Tybost 150mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Cobicistat

Dostupné s:

Gilead Sciences International Ltd

ATC kód:

V03AX03

INN (Mezinárodní Name):

Cobicistat

Dávkování:

150mg

Léková forma:

Tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 05030100; GTIN: 5391507140876

Informace pro uživatele

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TYBOST 150 MG FILM-COATED TABLETS
Cobicistat
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.
WHAT IS IN THIS LEAFLET
1.
What Tybost is and what it is used for
2.
What you need to know before you take Tybost
3.
How to take Tybost
4.
Possible side effects
5.
How to store Tybost
6.
Contents of the pack and other information
1.
WHAT TYBOST IS AND WHAT IT IS USED FOR
Tybost contains the active substance cobicistat.
Tybost is used in adults aged 18 years and over to treat infection
with HIV (human immunodeficiency
virus). It is TAKEN WITH ATAZANAVIR OR DARUNAVIR (both protease
inhibitors) and acts as a BOOSTER
(_pharmacokinetic enhancer_) to help improve their effect.
TYBOST DOES NOT DIRECTLY TREAT YOUR HIV, BUT BOOSTS THE LEVELS OF
ATAZANAVIR AND DARUNAVIR in the
blood. It does this by slowing down the breakdown of atazanavir and
darunavir which will make them
stay in the body for longer.
This medicine is not a cure for HIV infection. While taking Tybost you
may still develop infections or
other illnesses associated with HIV infection. You can also pass on
the virus to others, so it is
important to take precautions to avoid infecting other people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYBOST
DO NOT TAKE TYBOST

IF YOU ARE ALLERGIC TO C

Charakteristika produktu

OBJECT 1
TYBOST 150MG FILM COATED TABLET
Summary of Product Characteristics Updated 15-Jun-2018 | Gilead
Sciences Ltd
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
Tybost 150 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg of cobicistat.
Excipient(s) with known effect
Each tablet contains 59 micrograms sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Orange, round, biconvex, film-coated tablet of diameter 10.3 mm,
debossed with “GSI” on one side of the
tablet and plain-faced on the other side of the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg
once daily or darunavir 800 mg
once daily as part of antiretroviral combination therapy in human
immunodeficiency virus-1 (HIV-1)
infected adults. See sections 4.2, 4.4, 5.1 and 5.2.
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
Tybost is used in combination with atazanavir or darunavir, therefore
the atazanavir or darunavir
Summary of Product Characteristics should be consulted.
Tybost must be co-administered with atazanavir or darunavir, taken
orally, once daily with food.
The doses of Tybost and the co-administered protease inhibitor,
atazanavir or darunavir, are presented in
Table 1.
TABLE 1: DOSING REGIMENS
DOSE OF TYBOST
DOSE OF HIV-1 PROTEASE INHIBITOR
150 mg once daily
Atazanavir 300 mg once daily
Darunavir 800 mg once daily
If the patient misses a dose of Tybost within 12 hours of the time it
is usually taken, the patient should
take Tybost with food as soon as possible and resume their normal
dosing schedule