ERAXIS™ (anidulafungin) FOR INJECTION How Supplied

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Prescribing Information

ERAXIS™ (anidulafungin) FOR INJECTION
How Supplied


	Return to the ERAXIS Product Center

ERAXIS (anidulafungin) for Injection is supplied in a single-use vial of sterile, lyophilized, preservative-free, powder. ERAXIS (anidulafungin) is available in the following packaging configuration:

Single Use Vial of ERAXIS 50 mg
NDC 0049-0114-28 One - 50 mg vial

Single Use Vial of ERAXIS 100 mg
NDC 0049-0116-28 One - 100 mg vial

STORAGE

Unreconstituted vials
ERAXIS unreconstituted vials should be stored in a refrigerator at 2ºC – 8ºC (36ºF – 46ºF). Do not freeze.

Reconstituted solution
ERAXIS reconstituted solution can be stored in a refrigerator at 2ºC – 8ºC (36ºF – 46ºF) for up to 1 hour. Do not freeze.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 1 hour at 5ºC (41ºF).

Infusion solution
ERAXIS infusion solution can be stored in a refrigerator at 2ºC – 8ºC (36ºF – 46ºF ), but should be administered within 24 hours. Do not freeze.

Chemical and physical in-use stability of the infusion solution has been demonstrated for 24 hours at 5ºC (41ºF).

Rx only

LAB-0336-6.0
Revised June 2009

PRINTER-FRIENDLY

ERAXIS Safety Information

Important Safety Information

Abnormalities in LFTs have been observed with ERAXIS. Clinically significant hepatic abnormalities have occurred in some patients with serious underlying medical conditions who were receiving multiple medications concomitantly with ERAXIS. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported, but a causal relationship with ERAXIS has not been established. Patients who develop abnormal LFTs during ERAXIS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS therapy.

Possible histamine-mediated symptoms have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of infusion does not exceed 1.1 mg/min.

In the treatment of candidemia, the most common treatment-related AEs included diarrhea (3.1%), hypokalemia (3.1%), and elevated ALT (2.3%).

Please see full prescribing information.

Eraxis ™ (anidulafungin) for injection

eraxis_safety_information.htm

Full Prescribing Information