KISPLYX Hard capsule (2021)
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Περιεχόμενα
1. Name of the medicinal product
Kisplyx 4 mg hard capsules.
2. Qualitative and quantitative composition
<u>Kisplyx 4 mg hard capsules:</u> Each hard capsule contains 4 mg of lenvatinib (as mesilate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule. <u>Kisplyx 4 mg hard capsules:</u> 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.
4.1. Therapeutic indications
Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. ...
4.2. Posology and method of administration
Kisplyx treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies. Posology The recommended daily dose of lenvatinib is 18 mg (one 10 mg ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).
4.4. 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 ...
4.5. 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 ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/ Contraception in females Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for ...
4.7. Effects on ability to drive and use machines
Lenvatinib has 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 ...
4.8. Undesirable effects
Summary of the safety profile The safety profile of lenvatinib in combination with everolimus is based on data from 62 subjects, allowing characterisation only of common adverse drug reactions in RCC patients. ...
4.9. 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 also occurred in clinical trials. The most frequently ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antineoplastic agents, protein kinase inhibitors <b>ATC code:</b> L01EX08 Mechanism of action Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively ...
5.2. 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 ...
5.3. 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, ...
6.1. List of excipients
<u>Capsule contents:</u> Calcium carbonate Mannitol Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc <u>Capsule shell:</u> Hypromellose Titanium dioxide (E171) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original blister in order to protect from moisture.
6.5. 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.
6.6. Special precautions for disposal and other handling
Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule. Any unused medicinal product or waste material should be disposed of in accordance with local ...
7. Marketing authorization holder
Eisai Europe Limited, European Knowledge Centre, Mosquito Way, Hatfield, AL10 9SN, United Kingdom
8. Marketing authorization number(s)
PLGB 33967/0007
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 January 2021 Date of latest renewal: 01 September 2021
10. Date of revision of the text
09/2021
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