Auranofin 3 mg/1
auranofin · CAPSULE · Coral Way Pharma, LLC
Auranofin is a capsule containing auranofin at 3 mg/1, taken oral. Manufactured by Coral Way Pharma, LLC.
Key Facts
- Brand Name
- Auranofin
- Generic Name
- auranofin
- NDC Code (Product)
85437-093- Manufacturer
- Coral Way Pharma, LLC
- Strength
- 3 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA018689
- Marketing Start
- 10/29/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Auranofin Capsules (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. Auranofin Capsules should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, Auranofin Capsules does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage. In controlled clinical trials comparing Auranofin Capsules with injectable gold, Auranofin Capsules was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findi…
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Adult Dosage: The usual adult dosage of Auranofin Capsules (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, Auranofin 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 Auranofin Capsules (auranofin) by discontinuing the injectable agent and starting oral therapy with Auranofin Capsules, 6 mg daily. When patients are transferred to Auranofin Capsules, 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 Auranofin Capsules and those maintained on the injectable agent was not different. D…
Warnings
WARNINGS 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 Auranofin Capsules (auranofin), some of whom developed bleeding. The thrombocytopenia usually appears to be peripheral in origin and is usually reversible upon withdrawal of Auranofin Capsules. Its onset bears no relationship to the duration of Auranofin Capsules 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 Auranofin Capsules and other therapies with the potential to cause thrombocytopenia, and to obtain additional platelet counts. No additional Auranofin Capsules should be given unless the thrombocytopenia…
Contraindications
CONTRAINDICATIONS Auranofin Capsules (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.
Drug Interactions
Drug Interactions: In a single patient-report, there is the suggestion that concurrent administration of Auranofin Capsules and phenytoin may have increased phenytoin blood levels.
Adverse Reactions
ADVERSE REACTIONS The adverse reactions incidences listed below are based on observations of 1) 4,784 Auranofin Capsules 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 Auranofin Capsules-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…
Frequently Asked Questions
What is Auranofin used for?
Auranofin contains auranofin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Auranofin a controlled substance?
Auranofin is not classified as a controlled substance by the DEA.
What is the generic name for Auranofin?
The generic name for Auranofin is auranofin. There are 1 other brand versions of auranofin.
What is the NDC code for Auranofin 3 mg/1?
The NDC (National Drug Code) for Auranofin 3 mg/1 is 85437-093, listed by Coral Way Pharma, LLC.