Trodelvy

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Sacituzumab govitecan

Available from:

Gilead Sciences Ireland UC

ATC code:

L01FX

INN (International Name):

sacituzumab govitecan

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Breast Neoplasms; Triple Negative Breast Neoplasms

Therapeutic indications:

Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2021-11-22

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRODELVY 200 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
sacituzumab govitecan
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side affects 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 Trodelvy is and what it is used for
2.
What you need to know before you are given Trodelvy
3.
How you will be given Trodelvy
4.
Possible side effects
5.
How to store Trodelvy
6.
Contents of the pack and other information
1.
WHAT TRODELVY IS AND WHAT IT IS USED FOR
Trodelvy is a cancer medicine that contains the active substance
sacituzumab govitecan. One part of
the medicine is a monoclonal antibody that attaches specifically to a
protein on the surface of breast
cancer cells called Trop-2. The other active part of Trodelvy is
SN-38, a substance that can kill cancer
cells. Once the medicine has attached to cancer cells, the SN-38
enters the cancer cells and kills them,
thereby helping to fight your cancer.
TRODELVY IS USED TO TREAT A TYPE OF BREAST CANCER IN ADULTS CALLED
TRIPLE-NEGATIVE BREAST CANCER
(TNBC)
. Trodelvy should only be used after patients have tried at least two
other treatments for their
cancer, including at least one of them for a locally advanced cancer
or metastasised cancer.
TRODELVY IS USED TO TREAT
A TYPE OF BREAST CANCER IN ADULTS CALLED HORMONE RECEPTOR -POSITIVE
(HR+), HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 -NEGATIVE (HER2-)
BREAST CANCER.
Trodelvy
should only be used after patients have tried a treatment

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
Trodelvy 200 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 200 mg sacituzumab govitecan.
After reconstitution, one mL of solution contains 10 mg sacituzumab
govitecan.
Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate
(ADC). Sacituzumab is a
humanised monoclonal antibody (hRS7 IgG1κ) that recognises Trop-2.
The small molecule, SN-38, is
a topoisomerase I inhibitor, which is covalently attached to the
antibody by a hydrolysable linker.
Approximately 7-8 molecules of SN-38 are attached to each antibody
molecule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
Off-white to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trodelvy as monotherapy is indicated for the treatment of adult
patients with unresectable or
metastatic triple-negative breast cancer (mTNBC) who have received two
or more prior systemic
therapies, including at least one of them for advanced disease (see
section 5.1).
Trodelvy as monotherapy is indicated for the treatment of adult
patients with unresectable or
metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
who have received
endocrine-based therapy, and at least two additional systemic
therapies in the advanced setting (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Trodelvy must only be prescribed and administered to patients by
healthcare professionals experienced
in the use of anti-cancer therapies and administered in an environment
where full resuscitation
facilities are available.
Posology
The recommended dose of sacituzumab govitecan is 10