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Use and Important Safety Information you should know about Ridaura® (auranofin) capsules
What is Ridaura®?
Ridaura® is a prescription medicine for adults with active rheumatoid arthritis (RA) who have not responded to or cannot tolerate full doses of other medications.
RIDAURA® (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity, signs of which include: fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, the results of recommended laboratory work (See PRECAUTIONS) should be reviewed before writing each RIDAURA® prescription. Like other gold preparations, RIDAURA® is only indicated for use in selected patients with active 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 addition, the following precautions should be routinely employed:
1. The possibility of adverse reactions should be explained to patients before starting therapy.
2. Patients should be advised to report promptly any symptoms suggesting toxicity.
(See PRECAUTIONS – Information for Patients.)
Important Safety Information
What is the most important information I should know about Ridaura®?
You should discuss the potential benefits and risks of Ridaura® with your doctor before starting therapy.
Ridaura® contains gold and, like other drugs that contain gold, can cause gold toxicity. Signs of gold toxicity include changes in blood counts, excess protein in the urine, blood in the urine, itching, rash, mouth sores or diarrhea that doesn’t go away. Contact your doctor right away if you have any of these symptoms while you are taking Ridaura®. See the section titled, “Who should not take Ridaura®?”
Who should not take Ridaura®?
Do not take Ridaura® if you are allergic to auranofin or any of the ingredients in Ridaura®. Do not take Ridaura® if you have or have had any of the following reactions to medicines containing gold: severe allergic reaction, a severe intestinal disorder known as necrotizing enterocolitis, development of scar tissue in your lungs known as pulmonary fibrosis, widespread scaling and flaking of your skin or problems with your bone marrow and/or blood cell counts.
What should I tell my healthcare provider before taking Ridaura®?
Before taking Ridaura®, tell your healthcare provider if you have kidney disease, liver disease, inflammatory bowel disease (IBD), skin rash or history of problems with your bone marrow.
Tell your healthcare provider if you are pregnant or planning to become pregnant. Women who are pregnant or nursing should not take Ridaura®.
Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. It is not known whether it is safe to take Ridaura® with injectable gold, hydroxychloroquine, penicillamine, immunosuppressive agents or high doses of corticosteroids. Keep a list of your medicines to show your healthcare provider and pharmacist.
Ask your healthcare provider or pharmacist for a list of medicines that interact with Ridaura®.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Ridaura® with other medicines.
Will I need any routine tests while I am taking Ridaura®?
Your healthcare provider should do monthly blood tests while you are taking Ridaura®. Your healthcare provider should also regularly test your urine. If you have gastrointestinal (GI) symptoms, you should be monitored for GI bleeding.
What are the possible side effects of Ridaura®?
The most common side effect of Ridaura® is diarrhea/loose stools. Ulcerative colitis, a type of IBD, is a rare but serious reaction to gold therapy. Therefore, if you have GI symptoms, you should be monitored for GI bleeding.
These are not all of the possible side effects of Ridaura®. Contact your healthcare provider for information about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
- Ridaura® (auranofin) Capsules [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; 2017.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information for Ridaura®.