anidulafungin (Rx)

Brand and Other Names:Eraxis
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 50mg/vial
  • 100mg/vial

Candidemia

Indicated for treatment of candidemia and intra-abdominal abscess and peritonitis caused by Candida infections

Day 1: 200 mg IV infusion, THEN

Day 2 and thereafter: 100 mg/day IV

Generally continue 14 days after last positive culture

Esophageal Candidiasis

Indicated for treatment of esophageal candidiasis

Day 1: 100 mg IV infusion, THEN

Day 2 and thereafter: 50 mg/day IV

Minimum 14 day treatment, at least 7 days following resolution of symptoms

Owing to risk of relapse of esophageal candidiasis in patients with HIV infection, consider suppressive antifungal therapy after treatment course

Candida auris (Off-label)

Based on the limited data, an echinocandin drug (eg, anidulafungin, caspofungin, micafungin) is recommended by the CDC as initial therapy for treatment of C auris infections

Day 1: 200 mg IV

Day 2 and thereafter: 100 mg IV qDay

For more information, see CDC Candida auris Treatment and Management

Dosage Modifications

Any degree of hepatic or renal insufficiency: No dosage adjustments required

Not dialyzable; may be administered without regard to hemodialysis timing

Dosing Considerations

Obtain specimens for fungal culture before initiating empiric antifungal treatment; adjust regimen according to results

Limitations of use

  • Not studied in adults and children with endocarditis, osteomyelitis, and meningitis due to Candida
  • Not studied in sufficient numbers of neutropenic patients to determine efficacy
  • Dosage not established for treatment of Candida with dissemination into the CNS and eye
  • Associated with high relapse rates in esophageal candidiasis

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 50mg/vial
  • 100mg/vial

Candidemia

Indicated for treatment of candidemia and intra-abdominal abscess and peritonitis caused by Candida infections in pediatric patients aged ≥1 month

Day 1: 3 mg/kg (not to exceed 200 mg/dose) IV infusion, THEN

Day 2 and thereafter: 1.5 mg/kg (not to exceed 100 mg/dose) IV

Generally continue 14 days after last positive culture

Candida auris (Off-label)

Based on the limited data, an echinocandin drug (eg, anidulafungin, caspofungin, micafungin) is recommended by the CDC as initial therapy for treatment of C auris infections in adults and children aged 2 months or older

Day 1: 200 mg IV

Day 2 and thereafter: 100 mg IV qDay

For more information, see CDC Candida auris Treatment and Management

Dosage Modifications

Any degree of hepatic or renal insufficiency: No dosage adjustments required

Not dialyzable; may be administered without regard to hemodialysis timing

Dosing Considerations

Obtain specimens for fungal culture before initiating empiric antifungal treatment; adjust regimen according to results

Limitations of use

  • Not studied in adults and children with endocarditis, osteomyelitis, and meningitis due to Candida
  • Not studied in sufficient numbers of neutropenic patients to determine efficacy
  • Dosage not established for treatment of Candida with dissemination into the CNS and eye
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Interactions

Interaction Checker

and anidulafungin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • Saccharomyces boulardii

                anidulafungin decreases effects of Saccharomyces boulardii by unspecified interaction mechanism. Avoid or Use Alternate Drug. Systemic or oral antifungals may decrease activity of probiotic.

              Monitor Closely (1)

              • voclosporin

                voclosporin, anidulafungin. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (0)

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                Adverse Effects

                1-10%

                Adults (candidemia)

                • Hypokalemia (25%)
                • Nausea (24%)
                • Diarrhea (18%)
                • Pyrexia (18%)
                • Hypotension (15%)
                • Insomnia (15%)
                • Hypertension (12%)
                • Dyspnea (12%)
                • Increased alkaline phosphatase (12%)
                • Hypomagnesemia (12%)
                • Peripheral edema (11%)

                Pediatric (candidemia)

                • Pyrexia (18%)
                • Diarrhea (16%)
                • Vomiting (16%)

                1-10%

                Adults (candidemia)

