monograph for STATOBEX-G (STATOBEX-G).

How it works

What the body does with it

Metabolism	STATOBEX-G is metabolized via peptide hydrolysis into small amino acids and peptides; not dependent on hepatic CYP450 enzymes.
Excretion	Renal excretion accounts for 70% (30% unchanged), biliary/fecal elimination for 30% (15% unchanged and 15% as glucuronide conjugates).
Half-life	Terminal elimination half-life is 18-22 hours in healthy adults; prolonged to 30-40 hours in hepatic impairment and 24-30 hours in moderate renal impairment (CrCl 30-50 mL/min).
Protein binding	99.5% bound, primarily to albumin.
Volume of Distribution	0.15-0.20 L/kg, indicating extensive tissue distribution, especially to synovial fluid and inflamed tissues.
Bioavailability	Oral: 80-90% (first-pass metabolism limited); Intramuscular: 100% (complete absorption).
Onset of Action	Oral: 30-60 minutes; Intravenous: 2-5 minutes; Intramuscular: 10-15 minutes.
Duration of Action	6-8 hours for analgesic effect; up to 12 hours for anti-inflammatory effect (due to active metabolite).

Classification & Brands

Dosing & administration

STATOBEX-G 200 mg orally twice daily.

Dosage form	TABLET
Renal impairment	GFR ≥50 mL/min: no adjustment; GFR 30-49 mL/min: 200 mg once daily; GFR <30 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 200 mg once daily; Child-Pugh C: contraindicated.
Pediatric use	Weight <20 kg: 5 mg/kg orally twice daily; 20-40 kg: 100 mg orally twice daily; >40 kg: adult dose.
Geriatric use	Start at 200 mg once daily; titrate to twice daily based on renal function and tolerability.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for STATOBEX-G (STATOBEX-G).

Breastfeeding	No data on excretion in human milk; however, due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during therapy and for at least 2 weeks after last dose. M/P ratio unknown.
Teratogenic Risk	STATOBEX-G is contraindicated in pregnancy. First trimester exposure carries high risk of major congenital malformations including neural tube defects, cardiovascular anomalies, and oral clefts. Second and third trimester exposure is associated with fetal growth restriction, oligohydramnios, and neonatal renal impairment. Teratogenicity is dose-dependent and considered a Class X risk.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Active serious infections","Known hypersensitivity to STATOBEX-G or any of its excipients","History of recurrent or chronic infections","Concurrent use with other immunosuppressive agents"]