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ALECENSA Hard capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Alecensa 150 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib. Excipients with known effect: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate). ...

Pharmaceutical form

Hard capsule. White hard capsule of 19.2 mm length, with ALE printed in black ink on the cap and 150 mg printed in black ink on the body.

Therapeutic indications

Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Alecensa as monotherapy is ...

Posology and method of administration

Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. A validated ALK assay is necessary for the selection of ALK-positive NSCLC ...

Contraindications

Hypersensitivity to alectinib or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Interstitial lung disease (ILD)/pneumonitis Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8). Patients should be monitored for pulmonary symptoms indicative ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on alectinib Based on in vitro data, CYP3A4 is the primary enzyme mediating the metabolism of both alectinib and its major active metabolite M4, and CYP3A contributes ...

Fertility, pregnancy and lactation

Women of childbearing potential/contraception Women of childbearing potential must be advised to avoid pregnancy while on Alecensa. Female patients of child-bearing potential receiving Alecensa must use ...

Effects on ability to drive and use machines

Alecensa has minor influence on the ability to drive and use machines. Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, ...

Undesirable effects

Summary of the safety profile The data described below reflect exposure to Alecensa in 405 patients with ALK-positive advanced NSCLC who participated in one randomised Phase III clinical trial (BO28984) ...

Overdose

Patients who experience overdose should be closely supervised and general supportive care instituted. There is no specific antidote for overdose with Alecensa.

Pharmacodynamic properties

Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor ATC code: L01XE36 Mechanism of action Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor. In preclinical ...

Pharmacokinetic properties

The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects. Based on population pharmacokinetic analysis, ...

Preclinical safety data

Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of Alecensa. Mutagenicity Alectinib was not mutagenic in vitro in the bacterial reverse mutation ...

List of excipients

__Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium Capsule shell: Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Blisters: Store in the original package in order to protect from moisture. Bottles: Store in the original package and keep the bottle tightly closed in order to protect from moisture.

Nature and contents of container

Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules. Pack size: 224 (4 packs of 56) hard capsules. HDPE bottle with a child-resistant closure and an integrated desiccant. Pack size: ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization number(s)

EU/1/16/1169/001 EU/1/16/1169/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 February 2017 Date of latest renewal: 1 December 2017

Πηγαίο έγγραφο

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