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Anidulafungin

Pronunciation

(ay nid yoo la FUN jin)

Index Terms

  • LY303366

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Eraxis: 50 mg (1 ea); 100 mg (1 ea) [contains polysorbate 80]

Brand Names: U.S.

  • Eraxis

Pharmacologic Category

  • Antifungal Agent, Parenteral
  • Echinocandin

Pharmacology

Noncompetitive inhibitor of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide comprising 30% to 60% of Candida cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis

Distribution

30-50 L

Metabolism

No hepatic metabolism observed; undergoes slow chemical hydrolysis to open-ring peptide lacking antifungal activity

Excretion

Feces (30%, 10% as unchanged drug); urine (<1%)

Half-Life Elimination

Terminal: 40-50 hours

Protein Binding

~99%

Special Populations: Elderly

Clearance differed slightly between the elderly group and the nonelderly group, and the range of clearance was similar.

Special Populations: Children

Concentration and exposure in children were similar to those observed in adults.

Special Populations: Gender

In multiple-dose patient studies, drug clearance was slightly faster (~22%) in men. Dose adjustments are not necessary based on gender.

Use: Labeled Indications

Treatment of candidemia and other forms of Candida infections (including those of intra-abdominal, peritoneal, and esophageal locus)

Contraindications

Hypersensitivity to anidulafungin, other echinocandins, or any component of the formulation

Dosing: Adult

Aspergillosis (invasive) in HIV-infected patients: IV: 200 mg on day 1, then 100 mg once daily until infection resolution and CD4 count >200 cells/mm3 (HHS [OI adult 2015])

Candidemia, intra-abdominal or peritoneal candidiasis: IV: Initial dose: 200 mg on day 1; subsequent dosing: 100 mg daily; treatment should continue until 14 days after last positive culture. Note: IDSA Candidiasis guidelines recommend transition to fluconazole (eg, after 5 to 7 days in nonneutropenic patients) in clinically stable patients with fluconazole-susceptible isolates and negative repeat cultures (IDSA [Pappas 2016])

Candidiasis, chronic disseminated (hepatosplenic) (off-label use): IV: 200 mg on day 1; subsequent dosing: 100 mg daily for several weeks, followed by oral fluconazole therapy (IDSA [Pappas 2016])

Candidiasis, empiric therapy (suspected invasive candidiasis in nonneutropenic ICU patients) (off-label use): IV: 200 mg on day 1; subsequent dosing: 100 mg daily; treatment should continue for 14 days in patients with clinical improvement. Consider discontinuing after 4 to 5 days in patients with no clinical response (IDSA [Pappas 2016])

Candidiasis, intravascular infections (native or prosthetic valve endocarditis, infection of implantable cardiac devices, suppurative thrombophlebitis) (off-label use): IV: 200 mg daily. For native or prosthetic valve endocarditis, therapy should continue for at least 6 weeks after valve replacement surgery (longer durations in patients with abscesses or other complications); for patients with implantable cardiac devices, therapy should continue for 4 to 6 weeks after surgery (4 weeks for infections limited to generator pockets and at least 6 weeks for infections involving the wires); for suppurative thrombophlebitis, continue for at least 2 weeks after candidemia has cleared. Note: Step-down to fluconazole therapy is recommended in clinically stable patients with fluconazole-susceptible isolates and negative repeat cultures (IDSA [Pappas 2016])

Candidiasis, osteoarticular infections (osteomyelitis or septic arthritis) (alternative therapy) (off-label use): IV: 100 mg daily for at least 14 days, followed by fluconazole (IDSA [Pappas 2016])

Candidiasis, prophylaxis against invasive candidiasis (high-risk ICU patients in units with a high incidence of invasive candidiasis) (alternative therapy; off-label use): IV: Initial dose: 200 mg on day 1; subsequent doses: 100 mg daily (IDSA [Pappas 2016])

Candidiasis, esophageal: IV:

Manufacturer’s labeling: Initial dose: 100 mg on day 1; subsequent dosing: 50 mg daily; treatment should continue for a minimum of 14 days and for at least 7 days after symptom resolution

Alternate recommendations: 200 mg daily; may transition to oral fluconazole therapy once oral intake tolerable. In patients with fluconazole-refractory disease, continue anidulafungin for 14 to 21 days (IDSA [Pappas 2016])

Candidiasis, oropharyngeal (refractory disease) (alternative therapy) (off-label use): IV: Initial dose: 200 mg on day 1; subsequent dosing: 100 mg daily (IDSA [Pappas 2016])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Aspergillosis (invasive) in HIV-infected patients (off-label use): Adolescents: IV: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary, including dialysis patients.

