Ridaura

Browse PDR's full list of drug information

Ridaura

Classes

Gold compounds

Administration
Oral Administration

Administer with meals to minimize gastric irritation.

Adverse Reactions
Severe

proteinuria / Delayed / 3.0-9.0
GI bleeding / Delayed / 0.1-1.0
enterocolitis / Delayed / 0-0.1
angioedema / Rapid / 0-0.1
neutropenia / Delayed / 0-0.1
agranulocytosis / Delayed / 0-0.1
red cell aplasia / Delayed / 0-0.1
aplastic anemia / Delayed / 0-0.1
pancytopenia / Delayed / 0-0.1
exfoliative dermatitis / Delayed / Incidence not known
interstitial nephritis / Delayed / Incidence not known
azotemia / Delayed / Incidence not known
nephrotoxicity / Delayed / Incidence not known
glomerulonephritis / Delayed / Incidence not known
nephrotic syndrome / Delayed / Incidence not known
gold toxicity / Delayed / Incidence not known
pulmonary fibrosis / Delayed / Incidence not known

Moderate

stomatitis / Delayed / 13.0-13.0
conjunctivitis / Delayed / 3.0-9.0
constipation / Delayed / 1.0-3.0
glossitis / Early / 1.0-3.0
hematuria / Delayed / 1.0-3.0
thrombocytopenia / Delayed / 1.0-3.0
anemia / Delayed / 1.0-3.0
eosinophilia / Delayed / 1.0-3.0
leukopenia / Delayed / 1.0-3.0
elevated hepatic enzymes / Delayed / 1.0-3.0
melena / Delayed / 0.1-1.0
jaundice / Delayed / 0-1.0
cholestasis / Delayed / 0-1.0
dysphagia / Delayed / 0-0.1
peripheral neuropathy / Delayed / 0-0.1
pneumonitis / Delayed / 0-0.1
colitis / Delayed / Incidence not known
oral ulceration / Delayed / Incidence not known
bullous rash / Early / Incidence not known
bleeding / Early / Incidence not known
palpitations / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypotension / Rapid / Incidence not known
chest pain (unspecified) / Early / Incidence not known
wheezing / Rapid / Incidence not known
dyspnea / Early / Incidence not known

Mild

diarrhea / Early / 47.0-47.0
rash / Early / 24.0-24.0
pruritus / Rapid / 17.0-17.0
abdominal pain / Early / 14.0-14.0
vomiting / Early / 10.0-10.0
nausea / Early / 10.0-10.0
flatulence / Early / 3.0-9.0
anorexia / Delayed / 3.0-9.0
dyspepsia / Early / 3.0-9.0
urticaria / Rapid / 1.0-3.0
alopecia / Delayed / 1.0-3.0
metallic taste / Early / 1.0-3.0
dysgeusia / Early / 1.0-3.0
gingivitis / Delayed / 0.1-1.0
fever / Early / 0-1.0
skin discoloration / Delayed / Incidence not known
maculopapular rash / Early / Incidence not known
ecchymosis / Delayed / Incidence not known
purpura / Delayed / Incidence not known
petechiae / Delayed / Incidence not known
flushing / Rapid / Incidence not known
syncope / Early / Incidence not known
dizziness / Early / Incidence not known
diaphoresis / Early / Incidence not known
cough / Delayed / Incidence not known
weakness / Early / Incidence not known

Boxed Warning
Agranulocytosis, anemia, bleeding, bone marrow suppression, diarrhea, exfoliative dermatitis, gold toxicity, hematological disease, hematuria, hepatic disease, inflammatory bowel disease, leukopenia, necrotizing enterocolitis, neutropenia, proteinuria, pulmonary fibrosis, renal disease, renal failure, renal impairment, requires an experienced clinician, serious rash, stomatitis, thrombocytopenia

