SIZE: 60 Capsules
INDICATIONS: Ridaura® is indicated in the management of adults with active (classical or definite) rheumatoid arthritis who have not responded to adequate trials of conventional anti-inflammatory therapy. Ridaura® might also be of benefit in patients with psoriatic arthritis.
DIRECTIONS: The usual adult starting dose is 6mg per day given either twice a day (one capsule at breakfast and evening meal) or once a day (two capsules with breakfast or evening meal)
ACTIONS AND CLINICAL PHARMACOLOGY
Ridaura® (auranofin) is a gold preparation and therefore has the potential for serious gold toxicity. The mechanism by which auranofin exerts its therapeutic effect has not been established.
In patients with adult rheumatoid arthritis or psoriatic arthritis, Ridaura® may modify disease activity as manifested by synovitis and associated symptoms, and reflected by laboratory parameters such as elevated ESR. There is no substantial evidence, however, that gold-containing compounds induce remission of rheumatoid arthritis.
Clinically the usual time of onset of therapeutic response to Ridaura® is 3 to 4 months. Continuing therapy beyond this time depends upon patient responsiveness, which includes improvement in parameters such as joint swelling, tenderness, pain, morning stiffness and grip strength. Continuing therapy beyond 6 months is unwarranted in patients showing insufficient improvement in the above parameters, and auranofin should be discontinued because of potential serious adverse reactions.
INDICATIONS AND CLINICAL USE
Ridaura® (auranofin) is indicated in the management of adults with active (classical or definite) rheumatoid arthritis who have not responded to adequate trials of conventional anti-inflammatory therapy. Ridaura® might also be of benefit in patients with psoriatic arthritis.
Ridaura® should be considered only when salicylates or other non-steroidal anti-inflammatory drugs, and, when appropriate, steroids, have proven to be inadequate for controlling the symptoms of 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 controlled clinical trials, comparing Ridaura® with injectable gold, Ridaura® was associated with fewer drop-outs due to adverse reactions, while injectable gold was associated with fewer drop-outs for inadequate or poor therapeutic effects. Physicians should consider these findings when deciding on the use of Ridaura® in patients who are candidates for chrysotherapy.
Ridaura® should be added to an ongoing comprehensive treatment program which includes physical as well as other drug therapy. The usual time to onset of therapeutic response to Ridaura® is 3 to 4 months; some patients require as long as 6 months to show a full clinical response.
Ridaura® is not indicated in other arthropathies, such as osteoarthritis.
Ridaura® (auranofin) is contraindicated in patients with a history of serious gold-induced toxicity including necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis or hypersensitivity. Ridaura® should not be prescribed for patients with progressive renal disease, severe hepatological disorders.
Ridaura® (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity. Danger signs of possible gold toxicity include the following: fall in hemoglobin, leukopenia below 4000 WBC/mm3, granulocytes below 1500/mm3, decrease in platelets below 150,000/mm3, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, it is recommended that white blood cells with differential, platelet count, haemoglobin, urinary protein and renal and liver function be measured prior to Ridaura® therapy to establish a baseline and to identify pre-existing conditions.
The adverse reactions listed below are based on observations on 4784 rheumatoid arthritis patients treated with Ridaura® (auranofin) of whom 2729 were treated for more than 1 year and 573 for more than 3 years. The overall incidence of adverse reactions was 62%, of whom 18.6% discontinued therapy. The most common adverse reactions were diarrhea (47%), rash (24%) pruritus (17%), abdominal pain (14%) and stomatitis (13%). More serious adverse reactions were anemia (1.6%), leukopenia (1.9%), thrombocytopenia (0.9%) and proteinuria (5.0%). The highest incidence was during the first 6 months of treatment. However, reactions can occur at any time throughout the course of therapy. 10
Clinical trials were conducted assessing Ridaura® in the treatment of 438 psoriatic arthritis patients. The nature and incidence of adverse reactions were similar to those observed in rheumatoid arthritis patients.
