LIBTAYO Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
LIBTAYO 350 mg concentrate for solution for infusion.
Qualitative and quantitative composition
One ml of concentrate contains 50 mg of cemiplimab. Each vial contains 350 mg of cemiplimab in 7 ml of solution. Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg. The solution may ...
Therapeutic indications
LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. ...
Posology and method of administration
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. Posology Recommended dose The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Immune-related adverse reactions ...
Interaction with other medicinal products and other forms of interaction
No pharmacokinetic drug-drug interaction studies have been conducted with cemiplimab. The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for physiological doses ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose of cemiplimab. Pregnancy ...
Effects on ability to drive and use machines
Cemiplimab has no or negligible influence on the ability to drive and use machines. Fatigue has been reported following treatment with cemiplimab (see section 4.8).
Undesirable effects
Summary of the safety profile Immune-related adverse reactions can occur with cemiplimab. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal ...
Overdose
In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: not yet assigned Mechanism of action Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds ...
Pharmacokinetic properties
Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab. At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 ...
Preclinical safety data
No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity. Animal reproduction studies have not been conducted with cemiplimab (see section 4.6). As reported ...
List of excipients
L-histidine L-histidine monohydrochloride monohydrate Sucrose L-proline Polysorbate 80 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 30 months. After opening: Once opened, the medicinal product should be diluted and infused immediately. After preparation of infusion: Once prepared, administer the diluted solution ...
Special precautions for storage
Unopened vial: Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original carton in order to protect from light. For storage conditions after first opening or dilution of the medicinal ...
Nature and contents of container
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button. Each carton contains 1 vial.
Special precautions for disposal and other handling
Preparation and administration: Visually inspect medicinal product for particulate matter and discoloration prior to administration. LIBTAYO is a clear to slightly opalescent, colourless to pale yellow ...
Marketing authorization holder
Regeneron Ireland Designated Activity Company (DAC), Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland
Marketing authorization number(s)
EU/1/19/1376/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 June 2019
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