Ridaura (Auranofin)

You should not use this medication 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.

Before taking RIDAURA, tell your doctor if you have a weak immune system, bone marrow disorder, kidney or liver disease, or inflammatory bowel disease.

RIDAURA can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis.

Keep using RIDAURA as directed. Talk with your doctor if your symptoms do not improve after 3 or 4 months of treatment.

Stop taking RIDAURA and call your doctor at once if you have a skin rash or itching, mouth sores, severe diarrhea, easy bruising or bleeding, blood in your urine or stools, coughing up blood, or unusual weakness, or any signs of infection (fever, chills, flu symptoms).

You should not use this medication if you are allergic to RIDAURA, or if you have ever had any of these medical problems caused by using gold therapy:

• an allergic skin reaction;
• stomach or intestinal problems;
• a breathing disorder;
• a bone marrow disorder; or
• a severe blood cell disorder.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• a bone marrow disorder or weak immune system;
• kidney disease;
• liver disease; or
• inflammatory bowel disease.

FDA pregnancy category C. It is not known whether RIDAURA is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether RIDAURA passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• itching or skin rash;
• white patches or sores inside your mouth or on your lips;
• pain or swelling in your gums or tongue, metallic taste in your mouth;
• severe or ongoing diarrhea;
• severe nausea, vomiting, stomach cramps;
• pale skin, easy bruising or bleeding;
• blood in your urine;
• weakness or fainting;
• black, bloody, or tarry stools; or
• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

• mild stomach pain or upset;
• gas, bloating; or
• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid exposure to sunlight, sunlamps, or tanning beds. RIDAURA can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Tell your doctor about all other medications you use, especially:

• gold injections;
• hydroxychloroquine (Plaquenil);
• penicillamine (Cuprimine, Depen);
• phenytoin (Dilantin);
• high doses of steroid medication (prednisone and others); or
• drugs that weaken your immune system, such as cyclophosphamide (Cytoxan, Neosar), azathioprine, methotrexate (Rheumatrex, Trexall), and others.

This list is not complete and there may be other drugs that can interact with RIDAURA. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take this medicine with a full glass of water.

RIDAURA can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

It may take up to 6 months of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 or 4 months of treatment.

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

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an RIDAURA overdose are not known.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.