Zynlonta

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

loncastuximab tesirine

Beschikbaar vanaf:

Swedish Orphan Biovitrum AB

ATC-code:

L01FX22

INN (Algemene Internationale Benaming):

loncastuximab tesirine

Therapeutische categorie:

Antineoplastic agents

Therapeutisch gebied:

Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell

therapeutische indicaties:

Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

Product samenvatting:

Revision: 2

Autorisatie-status:

Authorised

Autorisatie datum:

2022-12-20

Bijsluiter

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B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYNLONTA 10 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
loncastuximab tesirine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zynlonta is and what it is used for
2.
What you need to know before you are given Zynlonta
3.
How you are given Zynlonta
4.
Possible side effects
5.
How to store Zynlonta
6.
Contents of the pack and other information
1.
WHAT ZYNLONTA IS AND WHAT IT IS USED FOR
Zynlonta is a cancer medicine that contains the active substance
loncastuximab tesirine.
Zynlonta is used to treat adults with a certain type of cancer called
DIFFUSE LARGE B-CELL LYMPHOMA
(DLBCL) that:
•
has come back (relapsed) after two or more treatments, or that
•
did not respond to previous treatment (refractory).
Diffuse large B-cell lymphoma is a cancer that develops from a type of
white blood cell called
B-lymphocyte (also called B-cell).
Talk to your doctor or nurse if you have any questions about how
Zynlonta works or why this
medicine has been prescribed for you.
HOW DOES ZYNLONTA WORK?
Loncastuximab tesirine consist of 2 parts; an antibody (a type of
protein designed to recognize and
attach to a specific target) and a cytotoxic agent (a medicine able to
kill cells, including cancer cells).
The antibody in this medicine is designed to attach to CD19, a protein
that is found

Productkenmerken

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zynlonta 10 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for solution for infusion contains
10 mg of loncastuximab tesirine.
After reconstitution, each mL contains 5 mg of loncastuximab tesirine.
Loncastuximab 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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white lyophilised powder, which has a cake-like
appearance.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zynlonta as monotherapy is indicated for the treatment of adult
patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma
(HGBL), after two or more
lines of systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zynlonta must only be administered under the supervision of a
healthcare professional experienced in
the diagnosis and treatment of cancer patients.
Posology
The recommended dose of Zynlonta is 0.15 mg/kg every 21 days for 2
cycles, followed by
0.075 mg/kg every 21 days for subsequent cycles until disease
progression or unacceptable toxicity.
_ _
_Premedication with dexame