Tybost

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

cobicistat

זמין מ:

Gilead Sciences Ireland UC

קוד ATC:

V03AX03

INN (שם בינלאומי):

cobicistat

קבוצה תרפויטית:

Antivirals for systemic use

איזור תרפויטי:

HIV Infections

סממני תרפויטית:

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 and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

leaflet_short:

Revision: 15

מצב אישור:

Authorised

תאריך אישור:

2013-09-19

עלון מידע

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TYBOST 150 MG FILM-COATED TABLETS
cobicistat
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 for the treatment of human immunodeficiency virus-1
(HIV-1) infection, the virus that
causes acquired immune deficiency syndrome (AIDS). It is used in HIV-1
infected adults and
adolescents aged 12 years and older:
•
weighing at least 35 kg (when co-administered with atazanavir 300 mg)
or
•
weighing at least 40 kg (when co-administered with darunavir 800 mg).
Tybost acts as a
BOOSTER
(
_enhancer_
) of ATAZANAVIR OR DARUNAVIR
(both protease inhibitors) to improve
their effect (see section 3 of this leaflet).
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TYBOST
DO NOT TAKE TYBOST
•
IF YOU ARE ALLERGIC TO COBICISTAT
or any of the other ingredients of this medicine (listed in
section 6 of this leaflet).
•
IF YOU ARE TAKING MEDICINES CONTAINING ANY OF THE FOLLOWING:
-
ALFUZOSIN,
used to treat an enlarged prostate gland

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 and adolescents aged 12 years and older:
•
weighing at least 35 kg co-administered with atazanavir or
•
weighing at least 40 kg co-administered with darunavir.
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 taken orally, once daily with food.
The doses of Tybost and the co-administered protease inhibitor,
atazanavir or darunavir, are presented
in Tables 1 and 2.
TABLE 1: DOSING REGIMENS IN ADULTS
DOSE OF TYBOST
DOSE OF HIV-1 PROTEASE INHIBITOR
150 mg once daily
Atazanavir 300 mg once daily
Darunavir 800 mg once daily
3
TABLE 2: DOSING REGIMENS IN ADOLESCENTS AGED 12 YEARS AND OLDER,
WEIGHING ≥ 35 KG
BODY WEIGHT (KG)
DOSE OF TYBOST
DOSE OF HIV-1 PROTEASE INHIBITOR
≥ 40
150 mg once daily
Atazanavir 300 mg once daily
Darunavir 800 mg once daily
35 to < 40
150 mg once daily
Atazanavir 300 mg once daily
If the patient misses a dose of Tybost within 12 hours of the time it
is usually taken, th