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auranofin (Ridaura)

 

Classes: Immunosuppressants; DMARDs, Other; DMARDs, Gold Compounds

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