Pifeltro

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

doravirine

Saatavilla:

Merck Sharp & Dohme B.V.

ATC-koodi:

J05AG06

INN (Kansainvälinen yleisnimi):

doravirine

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

HIV Infections

Käyttöaiheet:

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-11-22

Pakkausseloste

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIFELTRO 100 MG FILM-COATED TABLETS
doravirine
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,
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 Pifeltro
is and what
it is used for
2.
What you need to know before you take
Pifeltro
3.
How to take
Pifeltro
4.
Possible side effects
5.
How to store
Pifeltro
6.
Con
tents of the pack and other information
1.
WHAT PIFELTRO
IS AND WHAT IT IS USED
FOR
WHAT PIFELTRO IS
Pifeltro is used to treat HIV (‘human immunodeficiency virus’)
infection. It belongs to a group of
medicines called ‘antiretroviral medicines’.
Pifeltro
contains the active substance doravirine
- a non-
nucleoside reverse
transcriptase inhibitor
(NNRTI).
WHAT PIFELTRO IS USED FOR
Pifeltro
is used to treat HIV
infection in adults, and
adolescents
aged 12
years and older
weighing at
least 35 kg
. HIV is the virus that causes AIDS (‘
acquired immune deficiency s
yndrome’).
You should
not take Pifeltro
if your doctor has told you that the virus causing your infection is
resistant to
doravirine.
Pifeltro
must be used in combinatio
n with other medicines for HIV.
HOW PIFELTRO WORKS
When used with othe
r medicines,
Pifeltro works by
preventing HIV from making more viruses in your
body. This will help by
:
•
reducing the amount of HIV in your blood (this is called your
‘
viral load
’
)
•
increasing the
number
of white blood cells called ‘CD4
+
T’. This can make yo
ur immune
system stronger. This may reduce your risk of
early death or

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF
THE
MEDICINAL PRODUCT
Pifeltro 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-
coated tablet contains 100
mg of
doravirine.
Excipient
with known effect
Each film-
coated tablet contains
222 mg lactose (as
monohydrate
).
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet
(tablet).
White, oval-
shaped, tablet
of dimensions 19.00
mm x 9.50 mm
, debossed with
the corporate
logo and
700
on one side and plain on the other side.
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pifeltro
is indicated, in combination with other antiretroviral medicinal
products,
for the treatment of
adults,
and adolescents aged 12
years and older
weighing at least 35
kg
infected with
human
immunodeficiency virus
type 1 (HIV-1)
without past or present evidence of resistance to the
non-
nucleoside reverse transcriptase inhibitors
(NNRTI)
class (see sections
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy
should be initiated by a physician experienced in the
management of HIV infection
.
Posology
The recommended dose
is one 100 mg
tablet taken orally
once daily with or without food.
Dose adjustment
If Pifeltro is co-
administered with rifabutin,
one 100 mg tablet of Pifeltro
should be taken twice daily
(approximately 1
2 hours apart)
(see section
4.5).
Co-
administration of doravirine with other moderate CYP3A inducers has
not been evaluated, but
decreased doravirine concentrations are expected. If co
-
administration with other moderate CYP3A
inducers (e.g
.,
dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil,
telotristat ethyl)
cannot be avoided, one
100 mg tablet of Pifeltro
should be taken twice daily (approximately 12
hours
apart).
Missed dose
If the patient misses a dose of
Pifeltro within 12
hours of the time it is usually taken, the patient should
take as soon as possible and resume the normal dosing schedule. If a
patient misses a dose by more
than 12
hours, the pat