Ridaura

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.

Ridaura is a prescription medication used to treat symptoms of rheumatoid arthritis, including including painful, swollen, and tender joints and morning stiffness.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Prometheus Laboratories Inc.

Serious side effects have been reported with Ridaura. See the “Ridaura Precautions” section.

Common side effects of Ridaura include:

• Metallic taste
• Loose stools/diarrhea
• Rash
• Stomach pain or discomfort
• Vomiting
• Gas
• Hair loss

This is not a complete list of Ridaura side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Phenytoin (Dilantin)

This is not a complete list of Ridaura drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ridaura including:

• Gastrointestinal reactions.
  • Diarrhea or loose stools
  • Nausea or vomiting
  • Decreased appetite or anorexia
  • Abdominal cramps
  • Bloody or tar-like stools
• Dermatitis. An itchy rash may appear after exposure to Ridaura; it may be worsened by exposure to sunlight.
• Ulcers in the mouth, on the touch, on the palate, or in the throat. These sores may appear with or without dermatitis. A metallic taste may precede the appearance of the ulcers.
• Blood or protein in the urine.
• Changes in the composition of blood, including decreased white blood cells and decreased thrombocytes, and aplastic anemia.

Do not take Ridaura if you:

• are allergic to Ridaura or to any of its ingredients
• have a history of anaphylactic reactions to gold
• have or have had necrotizing enterocolitis
• have or have had pulmonary fibrosis
• have or have had exfoliative dermatitis
• have or have had bone marrow aplasia
• have or had had a severe blood disorder

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ridaura, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Ridaura, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ridaura or to any of its ingredients
• have or have had diabetes
• have liver problems
• have heart problems
• have kidney problems
• have bleeding or blood disorders
• have inflammatory bowel disease
• have colitis
• have a rash or eczema
• have systemic lupus erythematosus
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ridaura falls into category C.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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 Ridaura exactly as prescribed.

Ridaura comes in capsule form and is taken once or twice a day.

Take shortly after a meal or snack to decrease stomach upset.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Ridaura at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your age

The recommended dose of Ridaura for the treatment of rheumatoid arthritis is 6 mg daily, taken as 6 mg once or 3 mg twice daily. After 6 months, the dose may be increased to 9 mg daily if the response to treatment is inadequate. If the response is still inadequate after 3 months, Ridaura should be discontinued. The safety of doses greater than 9 mg daily have not been established.

Ridaura should not be given to children.

If you take too much Ridaura, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Ridaura at room temperature.

Keep this and all medicines out of the reach of children.

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 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.