ROZLYTREK 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ENTRECTINIB

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L01XE56

Pharmaceutical form:

HARD CAPSULE

Composition:

ENTRECTINIB 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Therapeutic area:

ENTRECTINIB

Therapeutic indications:

ROZLYTREK is indicated for the treatment of adults with solid tumors that:• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,• are metastatic or where surgical resection is likely to result in severe morbidity, and• have either progressed following treatment or have no satisfactory alternative therapy.ROZLYTREK is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

Authorization date:

2020-04-22

Patient Information leaflet

Rozlytrek PL version 2
PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a
doctor’s prescription only
ROZLYTREK
ROZLYTREK
100 MG
200 MG
HARD CAPSULES
HARD CAPSULES
COMPOSITION:
EACH CAPSULE CONTAINS:
entrectinib 100 mg
EACH CAPSULE CONTAINS:
entrectinib 200 mg
Inactive ingredients and allergens in the preparation:
See section 2 under ‘Important information about some
of this medicine’s ingredients’ and see also section 6,
‘Further
information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have any further questions,
contact the doctor or pharmacist. Keep this leaflet. You
may need to read it again.
This medicine has been prescribed for the treatment of
your ailment. Do not pass it on to others. It may harm
them even if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Rozlytrek is intended to treat adults with:
A.
A solid tumor that:
was caused by a change in a NTRK-class gene AND
has spread to other parts of the body, or in
instances when surgery to remove the tumor may
cause
severe
complications
AND
there is no satisfactory treatment alternative or
the tumor grew or spread during the receipt of
another
treatment.
B.
Non-small cell lung cancer (NSCLC) that has spread to
other parts of the body and has a change in ROS1 gene.
THERAPEUTIC GROUP: kinase inhibitor
2. BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE IF:
You are allergic (sensitive) to the active ingredient,
entrectinib, or to any of the other ingredients of
this medicine referred to in section 6, ‘Further
information’.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
Before taking Rozlytrek, tell the doctor about all of your
previous medical conditions, including if:
you are suffering from liver or kidney problems
you have bone fractures
you are suffering from any heart problems, including a
medical condition called long QT syndrome
you

Summary of Product characteristics

Page 1 of
19
ROZLYTREK PI VER 4
ROZLYTREK
®
ENTRECTINIB
HARD CAPSULES
_______________________________________________________
NAME OF THE MEDICINAL PRODUCT
Rozlytrek 100 mg
Rozlytrek 200 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rozlytrek 100 mg hard capsules
Each hard capsule contains 100 mg of entrectinib.
_Excipient(s) with known effect _
Each hard capsule contains 65 mg lactose.
Rozlytrek 200 mg hard capsules
Each hard capsule contains 200 mg of entrectinib.
_Eexcipient(s) with known effect _
Each hard capsule contains 130 mg lactose, and 0.6 mg of the azo
colouring agent sunset yellow FCF (E110).
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 11.
1
INDICATIONS AND USAGE
1.1 Rozlytrek is indicated for the treatment of adults with solid
tumors that:

have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
without a known acquired resistance
mutation

are metastatic or where surgical resection is likely to result in
severe morbidity, and

have either progressed following treatment or have no satisfactory
alternative therapy.
1.2 Rozlytrek is indicated for the treatment of adult patients with
metastatic non-small cell lung cancer
(NSCLC) whose tumors are ROS1-positive.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for the treatment of metastatic NSCLC with ROZLYTREK
based on the presence of _ROS1_
rearrangement(s) in tumor specimens _[see Clinical Studies (14.1)]_.
Page 2 of
19
Select patients for treatment of locally advanced or metastatic solid
tumors with ROZLYTREK based on the
presence of a _NTRK_ gene fusion _[see Clinical Studies (14.2)]_.
2.2
RECOMMENDED DOSAGE FOR
ROS1
-POSITIVE NON-SMALL CELL LUNG CANCER
The recommended dosage of ROZLYTREK is 600 mg orally once daily with
or without food until disease
progression or unacceptable toxicity.
2.3
RECOMMENDED DOSAGE FOR
NTRK
GENE FUSION-POSITIVE SOLID TUMORS
Adults
The recommended dosage of ROZLYTREK in adults is 600 mg orally once
daily with or without food until
disease progression or unacceptable toxicity.
2.4
DOSAGE