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%); anorexia*; flatulence*; constipation and dysgeusia|
|Dermatological:||Rash (24%); pruritus (17%); hair loss; urticaria|
|Mucous membrane:||Stomatitis (13%); conjunctivitis*; glossitis|
|Hematological:||Anemia; leukopenia; thrombocytopenia; eosinophilia|
|Hepatic:||Elevated liver enzymes|
Reactions occurring in less than 1% of Ridaura-treated patients
|Gastrointestinal:||Gastrointestinal bleeding; melena; positive stool for occult blood; dysphagia (<0.1%); ulcerative enterocolitis (<0.1%)|
|Hematological:||Neutropenia; agranulocytosis (<0.1%), aplastic anemia (<0.1%)|
|Renal:||Membranous glomerulonephritis (<0.1%), nephrotic syndrome (<0.1%)|
|Hepatic:||Jaundice (<0.1 %)|
|Respiratory:||Interstitial pneumonitis (<0.1%)|
|Neurological:||Peripheral neuropathy (<0.1%)|
(* Reactions marked with an asterisk occurred in 3-9% of the patients. The other reactions listed occurred in 1-3%)
DOSAGE AND ADMINISTRATION
The usual adult starting dosage is 6 mg per day. This dose may be given:
Twice a day: one 3 mg capsule with breakfast and one with the evening meal OR once a day: two 3 mg capsules with breakfast OR two 3 mg capsules with the evening meal
Ridaura® (auranofin) should be discontinued in those patients in whom no response is observed after 4 months administration. In those patients in whom a partial response is observed after 4 months, Ridaura® may be continued at 6 mg/day, or the dose may be increased to 9 mg/day (one 3 mg capsule 3 times a day), for an additional 2 months. Ridaura® should be discontinued in patients in whom a satisfactory clinical response has not occurred after 6 months treatment. Daily dosages above 9 mg are not recommended.
Because of possible serious adverse reactions, some rheumatologists suggest reducing the dosage or discontinuing gold altogether when patients are in clinical remission (ARA criteria) lasting for at least six months, keeping in mind that cessation of therapy may allow the disease to progress further. Each patient must be evaluated individually.
**The information above is an excerpt from pages 2-12 in the product monograph
ABOUT THE DISEASE
Rheumatoid arthritis is a disease affecting primarily the joints, causing joint swelling, pain and stiffness. It is a fairly common ailment, affecting about 1% of the population. The disease occurs most frequently in adults (ages 20 to 60), but it may develop at any age. Rheumatoid arthritis is three times more common in women than in men.
Psoriatic arthritis is a disease affecting primarily the joints, causing joint swelling, pain and stiffness and is also associated with skin or nail lesions of psoriasis.
In the general populations, 1% – 2% are affected by psoriatic arthritis. The disease occurs most frequently in adults ages 30 – 50 years. Psoriasis precedes the onset of arthritis in approximately 75% of the patients, and occurs simultaneously in about 15%. In a small number of patients, arthritis precedes the appearance of skin lesions.
In order to understand the nature of the disease, it is helpful to review the joint’s normal structure.
THE NORMAL JOINT
THE ARTHRITIC JOINT
Disease Symptoms and Diagnosis
The first symptom of rheumatoid arthritis is usually general fatigue, accompanied by overall muscle soreness, stiffness, aches and pain. Joint inflammation is marked by pain, swelling, warmth and tenderness of one or more joints in the hands or feet. It can also affect the wrist, shoulders, elbows, hips and knees.
Once rheumatoid arthritis develops, it may progress over many months and years. Symptoms and discomfort can vary greatly from day to day or month to month. There may be repeated and prolonged periods when symptoms disappear and discomfort is greatly reduced (apparent remissions), as well as episodes when symptoms intensify (exacerbations), increasing discomfort.
A diagnosis of rheumatoid arthritis is based on the patient’s history of symptoms and an examination of joint involvement. The results of x-rays and blood tests for inflammation and rheumatoid arthritis markets may also contribute to the diagnosis. A diagnosis of psoriatic arthritis is based on the presence of symptoms of inflammatory arthritis coupled with typical skin or nail lesions of psoriasis.
FREQUENTLY ASKED QUESTIONS
**The information above is an excerpt from the product monograph