YESCARTA Dispersion for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
YESCARTA 0.4 – 2 10<sup>8</sup> cells dispersion for infusion.
Qualitative and quantitative composition
YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, patients own T cells are harvested and genetically modified ex vivo by retroviral ...
Pharmaceutical form
Dispersion for infusion. A clear to opaque, white to red dispersion.
Therapeutic indications
YESCARTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines ...
Posology and method of administration
YESCARTA must be administered in a qualified clinical setting. YESCARTA 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
General Due to the risks associated with YESCARTA treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with YESCARTA. Live vaccines The safety of immunisation with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception The pregnancy status of women of child bearing potential must be verified before starting YESCARTA treatment. See the prescribing information for lymphodepleting ...
Effects on ability to drive and use machines
YESCARTA has major influence on the ability to drive and use machines. Due to the potential for neurologic events, including altered mental status or seizures, patients should refrain from driving or operating ...
Undesirable effects
Summary of the safety profile The safety data described in this section reflect exposure to YESCARTA in ZUMA-1, a Phase ½ study in which 108 patients with relapsed/refractory B-cell non-Hodgkin lymphoma ...
Overdose
There are no data regarding the signs of overdose with YESCARTA.
Pharmacodynamic properties
Pharmacotherapeutic group: Other antineoplastic agents ATC code: not yet assigned Mechanism of action YESCARTA, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells ...
Pharmacokinetic properties
Peak levels of anti-CD19 CAR T cells occurred within the first 8 to 15 days after YESCARTA infusion. The median peak level of anti-CD19 CAR T cells in the blood (C<sub>max</sub>) was 38.3 cells/μL (range: ...
Preclinical safety data
YESCARTA comprises engineered human T cells, therefore there are no representative in vitro assays, ex vivo models, or in vivo models that can accurately address the toxicological characteristics of the ...
List of excipients
Cryostor CS10 Sodium chloride Human albumin
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life YESCARTA is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤-150°C). The stability of YESCARTA upon completion of thawing is up to 3 hours at room temperature (20°C ...
Special precautions for storage
YESCARTA bags must be stored in the vapour phase of liquid nitrogen (≤ -150°C) and YESCARTA must remain frozen until the patient is ready for treatment to ensure viable live autologous cells are administered ...
Nature and contents of container
Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion. One cryostorage bag is individually packed in a shipping ...
Special precautions for disposal and other handling
Irradiation could lead to inactivation of the product. Precautions to be taken for the disposal of the medicinal product YESCARTA contains genetically modified human blood cells. Local biosafety guidelines ...
Marketing authorization holder
Kite Pharma EU B.V., Science Park 408, 1098 XH Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/18/1299/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 August 2018
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