KYMRIAH Dispersion for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Kymriah 1.2 10<sup>6</sup> – 6 10<sup>8</sup> cells dispersion for infusion.
Qualitative and quantitative composition
Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR). Each ethylene ...
Pharmaceutical form
Dispersion for infusion. A colourless to slightly yellow dispersion.
Therapeutic indications
Kymriah is indicated for the treatment of: Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in ...
Posology and method of administration
Kymriah must be administered in a qualified treatment centre. Therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindications of the lymphodepleting chemotherapy must be considered.
Special warnings and precautions for use
Reasons to delay treatment Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially ...
Interaction with other medicinal products and other forms of interaction
No pharmacokinetic or pharmacodynamic drug interaction studies with tisagenlecleucel have been performed. The co-administration of agents known to inhibit T-cell function has not been formally studied. ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Pregnancy status for females of child-bearing age should be verified prior to starting treatment with Kymriah. See the prescribing information ...
Effects on ability to drive and use machines
Kymriah has major influence on the ability to drive and use machines. Due to the potential for neurological events, including altered mental status or seizures, patients receiving Kymriah are at risk for ...
Undesirable effects
Summary of the safety profile B-cell ALL The most common non-haematological adverse reactions were cytokine release syndrome (77%), infections (65%), hypogammaglobulinaemia (47%), pyrexia (40%) and decreased ...
Overdose
Not applicable.
Pharmacodynamic properties
Pharmacotherapeutic group: other antineoplastic agents ATC code: not yet assigned Mechanism of action Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient ...
Pharmacokinetic properties
Following infusion of Kymriah into paediatric and young adult r/r B-cell ALL and r/r DLBCL patients, Kymriah typically exhibited an initial rapid expansion followed by a slower bi-exponential decline. ...
Preclinical safety data
Non-clinical safety assessment of Kymriah addressed the safety concerns of potential uncontrolled cell growth of transduced T cells in vitro and in vivo as well as dose-related toxicity, biodistribution ...
List of excipients
Glucose Sodium chloride Human albumin solution Dextran 40 for injection Dimethylsulfoxide Sodium gluconate Sodium acetate Potassium chloride Magnesium chloride Sodium-N-acetyltryptophanate Sodium caprylate ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 9 months. The product should be administered immediately after thawing. After thawing, the product should be kept at room temperature (20°C-25°C) and infused within 30 minutes to maintain maximum ...
Special precautions for storage
Store and transport below -120°C, e.g. in a container for cryogenic storage (Dewar) in the vapour phase of liquid nitrogen. Store in the original protective envelope (Tyvek) containing the cassette protecting ...
Nature and contents of container
Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10–30 mL (50 mL bags) or 30–50 mL (250 mL bags) ...
Special precautions for disposal and other handling
Inspection and thawing of the infusion bag(s) Do not thaw the product until it is ready to be used. The infusion bag should be placed inside a second, sterile bag during thawing to protect ports from contamination ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/18/1297/001
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