INREBIC

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

FEDRATINIB AS DIHYDROCHLORIDE MONOHYDRATE

זמין מ:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

קוד ATC:

L01XE57

טופס פרצבטיות:

CAPSULES

הרכב:

FEDRATINIB AS DIHYDROCHLORIDE MONOHYDRATE 100 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

BRISTOL-MYERS SQUIBB COMPANY, USA

איזור תרפויטי:

FEDRATINIB

סממני תרפויטית:

INREBIC® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)

תאריך אישור:

2021-09-14

עלון מידע

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
INREBIC
100 MG, CAPSULES
Name and quantity of active ingredient:
Each
capsule
of
INREBIC
contains
100
mg
fedratinib
(as
dihydrochloride monohydrate).
Inactive ingredients See section 6 under ‘Additional information’
and section 2 under ‘Important information about some of this
medicine’s
ingredients’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains concise information about this
medicine. If you have any further questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even if it seems to you that their medical
condition is similar to yours.
What is the most important information I should know about
INREBIC?
INREBIC MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
Encephalopathy
(including
Wernicke’s
encephalopathy).
A serious and sometimes fatal neurological problem called
encephalopathy
(including
Wernicke’s
encephalopathy)
has
happened in some people who take INREBIC.
Wernicke’s encephalopathy is a neurologic emergency that can
happen if you do not have enough vitamin B1 (thiamine) in your
body. Your doctor will do a blood test to check your vitamin B1
level before starting and during treatment with INREBIC. Your
doctor may tell you to stop taking INREBIC and take a vitamin
B1 supplement if you develop side effects during treatment with
INREBIC.
Call your doctor right away if you develop diarrhea, nausea, or
vomiting that does not respond to treatment.
Get emergency medical help right away if you develop the
following:
confusion, memory problems or drowsiness
problems
with
balance
and
movement,
such
as
difficulty
walking
eye problems, such as double or blurred vision or abnormal eye
movements
Call your doctor if you experience rapid weight loss or weight
loss that does not get better with treatment.
1. What is this medicine i

מאפייני מוצר

Inrebic_NPI_Aug2023_corr_Sep2023_clean
1
INREBIC
fedratinib 100 mg
Capsules
WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S
Serious and fatal encephalopathy, including Wernicke’s, has occurred
in patients treated with
INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess
thiamine levels in all
patients prior to starting INREBIC, periodically during treatment, and
as clinically indicated.
Do not start INREBIC in patients with thiamine deficiency; replete
thiamine prior to treatment
initiation. If encephalopathy is suspected, immediately discontinue
INREBIC and initiate
parenteral thiamine. Monitor until symptoms resolve or improve and
thiamine levels normalize
[see Dosage and Administration (2.6), Warnings and Precautions (5.1)
and Adverse Reactions
(6.1)].
1
THERAPEUTIC INDICATION
INREBIC
®
is indicated for the treatment of adult patients with intermediate-2
or high-risk primary or secondary
(post-polycythemia vera or post-essential thrombocythemia)
myelofibrosis (MF).
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage
Conduct baseline testing of thiamine (Vitamin B1) levels prior to
initiation of INREBIC [see Dosage and
Administration (2.2), Warnings and Precautions (5.1)].
The recommended dosage of INREBIC is 400 mg taken orally once daily
for patients with a baseline platelet
count of greater than or equal to 50 x 10
9
/L.
INREBIC may be taken with or without food. Administration with a high
fat meal may reduce the incidence of
nausea and vomiting.
The capsules should not be opened, broken or chewed.
They should be swallowed whole, preferably
with water.
Modify the dose for patients using concomitant strong CYP3A4
inhibitors, and in patients with severe renal
impairment (creatinine clearance (CL
cr
) 15 mL/min to 29 mL/min) [see Dosage and Administration (2.3, 2.4)].
If a dose of INREBIC is missed, the next scheduled dose should be
taken the following day.
Patients that are on treatment with ruxolitinib before the initiation
of INREBIC must taper and discontinue
according to the ruxolitinib