ROZLYTREK Capsules 200mg (ロズリートレクカプセル200mg)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Entrectinib

Available from:

Chugai Pharmaceutical Co., Ltd.

INN (International Name):

Entrectinib

Pharmaceutical form:

bright yellow-red capsule, major axis: approx. 21.8 mm, minor axis: approx. 7.3 mm

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 02/2020
The information on this sheet is based on approvals granted by the
Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks)
as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To
obtain a better therapeutic response,
patients should understand their medication and cooperate with the
treatment.
BRAND NAME:
ROZLYTREK CAPSULES 200MG
ACTIVE INGREDIENT:
Entrectinib
DOSAGE FORM:
bright yellow-red capsule, major axis: approx. 21.8 mm,
minor axis: approx. 7.3 mm
IMPRINT OR PRINT ON WRAPPING:
EFFECTS OF THIS MEDICINE
This medicine is considered to suppress proliferation of cancer cells
by suppressing the action
of TRK (Tropomyosin receptor kinase) and tyrosine kinases such as ROS1
which is necessary
for proliferation of cancer cells.
It is usually used to treat advanced/recurrent solid cancers with NTRK
gene fusion-positive
and/or unresectable advanced/recurrent ROS1 gene fusion-positive
Non-Small Cell Lung
Cancer.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN USING THIS
MEDICINE.BE SURE TO TELL YOUR DOCTOR
AND PHARMACIST.
・If you have previously experienced any allergic reactions (itch,
rash, etc.) to any medicines
or foods.
If you have liver disorder.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may
interact to enhance or
diminish medicinal effects. Beware of over-the-counter medicines and
dietary supplements
as well as other prescription medicines.)
DOSING SCHEDULE (HOW TO TAKE THIS MEDICINE)
・
Your dosing schedule prescribed by your doctor is((         

to be written by a healthcare
professional
))
・For advanced/recurrent solid cancers with NTRK gene
fusion-positive:
For adults: In general, take 3 capsules (600 mg of the active
ingredient) at a time once a day.
The dosage may be decreased according to your condition.
For children (body surfac