CABOMETYX Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
CABOMETYX 20 mg film-coated tablets. CABOMETYX 40 mg film-coated tablets. CABOMETYX 60 mg film-coated tablets.
Qualitative and quantitative composition
CABOMETYX 20 mg film-coated tablets: Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib. Excipients with known effect: Each film-coated tablet contains 15.54 mg lactose. ...
Pharmaceutical form
Film-coated tablet. CABOMETYX 20 mg film-coated tablets: The tablets are yellow round with no score, and debossed with XL on one side and 20 on the other side of the tablet. CABOMETYX 40 mg film-coated ...
Therapeutic indications
Renal Cell Carcinoma (RCC) CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): in treatment-naïve adults with intermediate or poor risk (see section 5.1) in adults following ...
Posology and method of administration
Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products. Posology CABOMETYX (cabozantinib) tablets and COMETRIQ (cabozantinib) capsules ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
As most events occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted. Events ...
Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on cabozantinib CYP3A4 inhibitors and inducers Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential must be advised to avoid pregnancy while on cabozantinib. Female partners of male patients taking cabozantinib ...
Effects on ability to drive and use machines
Cabozantinib has minor influence on the ability to drive and use machines. Adverse reactions such as fatigue and weakness have been associated with cabozantinib. Therefore, caution should be recommended ...
Undesirable effects
Summary of safety profile The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, ...
Overdose
There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established. In the event of suspected overdose, cabozantinib should be withheld and supportive ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC code: L01XE26 Mechanism of action Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) ...
Pharmacokinetic properties
Absorption Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 3 to 4 hours post-dose. Plasma-concentration time profiles show a second absorption peak ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: In rat and dog ...
List of excipients
Tablet content: Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Film-coating: Hypromellose 2910 Titanium dioxide ...
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
PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets. Each carton contains 4 blisters with 28 film-coated tablets. HDPE bottle with a polypropylene child-resistant ...
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
Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France
Marketing authorization number(s)
Cabometyx 20 mg film-coated tablets: EU/1/16/1136/001 EU/1/16/1136/002 Cabometyx 40 mg film-coated tablets: EU/1/16/1136/003 EU/1/16/1136/004 Cabometyx 60 mg film-coated tablets: EU/1/16/1136/005 EU/1/16/1136/006 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 September 2016
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