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

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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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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 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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            Code Definition
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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.