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Ridaura (Auranofin) - Indications and Dosage

 


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INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Capsules, containing 3 mg auranofin, in bottles of 60.

NDC 65483-093-06

STORAGE AND HANDLING

Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light-resistant container.

REVISED AUGUST 2004

©Prometheus, 2004

Manufactured for:
Prometheus Laboratories Inc.
San Diego, CA 92121-4203
by Cardinal Health
Winchester, KY 40391
RI002C04

Page last updated: 2007-06-25

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