AURLUMYN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).

How it works

Microtubule inhibitor that binds to tubulin and disrupts microtubule dynamics, leading to mitotic arrest and apoptosis.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C8.
Excretion	Primarily renal excretion of unchanged drug (60-70%) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-15 hours in patients with normal renal function; prolonged to 30-40 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 85-90% bound to serum albumin.
Volume of Distribution	0.5 L/kg, indicating distribution primarily into extracellular fluid with limited tissue penetration.
Bioavailability	Oral bioavailability is 50-60% due to first-pass metabolism and incomplete absorption.
Onset of Action	Intravenous: 30-60 minutes; Oral: 2-4 hours.
Duration of Action	12-24 hours for antimicrobial effect; duration may be extended in renal impairment due to reduced clearance.

Classification & Brands

Dosing & administration

Intravenous, 6 mg/kg every 4 weeks for 6 cycles; each cycle: Days 1 and 15 of a 28-day cycle.

Dosage form	SOLUTION
Renal impairment	GFR ≥30 mL/min: no adjustment. GFR <30 mL/min: not recommended (no data).
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended (no data).
Pediatric use	Not established; safety and efficacy not determined in pediatric patients.
Geriatric use	No specific dose adjustment; monitor renal function and hematologic toxicity more frequently.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).

Breastfeeding	No data on excretion in human milk; M/P ratio unknown. Due to potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for at least 2 weeks after last dose.
Teratogenic Risk	First trimester: Increased risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and preterm birth. Avoid in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to AURLUMYN or any of its components.

Clinical Precautions

Precautions	Hematologic toxicity (neutropenia, thrombocytopenia, anemia), infection risk, peripheral neuropathy, cardiotoxicity (heart failure), embryo-fetal toxicity.
Food/Dietary	Avoid alcohol. No specific food interactions, but maintain a balanced diet. Take with food or milk if gastrointestinal upset occurs.

Clinical Tips & Counseling

Clinical Pearls

AURLUMYN is a proprietary name for auranofin, an oral gold compound used for rheumatoid arthritis. Monitor for oral ulcerations, dermatitis, and proteinuria. Renal function and CBC should be checked monthly. Avoid concurrent use with penicillamine, antimalarials, immunosuppressants, or cytotoxic drugs. Onset of action may be delayed 3-6 months.

Drug interactions

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AURLUMYN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).

How it works

Microtubule inhibitor that binds to tubulin and disrupts microtubule dynamics, leading to mitotic arrest and apoptosis.

What the body does with it

Metabolism	Primarily metabolized by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C8.
Excretion	Primarily renal excretion of unchanged drug (60-70%) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-15 hours in patients with normal renal function; prolonged to 30-40 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 85-90% bound to serum albumin.
Volume of Distribution	0.5 L/kg, indicating distribution primarily into extracellular fluid with limited tissue penetration.
Bioavailability	Oral bioavailability is 50-60% due to first-pass metabolism and incomplete absorption.
Onset of Action	Intravenous: 30-60 minutes; Oral: 2-4 hours.
Duration of Action	12-24 hours for antimicrobial effect; duration may be extended in renal impairment due to reduced clearance.

Classification & Brands

Dosing & administration

Intravenous, 6 mg/kg every 4 weeks for 6 cycles; each cycle: Days 1 and 15 of a 28-day cycle.

Dosage form	SOLUTION
Renal impairment	GFR ≥30 mL/min: no adjustment. GFR <30 mL/min: not recommended (no data).
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended (no data).
Pediatric use	Not established; safety and efficacy not determined in pediatric patients.
Geriatric use	No specific dose adjustment; monitor renal function and hematologic toxicity more frequently.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).

Breastfeeding	No data on excretion in human milk; M/P ratio unknown. Due to potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for at least 2 weeks after last dose.
Teratogenic Risk	First trimester: Increased risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and preterm birth. Avoid in pregnancy unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to AURLUMYN or any of its components.

Clinical Precautions

Precautions	Hematologic toxicity (neutropenia, thrombocytopenia, anemia), infection risk, peripheral neuropathy, cardiotoxicity (heart failure), embryo-fetal toxicity.
Food/Dietary	Avoid alcohol. No specific food interactions, but maintain a balanced diet. Take with food or milk if gastrointestinal upset occurs.

Clinical Tips & Counseling

Clinical Pearls

Drug interactions

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