OFEV Soft capsule (2020)
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Περιεχόμενα
Name of the medicinal product
Ofev 100 mg soft capsules. Ofev 150 mg soft capsules.
Qualitative and quantitative composition
Ofev 100 mg soft capsules: One soft capsule contains 100 mg nintedanib (as esilate). Excipient with known effect: Each 100 mg soft capsule contains 1.2 mg of soya lecithin. Ofev 150 mg soft capsules: One ...
Pharmaceutical form
Soft capsule (capsule). Ofev 100 mg soft capsules: Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company ...
Therapeutic indications
Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Posology and method of administration
Treatment with Ofev should be initiated by physicians experienced in the diagnosis and treatment of IPF. Posology The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours ...
Contraindications
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Gastrointestinal disorders Diarrhoea In the INPULSIS trials (see section 5.1), diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with ...
Interaction with other medicinal products and other forms of interaction
P-glycoprotein (P-gp) intedanib is a substrate of P-gp (see section 5.2). Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception Nintedanib may cause foetal harm in humans (see section 5.3). Women of childbearing potential should be advised to avoid becoming pregnant while receiving ...
Effects on ability to drive and use machines
Ofev has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines during treatment with Ofev.
Undesirable effects
Summary of the safety profile Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomised, ...
Overdose
There is no specific antidote or treatment for Ofev overdose. Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days. Observed adverse reactions were consistent ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01XE31 Mechanism of action Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived ...
Pharmacokinetic properties
Absorption Nintedanib reached maximum plasma concentrations approximately 2-4 h after oral administration as soft gelatine capsule under fed conditions (range 0.5-8 h). The absolute bioavailability of ...
Preclinical safety data
General toxicology Single dose toxicity studies in rats and mice indicated a low acute toxic potential of nintedanib. In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal ...
List of excipients
Capsule content: Triglycerides, medium-chain Hard fat Lecithin (soya) (E322) Capsule shell: Gelatin Glycerol (85%) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Printing ink: ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Ofev 100 mg soft capsules: Ofev 100 mg soft capsules are available in the following pack-sizes: 30 1 soft capsules in Aluminium/aluminium perforated unit dose blisters 60 1 soft capsules in Aluminium/aluminium ...
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
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216, Ingelheim am Rhein, Germany
Marketing authorization number(s)
Ofev 100 mg soft capsules: EU/1/14/979/001 EU/1/14/979/002 Ofev 150 mg soft capsules: EU/1/14/979/003 EU/1/14/979/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 January 2015 Date of latest renewal: 23 September 2019
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