Anidula 100 Powder For Infusion

✔️ Dosage & Administration

Treatment Duration

Data are insufficient to support the 100 mg dose beyond 35 days

Renal & Hepatic Impairment

No dose adjustment required for mild, moderate, or severe hepatic impairment

No dose adjustment required for any degree of renal impairment, including dialysis

Other Special Populations

No dose adjustment required based on age, gender, body weight, ethnicity, HIV status, or elderly status

Adult & Pediatric Dosage (≥1 Month of Age)

Candidemia and Other Candida Infections

Adults

200 mg loading dose on Day 1

Followed by 100 mg once daily

Continue for at least 14 days after the last positive culture

Pediatrics (≥1 month)

3 mg/kg loading dose (maximum 200 mg) on Day 1

Followed by 1.5 mg/kg once daily (maximum 100 mg)

Continue for at least 14 days after the last positive culture

Esophageal Candidiasis

Adults

100 mg loading dose on Day 1

Followed by 50 mg once daily

Treat for a minimum of 14 days and at least 7 days after symptom resolution

Pediatrics

Not approved

Method of Administration

For intravenous use only

Reconstitute with water for injection to a concentration of 3.33 mg/mL

Further dilute to 0.77 mg/mL

Infusion rate must not exceed 1.1 mg/min

Do not administer as a bolus injection

✔️ Pregnancy & Lactation

No adequate data are available regarding use in pregnant women

Unknown whether anidulafungin is excreted in human milk

Effects on breastfed infants and milk production are unknown

Use only if clearly necessary and under medical supervision

✔️ Adverse Effects

Commonly reported adverse reactions include:

• Hypokalemia
• Nausea, vomiting, diarrhea
• Dyspepsia, abdominal pain
• Fever
• Insomnia
• Hypotension
• Headache
• Anemia
• Thrombocytopenia

✔️ Drug Interactions

Co-administration with cyclosporine, tacrolimus, rifampin, voriconazole, or amphotericin B does not significantly affect the pharmacokinetics of Anidula®.
No dosage adjustment is required when used with these agents.

✔️ Contraindications

Known hypersensitivity to anidulafungin, any formulation component, or other echinocandins

✔️ Precautions & Warnings

Hepatic Effects

Risk of abnormal liver function tests, hepatitis, and hepatic failure

Monitor liver function during therapy

Hypersensitivity Reactions

Anaphylaxis, including shock, has been reported

Infusion-related reactions (rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension) may occur

Do not exceed an infusion rate of 1.1 mg/min

Neonatal Toxicity (Polysorbate 80)

Contains polysorbate 80

Serious adverse effects reported in low-birth-weight infants receiving high doses

Not approved for pediatric patients <1 month of age

Hereditary Fructose Intolerance (HFI)

Contains fructose

Risk of severe metabolic reactions including hypoglycemia, lactic acidosis, and hepatic failure

Obtain history of HFI before administration in pediatric patients

Overdose

A single 400 mg loading dose was inadvertently administered during clinical trials

No clinically significant adverse effects were observed

✔️ Reconstitution & Dilution

Reconstitute with water for injection

Further dilute only with:

5% Dextrose

0.9% Sodium Chloride (Normal Saline)

Final concentration: 0.77 mg/mL

Transfer aseptically into an IV infusion bag or bottle

✔️ Storage Conditions

Unreconstituted vial: Store at 2–8°C; do not freeze

Reconstituted vial: Store up to 25°C for 24 hours; do not freeze

Infusion solution: Store up to 25°C for 48 hours; do not freeze