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SPC: TAGRISSO Film-coated tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

TAGRISSO 40 mg film-coated tablets. TAGRISSO 80 mg film-coated tablets.

Qualitative and quantitative composition

TAGRISSO 40 mg tablets: Each tablet contains 40 mg osimertinib (as mesylate). TAGRISSO 80 mg tablets: Each tablet contains 80 mg osimertinib (as mesylate). Excipient with known effect: This medicine contains ...

Pharmaceutical form

Film-coated tablet (tablet). TAGRISSO 40 mg tablets: Beige, 9 mm, round, biconvex tablet, debossed with AZ and 40 on one side and plain on the reverse. TAGRISSO 80 mg tablets: Beige, 7.25 14.5 mm, oval, ...

Therapeutic indications

TAGRISSO as monotherapy is indicated for: the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor ...

Posology and method of administration

Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies. When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens should ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. St. Johns Wort should not be used together with TAGRISSO (see section 4.5).

Special warnings and precautions for use

Assessment of EGFR mutation status When considering the use of TAGRISSO as a treatment for locally advanced or metastatic NSCLC, it is important that the EGFR mutation positive status is determined. A ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions Strong CYP3A4 inducers can decrease the exposure of osimertinib. Osimertinib may increase the exposure of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates. ...

Pregnancy and lactation

Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO. Patients should be advised to use effective contraception for the ...

Effects on ability to drive and use machines

TAGRISSO has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Studies in EGFR mutation-positive NSCLC patients The data described below reflect exposure to TAGRISSO in 1142 patients with EGFR mutationpositive non-small cell lung cancer. ...

Overdose

In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities. In these studies, patients who were treated with TAGRISSO daily ...

Pharmacodynamic properties

Mechanism of action Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance ...

Pharmacokinetic properties

Osimertinib pharmacokinetic parameters have been characterised in healthy subjects and NSCLC patients. Based on population pharmacokinetic analysis, osimertinib apparent plasma clearance is 14.3 L/h, apparent ...

Preclinical safety data

The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea (accompanied by corneal translucencies ...

List of excipients

Tablet core: Mannitol Microcrystalline cellulose Low-substituted hydroxypropyl cellulose Sodium stearyl fumarate Tablet coating: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Yellow iron ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Al/Al perforated unit dose blisters. Cartons of 30 1 tablets (3 blisters). Al/Al perforated unit dose blisters. Cartons of 28 1 tablets (4 blisters). Not all pack sizes may be marketed.

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

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization number(s)

EU/1/16/1086/001 EU/1/16/1086/002 EU/1/16/1086/003 EU/1/16/1086/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016

Πηγαίο έγγραφο

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