Gold Sodium Thiomalate
Medically reviewed by Drugs.com. Last updated on Mar 6, 2019.
(gold SOW dee um thye oh MAL ate)
- Sodium Aurothiomalate
- Gold Compound
Unknown, may decrease prostaglandin synthesis or may alter cellular mechanisms by inhibiting sulfhydryl systems
Urine (60% to 90%); feces (10% to 40%)
Onset of Action
Delayed; may require up to 3 months
Time to Peak
Serum: 4-6 hours
5 days; may be prolonged with multiple doses
Use: Labeled Indications
Adjunctive treatment of active rheumatoid arthritis
Hypersensitivity to gold compounds or any component of the formulation; history of severe toxicity to gold compounds or heavy metals; systemic lupus erythematosus; severe debilitation
Rheumatoid arthritis: IM: 10 mg first week; 25 mg second week; then 25-50 mg/week until development of toxicity or 1 g cumulative dose has been given; if improvement occurs without adverse reactions, the dose may be decreased or the dosing interval increased; Maintenance: 25-50 mg every other week for 2-20 weeks, then every 3-4 weeks indefinitely
Note: Failure to improve during initial therapy may warrant continuation of 25-50 mg for additional 10 weeks or a dose increase in increments of 10 mg every 1-4 weeks (maximum: 100 mg/injection). Discontinue therapy if no improvement or toxicity develops.
Refer to adult dosing.
Rheumatoid arthritis: IM: Initial: Test dose of 10 mg is recommended, followed by 1 mg/kg/week (maximum: 50 mg/injection); maintenance: 1 mg/kg/dose (maximum: 50 mg/injection) at every-other-week intervals for 2 to 20 weeks, then every 3 to 4 weeks. Early improvement may be observed after 6 to 8 weeks of therapy; months of therapy may be required before clinical improvement is observed.
IM: Deep IM injection into the upper outer quadrant of the gluteal region; addition of 0.1 mL of 1% lidocaine to each injection may reduce the discomfort associated with IM administration. Patient should remain in recumbent position for approximately 10 minutes following administration.
Should not be used if solution is darker than pale yellow.
Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Gold Sodium Thiomalate. An increased risk of nitritoid reactions has been appreciated. Monitor therapy
Frequency not defined.
Cardiovascular: Bradycardia, syncope, vasomotor symptoms (nitritoid reaction)
Central nervous system: Confusion, Guillain-Barre syndrome, hallucination, metallic taste, peripheral neuropathy, seizure
Dermatologic: Alopecia, dermatitis, onycholysis, pruritus, skin rash, urticaria
Gastrointestinal: Anorexia, abdominal cramps, cholestasis, diarrhea, dysphagia, gingivitis, glossitis, nausea, stomatitis, ulcerative enterocolitis, vomiting
Genitourinary: Hematuria, nephrotic syndrome, proteinuria
Hematologic & oncologic: Agranulocytosis, aplastic anemia, eosinophilia, leukopenia, purpura, thrombocytopenia
Hepatic: Hepatitis, hepatotoxicity, jaundice
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema, tongue edema
Neuromuscular & skeletal: Arthralgia
Ophthalmic: Conjunctivitis, corneal ulcer, iritis
Respiratory: Bronchitis (gold bronchitis), dyspnea, interstitial pneumonitis, pulmonary fibrosis
Concerns related to adverse effects:
• Dermatologic reactions: Dermatitis and lesions of the mucous membranes are common and may be serious; pruritus may precede the early development of a skin reaction. Consider alternative therapy in patients with dermatitis (urticaria or eczema; relative contraindication); may increase risk and/or symptoms of gold toxicity may be more difficult to detect.
• Gastrointestinal effects: Signs of toxicity include persistent diarrhea, stomatitis, and enterocolitis; avoid use in patients with prior inflammatory bowel disease.
• Hematologic effects: Signs of toxicity include hematologic depression (depressed hemoglobin, eosinophilia >5%, leukocytes, granulocytes, or platelets). Avoid use in patients with a history of blood dyscrasias (anemia, agranulocytosis), hemorrhagic diathesis, or drug induced granulocytopenia. Symptoms of gold toxicity may be difficult to detect in patients with prior abnormalities; consider alternative therapy. Therapy should be discontinued if platelet count falls to <100,000/mm3, WBC <4000, granulocytes <1500/mm3.
• Hepatic effects: May be associated with the development of cholestatic jaundice. Consider alternative therapy in patients with hepatic impairment (relative contraindication); may increase risk and/or symptoms of gold toxicity may be more difficult to detect.
• Hypersensitivity reactions: Rare hypersensitivity reactions, including anaphylactic shock, syncope, bradycardia, thickening of the tongue, difficulty in swallowing and breathing, and angioedema have been reported in association with injections of sodium aurothiomalate; treatment should be discontinued if occur. In addition, a vasomotor (nitritoid) reaction characterized by acute flushing and tachycardia may occur within minutes of injection; this reaction should be differentiated from anaphylaxis and therapy may be continued, but a careful evaluation of risk vs benefit should be undertaken and extreme caution should be exercised before resuming therapy, particularly in patient with cardiovascular disease.
• Pulmonary toxicity: May be associated with interstitial fibrosis; monitor closely.
• Renal effects: Renal toxicity ranges from mild proteinuria to nephrotic syndrome. Consider alternative therapy in patients with renal impairment; may increase risk and/or symptoms of gold toxicity may be more difficult to detect.
• Cardiovascular disease: Use caution in patients with HF, hypertension, or cerebrovascular disease.
• Systemic lupus erythematosus (SLE): Consider alternative therapy is patients with SLE (relative contraindication); may increase risk and/or symptoms of gold toxicity may be more difficult to detect.
Concurrent drug therapy issues:
• ACE inhibitors: Concurrent use with ACE inhibitors may increase the risk of nitritoid reactions.
• Corticosteroids: In general, corticosteroids may be discontinued after initiation of therapy (corticosteroid tapering may be required).
• NSAIDs: May be discontinued after initiation of therapy.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
• Administration: Must not be injected IV
• Monitoring: Frequent monitoring of patients for signs and symptoms of toxicity will prevent serious adverse reactions.
Patients should have a CBC with differential, platelet count, hemoglobin determination and urinalysis for protein, white cells, red cells and casts; at baseline and prior to each injection. Skin and oral mucosa should be inspected for skin rash, bruising or oral ulceration/stomatitis. Specific questioning for symptoms such as pruritus, rash, stomatitis or metallic taste should be included. Dosing should be withheld in patients with significant gastrointestinal, renal, dermatologic, or hematologic effects (platelet count falls to <100,000/mm3, WBC <4000, granulocytes <1500/mm3
Pregnancy Risk Factor
Adverse events were observed in animal reproduction studies
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), mouth irritation, mouth sores, metallic taste, bruising, bleeding, severe loss of strength and energy, flushing, severe dizziness, passing out, itching, rash, hematuria, severe diarrhea, difficulty swallowing, or signs of ulcerative enterocolitis (severe abdominal pain; black, tarry, or bloody stools; or vomiting blood) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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