Ridaura

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid exposure to sunlight, sunlamps, or tanning beds. Auranofin can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Tell your doctor about all other medications you use, especially:

• gold injections;
• hydroxychloroquine (Plaquenil);
• penicillamine (Cuprimine, Depen);
• phenytoin (Dilantin);
• high doses of steroid medication (prednisone and others); or
• drugs that weaken your immune system, such as cyclophosphamide (Cytoxan, Neosar), azathioprine, methotrexate (Rheumatrex, Trexall), and others.

This list is not complete and there may be other drugs that can interact with auranofin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

>10%

Diarrhea (47%)

Rash (24%)

Pruritus (17%)

Abd pain (14%)

Stomatitis (13%)

1-10%

Nausea (10%)

Anorexia (3-9%)

Conjunctivitis (3-9%)

Dyspepsia (3-9%)

Flatulence (3-9%)

Proteinuria (3-9%)

Alopecia (1-3%)

Anemia (1-3%)

Constipation (1-3%)

Eosinophilia (1-3%)

Elevated liver enzymes (1-3%)

Glossitis (1-3%)

Hematuria (1-3%)

Leukopenia (1-3%)

Thrombocytopenia (1-3%)

Urticaria (1-3%)

Gold Toxicity

See Contraindications & Cautions

Pregnancy Category: C

Lactation: enters breast milk/not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Ridaura is a prescription medication used to treat symptoms of rheumatoid arthritis. Ridaura is a gold-containing compound. The exact mechanism of Ridaura is not understood, but it relieves symptoms of rheumatoid arthritis including painful, swollen, and tender joints.

This medication comes in capsule form and is taken once or twice a day, shortly after eating.

Common side effects of Ridaura include metallic taste, loose stools, stomach pain or discomfort, vomiting, gas, and hair loss.

• Prometheus Laboratories Inc.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Ridaura has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Ridaura, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Very bad belly pain.
• Skin irritation.
• Change in eyesight, eye pain, or very bad eye irritation.

Applies to auranofin: oral capsule

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Loose stools (diarrhea).
• Not hungry.
• Upset stomach or throwing up.
• Stomach cramps.
• Gas.
• Mouth irritation or mouth sores.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to auranofin: oral capsule

Gastrointestinal

In one study evaluating the incidence of diarrhea during auranofin (the active ingredient contained in Ridaura) therapy, diarrhea occurred in 74% of patients during the first month of treatment. The diarrhea was categorized as mild in 64% of cases, moderate in 28% of cases, and severe in 8% of cases. These symptoms may be reduced by the use of antidiarrheals or bulk-forming agents. Approximately 11% of patients required discontinuation of therapy.

Diarrhea is often dose-related as it increases in incidence with higher doses (for example, 9 mg per day). Initiating therapy at lower doses, or reducing the dose if diarrhea develops, may help to prevent or alleviate symptoms.

While diarrhea is generally mild and self-limiting, the possibility of more serious gastrointestinal pathology should be kept in mind. Enterocolitis and toxic megacolon have been reported. Diarrhea may be accompanied by nausea and/or vomiting, abdominal pain, and fever as well as bloody stools in cases of auranofin-induced enterocolitis.[Ref]

Gastrointestinal side effects are among the most common complaints in patients treated with auranofin. Diarrhea or loose stools may occur in 50% to 74% of patients. Abdominal pain (14%), nausea/vomiting (10%), anorexia (3% to 9%), flatulence (3% to 9%), dyspepsia (3% to 9%), stomatitis, constipation, and dysgeusia have also been reported. More serious gastrointestinal effects include gastrointestinal bleeding (0.1% to 1%), enterocolitis and toxic megacolon, as well as aphthous ulcerations of the gastric and intestinal mucosa.[Ref]

Dermatologic

Pruritus and rash may be early warning signs of gold toxicity. Any eruption during auranofin (the active ingredient contained in Ridaura) therapy should be considered a drug-related side effect until proven otherwise. Serious dermatologic toxicity, including exfoliative dermatitis, has been associated with parenteral gold.

Skin pigmentation--known as chrysiasis--characterized by a gray or blue discoloration of sun-exposed skin, has been reported following the use of parenteral gold salts.[Ref]

Dermatologic reactions are relatively common and include rash (24%) and pruritus (17%). Pityriasis rosea and discoid eczema as well as skin pigmentation, known as chrysiasis, have also been reported. While not associated with auranofin, per se, exfoliative dermatitis has been associated with parenteral gold therapy. Topical use of 0.1% to 0.6% products may produce contact dermatitis.[Ref]

Ocular

Ocular side effects include gold deposits in the cornea and, occasionally, the lens. Vision is not usually affected. Conjunctivitis is also reported.[Ref]

Gold deposits in either the lens or cornea are not usually associated with visual disturbances. Deposits typically disappear within months following discontinuation of gold therapy.[Ref]

Hematologic

Hematologic abnormalities associated with auranofin (the active ingredient contained in Ridaura) include thrombocytopenia (>1%), eosinophilia (>1%), leukopenia (>1%), neutropenia (0.1% to 1%), agranulocytosis, aplastic anemia, pure red cell aplasia, and pancytopenia.[Ref]

Decreases in hemoglobin as well as leukopenia, granulocytopenia, and thrombocytopenia may be warning signs of gold toxicity. Any rapid decline in platelet counts or a platelet count of less than 100,000/mm3 necessitates discontinuation of auranofin. Gold therapy should not be reinstituted unless the thrombocytopenia is shown to be unrelated to gold.

Auranofin-induced thrombocytopenia appears to be due to an immune-mediated peripheral destruction of platelets. Bone marrow aspirates in cases of auranofin thrombocytopenia revealed an increased number of megakaryocytes. In addition, platelet reactive antibodies were detectable only in the presence of gold. In one case report, increased uptake of platelets by the spleen with subsequent platelet destruction was demonstrated.[Ref]

Renal

Renal side effects include hematuria, proteinuria, and nephropathy. Parenteral gold salts are associated with glomerulonephritis as well as nephrotic syndrome.[Ref]

Proteinuria occurs in 3% to 9% of patients treated with auranofin. Clinically significant proteinuria and/or hematuria may require cessation of auranofin therapy. Renal toxicity is usually reversible if recognized early and auranofin is discontinued.[Ref]

Hepatic

Hepatic side effects include elevations in liver function tests (>1%) and jaundice. These effects are usually reversible and may be more common in patients with preexisting liver disease. Cholestatic jaundice has been associated with the use of parenteral gold salts.[Ref]

Cardiovascular

Cardiovascular side effects are limited to a case report of a vasomotor or nitritoid reaction. While not usually seen with auranofin (the active ingredient contained in Ridaura) or aurothioglucose therapy, this reaction is not uncommon in patients treated with gold sodium thiomalate.[Ref]

Vasomotor, or nitritoid, symptoms typically include faintness, palpitations, and flushing and occur most often following injection of gold sodium thiomalate. In the elderly, this may result in myocardial infarction or central nervous system injury.

A 37-year-old female with a history of a nitritoid reaction to gold sodium thiomalate, developed similar symptoms during oral therapy with auranofin. Onset of symptoms (i.e. nausea, palpitations, and presyncope) occurred after 18 months of auranofin (6 mg/day) therapy.

Several case reports suggest that concomitant therapy with angiotensin converting enzyme inhibitors may increase the risk of nitritoid reactions in some patients.[Ref]

Respiratory

Irreversible bronchiolitis developed in a 44-year-old female with seropositive rheumatoid arthritis treated with auranofin (the active ingredient contained in Ridaura) (6 mg/day) for five months. A lung biopsy revealed a dense, cellular infiltrate around the bronchioles, with mucous plugging and macrophage infiltration of the bronchiole lumens. The extent to which auranofin versus rheumatoid arthritis contributed to the pathology is uncertain.[Ref]

Respiratory side effects are uncommon although rare cases of bronchiolitis and interstitial pneumonitis have been reported.[Ref]

Nervous system

Nervous system side effects are rare. Peripheral neuropathy after long-term use has been reported. Serious nervous system toxicity, including Guillain Barre-type syndrome and acute disseminated encephalomyelitis, has been associated with parenteral gold salts.[Ref]

Endocrine

Endocrine side effects are limited to a single case report of gynecomastia.[Ref]

Some side effects of Ridaura may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.