Auranofin is only recommended for use in selected patients with active rheumatoid arthritis. Auranofin therapy requires an experienced clinician knowledgeable with chrysotherapy and the toxicity and benefits of gold therapy with auranofin. Auranofin is contraindicated in patients with a history of gold-induced disorders including anaphylaxis, serious rash or exfoliative dermatitis, pulmonary fibrosis, necrotizing enterocolitis, bone marrow aplasia, or other severe hematological disease. Auranofin may cause serious gold toxicity. Signs of gold toxicity include a reduction in hemoglobin (anemia), leukopenia (less than 4000 WBC/mm3), neutropenia (less than 1500/mm3), thrombocytopenia (less than 150,000/mm3), and may be accompanied by other signs or symptoms such as proteinuria, hematuria, pruritus, rash, stomatitis, or persistent diarrhea. Because they have potentially serious consequences, blood dyscrasias should be constantly watched for through regular monitoring (at least monthly) of the formed elements of the blood throughout treatment. Review the recommended laboratory results before writing each auranofin prescription. Auranofin should be used cautiously in patients with a history of blood dyscrasias or bone marrow suppression such as agranulocytosis (severe neutropenia), granulocytopenia, aplastic anemia, or bleeding. The potential risks of auranofin therapy should be weighed against the potential benefits in patients with preexisting renal disease (e.g., renal impairment, renal failure) inflammatory bowel disease, hepatic disease, bone marrow suppression, or skin rash. These conditions indicate compromised organ systems, which could increase the risk of gold toxicity and could cause difficulty in rapidly detecting gold toxicity. Explain the possible adverse effects of auranofin before therapy initiation, and instruct patients to promptly report any potential toxicity symptoms.

Common Brand Names

Ridaura

Dea Class

Rx

Description

Only gold compound available for oral administration; used to treat early active cases of RA; less effective against advanced, chronic RA, and is typically employed only when salicylates or NSAIDs do not provide satisfactory relief.

Dosage And Indications
For the treatment of active rheumatoid arthritis in patients who have had an insufficient therapeutic response to or are intolerant of an adequate trial of full doses of at least one nonsteroidal anti-inflammatory drug.
NOTE: Add auranofin to a comprehensive baseline program that includes non-drug therapies.
NOTE: Improvement may not be observed before 6 months of use. Gold cannot reverse existing structural damage; best efficacy may occur in patients with active synovitis.
NOTE: Discontinuation of injectable gold and initiation of auranofin 6 mg PO daily led to similar disease control 6 months after the switch from injectable to oral gold receipt as compared with patients who remained on injectable gold.
NOTE: Obtain a complete blood count (CBC) with differential and platelet count, urinalysis, and renal and hepatic function tests before auranofin initiation. During therapy, obtain a CBC with differential and platelet count and urinalysis at least monthly.
Oral dosage Adults

Initially, 6 mg/day PO, administered either as 3 mg PO twice daily or 6 mg PO once daily. To reduce the incidence of adverse effects, a lower initial dose of 3 mg PO once daily may be used. This dose is increased to 6 mg PO daily after several weeks if the lower dose is tolerated. If inadequate response after 6 months, may increase dosage to 3 mg PO 3 times daily. If inadequate response after 3 months at 9 mg/day, discontinue auranofin. Safety at a dosage higher than 9 mg/day has not been established.

