Adult Dosing

Rheumatoid arthritis,

• 3 mg PO bid; Alt: 6 mg PO qd
• May increase to 9 mg PO qd or 3 mg PO tid after 6 months; if response inadequate after 3 months of therapy at 9 mg/day discontinue therapy
• Max: 9 mg/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of progressive rheumatoid arthritis resistant to one or more non steroidal antiinflammatory drugs

• Hypersensitivity to any of the ingredients of the product
• Prior gold toxicity, severe (e.g. anaphylaxis, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasia, hematologic disorders)
• Heavy metal toxicity, severe
• Pregnancy, use not recommended
• Lactation, use not recommended

• Auranofin contains gold and may cause gold toxicity including decreased Hgb, leukopenia <4000 WBC/mm³, granulocytes <1500/mm³, platelets <150,000/mm³, proteinuria, hematuria, pruritus, rash, stomatitis, or persistent diarrhea; Monitor labs before each prescription. Like other gold preparations, auranofin is only indicated for use in selected patients with active rheumatoid arthritis. Physicians should be experienced with chrysotherapy and should thoroughly familiarize themselves with the toxicity and benefits. Counsel patients about possible toxicity and monitoring

Renal Dose Adjustment (Based on CrCl)

• >50 mL/min: Decrease dose by 50%
• <50 mL/min: Avoid use. Caution advised, dose adjustments not defined

Hepatic Dose Adjustment

• Significant hepatic impairment: Caution advised, dose adjustments not defined

• Auranofin contains gold and has potential for multiorgan toxicity (refer adverse events section). Observe patient for early symptoms of toxicity
• Women of childbearing potential should be warned of the potential risks of therapy during pregnancy
• Therapy may take 3 months for effect to be seen; monitor platelets monthly
• The safety of concomitant use of auranofin with injectable gold, hydroxychloroquine, penicillamine, cyclophosphamide, azathioprine, or methotrexate or high doses of corticosteroids has not been established
• Review laboratory values for indications of gold toxicity such as decreased hemoglobin, WBC < 4,000/mm³, platelets < 100,000 to 150,000/mm³, proteinuria, and elevated liver enzymes
• Discontinue therapy if platelet count falls < 100,000/mm³, or if signs and symptoms (e.g., purpura, ecchymoses or petechiae) suggestive of thrombocytopenia
• Monitor BUN/creatinine, LFTs at baseline
• Monitor CBC with differential count, platelets, urinalysis at baseline; then every month

Cautions: Use cautiously in

• Hepatic impairment, severe
• Renal impairment, severe
• Hx of blood dyscrasias
• Inflammatory bowel disease
• SLE
• Skin disorders
• Eczema/urticaria
• Sjogren's syndrome
• Debilitation (extreme caution required)
• Cerebrovascular disease
• Cardiovascular disease
• Hypertension, severe
• Uncontrolled CHF (extreme caution required)
• Uncontrolled diabetes mellitus

Pregnancy Category:C

Breastfeeding: Unsafe; Manufacturer does not recommend use. Excretion of gold into milk after auranofin has not been studied. Case reports with other gold salts indicate that gold appears in milk in small quantities and little of it is absorbed because it is detectable in the infant's urine. No convincing cases of toxicity have been reported. Monitoring for possible adverse effects in the breastfed infant seems prudent. This information based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 June 2010).

• GI: Diarrhea, nausea, vomiting, anorexia, abdominal cramps, ulcerative enterocolitis, flatulence, stomatitis, dyspepsia, dysgeusia
• NEURO: peripheral neuropathy
• RESP: Gold bronchitis, interstitial pneumonitis, fibrosis
• DERM: Exfoliative dermatitis, rash, pruritus, hair loss, urticaria
• EENT: Conjunctivitis
• HEMA: Leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia
• GU: Nephrotic syndrome, glomerulonephritis, renal failure, proteinuria, hematuria
• HEPA: Elevated liver enzymes, cholestatic jaundice
• MISC: Angioedema, fever

• Immunosuppressants; Mechanism of action: Unknown
• Metabolized in GI tract; 25% absorption
• Excreted in urine (60%) and feces (40%)
• Half-life: 26 days (blood), 80 days (tissues)

US Trade Name(s)

• Ridaura

US Availability

Ridaura

• CAPS: 3 mg

Canadian Trade Name(s)

• Ridaura

Canadian Availability

Ridaura

• CAPS: 3 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Ridaura

Australian Availability

Ridaura

• TABS: 3 mg

[Outline]

Rheumatologic

Antirheumatic Agents

Pricing data from www.DrugStore.com in U.S.A.

• Ridaura 3 MG CAPS [Bottle] (PROMETHEUS)
  60 mg = $797.95
  180 mg = $2240.05

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Ridaura 3 MG Oral Capsule

Ingredient(s): Auranofin

Imprint: RIDAURA

Color(s): Brown

Shape: Capsule

Size (mm): 14.00

Score: 1

Inactive Ingredient(s): benzyl alcohol / cellulose, microcrystalline / cetylpyridinium chloride / d&c red no. 33 / fd&c blue no. 1 / fd&c red no. 40 / fd&c yellow no. 6 / gelatin / lactose / magnesium stearate / povidone / sodium lauryl sulfate / sodium starch glycolate type a potato / starch, corn / titanium dioxide

Drug Label Author:
Prometheus Laboratories Inc.

DEA Schedule:
Non-Scheduled