pharmacopeia
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Boxed warning

RIDAURA ® (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity, signs of which include: fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, the results of recommended laboratory work (See PRECAUTIONS ) should be reviewed before writing each RIDAURA prescription. Like other gold preparations, RIDAURA is only indicated for use in selected patients with active rheumatoid arthritis. Physicians planning to use RIDAURA should be experienced with chrysotherapy and should thoroughly familiarize themselves with the toxicity and benefits of RIDAURA. In addition, the following precautions should be routinely employed: The possibility of adverse reactions should be explained to patients before starting therapy. Patients should be advised to report promptly any symptoms suggesting toxicity. (See PRECAUTIONS—Information for Patients .)

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

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  • RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies.ICD-10: M06.9

Contraindications

Sourced from openFDA
  • RIDAURA (auranofin) is contraindicated in patients with a history of any of the following gold-induced disorders: anaphylactic reactions, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasia or other severe hematologic disorders.contraindicated

Dosage & administration

Sourced from openFDA

Usual Adult Dosage: The usual adult dosage of RIDAURA (auranofin) is 6 mg daily, given either as 3 mg twice daily or 6 mg once daily. Initiation of therapy at dosages exceeding 6 mg daily is not recommended because it is associated with an increased incidence of diarrhea. If response is inadequate after six months, an increase to 9 mg (3 mg three times daily) may be tolerated. If response remains inadequate after a three-month trial of 9 mg daily, RIDAURA therapy should be discontinued. Safety at dosages exceeding 9 mg daily has not been studied. Transferring from Injectable Gold: In controlled clinical studies, patients on injectable gold have been transferred to RIDAURA (auranofin) by discontinuing the injectable agent and starting oral therapy with RIDAURA, 6 mg daily. When patients are transferred to RIDAURA, they should be informed of its adverse reaction profile, in particular the gastrointestinal reactions. (See PRECAUTIONS— Information for Patients .) At six months, control of disease activity of patients transferred to RIDAURA and those maintained on the injectable agent was not different. Data beyond six months are not available.

Warnings & precautions

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Danger signs of possible gold toxicity include fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Thrombocytopenia has occurred in 1–3% of patients (See ADVERSE REACTIONS ) treated with RIDAURA (auranofin), some of whom developed bleeding. The thrombocytopenia usually appears to be peripheral in origin and is usually reversible upon withdrawal of RIDAURA. Its onset bears no relationship to the duration of RIDAURA therapy and its course may be rapid. While patients' platelet counts should normally be monitored at least monthly (See PRECAUTIONS— Laboratory Tests ), the occurrence of a precipitous decline in platelets or a platelet count less than 100,000/cu mm or signs and symptoms (e.g., purpura, ecchymoses or petechiae) suggestive of thrombocytopenia indicates a need to immediately withdraw RIDAURA and other therapies with the potential to cause thrombocytopenia, and to obtain additional platelet counts. No additional RIDAURA should be given unless the thrombocytopenia resolves and further studies show it was not due to gold therapy. Proteinuria has developed in 3-9% of patients (See ADVERSE REACTIONS ) treated with RIDAURA. If clinically significant proteinuria or microscopic hematuria is found (See PRECAUTIONS— Laboratory Tests ), RIDAURA and other therapies with the potential to cause proteinuria or microscopic hematuria should be stopped immediately.

