JAKAVI Tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Jakavi 5 mg tablets. Jakavi 10 mg tablets. Jakavi 15 mg tablets. Jakavi 20 mg tablets.
Qualitative and quantitative composition
Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate). Excipient with known effect: Each tablet contains 71.45 mg lactose monohydrate. Jakavi 10 mg tablets Each tablet contains 10 mg ...
Pharmaceutical form
Tablet. <u>Jakavi 5 mg tablets:</u> Round curved white to almost white tablets of approximately 7.5 mm in diameter with NVR debossed on one side and L5 debossed on the other side. <u>Jakavi 10 mg tablets: ...
Therapeutic indications
Myelofibrosis (MF) Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post ...
Posology and method of administration
Jakavi treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. A complete blood cell count, including a white blood cell count differential, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and lactation.
Special warnings and precautions for use
Myelosuppression Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia. A complete blood count, including a white blood cell count differential, ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9. Thus, medicinal products inhibiting these enzymes can give rise to increased ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Jakavi in pregnant women. Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic. Teratogenicity was not observed in rats or rabbits. However, ...
Effects on ability to drive and use machines
Jakavi has no or negligible sedating effect. However, patients who experience dizziness after the intake of Jakavi should refrain from driving or using machines.
Undesirable effects
Summary of the safety profile Myelofibrosis The most frequently reported adverse drug reactions were thrombocytopenia and anaemia. Haematological adverse drug reactions (any Common Terminology Criteria ...
Overdose
There is no known antidote for overdoses with Jakavi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, protein kinase inhibitors <b>ATC code:</b> L01XE18 Mechanism of action Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) ...
Pharmacokinetic properties
Absorption Ruxolitinib is a Biopharmaceutical Classification System (BCS) class 1 compound, with high permeability, high solubility and rapid dissolution characteristics. In clinical studies, ruxolitinib ...
Preclinical safety data
Ruxolitinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study. Target organs associated with the pharmacological ...
List of excipients
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30 Hydroxypropylcellulose 300 to 600 cps Lactose monohydrate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets. Not all pack sizes or types may be marketed.
Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
Jakavi 5 mg tablets: EU/1/12/773/004-006 Jakavi 10 mg tablets: EU/1/12/773/014-016 Jakavi 15 mg tablets: EU/1/12/773/007-009 Jakavi 20 mg tablets: EU/1/12/773/010-012
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 August 2012 Date of latest renewal: 24 April 2017
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