Litfulo

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

ritlecitinib tosilate

Inapatikana kutoka:

Pfizer Europe MA EEIG

ATC kanuni:

L04AF08

INN (Jina la Kimataifa):

ritlecitinib

Kundi la matibabu:

Immunosuppressants

Eneo la matibabu:

Alopecia Areata

Matibabu dalili:

Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

Idhini hali ya:

Authorised

Idhini ya tarehe:

2023-09-15

Taarifa za kipeperushi

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LITFULO 50 MG HARD CAPSULES
ritlecitinib
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 ALL OF THIS 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
In addition to this leaflet, your doctor will give you a patient card,
which contains important safety
information that you need to be aware of. Keep this patient card with
you.
WHAT IS IN THIS LEAFLET
1.
What Litfulo is and what it is used for
2.
What you need to know before you take Litfulo
3.
How to take Litfulo
4.
Possible side effects
5.
How to store Litfulo
6.
Contents of the pack and other information
1.
WHAT LITFULO IS AND WHAT IT IS USED FOR
Litfulo contains the active substance ritlecitinib. It is used to
treat severe alopecia areata in adults and
adolescents 12 years of age and older. Alopecia areata is a disease
where the body’s own immune
system attacks hair follicles, causing inflammation that leads to hair
loss on the scalp, face and/or
other parts of the body.
Litfulo works by reducing the activity of enzymes called JAK3 and TEC
kinases, which are involved
in inflammation at the hair follicle. This reduces the inflammation,
leading to hair regrowth in patients
with alopecia areata.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LITFULO
_ _
DO NOT TAKE LITFULO
-
if you are allergic to ritlecitinib or any of the other ingredients of
this

Tabia za bidhaa

1
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
Litfulo 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ritlecitinib tosylate equivalent to 50 mg
ritlecitinib.
Excipient(s) with known effect
Each hard capsule contains 21.27 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Opaque hard capsules, yellow body and blue cap approximately 16 mm
long and 6 mm wide, of which
the body is printed with “RCB 50” and the cap is printed with
“Pfizer” in black.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Litfulo is indicated for the treatment of severe alopecia areata in
adults and adolescents 12 years of age
and older (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a healthcare
professional experienced in the diagnosis
and treatment of alopecia areata.
Posology
The recommended dose is 50 mg once daily.
The benefit-risk of treatment should be re-assessed at regular
intervals on an individual basis.
Consideration should be given to discontinuing patients who show no
evidence of therapeutic benefit
after 36 weeks.
_ _
3
_Laboratory monitoring _
TABLE 1.
LABORATORY MEASURES AND MONITORING GUIDANCE
LABORATORY
MEASURES
MONITORING GUIDANCE
ACTION
Platelet count
Before treatment initiation, 4 weeks after
initiation, and thereafter according to
routine patient management.
Treatment should be
discontinued if platelet count is
< 50 × 10
3
/mm
3
.
Lymphocytes
Treatment should be interrupted
if ALC is < 0.5 × 10
3
/mm
3
and
may be restarted once ALC
return above this value.
Abbreviation: ALC = absolute lymphocyte count
_Treatment initiation _
Treatment with ritleciti