STIVARGA Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Stivarga 40 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 40 mg of regorafenib. Excipients with known effect: Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium (see section 4.4). Each daily dose of 160 mg contains ...
Pharmaceutical form
Film-coated tablet. Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with BAYER on one side and 40 on the other side.
Therapeutic indications
Stivarga is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. ...
Posology and method of administration
Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy. Posology The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hepatic effects Abnormalities of liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with Stivarga. Severe ...
Interaction with other medicinal products and other forms of interaction
Inhibitors of CYP3A4 and UGT1A9 / inducers of CYP3A4 In vitro data indicate that regorafenib is metabolized by cytochrome CYP3A4 and uridine diphosphate glucuronosyl transferase UGT1A9. Administration ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing potential must be informed that regorafenib may cause foetal harm. Women of childbearing potential and men should ...
Effects on ability to drive and use machines
No studies on the effects of Stivarga on the ability to drive or use machines have been performed. If patients experience symptoms affecting their ability to concentrate and react during treatment with ...
Undesirable effects
Summary of the safety profile The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients ...
Overdose
The highest dose of Stivarga studied clinically was 220 mg per day. The most frequently observed adverse drug reactions at this dose were dermatological events, dysphonia, diarrhoea, mucosal inflammation, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21 Mechanism of action and pharmacodynamic effects Regorafenib is an oral tumour deactivation agent that potently ...
Pharmacokinetic properties
Absorption Regorafenib reaches mean peak plasma levels of about 2.5 mg/l at about 3 to 4 hours after a single oral dose of 160 mg given as 4 tablets each containing 40 mg. Following single doses of 60 ...
Preclinical safety data
Systemic toxicity After repeated dosing to mice, rats and dogs, adverse effects were observed in a number of organs, primarily in the kidneys, liver, digestive tract, thyroid gland, lympho-/haematopoietic ...
List of excipients
Tablet core: Cellulose microcrystalline Croscarmellose sodium Magnesium stearate Povidone (K-25) Silica, colloidal anhydrous Film coat: Iron oxide red (E172) Iron oxide yellow (E172) Lecithin (derived ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Once the bottle is opened the medicinal product has shown to be stable for 7 weeks. Thereafter, the medicinal product is to be discarded.
Special precautions for storage
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Nature and contents of container
White opaque HDPE bottle closed with a PP/PP (polypropylene) screw cap with sealing insert and a molecular sieve desiccant. Each bottle contains 28 film-coated tablets. Pack sizes: Pack of 28 film-coated ...
Special precautions for disposal and other handling
Keep the desiccant in the bottle. This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local ...
Marketing authorization holder
Bayer AG, 51368 Leverkusen, Germany
Marketing authorization number(s)
EU/1/13/858/001 EU/1/13/858/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
