GENERIC NAME: AURANOFIN - ORAL (aw-RAN-o-fin)
BRAND NAME(S): Ridaura
WARNING: This medication can cause serious (sometimes fatal) side effects, including blood cell problems (e.g., anemia, low white blood cells/platelets), kidney problems, rash, itching, mouth sores/irritation (stomatitis), or persistent diarrhea. Low white blood cells can increase your risk of infection. See Side Effects section for more details. Tell your doctor immediately if you develop any of these side effects.
Your doctor will be closely monitoring certain lab tests (e.g., white blood cells, platelets) before you start therapy and before he or she prescribes refills of your prescription. It is important that you keep all medical/lab appointments
USES: This medication is used as part of a complete treatment program including non-drug therapies (e.g., rest, physical therapy) to treat active rheumatoid arthritis. It is used to treat patients with severe rheumatoid arthritis who have not responded to or cannot take other medications. Auranofin is a gold compound.Auranofin is not a true pain reliever (e.g., like aspirin) but it is thought to decrease pain that occurs with arthritis by decreasing inflammation. It is known as a disease-modifying antirheumatic drug (DMARD). It decreases morning stiffness and pain/swelling in joints and can increase grip strength.
HOW TO USE: This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist if you have any questions.Take this medication by mouth, usually once or twice a day with or without food or as directed by your doctor. Dosage is based on your medical condition and response to therapy. To decrease side effects such as upset stomach, your doctor may start you at a low dose (once a day) and slowly increase to twice a day. Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased. The usual maximum adult dose is 9 milligrams each day.Almost half of all patients have diarrhea or more frequent/loose stools while taking this medication. If this persists or becomes a problem, your doctor may lower the dose or have you temporarily stop the medication. Do not stop or change the dose of your medicine without talking with your doctor.Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.If you have been receiving gold injections, you can usually start taking gold by mouth as soon as you stop the injections. If you are changing over from penicillamine, you will usually need to wait 1 month after stopping the penicillamine before starting auranofin. Ask your doctor for more details.It may take 3 to 4 months of therapy before you see the full benefits of this medication.Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: See also How to Use section.Stomach/abdominal cramping may occur, usually within the first several hours after taking this medication. Nausea, loss of appetite, heartburn, and headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: eye redness/pain, hair loss, numbness/tingling of arms/legs.This medication may cause mouth/lip/throat sores (stomatitis). Tell your doctor if you notice a metallic taste in your mouth. This could be the first sign of stomatitis. Rinsing your mouth with a mild salt solution may provide some relief. Discuss with your doctor.Tell your doctor immediately if any of these rare but very serious side effects occur: signs of low blood count (e.g., fast/pounding heartbeat, pale skin, unusual tiredness), easy bleeding/bruising, black/bloody stools, persistent cough, mucus/pus/blood in watery diarrhea, difficult/painful breathing, dizziness, signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, unusual tiredness, change in the amount/color of urine, vomit that looks like coffee grounds, yellowing eyes/skin.A very serious allergic reaction to this drug is uncommon. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.Skin rash is common with this medication and can be serious. Itching is often the first sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash or itching.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking auranofin, tell your doctor or pharmacist if you are allergic to it; or to any other gold or heavy metal compound; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of reaction to gold compound (e.g., blood disorders, kidney problems, lung problems, stomach/intestinal problems).Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood disorders (e.g., bone marrow depression), colitis/inflammatory bowel disease, eczema, certain lung problem (fibrosis), kidney disease, liver disease, SLE (systemic lupus erythematosus), recent radiation therapy.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medication because a very serious interaction may occur: penicillamine.If you are currently using the medication listed above, tell your doctor or pharmacist before starting auranofin.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: phenytoin.This medication may interfere with certain laboratory tests (including tuberculin skin test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood count, liver/kidney tests, urine tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.