Auranofin is a form of gold that reduces some of the effects of the inflammatory process in the body.

Auranofin is used to treat rheumatoid arthritis (RA) in adults.

Auranofin is usually given only to people unable to use other RA medications, or when other treatments did not work or have stopped working.

Auranofin will not reverse any cartilage or joint damage that has already occurred in your body.

Auranofin may also be used for other purposes not listed in this medication guide.

You should not use auranofin if you have ever had a severe reaction to gold therapy that affected your skin, lungs, bone marrow, blood cells, or your stomach or intestines.

Auranofin contains gold, which may be toxic and can cause symptoms such as rash, itching, mouth sores, or blood in your urine, or severe diarrhea.

Call your doctor at once if you have a severe skin rash or itching, mouth sores, severe diarrhea, pale skin, unusual tiredness, easy bruising or bleeding, blood in your urine or stools, or if you cough up blood.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take this medicine with a full glass of water.

It may take up to 6 months of using this medicine before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 3 or 4 months of treatment.

Auranofin can increase your risk of bleeding or infection. You will need frequent medical tests.

Your liver and kidney function may also need to be checked.

Store auranofin at room temperature away from moisture, heat, and light.

Usual Adult Dose for Rheumatoid Arthritis:

3 mg orally 2 times a day OR 6 mg orally once a day; if response is inadequate after 6 months, increase to 3 mg orally 3 times a day; discontinue therapy if response is inadequate after 3 months at 9 mg/day

Comments:
-Therapy should not be initiated at doses exceeding 6 mg daily because it is associated with an increased incidence of diarrhea.
-This drug should be added to a comprehensive program, including nondrug therapies.
-This drug does not produce an immediate response. Therapeutic effects may be seen after 3 to 4 months, although improvement has not been seen in some patients before 6 months.
-Gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage.

Use: For active classical or definite rheumatoid arthritis patients who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs

You should not use auranofin if you are allergic to it, or if you have ever had medical problems caused by using gold therapy, such as:

• an allergic skin reaction;

• stomach or intestinal problems;

• a breathing disorder;

• a bone marrow disorder; or

• a severe blood cell disorder.

Tell your doctor if you have ever had:

• a bone marrow disorder or weak immune system;

• kidney disease;

• liver disease; or

• inflammatory bowel disease.

It is not known whether auranofin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using auranofin.

Auranofin is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Auranofin may cause an upset stomach. Take auranofin after meals or a light snack.

Auranofin could make your skin more sensitive to sunlight and you may develop a rash or itching. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Auranofin may cause serious side effects. Call your doctor at once if you have:

• pale skin, easy bruising, unusual bleeding (nosebleeds, bleeding gums), purple or red spots under your skin;

• unusual tiredness, feeling short of breath;

• severe skin rash or itching;

• sudden chest pain, wheezing, dry cough, feeling short of breath;

• severe or ongoing diarrhea, nausea, vomiting, or loss of appetite;

• black, bloody, or tarry stools; or

• kidney problems--puffy eyes, swelling in your ankles or feet, blood in your urine, urine that looks foamy.

Auranofin may cause more side effects on the stomach than gold injections cause. If you were switched from gold injections to auranofin capsules, tell your doctor if you have concerns about these side effects. You may need to use auranofin for a few months before your symptoms improve.

Common side effects of auranofin may include:

• diarrhea, loose stools;

• rash, itching; or

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• gold injections;

• hydroxychloroquine;

• penicillamine;

• phenytoin;

• high doses of steroid medication (prednisone and others); or

• drugs that weaken your immune system, such as azathioprine, cyclophosphamide, methotrexate, and others.

This list is not complete. Other drugs may affect auranofin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to auranofin.

If you have a tuberculin (TB) skin test, tell the person performing the test that you take auranofin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.