Dosing & Uses
Dosage Forms & Strengths
capsule
- 3mg
Rheumatoid Arthritis
Indicated for active rheumatoid arthritis in patients who have failed adequate trials of NSAIDs
6 mg PO qDay or divided BID; may increase to 9 mg/day divided TID after 3 months; if no response after 3 months, discontinue drug
Dosage Forms & Strengths
capsule
- 3mg
Juvenile Idiopathic Arthritis (Off-label)
Data are limited
0.1 mg/kg/day PO in divided doses
Maintenance: 0.15 mg/kg PO qDay or divided BID; not to exceed 0.2 mg/kg/day PO qDay divided BID
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- influenza virus vaccine quadrivalent, adjuvanted
auranofin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
auranofin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- pexidartinib
auranofin and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pretomanid
auranofin, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- selinexor
selinexor, auranofin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- tofacitinib
auranofin, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (6)
- cholera vaccine
auranofin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- meningococcal group B vaccine
auranofin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ocrelizumab
auranofin and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- ofatumumab SC
ofatumumab SC, auranofin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
auranofin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- sipuleucel-T
auranofin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
Minor (3)
- ethotoin
auranofin increases levels of ethotoin by unspecified interaction mechanism. Minor/Significance Unknown.
- fosphenytoin
auranofin increases levels of fosphenytoin by unspecified interaction mechanism. Minor/Significance Unknown.
- phenytoin
auranofin increases levels of phenytoin by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
>10%
Diarrhea (47%)
Rash (24%)
Pruritus (17%)
Abd pain (14%)
Stomatitis (13%)
1-10%
Nausea (10%)
Anorexia (3-9%)
Conjunctivitis (3-9%)
Dyspepsia (3-9%)
Flatulence (3-9%)
Proteinuria (3-9%)
Alopecia (1-3%)
Anemia (1-3%)
Constipation (1-3%)
Eosinophilia (1-3%)
Elevated liver enzymes (1-3%)
Glossitis (1-3%)
Hematuria (1-3%)
Leukopenia (1-3%)
Thrombocytopenia (1-3%)
Urticaria (1-3%)
Warnings
Black Box Warnings
Prescribing physicians should understand severe and fatal toxicities of chrysotherapy
Thorough patient discussion explaining adverse reactions is essential; encourage patients to report any adverse reactions
Monitor for signs of gold toxicity (ie, decreased hemoglobin, leukopenia <4,000/cu.mm, granulocytes <1,500/cu.mm, platelets <150,000/cu.mm, proteinuria, hematuria, pruritus, rash, stomatitis, persistent diarrhea) and establish baseline measurements before prescribing
Should be reserved for use in certain patients with active rheumatoid arthritis
Contraindications
Pts who have had previous gold-induced disorders (anaphylaxis, necrotizing enterocolitis, pulmonary fibrosis, dermatitis, bone marrow suppression, or other hematologic disorder)
Cautions
Not to be used as the sole agent in treatment of RA
No evidence that gold compounds induce remission of RA
Gold toxicity
- Hemoglobin (decreased)
- Leukopenia (WBC <4000/cu.mm) [4 x10^9/L]
- Granulocytes (<1500/cu.mm) [1.5 x10^9/L]
- Platelets (<150 x 10^3/cu.mm) [150 x10^9/L]
- Proteinuria, hematuria, pruritus, rash, stomatitis, chronic diarrhea
Pregnancy & Lactation
Pregnancy Category: C
Lactation: enters breast milk/not recommended
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Unknown
Gold compound, has anti-inflammatory, antiarthritic, and immunomodulating effects
Pharmacokinetics
Peak plasma time: 2 hr
Peak plasma concentration: 0.025 mcg/mL
Onset of effects: 3-6 months
Half-life: 21-31 days
Protein bound: 60%
Excretion: 50% urine; feces
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ridaura oral - | 3 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
auranofin oral
AURANOFIN - ORAL
(aw-RAN-o-fin)
COMMON BRAND NAME(S): Ridaura
WARNING: This medication can cause serious (sometimes fatal) side effects, including diarrhea that doesn't go away, blood cell problems (such as 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 right away if you develop any of these side effects.Your doctor will be closely monitoring certain lab tests (such as white blood cells, platelets) before you start taking this medication and while you are taking it. It is important that you keep all medical/lab appointments.
USES: This medication is used as part of a complete treatment program including non-drug therapies (such as rest, physical therapy) to treat active rheumatoid arthritis. It is used to treat patients with severe rheumatoid arthritis who have not responded to or cannot take other medications. Auranofin is a gold compound.Auranofin is not a true pain reliever (such as like aspirin) 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: Read the Patient Information Leaflet if available from your pharmacist before you start taking auranofin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once or twice a day. The dosage is based on your medical condition and response to treatment. To decrease side effects such as upset stomach, your doctor may start you at a low dose (once a day) and slowly increase to twice a day. Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.If you have been receiving gold injections, you can usually start taking gold by mouth as soon as you stop the injections. If you are changing over from penicillamine, you will usually need to wait 1 month after stopping the penicillamine before starting auranofin. Ask your doctor for more details.It may take 3 to 4 months of therapy before you see the full benefits of this medication.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Diarrhea, frequent/loose stools, stomach/abdominal cramping, nausea, loss of appetite, heartburn, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: eye redness/pain, hair loss, numbness/tingling of arms/legs, signs of low blood count (such as fast/pounding heartbeat, pale skin, unusual tiredness), easy bleeding/bruising, black/bloody stools, cough that doesn't go away, mucus/pus/blood in watery diarrhea, dizziness, signs of infection (such as sore throat that doesn't go away, fever), severe stomach/abdominal pain, change in the amount/color of urine, vomit that looks like coffee grounds, yellowing eyes/skin.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. Rinsing your mouth with a mild salt solution may provide some relief. Discuss with your doctor.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.Auranofin can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.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 or at www.fda.gov/medwatch.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 taking auranofin, 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: reaction to gold compound (such as blood disorders, kidney problems, lung problems, stomach/intestinal problems), bleeding problems, blood disorders (such as bone marrow depression), colitis/inflammatory bowel disease, eczema, certain lung problem (fibrosis), kidney disease, liver disease, SLE (systemic lupus erythematosus), recent radiation therapy.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using auranofin. Auranofin may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain lab tests (such as tuberculin skin test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver/kidney function, urine tests) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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