|
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.)
|
RIDAURA SUMMARY
PRESCRIBING INFORMATION
RIDAURA.
Auranofin
Capsules
Ridaura (auranofin) is available in oral form as capsules containing 3 mg auranofin.
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.
Unlike anti-inflammatory drugs, Ridaura 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 Ridaura with injectable gold, Ridaura 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 findings when deciding on the use of Ridaura in patients who are candidates for chrysotherapy.
|
