Loncastuximab tesirine

Therapeutic Loncastuximab tesirine ADC from the original Zynlonta® commercial drug.

Reference Standard as Aliquots

Zynlonta®
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2026.04
Zynlonta®
DE
1.392,00 /mg
Max: 16
Min: 1
Step: 1
mg

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Product Information

Here you will find the product information for the reference product.

Zynlonta® / Loncastuximab tesirine Reference Product

Drug nameZynlonta®
INNLoncastuximab tesirine
API typeLoncastuximab tesirine is a CD19-directed antibody and alkylating agent conjugate, consisting of a
humanised IgG1 kappa monoclonal antibody, produced in Chinese Hamster Ovary cells by
recombinant DNA technology, and conjugated to SG3199, a pyrrolobenzodiazepine (PBD) dimer
cytotoxic alkylating agent, through a protease-cleavable valine-alanine linker. SG3199 attached to the
linker is designated as SG3249, also known as tesirine.
Pharmacotherapeutic group
Antineoplastic and immunomodulating agents, antineoplastic agents,
monoclonal antibodies and antibody drug conjugates, other monoclonal antibodies and antibody drug
conjugates
ATC code
L01FX22
Target of antibody
CD19
General function
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Loncastuximab tesirine is an antibody-drug conjugate (ADC) targeting CD19. The monoclonal IgG1
kappa antibody component binds to human CD19, a transmembrane protein expressed on the surface
of cells of B-lineage origin. The small molecule component is SG3199, a PBD dimer and alkylating
agent.
Upon binding to CD19, loncastuximab tesirine is internalised followed by release of SG3199 via
proteolytic cleavage. The released SG3199 binds to the DNA minor groove and forms highly
cytotoxic DNA interstrand crosslinks, subsequently inducing cell death.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Higher loncastuximab tesirine exposure in Cycle 1 was associated with higher efficacy over the dose
range of 0.015-0.2 mg/kg (0.1 to 1.33 times the maximum recommended dose). Higher loncastuximab
tesirine exposure in Cycle 1 was associated with higher incidence of some Grade ≥2 adverse reactions,
including skin and nail reactions, liver function test abnormalities and increased γ-glutamyltransferase.
Original license holder
Marketing authorisation numbers
EU/1/22/1695/001
Marketing authorisation holder
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden
Name of the manufacturer of the biological active substance
BSP Pharmaceuticals S.p.A
Via Appia Km 65,561
04013 Latina Scalo (LT)
Italy
Name and address of the manufacturer(s) responsible for batch releaseSwedish Orphan Biovitrum AB (publ)
Strandbergsgatan 49
SE-112 51 Stockholm
Sweden
Max shelf life
Unopened vial
5 years
14
Reconstituted solution
From a microbiological point of view, the reconstituted solution should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the user
and should not be longer than 4 hours refrigerated (2℃ - 8℃) or 4 hours at room temperature
(20℃ - 25℃), unless reconstitution has taken place in controlled and validated aseptic conditions.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to
4 hours refrigerated (2℃ - 8℃) or 4 hours at room temperature (20℃ - 25℃).
Diluted solution
From a microbiological point of view, the prepared solution for infusion should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the
user and should not be longer than 24 hours refrigerated (2℃ - 8℃) or 8 hours at room temperature
(20℃ - 25℃), unless dilution has taken place in controlled and validated aseptic conditions. Chemical
and physical in-use stability of the prepared solution for infusion has been demonstrated for up to
24 hours at room temperature (20℃ - 25℃).
Do not use the medicinal product if the storage conditions exceed the limits.
Storage conditions
2°C – 8°C
List of excipients
L-histidine
L-histidine monohydrochloride
Polysorbate 20
Sucrose

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