LENVIMA Hard capsule (2019)
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Περιεχόμενα
Name of the medicinal product
LENVIMA 4 mg hard capsules. LENVIMA 10 mg hard capsules.
Qualitative and quantitative composition
LENVIMA 4 mg hard capsules: Each hard capsule contains 4 mg of lenvatinib (as mesylate). LENVIMA 10 mg hard capsules: Each hard capsule contains 10 mg of lenvatinib (as mesylate). For the full list of ...
Pharmaceutical form
Hard capsule. LENVIMA 4 mg hard capsules: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with Є on the cap, and LENV 4 mg on the body. LENVIMA 10 mg hard ...
Therapeutic indications
LENVIMA is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory ...
Posology and method of administration
LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies. If a patient misses a dose, and it cannot be taken within 12 hours, then ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
Special warnings and precautions for use
Hypertension Hypertension has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions). Blood pressure ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on lenvatinib Chemotherapeutic agents Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of ...
Pregnancy and lactation
Women of childbearing potential Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least one month after ...
Effects on ability to drive and use machines
Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness. Patients who experience these symptoms should use caution when driving ...
Undesirable effects
Summary of the safety profile The safety profile of lenvatinib is based on data from 452 DTC patients and 496 HCC patients; allowing characterisation only of common adverse drug reactions in DTC and HCC ...
Overdose
The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day. Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials. The most frequently ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors ATC code: L01XE29 Lenvatinib is a multikinase inhibitor which has shown mainly antiangiogenic properties in vitro and in vivo, ...
Pharmacokinetic properties
Pharmacokinetic parameters of lenvatinib have been studied in healthy adult subjects, adult subjects with hepatic impairment, renal impairment, and solid tumours. Absorption Lenvatinib is rapidly absorbed ...
Preclinical safety data
In the repeated-dose toxicity studies (up to 39 weeks), lenvatinib caused toxicologic changes in various organs and tissues related to the expected pharmacologic effects of lenvatinib including glomerulopathy, ...
List of excipients
Capsule contents: Calcium carbonate Mannitol Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc Capsule shell: Hypromellose Titanium dioxide (E171) Yellow iron ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Do not store above 25°C. Store in the original blister in order to protect from moisture.
Nature and contents of container
Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules. Each carton contains 30 ,60,or 90 hard capsules. 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. Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of ...
Marketing authorization holder
Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
Marketing authorization number(s)
Lenvima 4mg hard capsules: EU/1/15/1002/001 EU/1/15/1002/003 EU/1/15/1002/004 Lenvima 10 mg hard capsules: EU/1/15/1002/002 EU/1/15/1002/005 EU/1/15/1002/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 May 2015
Date of revision of the text
18<sup>th</sup> September 2019
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