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SPC: FASLODEX Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Faslodex 250 mg solution for injection.

Qualitative and quantitative composition

One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. Excipients with known effect (per 5 ml): Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg) For the full list of ...

Pharmaceutical form

Solution for injection. Clear, colourless to yellow, viscous solution.

Therapeutic indications

Faslodex is indicated: as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, ...

Posology and method of administration

Posology Adult females (including Elderly) The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose. When Faslodex is used in combination ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and lactation (see section 4.6). Severe hepatic impairment (see sections 4.4 and 5.2).

Special warnings and precautions for use

Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2). Faslodex should be used with caution in patients with severe renal impairment ...

Interaction with other medicinal products and other forms of interaction

A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole ...

Fertility, pregnancy and lactation

Women of childbearing potential Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose. Pregnancy Faslodex is contraindicated ...

Effects on ability to drive and use machines

Faslodex has no or negligible influence on the ability to drive or use machines. However, since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who ...

Undesirable effects

Summary of the safety profile Monotherapy This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports. In the pooled dataset of ...

Overdose

There are isolated reports of overdose with Faslodex in humans. If overdose occurs, symptomatic supportive treatment is recommended. Animal studies suggest that no effects other than those related directly ...

Pharmacodynamic properties

Pharmacotherapeutic group: Endocrine therapy, Antiestrogens ATC code: L02BA03 Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity ...

Pharmacokinetic properties

Absorption After administration of Faslodex long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (C<sub>max</sub>) are reached after about 5 days. Administration ...

Preclinical safety data

The acute toxicity of fulvestrant is low. Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies. Local reactions, including myositis and granulomata ...

List of excipients

Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil refined

Incompatibilities

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

Shelf life

Shelf life: 4 years.

Special precautions for storage

Store and transport in a refrigerator (2°C-8°C). Temperature excursions outside 2°C-8°C should be limited. This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28 day period ...

Nature and contents of container

The pre-filled syringe presentation consists of: One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml Faslodex solution for injection. ...

Special precautions for disposal and other handling

Instructions for administration Administer the injection according to the local guidelines for performing large volume intramuscular injections. NOTE: Due to the proximity of the underlying sciatic nerve, ...

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization number(s)

EU/1/03/269/001 EU/1/03/269/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009

Πηγαίο έγγραφο

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