Eraxis

anidulafungin

Eraxis

Pharmacologic class: Semisynthetic echinocandin

Therapeutic class: Antifungal

Pregnancy risk category C

Action

Inhibits glucan synthase, an enzyme present in fungal (but not mammalian) cells; this action inhibits formation of 1,3-beta-D-glucan, an essential component of fungal cell wall.

Availability

Powder for injection (lyophilized): 50-mg single-use vial

Indications and dosages

Candidemia and other Candida infections (intra-abdominal abscess, peritonitis)

Adults: Single 200-mg loading dose by I.V. infusion on day 1, followed by 100 mg I.V. daily thereafter. Duration depends on clinical response; generally, therapy continues at least 14 days after last positive culture.

Esophageal candidiasis

Adults: Single 100-mg loading dose by I.V. infusion on day 1, followed by 50 mg I.V. daily thereafter. Treatment should continue for at least 14 days, and for at least 7 days after symptoms resolve; duration depends on clinical response. Due to risk of esophageal candidiasis relapse in patients with human immunodeficiency virus, suppressive antifungal therapy may be considered after treatment ends.

Contraindications

• Hypersensitivity to drug, its components, or other echinocandins

Precautions

Use cautiously in:
• hepatic impairment
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

Don't give by I.V. bolus.
• Reconstitute only with supplied diluent (20% dehydrated alcohol in water for injection).
• Further dilute only with 5% dextrose injection or normal saline solution, to yield infusion solution concentration of 0.5 mg/ml.
• Give by I.V. infusion within 24 hours of reconstitution.

Don't infuse at a rate exceeding 1.1 mg/minute.
• Don't dilute with other solutions or infuse through same I.V. line with other drugs or electrolytes.

Adverse reactions

CNS: headache

CV: hypotension, phlebitis

GI: aggravated dyspepsia, nausea, vomiting

Hematologic: neutropenia, leukopenia

Respiratory: dyspnea

Skin: rash, urticaria, pruritus, flushing

Other: fever

Interactions

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase: increased

Patient monitoring

• If patient has abnormal liver function tests during therapy, monitor for evidence of worsening hepatic function and weigh risks and benefits of continuing therapy.
• Monitor for rash, urticaria, flushing, dyspnea, and hypotension. (However, these are rare when drug is administered slowly.)

Patient teaching

Instruct patient to report rash, itching, unusual bruising or bleeding, unusual tiredness, or yellowing of skin or eyes.
• Advise patient to report troublesome side effects such as GI upset.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the tests mentioned above.

anidulafungin

(a-ni-du-la-fun-gin) ,

Eraxis

(trade name)

Classification

Therapeutic: antifungals
Pharmacologic: echinocandins
Pregnancy Category: C

Indications

Candidemia and other serious candidal infections including intra-abdominal abscess, peritonitis.Esophageal candidiasis.

Action

Inhibits the synthesis of fungal cell wall.

Therapeutic effects

Death of susceptible fungi.
Active against Candida albicans, C. glabrata, C. parapsilosis, and C. tropicalis.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Crosses the placenta.
Metabolism and Excretion: Undergoes chemical degradation without hepatic metabolism; <1% excreted in urine.
Half-life: 40–50 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusion24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Underlying liver disease (may worsen); Obstetric / Lactation: Pregnancy or lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Respiratory

  • bronchospasm
  • dyspnea

Cardiovascular

  • hypotension

Gastrointestinal

  • diarrhea
  • ↑ liver enzymes

Dermatologic

  • flushing
  • rash
  • urticaria

Fluid and Electrolyte

  • hypokalemia

Miscellaneous

  • anaphylaxis (life-threatening)
  • infusion reaction

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults) Esophageal candidiasis—100 mg loading dose on day 1, then 50 mg daily. Candidemia and other candidal infections—200 mg loading dose on day 1, then 100 mg daily.

