Uses

This medication is used as part of a complete treatment program including non-drug therapies (such as 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 (such as 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

Read the Patient Information Leaflet if available from your pharmacist before you start taking auranofin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice a day. The dosage is based on your medical condition and response to treatment. 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.

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.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Diarrhea, frequent/loose stools, stomach/abdominal cramping, nausea, loss of appetite, heartburn, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• eye redness/pain
• hair loss
• numbness/tingling of arms/legs
• signs of low blood count (such as fast/pounding heartbeat, pale skin, unusual tiredness)
• easy bleeding/bruising
• black/bloody stools
• cough that doesn't go away
• mucus/pus/blood in watery diarrhea
• dizziness
• signs of infection (such as sore throat that doesn't go away, fever)
• severe stomach/abdominal pain
• change in the amount/color of urine
• vomit that looks like coffee grounds
• yellowing eyes/skin

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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• itching/swelling (especially of the face/tongue/throat)
• rash
• severe dizziness
• trouble breathing

Auranofin can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

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 or at www.fda.gov/medwatch.

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• reaction to gold compound (such as blood disorders, kidney problems, lung problems, stomach/intestinal problems)
• bleeding problems
• blood disorders (such as 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. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using auranofin. Auranofin may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as tuberculin skin test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver/kidney function, urine tests) should be done while you are taking this medication. Keep all medical and lab appointments. 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. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.