Dosing Considerations
Hepatic Impairment

Use with caution in patients with preexisting hepatic impairment. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Use with caution in patients with preexisting renal impairment. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Acetaminophen; Ibuprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Amikacin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Aminoglycosides: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Amlodipine; Benazepril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Amlodipine; Celecoxib: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Amphotericin B lipid complex (ABLC): (Minor) Both amphotericin and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Amphotericin B liposomal (LAmB): (Minor) Both amphotericin and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Amphotericin B: (Minor) Both amphotericin and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Angiotensin-converting enzyme inhibitors: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Benazepril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Benazepril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Bupivacaine; Meloxicam: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Captopril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Captopril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Carbamazepine: (Minor) Auranofin should be used cautiously in patients receiving carbamazepine, due to the potential for additive bone marrow/hematologic effects.
Celecoxib: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Celecoxib; Tramadol: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Diclofenac: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Diclofenac; Misoprostol: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Diflunisal: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Dimercaprol: (Contraindicated) To avoid compromising the actions of dimercaprol, gold compounds (auranofin, gold sodium thiomalate, and aurothioglucose) should be withheld in a patient requiring dimercaprol therapy. Dimercaprol is used to treat gold toxicity and will bind with gold compounds.
Diphenhydramine; Ibuprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Diphenhydramine; Naproxen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Enalapril, Enalaprilat: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Enalapril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Etodolac: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Fenoprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Flurbiprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Foscarnet: (Moderate) The risk of renal toxicity may be increased if foscarnet is used in conjunction with other nephrotoxic agents, including gold compounds.
Fosinopril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Fosinopril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Gentamicin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Hydrochlorothiazide, HCTZ; Moexipril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Hydrocodone; Ibuprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ibuprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ibuprofen; Famotidine: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ibuprofen; Oxycodone: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ibuprofen; Pseudoephedrine: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Indomethacin: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ketoprofen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Ketorolac: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Lisinopril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Lisinopril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Meclofenamate Sodium: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Mefenamic Acid: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Meloxicam: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Moexipril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Nabumetone: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Naproxen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Naproxen; Esomeprazole: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Naproxen; Pseudoephedrine: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Nonsteroidal antiinflammatory drugs: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Oxaprozin: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Paromomycin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Penicillamine: (Contraindicated) Gold compounds have adverse reactions similar to those of penicillamine. Concomitant use of these agents is contraindicated because of the increased risk of developing severe hematologic and renal toxicity.
Perindopril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Perindopril; Amlodipine: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Pexidartinib: (Moderate) Monitor for evidence of hepatotoxicity if pexidartinib is coadministered with auranofin. Avoid concurrent use in patients with increased serum transaminases, total bilirubin, or direct bilirubin (more than ULN) or active liver or biliary tract disease.
Phenytoin: (Minor) One patient receiving concomitant phenytoin and auranofin therapy developed an increased blood concentration of phenytoin. Further studies of this potential interaction are warranted.
Piroxicam: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Plazomicin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Pretomanid: (Major) Avoid coadministration of pretomanid with auranofin, especially in patients with impaired hepatic function, due to increased risk for hepatotoxicity. Monitor for evidence of hepatotoxicity if coadministration is necessary. If new or worsening hepatic dysfunction occurs, discontinue hepatotoxic medications.
Quinapril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Quinapril; Hydrochlorothiazide, HCTZ: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Ramipril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Riluzole: (Moderate) Monitor for signs and symptoms of hepatic injury during coadministration of riluzole and auranofin. Concomitant use may increase the risk for hepatotoxicity. Discontinue riluzole if clinical signs of liver dysfunction are present.
Rituximab: (Moderate) The concomitant use of rituximab with other disease modifying anti-rheumatic drugs (DMARDs), including gold compounds, may result in additive immunosuppression and an increased risk of infection. According to treatment guidelines, thare no data that adequately address the safety and efficacy of gold compounds in combination with biologic therapies. Monitor patients closely for signs or symptoms of infection.
Rituximab; Hyaluronidase: (Moderate) The concomitant use of rituximab with other disease modifying anti-rheumatic drugs (DMARDs), including gold compounds, may result in additive immunosuppression and an increased risk of infection. According to treatment guidelines, thare no data that adequately address the safety and efficacy of gold compounds in combination with biologic therapies. Monitor patients closely for signs or symptoms of infection.
Streptomycin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Sulindac: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Sumatriptan; Naproxen: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Tobramycin: (Minor) Both aminoglycosides and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.
Tolmetin: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Trandolapril: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Trandolapril; Verapamil: (Minor) Nitritoid reactions (facial flushing, diaphoresis, dizziness, nausea/vomiting, hypotension, tachycardia, syncope, and anaphylactic type reactions) or vasomotor reactions have been reported rarely in patients receiving injectable gold and concomitant ACE inhibitor therapy. Monitor closely for nitritoid reactions during co-therapy with gold and ACE inhibitor agents.
Valdecoxib: (Moderate) Due to the inhibition of renal prostaglandins by NSAIDs, concurrent use with other nephrotoxic agents, such as gold compounds, may lead to additive nephrotoxicity. Monitor renal function carefully during concurrent therapy.
Vancomycin: (Minor) Both vancomycin and gold compounds can cause nephrotoxicity. Auranofin has been reported to cause a nephrotic syndrome or glomerulonephritis with proteinuria and hematuria. Monitor renal function carefully during concurrent therapy.

