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LORVIQUA Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lorviqua 25 mg film-coated tablets. Lorviqua 100 mg film-coated tablets.

Qualitative and quantitative composition

Lorviqua 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of lorlatinib. Excipient with known effect: Each film-coated tablet contains 1.58 mg of lactose monohydrate. Lorviqua 100 mg film-coated ...

Pharmaceutical form

Film-coated tablet (tablet). Lorviqua 25 mg film-coated tablets: Round (8 mm) light pink immediate release film-coated tablet, debossed with Pfizer on one side and 25 and LLN on the other side. Lorviqua ...

Therapeutic indications

Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after: ...

Posology and method of administration

Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended dose is 100 mg lorlatinib taken orally once ...

Contraindications

Hypersensitivity to lorlatinib or to any of the excipients listed in section 6.1. Concomitant use of strong CYP3A4/5 inducers (see sections 4.4 and 4.5).

Special warnings and precautions for use

Hyperlipidaemia The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see section 4.8). Median time of occurrence of severe increase in serum cholesterol and ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions In vitro data indicate that lorlatinib is primarily metabolised by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving lorlatinib. A highly effective non-hormonal ...

Effects on ability to drive and use machines

Lorlatinib has moderate influence on the ability to drive and use machines. Caution should be exercised when driving or operating machines as patients may experience CNS effects (see section 4.8).

Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive ...

Overdose

Treatment of overdose with the medicinal product consists of general supportive measures. Given the dose-dependent effect on PR interval, ECG monitoring is recommended. There is no antidote for lorlatinib. ...

Pharmacodynamic properties

Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors ATC code: L01XE44 Mechanism of action Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and ...

Pharmacokinetic properties

Absorption Peak lorlatinib concentrations in plasma are rapidly reached with the median T<sub>max</sub> of 1.2 hours following a single 100 mg dose and 2.0 hours following multiple dosing of 100 mg once ...

Preclinical safety data

Repeat-dose toxicity The main toxicities observed were inflammation across multiple tissues (skin and cervix of rats and lung, trachea, skin, lymph nodes and/or the oral cavity including mandibular bone ...

List of excipients

Tablet core: Microcrystalline cellulose Calcium hydrogen phosphate Sodium starch glycolate Magnesium stearate Film-coating: Hypromellose Lactose monohydrate Macrogol Triacetin Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets. Lorviqua 25 mg film-coated tablets: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets ...

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

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization number(s)

EU/1/19/1355/001 EU/1/19/1355/002 EU/1/19/1355/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 6 May 2019

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