Adverse reactions

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The adverse reactions incidences listed below are based on observations of 1) 4,784 RIDAURA treated patients in clinical trials (2,474 U.S., 2,310 foreign), of whom 2,729 were treated more than one year and 573 for more than three years; and 2) postmarketing experience. The highest incidence is during the first six months of treatment; however, reactions can occur after many months of therapy. With rare exceptions, all patients were on concomitant nonsteroidal anti-inflammatory therapy; some of them were also taking low dosages of corticosteroids. Reactions occurring in more than 1% of RIDAURA-treated patients Gastrointestinal: loose stools or diarrhea (47%); abdominal pain (14%); nausea with or without vomiting (10%); constipation; anorexia*; flatulence*; dyspepsia*; dysgeusia. Dermatological: rash (24%); pruritus (17%); hair loss; urticaria. Mucous Membrane: stomatitis (13%); conjunctivitis*; glossitis. Hematological: anemia; leukopenia; thrombocytopenia; eosinophilia. Renal: proteinuria*; hematuria. Hepatic: elevated liver enzymes. *Reactions marked with an asterisk occurred in 3-9% of the patients. The other reactions listed occurred in 1-3%. Reactions occurring in less than 1% of RIDAURA-treated patients Gastrointestinal: dysphagia; gastrointestinal bleeding†; melena†; positive stool for occult blood†; ulcerative enterocolitis. Dermatological: angioedema. Mucous Membrane: gingivitis†. Hematological: aplastic anemia; neutropenia†; agranulocytosis; pure red cell aplasia; pancytopenia. Hepatic: jaundice. Respiratory: interstitial pneumonitis.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects— Pregnancy Category C. Use of RIDAURA (auranofin) by pregnant women is not recommended. Furthermore, women of childbearing potential should be warned of the potential risks of RIDAURA therapy during pregnancy. (See below.) Pregnant rabbits given auranofin at doses of 0.5, 3 or 6 mg/kg/day (4.2 to 50 times the human dose) had impaired food intake, decreased maternal weights, decreased fetal weights and an increase above controls in the incidence of resorptions, abortions and congenital abnormalities, mainly abdominal defects such as gastroschisis and umbilical hernia. Pregnant rats given auranofin at a dose of 5 mg/kg/day (42 times the human dose) had an increase above controls in the incidence of resorptions and a decrease in litter size and weight linked to maternal toxicity. No such effects were found in rats given 2.5 mg/kg/day (21 times the human dose). Pregnant mice given auranofin at a dose of 5 mg/kg/day (42 times the human dose) had no teratogenic effects. There are no adequate and well-controlled RIDAURA studies in pregnant women.

Pharmacokinetics

Sourced from openFDA
Metabolism
Pharmacokinetic studies were performed in rheumatoid arthritis patients, not in normal volunteers. Auranofin is rapidly metabolized and intact auranofin has never been detected in the blood.

Overdosage

Sourced from openFDA

The acute oral LD50 for auranofin is 310 mg/kg in adult mice and 265 mg/ kg in adult rats. The minimum lethal dose in rats is 30 mg/kg. In case of acute overdosage, immediate induction of emesis or gastric lavage and appropriate supportive therapy are recommended. RIDAURA overdosage experience is limited. A 50-year-old female, previously on 6 mg RIDAURA daily, took 27 mg (9 capsules) daily for 10 days and developed an encephalopathy and peripheral neuropathy. RIDAURA was discontinued and she eventually recovered. There has been no experience with treating RIDAURA overdosage with modalities such as chelating agents. However, they have been used with injectable gold and may be considered for RIDAURA overdosage.

Approval history

Sourced from openFDA
  • May 24, 1985NDANDA018689Legacy Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
205 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Hypersensitivity188.8%
  2. 2Drug Ineffective167.8%
  3. 3Nausea157.3%
  4. 4Anaemia125.9%
  5. 5Fall115.4%
  6. 6Fatigue115.4%
  7. 7Pneumonia115.4%
  8. 8Pain104.9%
  9. 9Pyrexia94.4%
  10. 10Myocardial Infarction83.9%
  11. 11Rheumatoid Arthritis83.9%
  12. 12Abdominal Pain Upper73.4%
  13. 13Constipation73.4%
  14. 14Cough73.4%
  15. 15Dizziness73.4%

Literature

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Recent PubMed references pinned to Auranofin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Auranofin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Auranofin work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Auranofin used for?
According to FDA labeling, Auranofin carries indications including: RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Auranofin?
Auranofin is classified as Gold preparations, Unknown Cellular or Molecular Interaction, Decreased Complement Activity, Decreased Lysosomal Function, Decreased Phagocytosis, Decreased Prostaglandin Production.
What are the brand names for Auranofin?
Auranofin is marketed under brand names including Ridaura.
What are the contraindications for Auranofin?
Auranofin labeling lists contraindications including: RIDAURA (auranofin) is contraindicated in patients with a history of any of the following gold-induced disorders: anaphylactic reactions, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasia or other severe hematologic disorders.. Always consult the full prescribing information and a clinician.
Note. Data for auranofin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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