How Supplied

Ridaura Oral Cap: 3mg

Maximum Dosage
Adults

9 mg/day PO.

Elderly

9 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Mechanism Of Action

Auranofin contains 29% gold. Like other gold compounds, auranofin exhibits antiarthritic, anti-inflammatory, and immunomodulating properties. Gold compounds are known as disease-modifying drugs. Auranofin may modify disease activity; reduced synovitis and ESR may occur. No substantial evidence, however, exists to support induction of rheumatoid arthritis (RA) remission by gold-containing compounds. Gold cannot reverse existing structural damage; best efficacy may occur in patients with active synovitis.
 
The mechanism of the antiarthritic effects of auranofin is unknown. Auranofin appears to induce heme oxygenase 1 (HO-1) mRNA. Heme oxygenase 1 is an inducible heme-degrading enzyme with anti-inflammatory properties. Induction of HO-1 appears to suppress inflammatory responses in patients with RA. Auranofin incubation of synovial cells from patients with RA led to HO-1 expression induction in a concentration-dependent manner. Further, cells incubated with auranofin had significantly suppressed TNFalpha mRNA expression and COX-2 expression in a dose-dependent manner. Expression levels of TNFalpha mRNA and COX-2 protein were negatively correlated with the level of HO-1 protein. The impact of HO-1 induction inhibition by use of a HO-1 small interfering RNA was examined. Incubation of the cell lines with auranofin and HO-1 small interfering RNA reduced the induction of HO-1 mRNA as compared with incubation of the cells with only auranofin. Further, the TNF alpha mRNA concentration in the presence of HO-1 small interfering RNA was similar to the control value. Thus, auranofin appears to induce HO-1 mRNA, which reduces TNF alpha mRNA expression.

Pharmacokinetics

Auranofin is administered orally.
 
Following multiple dosing, steady state is achieved within 8—12 weeks, although 13—16 weeks of therapy may be required in some patients. The mean steady-state gold concentrations in the blood of patients taking auranofin 6 mg daily was 0.68 +/- 0.45 mcg/mL. The mean blood-gold concentrations are proportional to dose, but no correlation between concentrations and either safety or efficacy has been established. Blood gold concentrations are generally higher than serum or plasma gold concentrations because the gold is sequestered with circulating cells. Gold distributes widely throughout the body and is found in the lymph nodes, bone marrow, spleen, adrenals, liver, and kidneys. Auranofin is approximately 60% plasma protein-bound, and gold appears to cross the placenta and to be distributed in breast milk in animals.
 
Approximately 60% of an auranofin dose is excreted in the urine, and the remainder is excreted in the feces. The elimination half-life of auranofin following cumulative dosing is 26 days (blood) and 80 days (tissues).

Oral Route

Twenty-five percent of the gold in an orally administered dose of auranofin is absorbed from the GI tract. The drug is metabolized rapidly; unchanged auranofin does not appear in the blood following oral administration. Auranofin may undergo rapid deacetylation within the GI mucosa before absorption.
 
Peak blood gold concentrations of 0.025 mcg/ml are usually obtained within 2 hours following oral administration.

Pregnancy And Lactation
Pregnancy

Auranofin use by pregnant women is not recommended. Although no adequate and well-controlled studies in pregnant women exist, animal reproduction studies have shown adverse fetal effects. Chrysotherapy is usually avoided during pregnancy, given the potential toxicities of the drug. If auranofin will be used by a pregnant woman, discuss the potential risks of auranofin therapy with her.

Auranofin may distribute in breast milk and is, therefore, not recommended for use in women who are breast-feeding by the manufacturer. Although human data are unavailable, gold is excreted in the milk of rats and mice given auranofin. Furthermore, gold does appear in milk of women who receive injectable gold. Consider alternative agents. Assess indication and patient-specific factors before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.