ERAXIS

, Carcinogenesis and Mutagenesis No long - term studies in animals have been performed to evaluate the carcinogenic potential of anidulafungin. For information on animal data, see 16 NON-CLINICAL TOXICOLOGY sections of the Product Monograph.

Hepatic/Biliary/Pancreatic Laboratory abnormalities in liver function tests have been seen in healthy subjects and patients treated with anidulafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with anidulafungin, clinically-significant hepatic abnormalities have occurred.

Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to anidulafungin has not been established. Patients who develop abnormal liver function tests during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.

Immune Anaphylactic reactions Anaphylactic reactions, including shock, were reported with the use of anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered. 1 Pregnant Women Animal studies have shown no selective reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY).

There are no adequate and well-controlled studies in pregnant women. Therefore, ERAXIS (anidulafungin) should be used during pregnancy only if the potential benefit justifies the risk to the fetus. 2 Breast-feeding Animal studies have shown excretion of anidulafungin in breast milk (see 16 NON-CLINICAL TOXICOLOGY).

It is not known whether anidulafungin is excreted in human breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with anidulafungin should be made taking into account the benefit of breast-feeding to the child and the benefit of anidulafungin to the woman.

3 Pediatrics The safety and efficacy of ERAXIS have not been established in neonates (less than 1 month of age). Nonclinical infection models indicate that higher doses of anidulafungin are needed to achieve adequate CNS penetration (16 NON-CLINICAL TOXICOLOGY), resulting in higher doses of polysorbate 80, a formulation excipient.

High doses of polysorbates have been associated with potentially life- threatening toxicities in neonates as reported in the literature. There is no clinical data to support the efficacy and safety of higher doses of anidulafungin than recommended.

). 9% Sodium Chloride Injection, USP (normal saline). 9% Sodium Chloride Injection, USP (normal saline) has not been established. The infusion solution must not be frozen. 33 mg/mL. The reconstitution time can be up to 5 minutes. If not used immediately, the reconstituted solution should be stored at 15 - 30 °C for up to 24 hours.

77 mg/ml. The table below provides the volumes required for each dose. 9% Sodium Chloride Injection, USP (normal saline). 4 mL/minute). The infusion solution should be stored at 15 - 30 °C, for up to 48 hours. Do not freeze. For single use only.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If particulate matter or discolouration are identified, discard the solution.

For further information on storage and stability for the infusion and reconstituted solution, see section 11 STORAGE, STABILITY AND DISPOSAL. 1 mg/minute. 5 OVERDOSAGE As with any overdose, general supportive measures should be utilized as necessary.

During clinical trials a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, anidulafungin was well tolerated with no dose ERAXIS® (anidulafungin) - Product Monograph Page 7 of 32 limiting toxicity; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (3 x ULN).

During a pediatric clinical trial, one subject received two doses of anidulafungin that were 143% of the expected dose. No clinical adverse reactions were reported. Anidulafungin is not dialyzable. The maximum non-lethal single dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 5 times the recommended daily dose in humans for Candidemia and other Candida infections [100 mg/day] , based on the relative body surface area comparison.

ERAXIS is contraindicated in patients who are hypersensitive to anidulafungin or to any ingredient in the formulation, including any non-medicinal ingredient or other echinocandins, or component of the container. 3 Reconstitution. 2 Recommended Dose and Dosage Adjustment Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s).

Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.

Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. 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. Anidulafungin can be given without regard to the timing of hemodialysis (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).

Other Special Populations No dose adjustments are required for adult patients based on patient gender, ethnicity, HIV positivity, or geriatric status. (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 5 mg/kg (not to exceed 100 mg) daily dose thereafter.

In general, antifungal therapy should continue for at least 14 days after the last negative culture (defined as the second of two consecutive negative cultures, separated by at least 24 hours, following the last positive culture) and improvement of clinical signs and symptoms of invasive candidiasis including candidemia (ICC).