Gold Sodium Thiomalate Solution for injection

What is this medicine?

GOLD SODIUM THIOMALATE (gold SO dee um thye oh MAH late) lowers the swelling of rheumatoid disease. It is used to treat both adult and juvenile type rheumatoid arthritis. It will not repair any damage to cartilage or bones that has already occured.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• high blood pressure

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lupus

• an unusual or allergic reaction to gold sodium thiomalate, benzyl alcohol, heavy metals, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• dimercaprol

• penicillamine

This medicine may also interact with the following medications:

• medicines to treat cancer

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular checks on your progress. You will need lab work done while you take this medicine.

If you get a rash while taking this medicine call your doctor. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• hallucination, loss of contact with reality

• loss of appetite, nausea

• metallic taste

• mouth sores

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• stomach cramps

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches and pains

• diarrhea

• hair loss

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.