GENERIC NAME: GOLD SODIUM THIOMALATE - INJECTION (gold So-dee-um thigh-oh-MAL-ate)
WARNING: This medication can cause serious (sometimes fatal) side effects, including blood cell problems (e.g., anemia, low white blood cells/platelets), kidney problems, rash, itching, or mouth sores/irritation (stomatitis). Low white blood cells can increase your risk of infection. See Side Effects section for more details. Tell your doctor immediately if you develop any of these side effects.
Your doctor will be closely monitoring certain lab tests (e.g., white blood cells, platelets) before you start therapy and before each injection. It is important that you keep all medical/lab appointments.
USES: This medication is used as part of a complete treatment program to treat active rheumatoid arthritis, including non-drug therapies (e.g., rest, physical therapy). It is used to treat patients with severe rheumatoid arthritis who have not responded to or cannot take other medications.Gold sodium thiomalate is not a true pain reliever, 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: This medicine is injected into a muscle by a healthcare professional, usually in the buttock. You will need to lie down during your injection and for 10 minutes afterward to lower the risk of side effects such as dizziness. You will be monitored for 15 minutes after your injection. When you begin therapy, injections are usually given once a week or as directed by your doctor.Dosage is based on your medical condition and response to therapy. Injections are usually given once a week until improvement occurs or you have received a total of 1 gram. Once improvement occurs, your doctor may decrease your injections to once every 2-3 weeks or less. If your arthritis worsens, your doctor may order weekly injections again.Use this medication regularly in order to get the most benefit from it. Keep all medical appointments.If you are changing over from penicillamine, you will usually need to wait 1 month after stopping the penicillamine before starting gold injections. Ask your doctor for more details.Some decrease in morning stiffness is usually seen in 6-8 weeks. It may take several months of therapy before you see the full benefits of this medication.Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: See also How to Use section.Flushing, dizziness, headache, nausea, vomiting, weakness, and sweating may occur soon after the injection. Increased joint pain may occur 1-2 days after your injection. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: eye redness/pain, fainting, hair loss, mental/mood changes (e.g., confusion, hallucinations), numbness/tingling of arms/legs, seizure.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.Tell your doctor immediately if any of these rare but very serious side effects occur: difficult/painful breathing, signs of low blood count (e.g., fast/pounding heartbeat, pale skin, unusual tiredness), easy bleeding/bruising, black/bloody stools, persistent cough, severe diarrhea, signs of infection (e.g., fever, persistent sore throat), gray/blue skin color, severe stomach/abdominal pain, unusual tiredness, change in the amount/color of urine, vaginal itching/sores, vomit that looks like coffee grounds, yellowing eyes/skin.A very serious allergic reaction to this drug is uncommon. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.Skin rash is common with this medication and can be serious. Itching is often the first sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash or itching.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.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 using gold sodium thiomalate injection, 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.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of reaction to gold compound (e.g., blood disorders, kidney problems, lung problems, severe rash, stomach/intestinal problems), SLE (systemic lupus erythematosus).Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (e.g., chest pain, heart attack, stroke), blood disorders (e.g., bleeding problems, bone marrow depression), colitis/inflammatory bowel disease, diabetes, eczema, heart problems (e.g., congestive heart failure), certain lung problem (fibrosis), very high blood pressure, kidney disease, liver disease, recent radiation therapy.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medication because a very serious interaction may occur: penicillamine.If you are currently using the medication listed above, tell your doctor or pharmacist before starting gold injections.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (e.g., lisinopril), drugs that suppress the immune system (e.g., azathioprine, cancer chemotherapy), anti-malarial drugs (e.g., chloroquine, primaquine), phenylbutazone, phenytoin.This medication may interfere with certain laboratory tests (including tuberculin skin test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (e.g., complete blood count, liver/kidney tests, urine tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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