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Eraxis

Generic Name: Anidulafungin
Class: Echinocandins
VA Class: AM700
Chemical Name: 1-[(4R,5R)-4,5-dihydroxy-N2-[[4″-(pentyloxy)[1,1′:4′,1″-terphenyl]-4-yl]carbonyl]-l-ornithine] Echinocandin B
Molecular Formula: C58H73N7O17
CAS Number: CAS-166663-25-8

Introduction

Antifungal; echinocandin.1 2 4 5 7

Uses for Eraxis

Candidemia and Other Invasive Candida Infections

Treatment of candidemia and certain other invasive Candida infections (intra-abdominal abscess, peritonitis).1 5 8 19 425 436 A drug of choice.425 436

Manufacturer states safety and efficacy not established for treatment of endocarditis, osteomyelitis, or meningitis caused by Candida.1

Manufacturer states efficacy data insufficient to date regarding use of anidulafungin for treatment of candidemia or other invasive Candida infections in neutropenic patients.1

For treatment of candidemia in nonneutropenic patients or for empiric treatment of suspected invasive candidiasis in nonneutropenic patients in intensive care units (ICUs), IDSA recommends an IV echinocandin (anidulafungin, caspofungin, micafungin) for initial therapy;425 IV or oral fluconazole is an acceptable alternative for initial therapy in selected patients, including those who are not critically ill and unlikely to have infections caused by fluconazole-resistant Candida.425 IV amphotericin B recommended if echinocandin- and azole-resistant Candida suspected and is an alternative when echinocandins and fluconazole have been ineffective or cannot be used.425 Consider transition from the echinocandin to fluconazole (usually within 5–7 days) in clinically stable patients if strain susceptible to fluconazole (e.g., C. albicans) and initial treatment resulted in negative repeat blood cultures.425

For treatment of candidemia in neutropenic patients, IDSA recommends an IV echinocandin (anidulafungin, caspofungin, micafungin) or, alternatively, IV amphotericin B for initial therapy.425 Fluconazole is an alternative for initial therapy in those who are not critically ill and have had no prior exposure to azole antifungals;425 also can be used for step-down therapy in clinically stable patients who have fluconazole-susceptible isolates and documented bloodstream clearance.425 Voriconazole can be used as an alternative for initial therapy when broader antifungal coverage is required and also can be used as step-down therapy during neutropenia in clinically stable patients who have voriconazole-susceptible isolates and documented bloodstream clearance.425 An echinocandin, amphotericin B, or voriconazole recommended for infections known to be caused by C. krusei.425

For treatment of osteoarticular infections (e.g., osteomyelitis, septic arthritis) caused by Candida, IDSA recommends initial treatment with fluconazole or an IV echinocandin (anidulafungin, caspofungin, micafungin) and follow-up treatment with fluconazole.425 If septic arthritis involves a prosthetic device that cannot be removed, long-term suppressive or maintenance therapy (secondary prophylaxis) with fluconazole recommended if isolate is susceptible.425

For treatment of endocarditis (native or prosthetic valve) or implantable cardiac device infections caused by Candida, IDSA recommends initial treatment with IV amphotericin B (with or without flucytosine) or an IV echinocandin (anidulafungin, caspofungin, micafungin) and follow-up treatment with fluconazole.425 If isolate is susceptible, long-term suppressive or maintenance therapy (secondary prophylaxis) with fluconazole recommended to prevent recurrence in those with native valve endocarditis who cannot undergo valve replacement and in those with prosthetic valve endocarditis.425

Consult current IDSA clinical practice guidelines available at for additional information on management of candidemia and disseminated candida infections.425

Esophageal Candidiasis

Treatment of esophageal candidiasis.1 3 5 11 425 436 440 A drug of choice.425 436

Esophageal candidiasis requires treatment with a systemic antifungal (not a topical antifungal).425 440

IDSA recommends oral fluconazole as the preferred drug of choice for treatment of esophageal candidiasis;425 if oral therapy not tolerated, IV fluconazole or an IV echinocandin (anidulafungin, caspofungin, micafungin) recommended.425 For fluconazole-refractory esophageal candidiasis, IDSA recommends itraconazole oral solution or IV or oral voriconazole;425 alternatives are an IV echinocandin (anidulafungin, caspofungin, micafungin) or IV amphotericin B.425 IDSA states oral posaconazole (oral suspension or delayed-release tablets) is another possible alternative for treatment of fluconazole-refractory esophageal candidiasis.425

