Imjudo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Tremelimumab

Available from:

AstraZeneca AB

ATC code:

L01FX20

INN (International Name):

tremelimumab

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Hepatocellular

Therapeutic indications:

Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).Imjudo 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.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2023-02-20

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMJUDO 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 IMJUDO is and what it is used for
2.
What you need to know before you are given IMJUDO
3.
How you are given IMJUDO
4.
Possible side effects
5.
How to store IMJUDO
6.
Contents of the pack and other information
1.
WHAT IMJUDO IS AND WHAT IT IS USED FOR
IMJUDO 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. IMJUDO works by helping your immune system
fight your cancer.
IMJUDO in combination with durvalumab is used to treat a type of liver
cancer, called advanced or
unresectable hepatocellular carcinoma (HCC). It is used when your HCC:

cannot be removed by surgery (unresectable), and

may have spread within your liver or to other parts of the body.
IMJUDO is used to treat a type of lung cancer called advanced
non-small cell lung cancer in adults. It
will be used in combination with other anti-cancer medicines
(durvalumab and chemotherapy).
As IMJUDO 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 these
medicines, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE G

Summary of Product characteristics

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
IMJUDO
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 from 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
IMJUDO in combination with durvalumab is indicated for the first line
treatment of adults with
advanced or unresectable hepatocellular carcinoma (HCC).
IMJUDO 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 must be initiated and supervised by a physician experienced
in the treatment of cancer.
Posology
The recommended dose of IMJUDO is presented in Table 1. IMJUDO is
administered as an
intravenous infusion over 1 hour.
3
TABLE 1. RECOMMENDED DOSE OF IMJUDO
INDICATION
RECOMMENDED IMJUDO
DOSAGE
DURATION OF THERAPY
Advanced or unresectable HCC
IMJUDO 300 mg
a
as a single
dose adminis