Lumykras

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

sotorasib

Tillgänglig från:

Amgen Europe BV

ATC-kod:

L01XX73

INN (International namn):

sotorasib

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

Carcinoma, Non-Small-Cell Lung

Terapeutiska indikationer:

Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

Produktsammanfattning:

Revision: 2

Bemyndigande status:

Authorised

Tillstånd datum:

2022-01-06

Bipacksedel

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUMYKRAS 120 MG FILM-COATED TABLETS
sotorasib
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 START TAKING 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LUMYKRAS is and what it is used for
2.
What you need to know before you take LUMYKRAS
3.
How to take LUMYKRAS
4.
Possible side effects
5.
How to store LUMYKRAS
6.
Contents of the pack and other information
1.
WHAT LUMYKRAS IS AND WHAT IT IS USED FOR
LUMYKRAS contains the active substance sotorasib and belongs to a
group of medicines known as
antineoplastic agents (cancer medicines).
LUMYKRAS is used to treat adults with a type of lung cancer called
non-small cell lung cancer
(NSCLC) when it is advanced and has spread to other parts of the body.
LUMYKRAS is used when previous treatments were not effective in
stopping the growth of the
cancer, and when the cancer cells have a genetic change that allows
them to produce an abnormal form
of protein called
_KRAS G12C_
. Your doctor will test your cancer cells for this change beforehand
to
make sure that LUMYKRAS is right for you.
HOW DOES LUMYKRAS WORK?
The abnormal
_KRAS G12C_
protein, acts to help make cancer cells grow out of control. LUMYKRAS
attaches to the protein and stops it from working, which may slow down
or stop the growth of the
cancer.
If

Produktens egenskaper

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
LUMYKRAS 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 120 mg of sotorasib.
Excipient with known effect
Each film-coated tablet contains 108 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow film-coated tablet, oblong-shaped (7 mm × 16 mm), debossed
with “AMG” on one side and
“120” on the opposite side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUMYKRAS as monotherapy is indicated for the treatment of adults with
advanced non-small cell
lung cancer (NSCLC) with
_KRAS G12C_
mutation and who have progressed after at least one prior line
of systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with LUMYKRAS must be initiated by a physician experienced
in the use of anticancer
medicinal products.
The presence of a
_KRAS G12C_
mutation must be confirmed using a validated test prior to initiation
of
LUMYKRAS therapy.
Posology
The recommended dose is 960 mg sotorasib (eight 120 mg tablets) once
daily, at the same time each
day.
_Duration of treatment _
Treatment with LUMYKRAS is recommended until disease progression or
unacceptable toxicity.
_Missed doses or vomiting _
If less than 6 hours have passed since the scheduled time of dosing,
the patient should take the dose as
normal. If more than 6 hours have passed since the scheduled time of
dosing, the patient must not take
the dose. Treatment should be continued as prescribed the next day.
3
If vomiting occurs after taking LUMYKRAS, the patient must not take an
additional dose on the same
day, and treatment must be continued as prescribed the next day.
_Dose mo