Gold Sodium Thiomalate

A to Z Drug Facts

 Action Mechanism unknown; suppresses symptoms of rheumatoid arthritis and may slow progression of this disease.

 Indications Symptomatic relief of active adult and juvenile rheumatoid arthritis not adequately controlled by other therapies. unlabeled use(s): Treatment of pemphigus and psoriatic arthritis.

 Contraindications Previous severe reaction to gold compounds or other heavy metals; uncontrolled diabetes mellitus or CHF; severe debilitation; kidney disease; liver disease; severe hypertension; agranulocytosis or bleeding disorder; recent radiation exposure; systemic lupus erythematosus; urticaria; eczema.

 Route/Dosage

ADULTS: IM As weekly injections: First wk, 10 mg; second wk, 25 mg; third and following wks, 25 to 50 mg until major clinical improvement or toxicity occurs. If cumulative dose reaches 1 g without improvement, re-evaluate use of gold therapy. Once improvement occurs, dose may be decreased or dosing interval increased. Maintenance therapy: 25 to 50 mg every other wk for 2 to 20 wk. On basis of response, dosage interval may be increased to every third and subsequently fourth wk (maximum dose per injection: 100 mg). CHILDREN: After test dose of 10 mg, give 1 mg/kg (maximum dose per injection: 50 mg). Dosage schedule similar to that for adults.

 Interactions

Cytotoxic drugs, immunosuppressives (except steroids), phenylbutazone: May increase risk of blood dyscrasias. Antimalarials, penicillamine: Safety of combination antirheumatic therapy is unknown.

 Lab Test Interferences None well documented.

 Adverse Reactions May occur months after therapy is discontinued.

DERM: Dermatitis; pruritus; exfoliative dermatitis; angioedema; chrysiasis (gray-blue skin pigmentation). EENT: Stomatitis; corneal gold deposition; corneal ulceration; iritis; conjunctivitis; metallic taste. Children: Safety and efficacy in children < 6 yr has not been established. GI: Diarrhea; nausea; cholestatic jaundice; ulcerative enterocolitis; GI bleeding; difficulty swallowing; abdominal pain and cramping. GU: Nephrotic syndrome or glomerulitis with proteinuria and hematuria. HEMA: Anemia; thrombocytopenia; leukopenia; aplastic anemia. RESP: Interstitial pneumonitis; pulmonary fibrosis. OTHER: Anaphylactoid reactions within minutes of injection, arthralgias for several days after injection, “nitritoid reaction” (vasomotor reaction with flushing, fainting, weakness, dizziness, sweating, nausea, vomiting, malaise and headache).

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. CNS: Confusion; hallucinations; seizures. Elderly or debilitated patient: Use with caution. Tolerance to gold decreases with age. Special risk patients: Use with caution in patients with diabetes mellitus, CHF, history of blood dyscrasias, cardiovascular or cerebral circulation problems, skin rash, previous kidney or liver disease, marked hypertension, compromised circulation or inflammatory bowel disease.

 Administration/Storage

• Color of solution is pale yellow. Do not administer drug if drug has darkened in color or contains precipitate.
• Mix contents of vial thoroughly before withdrawing into syringe.
• Administer drug only by IM injection into upper outer quadrant of gluteus maximus muscle.
• Instruct patient to remain lying down for 10 to 15 min after injection.
• Store in light-resistant containers at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review patient's history for indications of uncontrolled diabetes mellitus, systemic lupus erythematosus, renal disease, inflammatory bowel disease, liver disease, granulocytopenia, and previous hypersensitivity to medication.
• Review patient's laboratory values for indications of gold toxicity such as decreased hemoglobin, WBC < 4000 mm³, platelets < 100,000 to 150,000/mm³, granulocytes < 1500/mm³, proteinuria and elevated liver enzymes.
• Prior to each injection, assess patient for early signs and symptoms of toxicity: Pruritus, dermatitis, stomatitis, metallic taste in mouth, indigestion, or diarrhea.
• Collect urine to test for proteinuria and sediment changes prior to each injection.
• Assess patient for possible nitritoid reaction (sweating, fainting, bradycardia, dizziness, flushing, nausea, vomiting, headaches, and weakness) and hypersensitivity of allergic reactions (swelling of face, lips or eyelids, thickening of tongue, shortness of breath, rash, hypotension, tachycardia).
• If anaphylactic shock, syncope, bradycardia, thickening of the tongue, dysphagia, shortness of breath, or angioneurotic edema occur within minutes of injection, notify health care provider immediately.
• Exfoliative dermatitis, nephrosis, thrombocytopenia, and leukopenia require cessation of gold treatment.
• Order laboratory test for CBC including platelet estimation before every other injection throughout treatment.
• Monitor patients with GI symptoms for GI bleeding.

 Patient/Family Education

• Explain that adverse reactions can occur any time during therapy, even months after drug has been discontinued.
• Caution patient to minimize exposure to sun and other sources of ultraviolet light (eg, sunlamp). Explain need to wear protective clothing outdoors.
• Advise patient of importance of continued assessment of disease status and monitoring of renal, hepatic, and hematologic functions.
• Teach patient to perform good oral hygiene, including use of soft toothbrush and daily flossing. If mild stomatitis develops, isotonic sodium chloride and sodium bicarbonate solution can be used. Advise patient to avoid strong commercial mouthwashes and spicy or acidic foods.
• Inform patient that joint pain may continue for 1 to 2 days after injection but will usually decrease after first few injections. Therapeutic effects may not be seen until after 3 to 6 mo of treatment. Explain that drug will not reverse damage or cure disease but may slow or stop its progression.
• Instruct patient to report these symptoms to health care provider: Dermatitis, pruritus, weakness, metallic taste, fatigue, hematuria, unusual bruising or ecchymosis, nose bleeds, sore mouth, or dark-colored stools.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts