PIFELTRO TABLET

Država: Južnoafrička Republika

Jezik: engleski

Izvor: South African Health Products Regulatory Authority (SAHPRA)

Dostupno od:

MSD (Pty) Ltd

Doziranje:

See ingredients

Farmaceutski oblik:

TABLET

Sastav:

EACH TABLET CONTAINS DORAVIRINE 100,0 mg

Status autorizacije:

Registered

Uputa o lijeku

PRODUCT NAME: PIFELTRO TABLETS
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
DATE APPROVED: 25 JANUARY 2022
TP
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PIFELTRO
® 100 MG FILM-COATED TABLET
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.
•
PIFELTRO has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
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.
Contents of the pack and other information
1.
WHAT PIFELTRO IS AND WHAT IT IS USED FOR
WHAT PIFELTRO IS
S4
PRODUCT NAME: PIFELTRO TABLETS
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
DATE APPROVED: 25 JANUARY 2022
TP
Page 2 of 11
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 people 18 years of age and
older. HIV is the virus
that causes AIDS (“Acquired Immune Deficiency Syndrome”). 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 combination with other medicines for HIV.
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

Svojstava lijeka

PRODUCT NAME: PIFELTRO TABLETS
COMPONENT: ENGLISH PROFESSIONAL
INFORMATION
DATE APPROVED: 25 JANUARY 2022
TP
Page 1 of 42
SCHEDULING STATUS
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.
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
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 resistance to the
NNRTI class (see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
S4
PRODUCT NAME: PIFELTRO TABLETS
COMPONENT: ENGLISH PROFESSIONAL
INFORMATION
DATE APPROVED: 25 JANUARY 2022
TP
Page 2 of 42
Therapy should be initiated by a medical practioner 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 pa