Ridaura (auranofin)

Dosage of auranofin must be adjusted according to the clinical response and tolerance of the patient. Therapeutic effects occur slowly and generally are not evident until at least 3-4 months after beginning therapy with the drug. To encourage patient compliance with visits to the physician for appropriate clinical and laboratory monitoring, it is recommended that treatment with auranofin be initiated with a prescription for 2 weeks of therapy and only one authorized refill, and that subsequent prescriptions for the drug be limited to a quantity sufficient for 1 month of therapy.

For the management of active rheumatoid arthritis in adults, the recommended initial dosage of auranofin is 6 mg daily, administered as a single dose or in 2 divided doses. Because of potential adverse GI effects, some clinicians initiate therapy with 3 mg once daily and increase dosage to 6 mg daily after several weeks if the initial dosage is well tolerated. Initiating therapy with dosages greater than 6 mg daily is not recommended, since these dosages are associated with an increased incidence of diarrhea.

If diarrhea or loose stools occur and are not self-limiting or are intolerable, these adverse GI effects can generally be managed by dosage reduction (e.g., from 6 to 3 mg daily) or temporary discontinuance of auranofin (e.g., for 3-7 days). Because an adequate response is more likely to be attained, subsequent attempts should be made to increase dosage back to 6 mg daily in patients who require a reduction to 3 mg daily. About one-third of patients in whom dosage is reduced from 6 to 3 mg daily will have a deterioration in clinical status during the period of dosage reduction. In patients who do not tolerate a dosage of 6 mg daily, a dosage of 3 mg daily may be continued for 6 months or longer; however, because the likelihood of attaining an adequate response with this dosage may be reduced, many clinicians would discontinue auranofin and institute therapy with another antirheumatic agent.

If a patient's response to auranofin is inadequate after 6 months of therapy at a dosage of 6 mg daily, dosage may be increased to 9 mg daily (3 mg 3 times daily), if tolerated. Some clinicians would increase dosage from 6 to 9 mg daily as early as 4 months after initiating therapy if the patient's response is inadequate. If a patient's response remains inadequate after 3 months at a dosage of 9 mg daily, auranofin therapy should be discontinued. Alternatively, if a patient's response is inadequate after 6 months of therapy at a dosage of 6 mg daily, some clinicians would continue this dosage for an additional 3-6 months to assess response, while others would discontinue auranofin and institute therapy with another antirheumatic agent. The safety of auranofin dosages exceeding 9 mg daily has not been assessed.

When transferring patients from therapy with another second-line antirheumatic agent to auranofin, patients should be informed of the adverse effect profile of auranofin, particularly its adverse GI effects. (See Cautions: Precautions and Contraindications.) When transferring patients from therapy with a parenteral gold compound to auranofin, a transition period is not necessary; therapy with the parenteral gold compound may be discontinued and auranofin therapy initiated at a dosage of 6 mg daily. When transferring patients from therapy with penicillamine to auranofin, it is recommended that penicillamine therapy be discontinued 1 month before auranofin therapy is initiated.

The optimum duration of treatment in patients who benefit from chrysotherapy has not been established, but chrysotherapy is generally continued as long as clinical improvement is evident and adverse effects do not require discontinuance of treatment. Various maintenance dosage regimens of auranofin and the value of continuing therapy in patients who respond to the drug are currently being evaluated.

Auranofin is administered orally.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits have shown auranofin to have maternotoxic and/or teratogenic effects. In pregnant rabbits receiving oral auranofin dosages of 0.5, 3, or 6 mg/kg daily (4.2, 25, or 50 times the human dosage, respectively), impaired maternal food intake, decreased maternal weight, decreased fetal weight, and an increased incidence of fetal resorptions, abortions, and congenital abnormalities (mainly abdominal defects such as gastroschisis and umbilical hernia, but also anomalies of the brain, heart, lung, and skeleton) were observed. In rats, an increased incidence of fetal resorptions and decreases in litter size and weight related to maternal toxicity were observed with an oral auranofin dosage of 5 mg/kg daily (42 times the human dosage), but these effects were not observed with a dosage of 2.5 mg/kg daily (21 times the human dosage). In mice, auranofin was not found to be maternotoxic or embryotoxic at dosages up to 5 mg/kg daily or teratogenic at dosages up to 40 mg/kg daily.

There are no adequate and controlled studies to date using auranofin in pregnant women. The drug has reportedly been used in a small number of pregnant women and these women subsequently delivered healthy infants, but the manufacturer recommends that auranofin not be used during pregnancy. In addition, the manufacturer recommends that women of childbearing potential be warned of the potential risks of auranofin therapy during pregnancy. Women of childbearing potential in whom auranofin therapy is considered should be counseled about methods of birth control and advised not to become pregnant while receiving the drug; these women should be advised to inform their physician if pregnancy occurs or is suspected during auranofin therapy. The prolonged elimination of gold from the body after discontinuance of chrysotherapy should be considered when a woman of childbearing potential receiving chrysotherapy plans to become pregnant. Chrysotherapy is usually not administered to pregnant women and is usually discontinued if pregnancy occurs; however, chrysotherapy may be used with caution during pregnancy when the potential benefits to the mother justify the possible risks to the fetus. There are no adequate and controlled studies to date using parenteral gold compounds in pregnant women, but clinical experience to date has not revealed substantial evidence of adverse effects on the fetus.

It is not known if gold from auranofin is distributed into human milk. Gold from auranofin is distributed into milk in rats and mice, but has not been detected in their nursing pups. Small amounts of gold have been shown to be distributed into milk in women receiving currently available parenteral gold compounds and to have been absorbed in their nursing infants. The manufacturer recommends that nursing not be undertaken by women receiving auranofin. The prolonged elimination of gold from the body after discontinuance of chrysotherapy should also be considered.

No enhanced messaging available.