AURLUMYN
Clinical safety rating
cautionComprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).
Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).
Treatment of relapsed or refractory multiple myelomaTreatment of relapsed or refractory mantle cell lymphoma
Microtubule inhibitor that binds to tubulin and disrupts microtubule dynamics, leading to mitotic arrest and apoptosis.
| 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. |
| Molecular Weight | 475.6 |
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. |
| 1st trimester | AURLUMYN is contraindicated in the first trimester due to known teratogenic effects in animal studies and potential for fetal harm. |
| 2nd trimester | Use in the second trimester is not recommended unless the benefit to the mother clearly outweighs the risk to the fetus; limited human data. |
| 3rd trimester | Third trimester use may be associated with potential neonatal effects; avoid use near term unless essential. |
Clinical note
Comprehensive clinical and safety monograph for AURLUMYN (AURLUMYN).
| Placental transfer | AURLUMYN crosses the placenta readily, achieving fetal plasma concentrations approximately 50-80% of maternal levels. |
| Breastfeeding | AURLUMYN is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment and for at least 2 weeks after the last dose. |
| Lactation Rating | L5 - Contraindicated |
| 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. |
| Fetal Monitoring | Monitor liver function tests, renal function, and complete blood count monthly. Perform fetal ultrasound for anatomy and growth every 4-6 weeks during pregnancy. Monitor for signs of oligohydramnios. |
| Fertility Effects | Animal studies show impaired fertility in males (reduced sperm count, motility) and females (altered estrous cycle, reduced ovulation). Human data limited; advise fertility preservation consultation. |
■ FDA Black Box Warning
None.
| Serious Effects |
PregnancyBreastfeedingSevere hepatic impairmentKnown hypersensitivity to AURLUMYN or any excipient
| 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 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. |
| Patient Advice | Take exactly as prescribed; do not adjust dose without consulting your doctor. · Report any mouth sores, skin rash, unexplained bruising, or change in urine color immediately. · Regular blood and urine tests are required to monitor for side effects. · May take 3-6 months to feel full benefit; do not stop suddenly. · Avoid alcohol as it may increase risk of liver toxicity. · Use effective contraception during treatment and for 6 months after stopping. · Do not take any other medications (including OTC) without approval from your doctor. |
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