Zokinvy

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Lonafarnib

Available from:

EigerBio Europe Limited

INN (International Name):

lonafarnib

Therapeutic group:

Other alimentary tract and metabolism products,

Therapeutic area:

Progeria; Laminopathies

Therapeutic indications:

Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2022-07-18

Patient Information leaflet

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOKINVY 50 MG HARD CAPSULES
ZOKINVY 75 MG HARD CAPSULES
lonafarnib
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side-effects you may get.
See the end of section 4 for how to
report side-effects.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zokinvy is and what it is used for
2.
What you need to know before you take Zokinvy
3.
How to take Zokinvy
4.
Possible side effects
5.
How to store Zokinvy
6.
Contents of the pack and other information
1.
WHAT ZOKINVY
IS AND WHAT IT IS USED FOR
WHAT ZOKINVY IS
Zokinvy contains the active substance lonafarnib.
WHAT ZOKINVY IS USED FOR
This medicine is used to treat patients aged 12 months and older with
the following rare disorders:
•
Hutchinson-Gilford progeria syndrome
•
processing-deficient progeroid laminopathies
These illnesses are caused by changes in genes needed to make certain
proteins. Normal versions of these
proteins help to keep cells strong and stable. However, the altered
genes cause a build-up of harmful forms of
the proteins called progerin or progerin-like proteins. These harmful
proteins lead to cell damage that
resembles the effects of aging.
HOW ZOKINVY WORKS
Zokinvy works by helping to reduce the build-up of the harmful
progerin or progerin-like proteins.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOKINVY
DO NOT TAKE ZOKINVY
•
if you are allerg

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Zokinvy 50 mg hard capsules
Zokinvy 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zokinvy 50 mg hard capsules
Each capsule contains 50 mg lonafarnib.
Zokinvy 75 mg hard capsules
Each capsule contains 75 mg lonafarnib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Zokinvy 50 mg hard capsules
Size 4 hard capsule (5 mm x 14 mm), opaque yellow with “LNF” and
“50” printed in black.
Zokinvy 75 mg hard capsules
Size 3 hard capsule (6 mm x 16 mm), opaque light orange with “LNF
and “75” printed in black.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zokinvy is indicated for the treatment of patients 12 months of age
and older with a genetically
confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a
processing-deficient progeroid
laminopathy associated with either a heterozygous
_LMNA_
mutation with progerin-like protein
accumulation or a homozygous or compound heterozygous
_ZMPSTE24_
mutation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
treatment of patients with progeroid
syndromes or patients with rare genetic metabolic syndromes.
Posology
_ _
_Starting dose _
For all indications, the recommended starting dose is 115 mg/m
2
twice daily. The Du Bois formula
was used in clinical trials and should be used to calculate body
surface area for dosing. All total daily
3
_ _
doses should be rounded to the nearest 25 mg increment and divided
into two equal, or near equal,
doses (see Table 1). Doses should be taken approximately 12 hours
apart from one another (morning
and evening).
TABLE 1: RECOMMENDED STARTING DOSE AND ADMINISTRATION SCHEDUL