LARTRUVO Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Lartruvo 10 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
One mL of concentrate for solution for infusion contains 10 mg of olaratumab. Each 19 mL vial contains 190 mg of olaratumab. Each 50 mL vial contains 500 mg of olaratumab. Olaratumab is a human IgG1 monoclonal ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is clear to slightly opalescent and colourless to slightly yellow solution without visible particles.
Therapeutic indications
Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who ...
Posology and method of administration
Olaratumab therapy must be initiated and supervised by physicians experienced in oncology. Patients should be monitored during the infusion for signs and symptoms of infusion-related reactions (IRRs) in ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Infusion-related reactions Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab. The majority of these reactions occurred during or following ...
Interaction with other medicinal products and other forms of interaction
Olaratumab is a human monoclonal antibody. In a dedicated DDI study, no pharmacokinetic interactions were observed in patients between olaratumab and doxorubicin. No other formal DDI studies with olaratumab ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on olaratumab and should be informed of the potential hazard ...
Effects on ability to drive and use machines
Olaratumab may have minor influence on the ability to drive and use machines. Due to frequent occurrence of fatigue, patients should be advised to use caution when driving or operating machinery.
Undesirable effects
Summary of the safety profile Olaratumab-treated patients from Phase 2 study In the olaratumab plus doxorubicin arm, the most serious (Grade ≥3) adverse drug reactions (ADRs) observed were neutropenia ...
Overdose
There is no experience with Lartruvo overdose in human clinical trials. Lartruvo has been administered in a Phase 1 study up to 20 mg/kg on days 1 and 8 of a 21 day cycle without reaching a maximum tolerated ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC27 Mechanism of action Olaratumab is an antagonist of platelet derived growth factor receptor-α (PDGFR-α), expressed ...
Pharmacokinetic properties
Absorption Olaratumab is administered as an intravenous infusion only. Distribution The population pharmacokinetic (PopPK) model-based mean (CV%) volume of distribution of olaratumab at steady state (Vss) ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on repeat dose toxicity studies in monkeys. No animal studies have been performed to test olaratumab for potential of carcinogenicity, genotoxicity, ...
List of excipients
Mannitol (E421) Glycine (E640) Sodium chloride L-Histidine monohydrochloride monohydrate L-Histidine Polysorbate 20 (E432) Water for injections
Incompatibilities
The medicinal product should not be administered or mixed with dextrose containing solutions.
Shelf life
Unopened vial: 2 years. After dilution: This product is preservative free. From a microbiological point of view the prepared dosing solution should be used immediately. If not used immediately, the dosing ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
19 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, an aluminium seal and a polypropylene cap. 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomeric stopper, ...
Special precautions for disposal and other handling
The infusion solution should be prepared using aseptic technique to ensure the sterility of the prepared solution. Each vial is intended for single use only. Do not shake the vial. The content of the vials ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/16/1143/001-003
Date of first authorization / renewal of the authorization
Date of first authorisation: 9 November 2016 Date of latest renewal: 21 September 2017
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