JEMPERLI Concentrate for solution for infusion (2024)
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Περιεχόμενα
1. Name of the medicinal product
JEMPERLI 500 mg concentrate for solution for infusion.
2. Qualitative and quantitative composition
One vial of 10 mL concentrate for solution for infusion contains 500 mg of dostarlimab. Each mL of concentrate for solution for infusion contains 50 mg of dostarlimab. Dostarlimab is an anti-programmed ...
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent colourless to yellow solution, essentially free from visible particles. The concentrate for solution for infusion ...
4.1. Therapeutic indications
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or ...
4.2. Posology and method of administration
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The identification of dMMR/MSI-H tumour status should be determined using a validated testing method ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Immune-related adverse reactions ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Monoclonal antibodies (mAb) such as dostarlimab are not substrates for cytochrome P450 or active substance transporters. Dostarlimab is not a cytokine and is ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / Contraception There is a risk associated with the administration of dostarlimab to women of childbearing potential. Women of childbearing potential must use effective ...
4.7. Effects on ability to drive and use machines
JEMPERLI has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Dostarlimab is most commonly associated with immune-related adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate medical ...
4.9. Overdose
If overdose is suspected, the patient should be monitored for any signs or symptoms of adverse reactions or effects, and appropriate symptomatic treatment instituted.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-neoplastic agents, monoclonal antibodies and antibody drug conjugates <b>ATC code:</b> L01FF07 Mechanism of action Dostarlimab is a humanised mAb of the IgG4 isotype ...
5.2. Pharmacokinetic properties
The pharmacokinetics (PK) of dostarlimab were assessed as a monotherapy and when administered in combination with carboplatin and paclitaxel. Dostarlimab monotherapy or in combination with carboplatin ...
5.3. Preclinical safety data
Nonclinical data reveal no special hazard for humans based on repeat-dose toxicity studies of duration up to 3 months in the cynomolgus monkey. No studies have been performed to assess the potential of ...
6.1. List of excipients
Trisodium citrate dihydrate Citric acid monohydrate L-arginine hydrochloride Sodium chloride Polysorbate 80 Water for injection
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Unopened vial:</u> 30 months. <u>After dilution:</u> If not used immediately, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C and 6 hours at room temperature (up ...
6.4. 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 dilution of the medicinal product, see section 6.3.
6.5. Nature and contents of container
10 mL type I borosilicate clear glass vial, with a grey chlorobutyl elastomer stopper laminated with fluoropolymer, sealed with an aluminium flip-off cap containing 500 mg dostarlimab. Each carton contains ...
6.6. Special precautions for disposal and other handling
Preparation/dilution Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. JEMPERLI is a slightly opalescent colourless to yellow ...
7. Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
EU/1/21/1538/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 21 April 2021 Date of latest renewal: 15 February 2023
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