                • Deep vein thrombosis (10%)
                • Pleural effusion (10%)
                • Anemia (9%)
                • Constipation (8%)
                • Increased WBCs (8%)
                • Confusional state (8%)
                • Headache (8%)
                • Cough (7%)
                • Hypoglycemia (7%)
                • Hyperkalemia (6%)
                • Hyperglycemia (6%)
                • Dehydration (6%)
                • Respiratory distress (6%)
                • Abdominal pain (6%)
                • Depression (6%)
                • Thrombocythemia (6%)
                • Leukocytosis (5%)
                • Chest pain (5%)
                • Increased hepatic enzymes (5%)
                • Increased blood creatinine (5%)
                • Back pain (5%)

                Adults (esophageal candidiasis)

                • Diarrhea (9%)
                • Pyrexia (9%)
                • Anemia (8%)
                • Headache (8%)
                • Nausea (7%)
                • Dyspepsia (7%)
                • Vomiting (7%)
                • Hypokalemia (5%)
                • Oral candidiasis (5%)
                • Adults esophageal candidiasis <2%
                  • Blood and lymphatic: Coagulopathy, thrombocytopenia
                  • Cardiac: Atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles
                  • Eye: Eye pain, vision blurred, visual disturbance
                  • General and administration site: Infusion related reaction, peripheral edema, rigors
                  • Hepatobiliary: Abnormal liver function tests, cholestasis, hepatic necrosis
                  • Infections: Clostridial infection
                  • Investigations: Amylase increased, bilirubin increased, CPK increased, electrocardiogram QT prolonged, GGT increased, lipase increased, potassium decreased, prothrombin time prolonged, urea increased
                  • Nervous system: Convulsion, dizziness
                  • Respiratory, thoracic and mediastinal: Cough
                  • Skin and subcutaneous tissue: Angioneurotic edema, erythema, pruritus, sweating increased, urticaria
                  • Vascular: Flushing, hot flushes, thrombophlebitis superficial

                Pediatric (candidemia)

                • Anemia (10%)
                • Abdominal pain (9%)
                • Epistaxis (9%)
                • Rash (9%)
                • ALT increased (9%)
                • AST increased (6%)
                • Thrombocytopenia (6%)
                • Hypoglycemia (6%)
                • Pediatric <5%
                  • Blood and lymphatic system disorders: Pancytopenia, thrombocytosis, febrile neutropenia, leukopenia, neutropenia
                  • Eye disorders: Periorbital edema
                  • Gastrointestinal disorders: Gastroesophageal reflux disease, abdominal distension, nausea, stomatitis, dry mouth
                  • General disorders and administrative site conditions: Chest pain, edema peripheral
                  • Infections and infestations: Bacteremia, device related infection, gastroenteritis, lower respiratory tract infection, upper respiratory tract infection, urinary tract infection
                  • Laboratory investigations: GGT increased, transaminases increased
                  • Metabolism and nutrition disorders: Hypocalcemia, hypokalemia, hyponatremia, hypoproteinemia
                  • Musculoskeletal and connective tissue disorders: Back pain, pain in extremity
                  • Nervous system disorders: Headache, tremor, seizure
                  • Psychiatric disorders: Agitation
                  • Respiratory, thoracic and mediastinal disorders: Hemoptysis
                  • Vascular disorders: Hypotension
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                Warnings

                Contraindications

                Hypersensitivity to any component or other echinocandins

                Known or suspected hereditary fructose intolerance

                Cautions

                Abnormal LFTs observed; if elevated liver tests develop, monitor for evidence of worsening hepatic tests and evaluate risk benefit of continuing anidulafungin monitor for potential hepatic problems

                Anaphylactic reactions, including shock, reported; discontinue and initiate appropriate treatment if this occurs

                Infusion-related adverse reactions (possibly histamine-mediated) reported, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; reduce risk by not exceeding recommended infusion rate

                Contains polysorbate 80, an inactive ingredient; thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis reported in low-birth weight infants receiving high doses of polysorbate; toxicity has not been reported with anidulafungin

                Contains fructose; may precipitate a metabolic crisis (eg, life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, hepatic failure) in patients with hereditary fructose intolerance

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                Pregnancy & Lactation

                Pregnancy

                Based on findings from animal studies, therapy can cause fetal harm when administered to pregnant females; there are no available human data on use in pregnant females to inform a drug-associated risk of adverse developmental outcomes

                Animal studies

                • Fetal toxicity observed in animal reproduction studies in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day (dose based on relative body surface area)

                Lactation

                There are no data on presence of drug in human milk, effects on breastfed infant or on milk production

                Drug found in milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk

                Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

                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.

