RIDAURA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RIDAURA (RIDAURA).
Gold compound with unknown mechanism; inhibits phagocytosis and lysosomal enzyme release, modulates immune response by suppressing T-cell and B-cell activity, and reduces prostaglandin synthesis.
| Metabolism | Not extensively metabolized; excreted largely unchanged in urine and feces. |
| Excretion | Approximately 60% of absorbed gold is eliminated renally, with the remainder excreted in feces via biliary secretion. Unabsorbed gold is nearly entirely fecal. |
| Half-life | Terminal elimination half-life is approximately 21–31 days after chronic dosing, reflecting slow release from tissue stores. Steady-state is reached after about 3 months. |
| Protein binding | Approximately 95% bound to serum proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.5–1 L/kg, indicating extensive tissue distribution, particularly into synovium and reticuloendothelial tissues. |
| Bioavailability | Oral bioavailability is about 50% (range 40–60%) after oral administration of auranofin. |
| Onset of Action | Clinical response typically begins after 3–4 months of continuous oral therapy; delayed onset is characteristic. |
| Duration of Action | Duration of action is prolonged; effects may persist for weeks to months after discontinuation due to slow clearance of gold from tissues. Clinical remission can last 1–2 years after stopping therapy. |
Adults: initial 6 mg orally once daily or 3 mg twice daily. Increase to 9 mg/day after 3–6 months if insufficient response. Maximum dose 9 mg/day.
| Dosage form | CAPSULE |
| Renal impairment | CrCl < 50 mL/min: contraindicated. No adjustment for mild impairment (CrCl ≥ 50 mL/min) but monitor closely. |
| Liver impairment | No specific guidelines. Use caution in hepatic impairment; monitor hepatic function. No dose adjustment established. |
| Pediatric use | Not recommended for pediatric use due to lack of safety and efficacy data. |
| Geriatric use | Start at low end of dosing range (3 mg/day). Monitor for toxicity, especially proteinuria, cytopenias, and dermatitis, due to potential age-related renal function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RIDAURA (RIDAURA).
| Breastfeeding | Excretion into breast milk is unknown. Due to potential for serious adverse reactions in the nursing infant, breastfeeding is contraindicated. M/P ratio not available. |
| Teratogenic Risk | Ridaura (auranofin) is contraindicated in pregnancy. Animal studies have shown embryotoxicity and teratogenicity. In humans, there are no adequate controlled studies. First trimester exposure carries a risk of congenital anomalies; second and third trimester exposure may cause fetal toxicity. Use is not recommended at any stage. |
■ FDA Black Box Warning
None.
| Serious Effects |
Severe renal disease, severe hepatic disease, history of gold-induced toxicity (e.g., exfoliative dermatitis, aplastic anemia), pregnancy, lactation.
| Precautions | Hematologic toxicity (leukopenia, thrombocytopenia, aplastic anemia), renal toxicity (proteinuria, hematuria), mucocutaneous reactions (stomatitis, rash, exfoliative dermatitis), pulmonary fibrosis, hepatotoxicity. Monitor CBC, urinalysis, renal/liver function regularly. |
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| Fetal Monitoring |
| Not applicable as drug is contraindicated. If accidental exposure occurs, monitor maternal renal/hepatic function, CBC, and urinalysis. Fetal ultrasound for anomaly detection. |
| Fertility Effects | Auranofin may impair fertility in both males and females based on animal studies. In males, oligospermia and decreased sperm motility have been reported. Reversibility upon discontinuation is unknown. |