ZOKINVY 75 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LONAFARNIB

متاح من:

NEOPHARM LTD, ISRAEL

ATC رمز:

A16AX20

الشكل الصيدلاني:

HARD GELATIN CAPSULES

تركيب:

LONAFARNIB 75 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EIGER BIOPHARMACEUTICALS, INC., USA

المجال العلاجي:

LONAFARNIB

الخصائص العلاجية:

ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of0.39 m2 and above:To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS)• For the treatment of processing-deficient Progeroid Laminopathies with either:o Heterozygous LMNA mutation with progerin-like protein accumulationo Homozygous or compound heterozygous ZMPSTE24 mutationsLimitations of UseZOKINVY is not indicated for other Progeroid Syndromes or processing-proficient Progeroid Laminopathies. Based upon its mechanism of action, ZOKINVY would not be expected to be effective in these populations.

تاريخ الترخيص:

2022-05-23

نشرة المعلومات

Zokinvy cap. PIL vr. 1A
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
ZOKINVY 50 MG
hard gelatin capsules
ZOKINVY 75 MG
hard gelatin capsules
THE ACTIVE INGREDIENT AND ITS QUANTITY IN A DOSAGE UNIT:
Each ZOKINVY capsule contains lonafarnib 50 mg or 75 mg.
For a list of inactive ingredients and allergens in the preparation:
see section 6 “Additional
information” in this leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have additional 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?
ZOKINVY is intended for the treatment of adults and children 12 months
of age and older, who have a
certain body surface area:
•
To lower the mortality risk in patients with Hutchinson-Gilford
progeria syndrome (HGPS).
•
For treatment of patients with certain types of processing-deficient
progeroid laminopathies.
ZOKINVY is not intended for patients with non-Hutchinson-Gilford
progeria syndromes or for
treatment of progeroid laminopathies that are not of the
processing-deficient types, since ZOKINVY
would not be expected to be effective in these patients
THERAPEUTIC CLASS: ZOKINVY
belongs to a group of preparations that are basic substances for body
metabolism.
ZOKINVY
contains the active ingredient lonafarnib, which inhibits the enzyme
farnesyltransferase,
thus preventing the accumulation of progerin or progerin-like proteins
in the inner membrane of the
cell nucleus.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients the
medicine contains (see section 6).
•
You are taking:
‐
Medicines that are strong or moderate CYP3A inhibitors or inducers
‐
Mid

خصائص المنتج

1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Zokinvy 50 mg
Zokinvy 75 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZOKINVY (lonafarnib) capsules for oral administration contain 50 mg or
75 mg of lonafarnib as the active
ingredient.
The inactive ingredients listed in section 11.
PHARMACEUTICAL FORM
Hard gelatin capsules for oral use
1
INDICATIONS AND USAGE
ZOKINVY is indicated in patients 12 months of age and older with a
body surface area (BSA) of
0.39
m
2
and above:
•
To reduce the risk of mortality in Hutchinson-Gilford Progeria
Syndrome (HGPS)
•
For the treatment of processing-deficient Progeroid Laminopathies with
either:
o
Heterozygous _LMNA _mutation with progerin-like protein accumulation
o
Homozygous or compound heterozygous _ZMPSTE24 _mutations
Limitations of Use
ZOKINVY is not indicated for other Progeroid Syndromes or
processing-proficient Progeroid
Laminopathies. Based upon its mechanism of action, ZOKINVY would not
be expected to be
effective in these populations.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
•
The starting dosage of ZOKINVY for patients with a BSA of 0.39 m
2
and above is
115 mg/m
2
twice daily with morning and evening meals (see Table 1) to reduce the
risk of
gastrointestinal adverse reactions _[see Adverse Reactions (6.1)]_. An
appropriate dosage
strength of ZOKINVY is not available for patients with a BSA of less
than 0.39 m
2
_[see _
_Indications and Usage (1)]_.
•
After 4 months of treatment, increase the dosage to 150 mg/m
2
twice daily with morning
and evening meals (see Table 2).
•
Round all total daily dosages to the nearest 25 mg increment (see
Table 1 and Table 2).
2
•
If a dose is missed, take the dose as soon as possible with food, up
to 8 hours prior to the next
scheduled dose. If less than 8 hours remains before the next scheduled
dose, skip the missed
dose, and resume taking ZOKINVY at the next scheduled dose.
Table 1 provides the BSA-based dosage recommendations for the starting
dosage of 115 mg/m
2
twice daily.
TABLE 1: RECOMMENDED D