IMBRUVICA Hard capsule (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
IMBRUVICA 140 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 140 mg of ibrutinib. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule (capsule). White opaque, hard capsule of 22 mm in length, marked with ibr 140 mg in black ink.
Therapeutic indications
IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). IMBRUVICA as a single agent or in combination with obinutuzumab is indicated ...
Posology and method of administration
Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology MCL The recommended dose for the treatment of MCL ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use of preparations containing St. Johns Wort is contraindicated in patients treated with IMBRUVICA.
Special warnings and precautions for use
Bleeding-related events There have been reports of bleeding events in patients treated with IMBRUVICA, both with and without thrombocytopenia. These include minor bleeding events such as contusion, epistaxis, ...
Interaction with other medicinal products and other forms of interaction
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4). Agents that may increase ibrutinib plasma concentrations Concomitant use of IMBRUVICA and medicinal products that strongly or ...
Fertility, pregnancy and lactation
Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women. Women should avoid becoming pregnant while taking ...
Effects on ability to drive and use machines
IMBRUVICA has minor influence on the ability to drive and use machines. Fatigue, dizziness and asthenia have been reported in some patients taking IMBRUVICA and should be considered when assessing a patient ...
Undesirable effects
Summary of the safety profile The safety profile is based on pooled data from 1200 patients treated with IMBRUVICA in three phase 2 clinical studies and six randomised phase 3 studies and from post-marketing ...
Overdose
There are limited data on the effects of IMBRUVICA overdose. No maximum tolerated dose was reached in the phase 1 study in which patients received up to 12.5 mg/kg/day (1,400 mg/day). In a separate study, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE27 Mechanism of action Ibrutinib is a potent, small-molecule inhibitor of Brutons tyrosine kinase (BTK). Ibrutinib ...
Pharmacokinetic properties
Absorption Ibrutinib is rapidly absorbed after oral administration with a median T<sub>max</sub> of 1 to 2 hours. Absolute bioavailability in fasted condition (n=8) was 2.9% (90% CI = 2.1–3.9) and doubled ...
Preclinical safety data
The following adverse effects were seen in studies of 13-weeks duration in rats and dogs. Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid ...
List of excipients
Capsule content: Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487) Capsule shell: Gelatin Titanium dioxide (E171) Printing ink: Shellac Black iron oxide (E172) ...
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
HDPE bottles with a child-resistant polypropylene closure. Each carton contains one bottle of either 90 or 120 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.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Marketing authorization number(s)
EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 October 2014 Date of latest renewal: 25 June 2019
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