Tremelimumab AstraZeneca

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Tremelimumab

Διαθέσιμο από:

AstraZeneca AB

Φαρμακολογική κατηγορία (ATC):

L01FX20

INN (Διεθνής Όνομα):

tremelimumab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Carcinoma, Non-Small-Cell Lung

Θεραπευτικές ενδείξεις:

Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Περίληψη προϊόντος:

Revision: 1

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2023-02-20

Φύλλο οδηγιών χρήσης

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TREMELIMUMAB ASTRAZENECA 20 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
tremelimumab
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.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tremelimumab AstraZeneca is and what it is used for
2.
What you need to know before you are given Tremelimumab AstraZeneca
3.
How you are given Tremelimumab AstraZeneca
4.
Possible side effects
5.
How to store Tremelimumab AstraZeneca
6.
Contents of the pack and other information
1.
WHAT TREMELIMUMAB ASTRAZENECA IS AND WHAT IT IS USED FOR
Tremelimumab AstraZeneca is an anti-cancer medicine. It contains the
active substance
tremelimumab, which is a type of medicine called a _monoclonal
antibody._This medicine is designed to
recognise a specific target substance in the body. Tremelimumab
AstraZeneca works by helping your
immune system fight your cancer.
Tremelimumab AstraZeneca is used to treat a type of lung cancer
(advanced non-small cell lung
cancer) in adults. It will be used in combination with other
anti-cancer medicines (durvalumab and
chemotherapy).
As Tremelimumab AstraZeneca will be given in combination with other
anti-cancer medicines, it is
important that you also read the package leaflet for these other
medicines. If you have any questions
about how Tremelimumab AstraZeneca works or why this medicine has been
prescribed for you, ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TREMELIMUMAB ASTRAZENECA
YOU S

Αρχείο Π.Χ.Π.

1
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
Tremelimumab AstraZeneca
20 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 20 mg of
tremelimumab.
One vial of 1.25 ml of concentrate contains 25 mg of tremelimumab.
One vial of 15 ml of concentrate contains 300 mg of tremelimumab.
Tremelimumab is a human anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4)
immunoglobulin
G2 IgG2a monoclonal antibody produced in murine myeloma cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to slightly yellow solution,
free or practically free from visible
particles. The solution has a pH of approximately 5.5 and an
osmolality of approximately
285 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tremelimumab AstraZeneca in combination with durvalumab and
platinum-based chemotherapy is
indicated for the first-line treatment of adults with metastatic
non-small cell lung cancer (NSCLC)
with no sensitising EGFR mutations or ALK positive mutations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Tremelimumab AstraZeneca must be initiated and
supervised by a physician
experienced in the treatment of cancer.
Posology
The recommended dose of Tremelimumab AstraZeneca is presented in Table
1.
TABLE 1: RECOMMENDED DOSE OF TREMELIMUMAB ASTRAZENECA
INDICATION
RECOMMENDED
TREMELIMUMAB ASTRAZENECA
DOSE
DURATION OF THERAPY
Metastatic NSCLC
During platinum
chemotherapy:
75 mg
a
in combination with
durvalumab 1 500 mg
b
and
Up to a maximum of 5 doses.
Patients may receive less than
five doses of