ANIDULAFUNGIN Drug Interactions: What You Need to Know

INTERACTIONS

7.1 Cyclosporine Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> .

7.2 Voriconazole Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> .

7.3 Tacrolimus Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> .

7.4 Rifampin Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with rifampin <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> .

7.5 Amphotericin B Liposome for Injection Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> .

ERAXIS is contraindicated in:

• Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins [see Warnings and Precautions (5.2) ]
• Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.4) ]
• Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins ( 4 , 5.2 )
• Known or suspected Hereditary Fructose Intolerance (HFI) ( 4 , 5.4 )

AND PRECAUTIONS

• Hepatic Effects : Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy. ( 5.1 , 13.2 )
• Hypersensitivity : Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute. ( 2.4 , 5.2 )
• Risk of Neonatal Toxicity Associated with Polysorbates : ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. ERAXIS is not approved in pediatric patients younger than 1 month of age. ( 5.3 , 8.4 )
• Hereditary Fructose Intolerance (HFI) : ERAXIS contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before ERAXIS administration. ( 5.4 , 8.4 )

5.1 Hepatic Adverse Reactions Laboratory abnormalities in liver tests have been seen in healthy volunteers and pediatric patients treated with ERAXIS. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with ERAXIS, 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 ERAXIS has not been established <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) and Nonclinical Toxicology (13.2) ]</span> . Patients who develop abnormal liver tests during ERAXIS therapy should be monitored for evidence of worsening hepatic tests and evaluated for risk/benefit of continuing ERAXIS therapy.

5.2 Anaphylactic and Hypersensitivity Reactions Anaphylactic reactions, including shock were reported with the use of ERAXIS. If these reactions occur, ERAXIS should be discontinued and appropriate treatment administered <span class="opacity-50 text-xs">[see Adverse Reactions (6) ]</span> . Infusion-related adverse reactions, possibly histamine-mediated, have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension <span class="opacity-50 text-xs">[see Adverse Reactions (6) ]</span> . To reduce occurrence of these reactions, do not exceed a rate of ERAXIS infusion of 1.1 mg/minute <span class="opacity-50 text-xs">[see Dosage and Administration (2.4) ]</span> .

5.3 Risk of Neonatal Toxicity Associated with Polysorbates ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis have been reported in low-birth weight infants receiving high doses of polysorbate. Polysorbate toxicity has not been reported with ERAXIS. ERAXIS is not approved in pediatric patients younger than 1 month of age <span class="opacity-50 text-xs">[see Indications and Usage (1.1 , 1.3) , Use in Specific Populations (8.4) ]</span>.

5.4 Risk in Patients with Hereditary Fructose Intolerance (HFI) ERAXIS contains fructose, an inactive ingredient, and may precipitate a metabolic crisis that may include, but is not limited to life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure in patients with HFI. Obtain careful history of HFI symptoms (nausea, vomiting, abdominal pain) with fructose/sucrose exposure prior to ERAXIS administration because a diagnosis of HFI may not yet be established in pediatric patients <span class="opacity-50 text-xs">[see Contraindications (4) and Use in Specific Populations (8.4) ]</span> .