Dosing and uses of Ridaura (auranofin)
Adult dosage forms and strengths
capsule
- 3mg
Rheumatoid Arthritis
6 mg PO qDay or divided BID; may increase to 9 mg/day divided TID after 3 months; if no response after 3 months, discontinue drug
Other Indications & Uses
ONLY for patients with active rheumatoid arthritis who have failed adequate trials of NSAIDs
Psoriatic arthritis (off-label)
Pediatric dosage forms and strengths
capsule
- 3mg
Rheumatoid Arthritis
0.1 mg/kg/day PO in divided doses
Maintenance: 0.15 mg/kg PO qDay or divided BID; maximum 0.2 mg/kg/day PO qDay divided BId
Safety & efficacy not established
Ridaura (auranofin) adverse (side) effects
>10%
Diarrhea (47%)
Rash (24%)
Pruritus (17%)
Abd pain (14%)
Stomatitis (13%)
1-10%
Nausea (10%)
Anorexia (3-9%)
Conjunctivitis (3-9%)
Dyspepsia (3-9%)
Flatulence (3-9%)
Proteinuria (3-9%)
Alopecia (1-3%)
Anemia (1-3%)
Constipation (1-3%)
Eosinophilia (1-3%)
Elevated liver enzymes (1-3%)
Glossitis (1-3%)
Hematuria (1-3%)
Leukopenia (1-3%)
Thrombocytopenia (1-3%)
Urticaria (1-3%)
Gold Toxicity
See Contraindications & Cautions
Warnings
Black box warnings
Prescribing physicians should understand severe and fatal toxicities of chrysotherapy
Thorough patient discussion explaining adverse reactions is essential; encourage patients to report any adverse reactions
Monitor for signs of gold toxicity (ie, decreased hemoglobin, leukopenia <4,000/cu.mm, granulocytes <1,500/cu.mm, platelets <150,000/cu.mm, proteinuria, hematuria, pruritus, rash, stomatitis, persistent diarrhea) and establish baseline measurements before prescribing
Should be reserved for use in certain patients with active rheumatoid arthritis
Contraindications
Pts who have had previous gold-induced disorders (anaphylaxis, necrotizing enterocolitis, pulmonary fibrosis, dermatitis, bone marrow suppression, or other hematologic disorder)
Cautions
Not to be used as the sole agent in Tx of RA
No evidence that gold compounds induce remission of RA
Gold toxicity
- Hemoglobin (decr)
- Leukopenia (WBC <4000/cu.mm) [4 x10^9/L]
- Granulocytes (<1500/cu.mm) [1.5 x10^9/L]
- Platelets (<150 x 10^3/cu.mm) [150 x10^9/L]
- Proteinuria, hematuria, pruritus, rash, stomatitis, chronic diarrhea
Pregnancy and lactation
Pregnancy category: C
Lactation: enters breast milk/not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ridaura (auranofin)
Half-Life: 21-31 d
Onset of effects: 3-6 mth
Peak Plasma (6 mg dose)
Time: 2 hr
Concentration: 0.025 mcg/mL
Other Information
Protein binding: 60%
Excretion: urine (60%), feces
Mechanism of action
Unknown
Gold compound, has anti-inflammatory, antiarthritic, and immunomodulating effects