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SPC: FIRMAGON Powder and solvent for solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

FIRMAGON 80 mg powder and solvent for solution for injection.

Qualitative and quantitative composition

Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix. For the full list of excipients, see section 6.1.

Pharmaceutical form

Powder and solvent for solution for injection. Powder: White to off-white powder. Solvent: Clear, colourless solution.

Therapeutic indications

FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

Posology and method of administration

Posology Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each. Maintenance dose – monthly administration: 80 mg administered as one subcutaneous injection. The first ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.

Special warnings and precautions for use

Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval. In the confirmatory study comparing FIRMAGON to leuprorelin periodic (monthly) electrocardiograms (ECGs) were ...

Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed. Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong ...

Fertility, pregnancy and lactation

Pregnancy and breast-feeding There is no relevant indication for use of FIRMAGON in women. Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.

Effects on ability to drive and use machines

FIRMAGON has no or negligible influence on the ability to drive and use machines. Fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone ...

Overdose

There is no clinical experience with the effects of an acute overdose with degarelix. In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if ...

Pharmacodynamic properties

Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents ATC code: L02BX02 Mechanism of action Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist ...

Pharmacokinetic properties

Absorption Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC<sub>0-28days</sub> was 635 (602-668) day*ng/ml, ...

Preclinical safety data

Animal reproduction studies showed that degarelix caused infertility in male animals. This is due to the pharmacological effect; and the effect was reversible. In female reproduction toxicity studies degarelix ...

List of excipients

Powder: Mannitol (E421) Solvent: Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 2 hours at 25oC. From a microbiological point of view, unless the method of reconstitution precludes ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection. Pre-filled glass (type I) syringe with elastomer plunger stopper, tip ...

Special precautions for disposal and other handling

The instructions for reconstitution must be followed carefully. Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration. The reconstituted ...

Marketing authorization holder

Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, DK-2300, Copenhagen S, Denmark, Tel: +45 88 33 88 34

Marketing authorization number(s)

EU/1/08/504/001 EU/1/08/504/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013

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