EMPLICITI Powder for concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Empliciti 300 mg powder for concentrate for solution for infusion. Empliciti 400 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Empliciti 300 mg powder for concentrate for solution for infusion: Each vial contains 300 mg elotuzumab*. Empliciti 400 mg powder for concentrate for solution for infusion: Each vial contains 400 mg elotuzumab. ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). The powder is white to off white whole or fragmented cake.
Therapeutic indications
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1). ...
Posology and method of administration
Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. Premedication for prevention of infusion reaction Patients must be administered with ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The Summary of Product Characteristics for all medicinal products used in combination with Empliciti must be ...
Special warnings and precautions for use
Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8). Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and paracetamol must be administered ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interaction studies have not been conducted. Empliciti, as a humanised monoclonal antibody, is not expected to be metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising ...
Fertility, pregnancy and lactation
Woman of childbearing potential/Contraception in the males and females Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with ...
Effects on ability to drive and use machines
On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines. Patients experiencing infusion reactions should be advised not to drive and use ...
Undesirable effects
Summary of safety profile The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone ...
Overdose
One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone. The patient had no symptoms, did not require any treatment for the overdose, and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC23 Mechanism of action Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets ...
Pharmacokinetic properties
The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma. Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg. Absorption Elotuzumab ...
Preclinical safety data
Elotuzumab only recognizes human SLAMF7 protein. Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant. In the same line, no carcinogenicity ...
List of excipients
Sucrose Sodium citrate Citric acid monohydrate Polysorbate 80
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Unopened vial: 3 years. After reconstitution and dilution: The reconstituted solution should be transferred from the vial into the infusion bag immediately. Chemical and physical in use stability ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. For storage conditions after reconstitution or dilution of the medicinal product, see section ...
Nature and contents of container
20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab. The flip-off seal button ...
Special precautions for disposal and other handling
Calculating the dose Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on patient weight. More than one vial of Empliciti may be needed to give ...
Marketing authorization holder
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/16/1088/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 May 2016
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