For treatment of esophageal candidiasis in HIV-infected adults and adolescents, CDC, NIH, and IDSA recommend oral or IV fluconazole or itraconazole oral solution.440 Alternatives include oral or IV voriconazole, an IV echinocandin (anidulafungin, caspofungin, micafungin), or IV amphotericin B.440 For refractory esophageal candidiasis, including fluconazole-refractory infections, in HIV-infected adults and adolescents, itraconazole oral solution or posaconazole oral suspension is recommended;440 alternatives are IV amphotericin B, an IV echinocandin (anidulafungin, caspofungin, micafungin), or oral or IV voriconazole.440

Although routine long-term suppressive or maintenance therapy (secondary prophylaxis) to prevent relapse or recurrence not usually recommended in patients adequately treated for esophageal candidiasis (including HIV-infected individuals), patients with frequent or severe recurrences of esophageal candidiasis may benefit from secondary prophylaxis with oral fluconazole or posaconazole oral suspension;425 440 441 however, consider potential for development of azole resistance.425 440 441

Consult current IDSA clinical practice guidelines available at 425 and current CDC, NIH, and IDSA clinical practice guidelines for prevention and treatment of opportunistic infections in HIV-infected individuals available at 440 441 for additional information on management of esophageal candidiasis.

Oropharyngeal Candidiasis

Treatment of oropharyngeal candidiasis.425 436 440 Considered an alternative, not a drug of choice.425 440

For mild oropharyngeal candidiasis, IDSA recommends topical treatment with clotrimazole lozenges or miconazole buccal tablets;425 nystatin (oral suspension or tablets) is an alternative.425 For moderate to severe oropharyngeal candidiasis, IDSA recommends oral fluconazole.425 For fluconazole-refractory oropharyngeal candidiasis, IDSA recommends itraconazole oral solution or posaconazole oral suspension;425 oral voriconazole or amphotericin B oral suspension (not commercially available in US) recommended as alternatives.425 Other alternatives for refractory oropharyngeal candidiasis are IV echinocandins (anidulafungin, caspofungin, micafungin) or IV amphotericin B.425

For treatment of oropharyngeal candidiasis in HIV-infected adults and adolescents, CDC, NIH, and IDSA recommend oral fluconazole as the preferred drug of choice for initial episodes;440 if topical therapy used (e.g., mild to moderate episodes), drugs of choice are clotrimazole lozenges or miconazole buccal tablets.440 Alternatives for systemic treatment are itraconazole oral solution or posaconazole oral suspension;440 nystatin oral suspension is an alternative for topical treatment.440 For fluconazole-refractory infections in HIV-infected adults and adolescents, posaconazole oral suspension is preferred;440 itraconazole oral solution is an alternative.440

Although routine long-term suppressive or maintenance therapy (secondary prophylaxis) to prevent relapse or recurrence not usually recommended in patients adequately treated for oropharyngeal candidiasis (including HIV-infected individuals), patients with frequent or severe recurrences of oropharyngeal candidiasis may benefit from secondary prophylaxis with oral fluconazole;425 440 441 however, consider potential for development of azole resistance.425 440 441

Consult current IDSA clinical practice guidelines available at 425 and current CDC, NIH, and IDSA clinical practice guidelines for prevention and treatment of opportunistic infections in HIV-infected individuals available at 440 441 for additional information on management of oropharyngeal candidiasis.

