Medicinal Products

ECALTA 100 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Anidulafungin
laboratory: Pfizer Limited

Powder for concentrate for solution for infusion IV
Box of 1 vial of powder of 100 mg
All forms

Indication

Treatment of invasive candidiasis in adults (see Warnings and Precautions and Pharmacodynamic Properties section).

Dosage ECALTA 100 mg Powder for concentrate for solution for infusion IV Box of 1 vial of powder of 100 mg

Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections. Samples for mycological culture should be made before initiation of treatment. The treatment can be initiated before knowing the results of this culture and be adapted accordingly according to these results.

Dosage

A single 200 mg loading dose should be given on the first day, followed by 100 mg daily on the following days. The duration of treatment will depend on the clinical response of the patient. In general, antifungal therapy should be continued for at least 14 days after the last positive culture.

Duration of treatment

There is insufficient data to recommend treatment for more than 35 days at a dose of 100 mg.

Inadequate patients with episodes and renal

No dose adjustment is necessary in patients with mild, moderate or severe hepatic impairment. No dose adjustment is required in patients with renal impairment, including dialysis patients. ECALTA can be given before, during or after hemodialysis sessions (see section 5.2 ).

Other special populations

No dose adjustment is necessary in adult patients based on sex, weight, ethnicity, HIV serology, or in elderly patients (see section 5.2 ).

Pediatric population

The safety and efficacy of ECALTA in children under 18 years of age have not been established. Currently available data are described under Pharmacokinetic properties but no dosage recommendation can be issued.

Administration mode

Intravenous only.

ECALTA should be reconstituted with water for injection to a concentration of 3.33 mg / ml and diluted to a concentration of 0.77 mg / ml. For instructions on reconstitution of the drug before administration, see the section Instructions for use, handling and disposal .

It is recommended to administer ECALTA at an infusion rate not exceeding 1.1 mg per minute (ie 1.4 ml / min after reconstitution and dilution as directed). Infusion-related reactions are infrequent when the rate of infusion of anidulafungin does not exceed 1.1 mg / minute (see Warnings and Precautions ).

ECALTA should not be bolus injected.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Hypersensitivity to other drugs in the echinocandin class.

Ecalta side effects

Summary of the security profile

One thousand five hundred and sixty-five (1, 565) patients received single or multiple doses of intravenous anidulafungin in clinical trials: 1, 308 patients in phase II / III trials (923 patients with candidemia / candidiasis invasive, 355 patients with oral / oropharyngeal candidiasis, 30 patients with invasive aspergillosis) and 257 patients in phase I studies.

The safety profile of anidulafungin is based on 840 patients with candidemia / invasive candidiasis receiving the recommended daily dose of 100 mg in 9 studies. Initially, 3 studies (a comparative study versus fluconazole, two non-comparative studies) involved 204 patients; the mean duration of intravenous treatment in these patients was 13.5 days (range: 1 to 38 days) and 119 patients received ≥14 days of anidulafungin. 6 additional studies (two comparative studies versus caspofungin and four non-comparative studies) involved 636 patients, including 53 neutropenic patients and 131 patients with deep tissue infection; the mean duration of intravenous treatment in neutropenic patients and those with deep tissue infection in these studies was 10.0 days (range: 1-42 days) and 14.0 days (range 1-42 days) days, respectively. In general, adverse events were mild to moderate and rarely required treatment discontinuation.

Infusion-related reactions have been described with anidulafungin in clinical studies, including flushing, hot flushes, pruritus, rash and urticaria, summarized in Table 1.

Tabulated list of adverse effects

The table below summarizes the adverse effects regardless of the causality (according to the MedDRA terms) from 840 patients receiving 100 mg of anidulafungin, with a frequency corresponding to "very frequent" (≥ 1/10), "Common" (≥ 1/100 to <1/10), "infrequent" (≥ 1/1000 to <1/100), "rare" (≥ 1/10 000 to <1/1000) "or "Very rare" (<1 / 10, 000) and from spontaneous notifications at an "undetermined frequency" (which can not be estimated on the basis of available data). Within each frequency group, adverse effects are presented in order of decreasing severity.

Table 1. Table of adverse reactions

Class of

systems

organ

Very

frequent

≥ 1/10

Frequent

≥ 1/100 to

<1/10

Rare

≥ 1/1000 to

<1/100

Rare

1/10 000

AT

<1/1 00 0

Very

rare

<

1/10 000

Not known frequency

Hematological disorders

and the lymphatic system

coagulopathy

Affections of

system

immune

Shock

anaplasty

,

reaction

anaplasty

*

Metabolism and nutrition disorders

Hypokali emitted

Hyperglyc emitted

Nervous system disorders

Seizures, c episodes

Vascular disorders

Hypotension, hypertension

Flushing, flushing

Respiratory, thoracic and ediastinal disorders

Bronchospasm, dyspnea

affections

gastrointestinal

intestinal

Diarrhea, nausea

vomiting

Pain

abdominal

high

Table 1. Table of adverse reactions

Class of

systems

organ

Very

frequent

≥ 1/10

Frequent

≥ 1/100 to

<1/10

Rare

≥ 1/1000 to

<1/100

Rare

≥ 1/10000

AT

<1/1 00 0

Very

rare

<

1/10 000

Not known frequency

Hematologic disorders

Elevation of

alanine rate

aminotransf eras e, elevation of

rate

of the

phosphatase

alkaline

blood,

elevation of

rate

of aspartate

aminotransf eras e, elevation of

rate of

bilirubin

blood,

cholestasis

El evation of the gamma

glutamyltransf erase

Skin and subcutaneous tissue disorders

Rash, pruritus

Urticaria

Renal and urinary disorders

Evaporation of serum creatinine

General disorders and administration site abnormalities

Pain in

site of

drip

* See section Warnings and precautions for use .

Disclaimer of suspected adverse reactions

The statement of suspected side effects after approval of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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