Brand Name
Eraxis
Generic Name
Anidulafungin
View Brand Information FDA approval date: February 17, 2006
Classification: Echinocandin Antifungal
Form: Injection
What is Eraxis (Anidulafungin)?
ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: Candidemia and other forms of Candida infections in adults and pediatric patients .
Approved To Treat
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Brand Information
ERAXIS (anidulafungin)
1DOSAGE FORMS AND STRENGTHS
For injection: 50 mg, and 100 mg of anidulafungin as a white to off-white sterile lyophilized powder in a single-dose vial for reconstitution.
2CONTRAINDICATIONS
ERAXIS is contraindicated in:
- Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins
- Patients with known or suspected Hereditary Fructose Intolerance (HFI)
3ADVERSE REACTIONS
The following most
- Hepatic Adverse Reactions
- Anaphylactic and Hypersensitivity Reactions
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Post-marketing Experience
The following adverse reactions have been identified during post approval use of anidulafungin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune: Anaphylactic shock, anaphylactic reaction, bronchospasm [see .
4OVERDOSAGE
During clinical trials a single 400 mg dose of ERAXIS 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; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 × ULN)
Anidulafungin is not dialyzable.
The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other
5DESCRIPTION
ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of
ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N
50 mg/vial – fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.
100 mg/vial – fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.
The empirical formula of anidulafungin is C
The structural formula is:
Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline).
6PRINCIPAL DISPLAY PANEL - 50 mg Vial Label
1 Sterile Single-dose Vial
Eraxis®
(anidulafungin)
for Injection
(anidulafungin)
for Injection
50 mg/vial
For Intravenous Infusion Only
Pfizer
Distributed by
Rx only
7PRINCIPAL DISPLAY PANEL - 50 mg Vial Carton
NDC 0049-0114-28
Unit Pack Contains:
1 Sterile Single-dose Vial
Eraxis® 50 mg
1 Sterile Single-dose Vial
Eraxis® 50 mg
Eraxis®
(anidulafungin)
for Injection
(anidulafungin)
for Injection
50 mg/vial
For Intravenous Infusion Only
Store Vial in Refrigerator
at 2° C - 8° C (36° F - 46° F).
Do Not Freeze.
at 2° C - 8° C (36° F - 46° F).
Do Not Freeze.
Pfizer
Distributed by
Rx only
8PRINCIPAL DISPLAY PANEL - 100 mg Vial Label
1 Sterile Single-dose Vial
Eraxis®
(anidulafungin)
for Injection
(anidulafungin)
for Injection
100 mg/vial
For Intravenous Infusion Only
Pfizer
Distributed by
Rx only
9PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
NDC 0049-0116-28
Unit Pack Contains:
1 Sterile Single-dose Vial
Eraxis® 100 mg
1 Sterile Single-dose Vial
Eraxis® 100 mg
Eraxis®
(anidulafungin)
for Injection
(anidulafungin)
for Injection
100 mg/vial
For Intravenous Infusion Only
Store Vial in Refrigerator
at 2° C - 8° C (36° F - 46° F).
Do Not Freeze.
at 2° C - 8° C (36° F - 46° F).
Do Not Freeze.
Pfizer
Distributed by
Rx only