Candida auris Infections

Treatment of infections caused by C. auris, an emerging pathogen associated with potentially fatal candidemia or other invasive infections.504 505 506 507 508 509 510

First identified in 2009, C. auris has now been reported as the cause of serious invasive infections (including fatalities) in multiple countries worldwide (e.g., Japan, South Korea, India, Kuwait, South Africa, Pakistan, United Kingdom, Venezuela, Colombia, US).504 505 506 507 509 As of May 2017, a total of 77 clinical cases of C. auris had been reported to CDC from 7 different US states.504 May be difficult to identify using standard in vitro methods.507 508 Large percentage of C. auris clinical isolates are resistant to fluconazole;505 507 508 509 multidrug-resistant isolates with reduced susceptibility or resistance to all 3 major classes of antifungal agents (azoles, polyenes, echinocandins) reported.505 507 508 509

CDC issued interim recommendations regarding laboratory diagnosis, treatment, and infection control measures for suspected or known C. auris infections.510 Based on limited data available to date, CDC recommends an IV echinocandin (anidulafungin, caspofungin, micafungin) for initial treatment of invasive C. auris infections (e.g., bloodstream or intra-abdominal infections) in adults.510 CDC states a switch to IV amphotericin B (lipid formulation) could be considered if patient is clinically unresponsive to the echinocandin or fungemia persists >5 days.510 Consultation with an infectious disease specialist highly recommended.510

CDC recommends that infection control measures be observed for all patients with cultures yielding C. auris, including those with positive cultures only from noninvasive body sites.510

If C. auris infection is suspected, immediately contact state or local public health authorities and the CDC (candidaauris@cdc.gov) for guidance.510 Consult interim recommendations and most recent information from CDC available at for additional information on diagnosis and management of C. auris infections.510

Aspergillosis

Safety and efficacy for treatment of invasive aspergillosis not established; only limited data are available regarding use of the drug for treatment of such infections.423

IDSA and other clinicians consider IV voriconazole the drug of choice for primary treatment of invasive aspergillosis in adult and pediatric patients, including HIV-infected patients;423 436 440 IV amphotericin B or isavuconazonium (prodrug of isavuconazole) usually recommended as alternatives for primary treatment.423

For salvage therapy in patients refractory to or intolerant of primary antifungal therapy, IDSA recommends IV amphotericin B, an IV echinocandin (caspofungin, micafungin), oral or IV posaconazole, or itraconazole oral suspension.423 IDSA states that echinocandins (either alone or in conjunction with other antifungals) may be effective for salvage therapy of invasive aspergillosis; however, routine use of echinocandin monotherapy not recommended for primary treatment of invasive aspergillosis.423

Consult current IDSA clinical practice guidelines available at 423 and current CDC, NIH, and IDSA clinical practice guidelines for prevention and treatment of opportunistic infections in HIV-infected individuals available at 440 441 for additional information on management of aspergillosis.

Eraxis Dosage and Administration

Administration

IV Administration

Administer by slow IV infusion.1 Do not administer by rapid IV injection.1

Do not admix or infuse concomitantly with other drugs.1

Must be reconstituted and diluted prior to administration.1 Use strict aseptic technique since the drug contains no preservatives.1

Reconstitution

Reconstitute 50- or 100-mg vials of lyophilized anidulafungin with 15 or 30 mL, respectively, of sterile water for injection to provide a solution containing 3.33 mg/mL.1

Dilution

Dilute total contents of the required number of reconstituted vials in 50, 100, or 200 mL of 5% dextrose injection or 0.9% sodium chloride injection as directed to provide an IV infusion solution containing 0.77 mg/mL.1 (See Table.)

Instructions for Diluting Reconstituted Vials of Anidulafungin1

Anidulafungin Dose Indicated

Number of Reconstituted Vials Required

Required Volume of Diluent (5% Dextrose Injection or 0.9% Sodium Chloride Injection)

Total Infusion Volume of 0.77-mg/mL Solution

Minimum Duration of Infusion (minutes)

50 mg

One 50-mg vial

50 mL

65 mL

45

100 mg

Two 50-mg vials or one 100-mg vial

100 mL

130 mL

90

200 mg

Four 50-mg vials or two 100-mg vials

200 mL

260 mL

180

Rate of Administration

Administer by IV infusion at a rate not exceeding 1.1 mg/minute (1.4 mL/minute).1 More rapid infusion may increase risk of histamine-mediated reactions.1 (See Histamine-mediated Reactions under Cautions.)

