Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Treatment with ECALTA 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.
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.
There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
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 (see section 5.2).
No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).
The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.
For intravenous use only.
ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL. For instructions on reconstitution of the medicinal product before administration (see section 6.6).
It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
ECALTA must not be administered as a bolus injection.
As with any overdose, general supportive measures should be utilised as necessary. In case of overdose, adverse reactions may occur as mentioned in section 4.8.
During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose. No clinical adverse reactions were reported. No dose limiting toxicity was observed 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 x Upper Limit of Normal (ULN)).
ECALTA is not dialysable.
3 years.
Excursions for 96 hours up to 25°C are permitted, and the powder can be returned to refrigerated storage.
Reconstituted solution:
The reconstituted solution may be stored at up to 25°C for up to 24 hours.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25°C.
Infusion solution:
The infusion solution may be stored at 25°C for 48 hours or stored frozen for at least 72 hours.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25°C.
Store in a refrigerator (2°C–8°C).
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
Pack size of 1 vial.
There are no special requirements for disposal.
ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose for infusion. The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.
Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL. The reconstitution time can be up to 5 mins. After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion obtaining an anidulafungin concentration of 0.77 mg/mL. The table below provides the volumes required for each dose.
Dilution requirements for ECALTA administration:
| Dose Number of vials of powder | Total reconstituted volume | Infusion volumeA | Total infusion volumeB | Rate of infusion | Minimum duration of infusion | |
|---|---|---|---|---|---|---|
| 100 mg | 1 | 30 mL | 100 mL | 130 mL | 1.4 mL/min | 90 min |
| 200 mg | 2 | 60 mL | 200 mL | 260 mL | 1.4 mL/min | 180 min |
A Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
B Infusion solution concentration is 0.77 mg/mL
The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions) (see sections 4.2, 4.4 and 4.8).
The solution should be inspected visually for particulate matter and discoloration prior to administration. If either particulate matter or discolouration are identified, discard the solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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