LUMYKRAS

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

SOTORASIB

Prieinama:

AMGEN EUROPE B.V.

ATC kodas:

L01XX73

Vaisto forma:

FILM COATED TABLETS

Sudėtis:

SOTORASIB 120 MG

Vartojimo būdas:

PER OS

Recepto tipas:

Required

Pagaminta:

AMGEN EUROPE B.V., NETHERLANDS

Gydymo sritis:

SOTORASIB

Terapinės indikacijos:

LUMYKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an approved test, who have received at least one prior systemic therapy.

Leidimo data:

2022-06-27

Pakuotės lapelis

Amgen Proprietary - Restricted
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) 1986
This medicine is dispensed according to a doctor’s prescription only
LUMYKRAS 120 MG FILM-COATED TABLETS
Each film-coated tablet contains 120 mg of sotorasib.
For inactive ingredients and allergens in the product - see section 6
"Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information
about the medicine. If you have any other questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
LUMYKRAS
is indicated for the treatment of adult patients with KRAS
G12C-mutated locally advanced
or metastatic non-small cell lung cancer (NSCLC), as determined by an
approved test, who have
received at least one prior systemic therapy.
THERAPEUTIC GROUP:
LUMYKRAS
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. 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.
Your doctor will test your cancer cells for this change beforehand to
make sure that
LUMYKRAS
is right
for you.
If you have any questions about how
LUMYKRAS
works or why this medicine has been prescribed for
you, ask your doctor, pharmacist, or nurse.
2. BEFORE USING THE MEDICINE
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Talk to your doctor, pharmaci

Prekės savybės

Amgen Proprietary - Restricted
1
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.
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 is indicated for the treatment of adult patients with KRAS
G12C-mutated locally
advanced or metastatic non-small cell lung cancer (NSCLC), as
determined by an approved test, who
have received at least one prior 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.
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.
Amgen Proprietary - Restricted
2
_Dose modifications _
Dosing should be modified based on LUMYKRAS toxicity. The dose
reduction rules outlined in
section 4.2 are based on clinical data. Pharmacokinetic (PK) data do
suggest a similar exposure at
lower sotorasib dose