Availability

Lyophilized powder for IV use (requires reconstitution): 50 mg/vial

Nursing implications

Nursing assessment

  • Assess infected area and monitor cultures before and periodically during therapy.
  • Specimens for culture should be taken before instituting therapy. Therapy may be started before results are obtained.
  • Monitor for signs and symptoms of anaphylaxis (rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension); usually related to histamine release. To decrease risk, do not exceed a rate of infusion of 1.1 mg/minute.
  • Lab Test Considerations: May cause ↑ ALT, AST, alkaline phosphatase, and hepatic enzymes.
    • May cause hypokalemia.
    • May cause neutropenia and leukopenia.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Intravenous Administration
  • pH: 4.5–4.6.
  • Intermittent Infusion: Reconstitute each 50 mg vial with 15 mL or the 100 mg vial with 30 mL of Sterile Water for Injection for a concentration of 3.33 mg/mL. May be stored in refrigerator for up to 1 hr. Diluent: Further dilute within 24 hr by transferring contents of reconstituted vial into IV bag of D5W or 0.9% NaCl. For the 50 mg dose, dilute with 85 mL for an infusion volume of 100 mL. For the 100 mg dose, dilute with 170 mL for an infusion volume of 200 mL. For the 200 mg dose, dilute with 340 mL for a total infusion volume of 400 mL.Concentration: Final concentration should not exceed 0.5 mg/mL. Do not administer solutions that are discolored or contain particulate matter. Store reconstituted solution in refrigerator; do not freeze. Administer within 24 hr.
  • Rate: Administer at a rate not to exceed 1.1 mg/min (1.4 mL/min or 84 mL/hr).
  • Y-Site Compatibility: acyclovir, alemtuzumab, alfentanil, allopurinol, amifostine, amikacin, aminophylline, amiodarone, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, argatroban, aresnic trioxide, atracurium, azithromycin, aztreonam, bivalirudin, bleomycin, bumetanide, buprenorphine, bulsulfan, butorphanol, calcium chloride, calcium gulconate, carboplatin, carmustine, casopfungin, cefazolin, cefepime, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, daunorubicin hydrochloride, dexamethasone, dexmedetomidine, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doripenem, doxacurium, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, eptifibatide, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, furosemide, ganciclovir, gemcitabine, gentamicin, glycopyrrolate, granisetron, haloperidol, heparin, hydralazine, hydrocortisone, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, linezolid, lorazepam, mannitol, mechlorethamine, melphalan, meperidine, meropenem, mesna, metaraminol, methotrexate, methyldopate, methylprednisolone, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitomycin, mitoxantrone, morphine, mycophenolate, nafcillin, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, pantoprazole, pentamidine, pentazocine, pentobarbital, phenobarbital, phentolamine, phenylephrine, piperacillin/tazobactam, potassium acetate, potassium chloride, procainamide, prochlorperazine, promethazine, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, rocuronium, sodium acetate, streptozocin, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiopental, thiotepa, ticarcillin/clavulanate, tirofiban, tobramycin, topotecan, trimethoprim/sulfamethoxazole, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: amphotericin B colloidal, dantrolene, diazepam, ertapenem, magnesium sulfate, nalbuphine, pemetrexed, phenytoin, potassium phosphates, sodium bicarbonate, sodium phosphates

Patient/Family Teaching

  • Explain purpose of medication to patient.
  • Instruct patient to notify health care professional if signs and symptoms of anaphylaxis occur or if diarrhea becomes pronounced.

Evaluation/Desired Outcomes

  • Resolution of clinical and laboratory indications of fungal infections. Duration of therapy should be based on the patients clinical response. Therapy should be continued for at least 14 days after the last positive culture. For esophageal candidiasis, treatment should continue for at least 7 days following resolution of symptoms.

Eraxis

a trademark for anidulafungin.
Mentioned in ?
References in periodicals archive ?
Decision Resources (Waltham, MA), one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, said that, because of their improvements in safety and efficacy, physicians are increasingly prescribing next-generation antifungals such as Pfizer's Vfend, Schering-Plough's Noxafil, Merck's Cancidas, Astellas' Mycamine and Pfizer's Eraxis.
Eraxis, an antifungal agent for candidemia and other forms of Candida
Comment: Eraxis was effective in studies of the approved indications and was generally well tolerated, with mild diarrhea, mild elevations in liver enzymes, and headache as the most commonly reported adverse events, according to an FDA statement announcing the approval.
New York, NY, announced the US Food and Drug Administration (FDA) has approved Eraxis (anidulafungin) to treat candidemia, a potentially life-threatening bloodstream infection.
In the primary analysis, treatment with the combination of VFEND and ERAXIS resulted in a lower all-cause mortality rate at six weeks compared to VFEND alone.
are Exubera for diabetes, Eraxis for the treatment of candidemia infections, and Sutent for the treatment of advanced
Schranz has worked on many anti-infective clinical and commercial development programs including CRIXIVAN, PRIMAXIN, CEFOXITIN, INVANZ, AUGMENTIN XR, ERAXIS, CANCIDAS, PREVENAR and PREVENAR 13.
Eraxis Builds on Pfizer's Strength in Antifungal Medicines
antifungal medicine Eraxis, and Zeven, an antibiotic.
5) Represents worldwide revenues for pharmaceutical products launched since 2006: Chantix/Champix, Eraxis, Selzentry/Celsentri, Sutent, Thelin and Toviaz.
19 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to their improvements in safety and efficacy, physicians are increasingly prescribing next-generation antifungals such as Pfizer's Vfend, Schering-Plough's Noxafil, Merck's Cancidas, Astellas' Mycamine and Pfizer's Eraxis.