ZYKADIA Hard capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zykadia 150 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 150 mg ceritinib. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Capsule with white opaque body and blue opaque cap, with LDK 150MG imprinted on the cap and NVR on the body, containing white to almost white powder.
Therapeutic indications
Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Zykadia as monotherapy is ...
Posology and method of administration
Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. ALK testing An accurate and validated ALK assay is necessary for the selection ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hepatotoxicity Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies. Increases to grade 3 or 4 ALT elevations were observed in 25% of patients. The majority of cases ...
Interaction with other medicinal products and other forms of interaction
Agents that may increase ceritinib plasma concentrations Strong CYP3A inhibitors In healthy subjects, co-administration of a single 450 mg fasted ceritinib dose with ketoconazole (200 mg twice daily for ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should be advised to use a highly effective method of contraception while taking Zykadia and for up to 3 months after discontinuing treatment ...
Effects on ability to drive and use machines
Zykadia has minor influence on the ability to drive or use machines. Caution should be exercised when driving or using machines during treatment as patients may experience fatigue or vision disorders. ...
Undesirable effects
Summary of the safety profile Adverse drug reactions (ADRs) described below reflect exposure to Zykadia 750 mg once daily fasted in 925 patients with ALK-positive advanced NSCLC across a pool of seven ...
Overdose
There is no reported experience with overdose in humans. General supportive measures should be initiated in all cases of overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplasic and immunomodulating agents ATC code: L01XE28 Mechanism of action Ceritinib is an orally highly selective and potent ALK inhibitor. Ceritinib inhibits autophosphorylation ...
Pharmacokinetic properties
Absorption Peak plasma levels (C<sub>max</sub>) of ceritinib are achieved approximately 4 to 6 hours after a single oral administration in patients. Oral absorption was estimated to be ≥25% based on metabolite ...
Preclinical safety data
Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems. In vitro data show that the IC50 for the inhibitory effect ...
List of excipients
Capsule content: Microcrystalline cellulose Low substituted-hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate Silica, colloidal anhydrous Capsule shell: Gelatin Indigotine (E132) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters containing 10 hard capsules. Packs containing 40, 90 or 150 (3 packs of 50) 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
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/15/999/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 06 May 2015 Date of latest renewal: 22 March 2017
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