PIFELTRO 100 MG FILM - COATED TABLETS

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

DORAVIRINE

Disponible des:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Codi ATC:

G05AG06

formulario farmacéutico:

FILM COATED TABLETS

Composición:

DORAVIRINE 100 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

MERCK SHARP & DOHME LLC, USA

Área terapéutica:

DORAVIRINE

indicaciones terapéuticas:

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.

Data d'autorització:

2020-05-07

Informació per a l'usuari

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is marketed upon physician’s prescription only
PIFELTRO
®
100mg FILM-COATED TABLETS
Each film coated tablet contains:
Doravirine 100 mg
For a list of inactive ingredients see section 6 "Further
Information". See also section 2.8 “Important
information about some of the ingredients of the medicine".
Read all of this leaflet carefully before you start using the
medicine.
•
This leaflet contains concise information about Pifeltro. If you have
any further 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
their medical condition seems similar to yours.
1.
WHAT PIFELTRO IS INTENDED FOR?
PIFELTRO is indicated, in combination with other antiretroviral
medicinal products, for the treatment
of adults infected with HIV-1 without past or present evidence of
viral resistance to doravirine.
Pifeltro must be used in combination with other medicines for HIV.
Therapeutic group:
a non-nucleoside reverse transcriptase inhibitor (NNRTI).
How Pifeltro works
When used with other 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 your immune
system stronger. This may reduce your risk of early death or catching
infections because your
immune system is weak.
2.
BEFORE USING PIFELTRO
_ _
2.1 Do not use Pifeltro:
•
if you are sensitive (allergic) to doravirine or any of the other
ingredients of this medicine
listed in section 6.
•
if you are taking any of the following medicines, which are strong
cytochrome P450 CYP3A
enzyme inducers. These medicines include, but are not limited to the
following:
−
carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for
seizures)
−
rifampicin, rifapentine (medici

Fitxa tècnica

1
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, debossed with the corporate logo and 700 on
one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
PIFELTRO is indicated, in combination with other antiretroviral
medicinal products, for the treatment
of adults infected with human immunodeficiency virus type 1 (HIV-1)
without past or present
evidence of viral resistance to doravirine.
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 12 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 patient should not take the missed dose and instead
take the next dose at the
regularly scheduled time. The patient should not take 2 doses at one
time.
2
Special populations
_Elderly _
No dose adjustment of doravirine is