Dosage

Pediatric Patients

General Pediatric Dosage
IV

AAP recommends a loading dose of 1.5–3 mg/kg, followed by 0.75–1.5 mg/kg once daily.292

Candidemia and Other Invasive Candida Infections
IV

HIV-infected children ≥2 years of age: Some experts recommend an initial loading dose of 3 mg/kg on day 1, followed by 1.5 mg/kg once daily.441

IDSA recommends that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 2 weeks after documented clearance of Candida from the bloodstream, resolution of candidemia symptoms, and resolution of neutropenia.425

Esophageal Candidiasis
IV

HIV-infected children ≥2 years of age: Some experts recommend an initial loading dose of 3 mg/kg on day 1, followed by 1.5 mg/kg (up to 100 mg) once daily.441

HIV-infected adolescents: A single 100-mg loading dose on day 1, followed by 50 mg once daily.440

IDSA and others recommend that antifungal treatment for esophageal candidiasis be continued for 14–21 days.425 440

Adults

Candidemia and Other Invasive Candida Infections
IV

A single 200-mg loading dose on day 1, followed by 100 mg once daily.1 425

IDSA states consider a transition from the echinocandin to fluconazole (usually within 5–7 days) in patients who are clinically stable, have isolates susceptible to fluconazole (e.g., C. albicans), and have negative repeat blood cultures after initial antifungal treatment.425

Duration of treatment is based on clinical response.1 Manufacturer recommends anidulafungin be continued for at least 14 days after last positive culture.1 IDSA recommend that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 2 weeks after documented clearance of Candida from the bloodstream and resolution of candidemia symptoms and neutropenia.425

Osteoarticular infections: IDSA recommends 100 mg once daily.425 After ≥2 weeks, can switch to fluconazole.425

Endocarditis (native or prosthetic valve) or implantable cardiac device infections: IDSA recommends 200 mg once daily.425 If infection caused by fluconazole-susceptible Candida, can switch to fluconazole after patient stabilized and Candida has been cleared from bloodstream.425

Esophageal Candidiasis
IV

A single 100-mg loading dose on day 1, followed by 50 mg once daily is recommended by the manufacturer.1

IDSA recommends 200 mg once daily if anidulafungin used for treatment of esophageal candidiasis, including fluconazole-refractory disease (see Esophageal Candidiasis under Uses).425

HIV-infected adults: A single 100-mg loading dose on day 1, followed by 50 mg once daily.440

Duration of treatment is based on clinical response.1 Manufacturer recommends a minimum of 14 days and at least 7 days following resolution of symptoms.1 IDSA and others recommend that antifungal treatment be continued for 14–21 days.425 440

Oropharyngeal Candidiasis
IV

IDSA recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily for 7–14 days.425

Candida auris Infections
IV

CDC recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily.510

Aspergillosis
IV

Some experts recommend a single 200-mg loading dose, followed by 100 mg daily.440

Duration of treatment is based on severity of patient's underlying disease, recovery from immunosuppression, and clinical response.423 440 IDSA recommends that treatment of invasive pulmonary aspergillosis be continued for at least 6–12 weeks.423

Special Populations

Hepatic Impairment

Mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C): Dosage adjustments not necessary.1

Renal Impairment

Mild, moderate, or severe renal impairment: Dosage adjustments not necessary.1

Not dialyzable;1 may administer without regard to dialysis timing.1 2 4 5 7 11

Geriatric Patients

Adults ≥65 years of age: Dosage adjustments not necessary.1 7 11

Cautions for Eraxis

Contraindications

  • Known hypersensitivity to anidulafungin, other echinocandin antifungals (e.g., caspofungin, micafungin), or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic reactions, including anaphylactic shock, reported in patients receiving anidulafungin.1 If such reactions occur, discontinue the drug and administer appropriate treatment.1

Possible histamine-mediated symptoms (e.g., rash, urticaria, flushing, pruritus, dyspnea, hypotension).1 6 12 Reported infrequently when infusion rate does not exceed 1.1 mg/minute.1

Infusion-related adverse reactions (e.g., rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension) reported and possibly may be histamine-mediated reactions.1 6 12 To reduce occurrence of such reactions, do not exceed infusion rate of 1.1 mg/minute.1