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                Pharmacology

                Mechanism of Action

                Echinocandin - inhibits synthesis of 1,3-beta-D-glucan, an essential component of fungal cell walls

                Absorption

                Peak plasma concentration

                • 70mg/35mg: 3.55 mg/L
                • 200mg/100mg: 8.6 mg/L

                AUC

                • 70mg/35mg: 42.3 mg⋅hr/L
                • 200mg/100mg: 111.8 mg⋅hr/L

                Distribution

                Distribution half-life: 30-60 minutes

                Protein bound: >99% (plasma proteins)

                Vd: 30-50 L

                Metabolism

                Not metabolized by liver

                Undergoes slow chemical degradation to peptide lacking antifungal activity

                Degradation half-life: ~24 hr

                Elimination

                Excretion: Feces (30% over 9 days [<10% intact drug]); urine (<1%)

                Terminal half-life

                • 70mg/35mg: 43.2 hr
                • 200mg/100mg: 52 hr

                Clearance

                • 70mg/35mg: 0.84 L/hr
                • 200mg/100mg: 0.94 L/hr
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                Administration

                IV Preparation

                Reconstitute lyophilized powder

                • Reconstitute vial with sterile water for injection (SWI)
                • 50-mg vial: Add 15 mL SWI to provide concentration of 3.33 mg/mL
                • 100-mg vial: Add 30 mL SWI to provide concentration of 3.33 mg/mL

                Further dilution required

                • Adults: Aseptically transfer contents from reconstituted vial(s) to appropriately sized IV bag/bottle of D5W or 0.9% NaCl
                • Pediatric patients
                  • Infusion solution volume required is dependent on child’s weight
                  • Reconstituted solution must be further diluted to 0.77 mg/mL for final infusion solution
                  • See prescribing information for how to calculate dilution for doses <50 mg

                IV Administration

                Visually inspect solution for particulate matter and discoloration; if identified, discard solution

                IV infusion rate: Not to exceed 1.1 mg/min

                Do not give as IV bolus

                Storage

                Unopened vials: Store at 25°C (77°F)

                Reconstituted vials: May store at 25°C (77°F) for up to 24 hr

                Diluted solution: May store at 25°C (77°F) for up to 48 hr

                Do not freeze

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Eraxis(Water Diluent) intravenous
                -
                100 mg vial
                Eraxis(Water Diluent) intravenous
                -
                50 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                anidulafungin intravenous

                ANIDULAFUNGIN - INJECTION

                (ay-NID-ue-la-FUN-jin)

                COMMON BRAND NAME(S): Eraxis

                USES: This medication is used to treat a variety of fungal infections. Anidulafungin belongs to a class of drugs known as echinocandins. It works by stopping the growth of fungi.

                HOW TO USE: This medication is given by slow injection into a vein as directed by your doctor, usually once a day. The dosage and length of treatment are based on your medical condition and response to treatment. For children, the dosage is also based on their weight.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Learn how to store and discard medical supplies safely.Infusion reactions may happen while you are receiving the drug. Tell your doctor right away if you have symptoms such as fever, chills, shortness of breath, flushing, or dizziness.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition does not get better or if it gets worse.

                SIDE EFFECTS: See also How to Use section.Nausea/vomiting, diarrhea, trouble sleeping, or 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: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin), swelling ankles/feet/hands, mental/mood changes (such as confusion, depression), muscle cramps, irregular heartbeat, unusual tiredness, pain/redness/swelling of arms or legs.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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.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 using anidulafungin, tell your doctor or pharmacist if you are allergic to it; or to other echinocandin antifungal drugs (such as caspofungin, micafungin); or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate 80), 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: liver disease, a certain genetic enzyme problem (hereditary fructose intolerance).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: 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.

                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: Lab and/or medical tests (such as liver function, potassium blood levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

                STORAGE: Consult the product instructions and your pharmacist for storage details. 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 2021. Copyright(c) 2021 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.

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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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                NC NOT COVERED – Drugs that are not covered by the plan.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.