Ecalta

Ecalta

anidulafungin

Manufacturer:

Pfizer
Full Prescribing Info
Contents
Anidulafungin.
Action
Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans. Anidulafungin selectively inhibits 1,3-β-D-glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. Anidulafungin has shown fungicidal activity against Candida spp and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
Indications/Uses
Treatment of candidemia in adult non-neutropenic patients. Ecalta has been studied primarily in patients with candidemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Dosage/Direction for Use
Treatment with anidulafungin should be initiated by a physician experienced in the management of invasive fungal infections. Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Loading Dose: Single 200-mg dose should be administered on Day 1, followed by 100 mg thereafter. Duration of treatment should be based on the patient's clinical response. In general, therapy should continue for at least 14 days after the last positive culture.
Anidulafungin should be reconstituted with the solvent to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.36 mg/mL before use.
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 mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Ecalta can be given without regard to the timing of haemodialysis.
Duration of Treatment: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Other Special Populations: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity or geriatric status.
Administration: Ecalta should be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 3 mL/min). Infusion-associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min. Ecalta should not be administered as a bolus injection. There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Contraindications
Hypersensitivity to anidulafungin or to any of the excipients of Ecalta, and to other medicinal products of the echinocandin class (eg, caspofungin).
Special Precautions
The efficacy of anidulafungin in neutropenic patients with candidemia and in patients with deep tissue Candida infections or intra-abdominal abscess, and peritonitis has not been established. Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy. Patients with rare hereditary problems of fructose intolerance should not take Ecalta.
Use in pregnancy & lactation: Anidulafungin is not recommended in pregnancy.
It is not known whether anidulafungin is excreted in human breast milk.
Use in children: Ecalta is not recommended for use in children <18 years due to insufficient data on safety and efficacy.
Use In Pregnancy & Lactation
Anidulafungin is not recommended in pregnancy.
It is not known whether anidulafungin is excreted in human breast milk.
Adverse Reactions
Anaphylactic reactions, rash, urticaria, flushing, pruritus, dyspnea, hypotension, thrombocytopenia, coagulopathy, hyperkalaemia, hypokalaemia, hypomagnesaemia, convulsion, headache, flushing, diarrhoea, increased γ-glutamyltransferase, blood alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase, rash, pruritis, increased blood bilirubin, decreased platelet count, increased blood creatinine and prolonged QT electrocardiogram.
Drug Interactions
No clinically relavant drug-drug interactions.
No clinically relevant drug-drug interactions were observed with the following drugs likely to be co-administered with anidulafungin: Cyclosporin (CYP3A4 substrate), voriconazole (CYP2C19, CYP2C9, CYP3A4 inhibitor and substrate), tacrolimus (CYP3A4 substrate), liposomal amphotericin B, rifampicin (potent CYP450 inducer).
Storage
Store at 2°-8°C. Do not freeze.
If the infusion solution is not used immediately, it should be stored at 2°-8°C (36°-46°F). The infusion solution should be administered within 24 hrs.
MIMS Class
ATC Classification
J02AX06 - anidulafungin ; Belongs to the class of other systemic antimycotics.
Presentation/Packing
Powd for infusion (vial) 100 mg x 1's.
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