Hepatic Effects

Abnormal liver function test results reported.1 Clinically important hepatic dysfunction, hepatitis, or worsening hepatic failure reported in patients with serious underlying conditions receiving multiple drugs concomitantly; causal relationship not established.1

If abnormal liver function test results occur, monitor for evidence of worsening hepatic function and evaluate benefits versus risks of continuing anidulafungin therapy.1

Selection and Use of Antifungals

Obtain specimens for fungal culture and other relevant laboratory studies (e.g., histopathology) prior to initiation of therapy.1 Therapy may be started pending results; adjust therapy as needed when results available.1

Specific Populations

Pregnancy

Category B.1

No adequate and well-controlled studies in pregnant women;1 use during pregnancy only if clearly needed.1

In rats, crosses the placenta, is detected in fetal plasma, and has been associated with incomplete ossification of several bones.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1

Use with caution in nursing women.1

Pediatric Use

Safety and efficacy not established in pediatric patients ≤16 years of age.1

Has been used in a limited number of neutropenic children 2–17 years of age without unusual adverse effects.18

Although data limited, some experts state anidulafungin can be considered for first-line treatment of invasive candidiasis or for alternative treatment of esophageal candidiasis in HIV-infected children 2–17 years of age.441

Geriatric Use

No overall differences in efficacy or safety were observed between adults ≥65 years of age and younger adults, but possibility that some older patients may have increased sensitivity to the drug cannot be ruled out.1

Hepatic Impairment

Mild, moderate or severe hepatic impairment (Child-Pugh class A, B, or C): No clinically important effects on pharmacokinetics;1 dosage adjustments not necessary.1

Renal Impairment

Mild, moderate, or severe renal impairment: No clinically important effects on pharmacokinetics;1 dosage adjustments not necessary.1

Common Adverse Effects

GI effects (nausea,1 3 5 6 8 diarrhea,1 vomiting1 , dyspepsia1 ), phlebitis/thrombophlebitis,3 5 6 hypokalemia,1 8 12 increased ALT,3 increased alkaline phosphatase,1 increased γ-glutamyltransferase (GGT, γ-glutamyl transpeptidase, GGPT),3 7 12 pyrexia,1 headache,1 3 5 6 8 rash,1 3 insomnia,1 anemia,1 neutropenia.3 5 6

Interactions for Eraxis

Does not inhibit or induce and is not a substrate for CYP isoenzymes.1 5 6 7 9 11 27 28

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A.1 7 28

Drugs Affecting or Affected by P-glycoprotein Transport

Not an inhibitor or substrate of the P-glycoprotein transport system; pharmacokinetic interactions unlikely.11 27 30

Specific Drugs

Drug

Interaction

Comments

Amphotericin B

Amphotericin B liposomal: No clinically important pharmacokinetic interactions1

In vitro evidence of additive antifungal effects against Candida, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22

In vitro evidence of antagonism against some strains of Aspergillus flavus and A. terreus; in vitro evidence of synergism against some strains of A. fumigatus16

Amphotericin B liposomal: Anidulafungin dosage adjustment not needed1

Clinical importance of in vitro studies unclear16 22

Fluconazole

In vitro evidence of additive or indifferent antifungal effects against C. albicans, C. glabrata; in vitro evidence of indifference against C. krusei, C. parapsilosis, C. tropicalis22

Clinical importance of in vitro studies unclear22

Flucytosine

In vitro evidence of additive or indifferent antifungal affects against C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22

Clinical importance of in vitro studies unclear22

Immunosuppressive agents (cyclosporine, tacrolimus)

Cyclosporine: Increased anidulafungin AUC at steady state but no clinically important change in anidulafungin steady-state peak plasma concentrations;1 5 9 11 no in vitro evidence of effect on cyclosporine metabolism1

Tacrolimus: No clinically important pharmacokinetic interactions with oral tacrolimus1 14

Cyclosporine: Dosage adjustments not needed for either drug1 9 11

Tacrolimus: Dosage adjustments not needed for either drug1

Itraconazole

In vitro evidence of additive or indifferent antifungal effects against Candida, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22

Synergistic or indifferent antifungal effects against Aspergillus; indifferent effects against Fusarium16

