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Anidulafungin

Generic Medicine
Indications

Anidulafungin is indicated for the treatment of invasive fungal infections, including:

  • Candidemia and other invasive Candida infections such as intra-abdominal abscess and peritonitis in adults and pediatric patients (aged 1 month and above)
  • Esophageal candidiasis in adults
Dosage Administration

Duration of treatment: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.

Patients with renal and hepatic impairment: No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.

Other special population: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.

Adults Pediatric (1 Month of Age and Older)
Candidemia and other forms of Candida infections  
200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture 3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture
Esophageal Candidiasis  
100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms Not approved

Method of Administration: For intravenous use only. Anidulafungin should be reconstituted with water for injection to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL. It is recommended that Anidulafungin be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Anidulafungin must not be administered as a bolus injection.

Interactions

Co-administration of Anidulafungin with drugs such as cyclosporine, tacrolimus, rifampin, voriconazole, and amphotericin B does not significantly affect its steady-state pharmacokinetics. Therefore, no dose adjustment is required when used together with these medications.

Contraindications

Anidulafungin is contraindicated in patients with known hypersensitivity to Anidulafungin or other echinocandin antifungal agents.

Side Effects

Common side effects include hypokalemia, nausea, vomiting, diarrhea, indigestion, abdominal pain, fever, insomnia, low blood pressure, headache, anemia, and thrombocytopenia.

Pregnancy & Lactation

There is limited information on the use of Anidulafungin in pregnant women. Its presence in breast milk and effects on the infant or milk production are unknown. Use only if clearly necessary.

Precautions & Warnings
  • Liver effects: Monitor liver function as there is a risk of abnormal liver tests, hepatitis, or hepatic failure
  • Hypersensitivity reactions: Severe allergic reactions including anaphylaxis may occur
  • Infusion-related reactions: Symptoms such as rash, itching, flushing, breathing difficulty, and hypotension may occur; infusion rate should not exceed 1.1 mg/min
  • Neonatal toxicity risk: Contains polysorbate 80, which may cause toxicity in low-birth-weight infants
  • Hereditary fructose intolerance: Contains fructose; may cause severe metabolic complications in affected patients
Overdose Effects

In clinical trials, a single dose of 400 mg was administered without significant adverse effects. No specific toxicity was observed.

Therapeutic Class

Echinocandin antifungal agent used for Candida infections.

Storage Conditions
  • Unreconstituted vial: Store in refrigerator at 2–8°C, do not freeze
  • Reconstituted solution: Store up to 25°C for 24 hours
  • Infusion solution: Store up to 25°C for 48 hours, do not freeze
Common Questions

What is Anidulafungin for?

What does Anidulafungin do?

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Can Anidulafungin be taken during pregnancy?

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