Ridaura

Ridaura®Auranofin Capsules

SKU: 835659001012
DIN: 01916823
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)

Product Description

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.

CONTRAINDICATIONS

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.

WARNINGS

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.

ADVERSE REACTIONS

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
Renal:Proteinuria*; hematuria
Hepatic:Elevated liver enzymes
Miscellaneous:Weight loss

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%)
Dermatological:Angioedema (<0.1%)
Mucous membrane:Gingivitis
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

A joint is an area where two bones meet end-to-end. Joints can be thought of as hinges that enable us to walk, lift objects, bend, turn, and sit down. Muscles and ligaments support the joint, and keep the bones aligned within the joint capsule, permitting movement and providing protection from injury. The ends of the opposing bones are covered by tough elastic sheaths of cartilage and separated by a pocket of fluid – synovial fluid – which is produced by the synovium (the inner lining of the joint capsule). Synovial fluid has two main functions: 1) to lubricate the cartilage, reducing the mechanical stress caused by movement, and 2) to supply nutrients that maintain the health of surrounding tissues. Disorders such as rheumatoid arthritis that adversely affect the synovium or synovial fluid will alter the joint’s delicate architecture, possibly impairing joint function and movement.

THE ARTHRITIC JOINT

The causes of rheumatoid and psoriatic arthritis are unknown. Whatever the cause, the result is joint inflammation and its accompanying symptoms and, later, joint damage. Inflammation attracts blood components that release enzymes capable of attacking the synovium. Once irritated and inflamed, the synovium produces excess fluid, which puts painful pressure on surrounding tissues. Cellular debris from the inflammatory process, called pannus, accumulates on the cartilage surfaces and releases enzymes that can destroy the joint tissues and, eventually, the bone. Such damage is irreversible, eventually limiting joint motion.

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.

RESOURCES

PRODUCT MONOGRAPH

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PRESCRIBING INFORMATION

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FREQUENTLY ASKED QUESTIONS

What is Rheumatoid Arthritis?
Rheumatoid arthritis is a disease affecting primarily the joints, causing joint swelling, pain and stiffness.
What is Ridaura®?
Ridaura® is an oral preparation containing gold. Gold in the form of an injection has been used in treatment of severe rheumatoid arthritis for a number of years.
What is Ridaura® used for? How does it work?
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. 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.
Who should not take Ridaura®?
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® should not be given to pregnant women. Furthermore, women of childbearing potential should be made aware of the necessity to avoid pregnancy during treatment and for at least six months after because of the slow excretion of gold and its persistence in the body tissues after discontinuation of treatment. Ridaura® not be given during nursing.
How should Ridaura® be taken?
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
How soon can I see the beneficial effects of Ridaura®?
The beneficial effects of Ridaura® take time to become apparent. A response may be seen after 3 to 4 months, but it may take up to 6 months. Your doctor will instruct you to continue taking ASA or NSAIDs to relieve more immediate symptoms of rheumatoid arthritis.
What are the possible unwanted effects of Ridaura®?
The most frequent adverse reaction to Ridaura® has been a change in stool pattern – loose stools or diarrhea. Stomach pain, nausea, skin rashes, itching, eye inflammation (conjunctivitis), and inflammation of the tissues of the mouth (stomatitis) have also been reported during therapy with Ridaura®. These events generally occur early in the treatment program and can usually be relieved without discontinuing Ridaura® therapy but sometimes discontinuation is necessary.
What possible unwanted effects require immediate medical attention?
Rarely, more severe reactions occur which include changes in blood cells or kidneys. These can be reversed if discovered early. Therefore, your doctor will be monitoring therapy with frequent laboratory tests and office visits and will make any necessary adjustments in your therapy. If you notice any unusual or troublesome symptoms including fever, sore throat, lesions in the mouth, spontaneous bruising, black or tarry stools, skin reactions, or persistent or severe indigestion while taking Ridaura®, contact your doctor immediately.
What should you do in case of an overdose or accidental taking of Ridaura®?
In case of acute overdosage, immediate induction of emesis or gastric lavage and appropriate supportive therapy are recommended. There has been no experience with treating Ridaura® overdosage with modalities such as chelating agents; however, they have been used with injectable gold and may be considered when treating Ridaura® overdosage.
How should this product be stored?
Store at room temperature (15 – 30 C°). Dispense in a tight, light resistant container.

**The information above is an excerpt from the product monograph