Clinical importance of in vitro studies unclear16

Ketoconazole

In vitro evidence of additive or indifferent antifungal effects against C. albicans, C. glabrata, C. krusei, C. parapsilosis; in vitro evidence of antagonism against C. tropicalis22

Clinical importance of in vitro studies unclear16

Rifampin

No clinically important pharmacokinetic interactions1 6 11

Anidulafungin dosage adjustment not needed1

Voriconazole

No clinically important pharmacokinetic interactions with oral voriconazole1 7 17

Dosage adjustments not needed for either drug1 7

Eraxis Pharmacokinetics

Absorption

Plasma Concentrations

Linear relationship between dose and peak plasma concentration and AUC.30 31

Steady state achieved on the first day after an IV loading dose.1

Distribution

Extent

Crosses placenta in rats and detected in rat fetal plasma;1 not known whether crosses placenta in humans.1

Distributed into milk of lactating rats;1 not known whether distributed into human milk.1

Plasma Protein Binding

>99%.1

Elimination

Metabolism

Slow chemical degradation at physiologic temperature and pH; metabolite exhibits no antifungal activity.1 5 6 7 12

Elimination Route

Eliminated principally in feces via the biliary tract.5 28 30 Following a single IV dose, 30% recovered in feces over 9 days (<10% as unchanged drug); <1% excreted in urine.1 5 7 28

Half-life

Distribution half-life is 0.5–1 hour;1 terminal elimination half-life is 27–52 hours.1 5 28

Special Populations

Geriatric adults: Median clearance in adults ≥65 years of age slightly less than that in younger adults; dosage adjustments not required.1

Hepatic impairment: Not metabolized in the liver;1 6 7 9 concentrations not increased in adults with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).1

Renal impairment or end-stage renal disease: Negligible renal clearance; pharmacokinetics not affected by mild, moderate, or severe renal impairment.1

Not removed by hemodialysis.1

Stability

Storage

Parenteral

Powder for IV Infusion

2–8°C;1 may be exposed to temperatures up to 25°C for 96 hours and then returned to 2–8°C.1 Do not freeze.1

Following reconstitution with sterile water for injection, may be stored at temperatures up to 25°C for ≤24 hours.1

Following further dilution in 5% dextrose injection or 0.9% sodium chloride injection to a concentration of 0.77 mg/mL, may be stored at temperatures up to 25°C for ≤48 hours or, alternatively, may be stored frozen for at least 72 hours.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1

Compatible

Dextrose 5%

Sodium chloride 0.9%

Drug CompatibilityHID
Y-Site Compatibility

Compatible

Acyclovir sodium

Amikacin sulfate

Aminophylline

Amphotericin B lipid complex

Amphotericin B liposomal

Ampicillin sodium

Ampicillin sodium-sulbactam sodium

Carboplatin

Cefazolin sodium

Cefepime HCl

Cefoxitin sodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Ciprofloxacin

Cisplatin

Clindamycin phosphate

Cyclophosphamide

Cyclosporine

Cytarabine

Daunorubicin HCl

Dexamethasone sodium phosphate

Digoxin

Dobutamine HCl

Docetaxel

Dopamine HCl

Doripenem

Doxorubicin HCl

Epinephrine HCl

Erythromycin lactobionate

Etoposide phosphate

Famotidine

Fentanyl citrate

Fluconazole

Fluorouracil

Furosemide

Ganciclovir sodium

Gemcitabine HCl

Gentamicin sulfate

Heparin sodium

Hydrocortisone sodium succinate

Ifosfamide

Imipenem-cilastatin sodium

Leucovorin calcium

Levofloxacin

Linezolid

Meperidine HCl

Meropenem

Methylprednisolone sodium succinate

Metronidazole

Midazolam HCl

Morphine sulfate

Mycophenolate mofetil HCl

Norepinephrine bitartrate

Paclitaxel

Pantoprazole sodium

Phenylephrine HCl

Piperacillin sodium-tazobactam sodium

Potassium chloride

Quinupristin-dalfopristin

Ranitidine HCl

Tacrolimus

Ticarcillin disodium-clavulanate potassium

Tobramycin sulfate

Trimethoprim-sulfamethoxazole

Vancomycin HCl

Vincristine sulfate

Voriconazole

Zidovudine

Incompatible

Amphotericin B

Ertapenem

Sodium bicarbonate

Actions and Spectrum

  • Semisynthetic echinocandin antifungal;1 lipopeptide synthesized from a fermentation product of Aspergillus nidulans.1