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Reconstitution

Aseptically add 15 mL (50 mg vial) or 30 mL (100 mg vial) of sterile water for injection to each vial. Further dilute 50 mg or 100 mg vials in 50 mL or 100 mL, respectively, of D5W or NS.

Administration

For intravenous use only; infusion rate should not exceed 1.1 mg/minute (1.4 mL/minute or 84 mL/hour).

Compatibility

Stable in D5W, NS.

Y-site administration: Incompatible with ertapenem, sodium bicarbonate.

Storage

Store vials at 2°C to 8°C (36°F to 46°F); excursions at 25°C (77°F) are permitted for 96 hours and the vial may be returned to storage at 2°C to 8°C (36°F to 46°F). Do not freeze. The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C (77°F) prior to dilution into the infusion solution (D5W or NS). The infusion solution may be stored for up to 48 hours at temperatures up to 25°C (77°F) or stored in the freezer for ≥72 hours prior to administration.

Drug Interactions

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination

Adverse Reactions

>10%:

Cardiovascular: Hypotension (15%), hypertension (12%), peripheral edema (11%)

Central nervous system: Insomnia (15%)

Endocrine & metabolic: Hypokalemia (≤25%), hypomagnesemia (12%)

Gastrointestinal: Nausea (7% to 24%), diarrhea (9% to 18%), vomiting (7% to 18%)

Genitourinary: Urinary tract infection (15%)

Hepatic: Increased serum alkaline phosphatase (12%)

Infection: Bacteremia (18%)

Respiratory: Dyspnea (12%)

Miscellaneous: Fever (9% to 18%)

2% to 10%:

Cardiovascular: Deep vein thrombosis (10%), chest pain (5%)

Central nervous system: Confusion (8%), headache (8%), depression (6%)

Dermatologic: Decubitus ulcer (5%)

Endocrine & metabolic: Hypoglycemia (7%), dehydration (6%), hyperglycemia (6%), hyperkalemia (6%)

Gastrointestinal: Constipation (8%), dyspepsia (7%), abdominal pain (6%), oral candidiasis (5%)

Hematologic & oncologic: Anemia (8% to 9%), leukocytosis (5% to 8%), thrombocythemia (6%)

Hepatic: Increased serum transaminases (≤5%)

Infection: Sepsis (7%)

Neuromuscular & skeletal: Back pain (5%)

Renal: Increased serum creatinine (5%)

Respiratory: Pleural effusion (10%), cough (7%), pneumonia (6%), respiratory distress (6%)

<2% (Limited to important or life-threatening): Anaphylactic shock, anaphylaxis, angioedema, atrial fibrillation, blood coagulation disorder, blurred vision, cholestasis, clostridium infection, ECG abnormality (including ECG changes – prolonged Q-T interval), hepatic insufficiency, hepatic necrosis, hepatitis, increased amylase, infusion related reaction, prolonged prothrombin time, right bundle branch block, seizure, sinus arrhythmia, thrombocytopenia, thrombophlebitis, ventricular premature contractions

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic reactions: Severe hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported; immediate treatment for hypersensitivity reactions should be available. Discontinue treatment immediately if reactions occur.

• Hepatic effects: Elevated liver function tests, hepatitis, and hepatic failure have been reported; monitor for progressive hepatic impairment if increased transaminase enzymes noted.

• Infusion reactions: Infusion reactions (eg, bronchospasm, dyspnea, flushing, hypotension, pruritus, rash, urticaria) may occur; do not exceed rate of infusion.

Disease-related concerns:

• Candidal infections: Safety and efficacy have not been established in other Candida infections (eg, endocarditis, osteomyelitis, meningitis).

Monitoring Parameters

Liver function tests

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. Other agents are currently preferred for the treatment of Candida infections in pregnant women (IDSA [Pappas 2016]).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, diarrhea, or insomnia. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, vomiting blood, difficult urination, painful urination, severe dizziness, passing out, chills, pharyngitis, flushing, severe headache, shortness of breath, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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