Anidulafungin

Anidulafungin is an antifungal medication used in the treatment of severe fungal infections including candidemia, intra-abdominal abscess, peritonitis, and esophageal candidiasis. It kills the fungi that cause infections by preventing them from making their protective covering.

Anidulafungin is a semi-synthetic echinocandin antifungal that inhibits 1,3-beta-D-glucan synthesis, an essential component of the fungal cell wall. It has in vitro activity against many Aspergillus spp and Candida spp.

This medicine is administered as an intravenous infusion by a healthcare professional. Common side effects include decreased potassium levels, nausea, diarrhea, headache, and injection site reactions.

• Candidemia
• Other forms of Candida infections (intra-abdominal abscess, peritonitis)
• Esophageal candidiasis

Anidulafungin is a semi-synthetic echinocandin antifungal that inhibits 1,3-beta-D-glucan synthesis, an essential component of the fungal cell walls. It inhibits glucan synthase, an enzyme present in fungal but not mammalian cells.

It has been shown to have in vitro activity against many Aspergillus spp and Candida spp (including C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. krusei).

Anidulafungin inhibits 1,3-beta-D-glucan synthesis in the fungal cell wall. Glucan is an essential component of the fungal cell wall. By inhibiting glucan synthase, it disrupts fungal cell wall formation, leading to cell lysis and fungal death. Since mammalian cells do not have glucan synthase, it does not affect human cells.

Special Instructions:

• Infusion rate: Do not exceed 1.1 mg/min
• No dose adjustment needed in renal or hepatic impairment
• No dose adjustment needed based on gender, weight, ethnicity, HIV positivity, or elderly

For intravenous use only. Administered by healthcare professional. Reconstitute with water for injection to 3.33 mg/mL concentration and dilute to 0.77 mg/mL. Do not administer as bolus injection. Infusion rate should not exceed 1.1 mg/min (1.4 mL/min).

Reconstitution: Dilute only with 5% Dextrose, 0.9% Sodium Chloride, or normal saline.

If you miss a dose of Anidulafungin, please consult your doctor.

• Hypokalemia (decreased potassium level in blood)
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Abdominal pain
• Pyrexia/Fever
• Insomnia
• Hypotension
• Headache
• Anemia
• Thrombocytopenia
• Injection site reactions (pain, swelling, redness)

Serious Precautions:

• Monitor liver function regularly - risk of abnormal liver tests, hepatitis, hepatic failure
• Anaphylaxis including shock may occur - seek immediate medical attention if allergic symptoms occur
• Infusion-related reactions (rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension) - do not exceed infusion rate of 1.1 mg/min
• Not approved in pediatric patients younger than 1 month (risk of polysorbate 80 toxicity)
• Hereditary Fructose Intolerance (HFI) - check history in pediatric patients
• Consult your doctor if pregnant, planning pregnancy or breastfeeding
• Complete the full course - do not stop even if you feel better

• Hypersensitivity to Anidulafungin or other Echinocandins
• Pediatric patients younger than 1 month (polysorbate 80 toxicity risk)

• Cyclosporine: No significant alteration in steady state pharmacokinetics
• Tacrolimus: No significant alteration in pharmacokinetics
• Rifampin: No significant alteration in pharmacokinetics
• Voriconazole: No significant alteration in pharmacokinetics
• Amphotericin B: No significant alteration in pharmacokinetics

No dosage adjustment of Anidulafungin is needed when the mentioned drugs are co-administered.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Anidulafungin. Please consult your doctor.

[SAFE IF PRESCRIBED] Anidulafungin is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.

[CONSULT YOUR DOCTOR] Anidulafungin is probably unsafe to use during breastfeeding. There are no data on the presence of Anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production.

Pediatric patients (1 month to 18 years): Doses as per table above. Safety and efficacy in pediatric patients younger than 1 month have not been established (polysorbate 80 toxicity risk).

No dose adjustment required for elderly patients.

[SAFE IF PRESCRIBED] Safe to use in patients with kidney disease. No dose adjustment recommended. Can be used in patients undergoing dialysis without any adjustment in dose and time.

[SAFE IF PRESCRIBED] Safe to use in patients with liver disease. No dose adjustment recommended for mild, moderate, or severe hepatic impairment. However, monitor hepatic function during therapy.

In clinical trials, a single 400 mg dose was inadvertently administered as a loading dose. No clinical adverse events were reported. No specific antidote; symptomatic treatment required.

Vial (unreconstituted): Store in a refrigerator (2-8°C). Do not freeze.

Reconstituted solution (in vial): Store at up to 25°C for up to 24 hours. Do not freeze.

Infusion solution: Store at up to 25°C for up to 48 hours. Do not freeze.