  • Echinocandins (e.g., anidulafungin, caspofungin, micafungin) differ structurally and pharmacologically from other available antifungals.1 2 4 5 6 7 11

  • Inhibits synthesis of β-d-glucan, an essential component of fungal cell walls that is not present in mammalian cells.1 2 3 4 5 7

  • May be fungistatic or fungicidal in action.1 2 3 4 5 7 13

  • Active in vitro against Candida, including C. albicans,1 10 11 29 C. dubliniensis,11 23 C. glabrata,1 10 11 13 C. guilliermondii,1 10 C. keyfri,10 C. krusei,1 10 11 C. lusitaniae,10 C. metapsilosis,37 C. orthopsilosis,37 C. parapsilosis,1 10 37 and C. tropicalis.1 10 11 27 30 31

  • Clinical isolates of C. auris (often misidentified as C. haemulonii, C. famata, or Rhodotorula glutinis) generally inhibited in vitro by anidulafungin concentrations of 0.125–1 mcg/mL.505 508 508

  • Active against some strains of fluconazole-resistant C. albicans,1 10 C. glabrata,10 29 and C. krusei.10

  • Active in vitro against Aspergillus, including A. fumigatus, A. flavus, A. niger, and A. terreus.2 4 5 6 7 11 12 27 29 30 31

  • Like other echinocandins, not active against Cryptococcus neoformans,2 4 5 11 27 29 30 31 Trichosporon,2 29 31 33 Fusarium,2 4 11 27 31 33 or zygomycetes.2 4 29 30 31 33

  • Although clinical importance unclear, Candida (e.g., C. glabrata) with reduced susceptibility to echinocandins reported.1 425 Some clinical isolates of C. auris have reduced susceptibility or resistance to anidulafungin in vitro (i.e., MICs ≥4 mcg/mL).504 508 509 510

  • Resistance to echinocandins usually due to point mutations within the genes (FKS1 and FKS2) encoding for subunits in the glucan synthase enzyme complex.1

  • Potential for development of resistance or for cross-resistance with other echinocandins (caspofungin, micafungin) not known.2 6 11 12 Active against some strains of C. glabrata resistant to caspofungin13 and C. parapsilosis resistant to caspofungin and micafungin.36

Advice to Patients

  • Inform patients about risk of developing abnormal liver function tests and/or hepatic dysfunction and that liver function tests may be monitored during anidulafungin treatment.1

  • Inform patients that anaphylactic reactions, including shock, reported in patients receiving anidulafungin.1 Advise patients that the drug may be discontinued and appropriate treatment administered if such reactions occur.1

  • Inform patients that infusion-related adverse reactions, possibly histamine mediated, may occur;1 importance of reporting symptoms (e.g., rash, urticaria, flushing, pruritus, dyspnea, hypotension) to their clinician.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Anidulafungin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion

50 mg

Eraxis

Pfizer

100 mg

Eraxis

Pfizer

AHFS DI Essentials. © Copyright 2017, Selected Revisions September 4, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Pfizer Inc. Eraxis (anidulafungin) for injection for intravenous use prescribing information. New York, NY; 2015 Nov.

2. Denning DW. Echinocandin antifungal drugs. Lancet. 2003; 362:1142-51. [PubMed 14550704]

3. Krause DS, Simjee AE, van Rensburg C et al. A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. Clin Infect Dis. 2004; 39:770-5. [PubMed 15472806]

4. Zaas AK, Alexander BD. Echinocandins: role in antifungal therapy, 2005. Expert Opin Pharmacother. 2005; 6:1657-68. [PubMed 16086652]

5. Murdoch D, Plosker GL. Anidulafungin. Drugs. 2004; 64:2249-58. [PubMed 15456342]

6. Vazquez JA. Anidulafungin: a new echinocandin with a novel profile. Clin Ther. 2005; 27:657-73. [PubMed 16117974]

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