QINLOCK

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

RIPRETINIB

Disponibbli minn:

MEDISON PHARMA LTD

Kodiċi ATC:

L01EX19

Għamla farmaċewtika:

TABLETS

Kompożizzjoni:

RIPRETINIB 50 MG

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

DECIPHERA PHARMACEUTICALS, LLC, USA

Żona terapewtika:

RIPRETINIB

Indikazzjonijiet terapewtiċi:

QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Data ta 'l-awtorizzazzjoni:

2023-01-05

Fuljett ta 'informazzjoni

QINL-PIL-06-V1
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The
medicine is dispensed with a doctor’s prescription only
QINLOCK
TABLETS
ACTIVE INGREDIENT: Ripretinib 50 mg
INACTIVE AND ALLERGENIC INGREDIENTS: see Section 6
“
Further Information
”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine.
If you have further questions, consult with the doctor or pharmacist.
This medicine has been prescribed to treat 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?
QINLOCK is intended for the treatment of adult patients with advanced
gastrointestinal
stromal tumor (GIST), who have received prior treatment with three or
more kinase
inhibitors, including imatinib.
THERAPEUTIC GROUP: protein kinase inhibitors.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to ripretinib or to any of the additional
ingredients contained
in the medicine (see Section 6).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
Before treatment with QINLOCK tell the doctor about all of your
medical conditions,
including if you:
-
have suffered in the past from a skin problem called palmar-plantar
erythrodysesthesia syndrome
-
have high blood pressure
-
have heart problems
-
have had or plan to have surgery
-
are pregnant or planning to become pregnant (see "Pregnancy,
breastfeeding
and fertility")
-
are breastfeeding or planning to breastfeed (see "Pregnancy,
breastfeeding and
fertility").
SPECIAL WARNINGS REGARDING SENSITIVITY TO LIGHT (PHOTOSENSITIVITY):
Your skin may be sensitive to sunlight or to other forms of light
during treatment with
QINLOCK. Avoid or limit exposure to direct sunlight, sunlamps and
other sources of
ultraviolet radiation during treatment and for at least 1 week after
stopping treatment with
QINLOCK. Use sunscreen or wear clothes that cover your sk

Karatteristiċi tal-prodott

QINLOCK-SPC-1123-V1
PHYSICIAN PRESCRIBING INFORMATION
NAME OF MEDICINAL PRODUCT
QINLOCK 50 mg tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of Ripretinib
Excipients with known effect
Each tablet contains 179 mg of lactose monohydrate (_see section
Description (11)_).
For the full list of excipients, _see Description (11)_.
1
THERAPEUTIC INDICATION
QINLOCK is indicated for the treatment of adult patients with advanced
gastrointestinal stromal tumor (GIST)
who have received prior treatment with 3 or more kinase inhibitors,
including imatinib.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
The recommended dosage of QINLOCK is 150 mg orally once daily with or
without food until disease
progression or unacceptable toxicity.
Instruct patients to swallow tablets whole.
Advise patients to take QINLOCK at the same time each day.
Advise patients to take a missed dose if less than 8 hours have passed
since the missed scheduled dose.
Advise patients not to take an additional dose if vomiting occurs
after taking QINLOCK and to continue with
their next scheduled dose.
2.2
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
The recommended dose reduction for adverse reactions is:
•
QINLOCK 100 mg orally once daily.
Permanently discontinue QINLOCK in patients who are unable to tolerate
100 mg orally once daily.
The recommended dosage modifications of QINLOCK for adverse reactions
are provided in Table 1.
QINLOCK-SPC-1123-V1
TABLE 1:
RECOMMENDED DOSAGE MODIFICATIONS FOR QINLOCK FOR ADVERSE REACTIONS
ADVERSE REACTION
SEVERITY
A
QINLOCK DOSAGE MODIFICATIONS
Palmar-Plantar
Erythrodysesthesia Syndrome
(PPES) _[see Warnings and _
_Precautions (5.1)]_
Grade 2
•
Withhold QINLOCK until
Grade ≤1
or baseline. If recovered within
7 days, resume QINLOCK at same dose; otherwise resume at reduced
dose.
•
Consider re-escalating QINLOCK if
maintained at Grade ≤1 or
baseline for at least 28 days.
•
If PPES recurs, withhold QINLOCK until
Grade ≤
1 or baseline and
then resume QINLOCK at a reduced dose regardle