Tybost

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cobicistat 150mg;  ;  ;  

Available from:

Gilead Sciences (NZ)

INN (International Name):

Cobicistat 150 mg

Dosage:

150 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Cobicistat 150mg       Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry orange 85F93642

Prescription type:

Prescription

Manufactured by:

Flamma S.p.A.

Therapeutic indications:

Tybost is indicated as a pharmacokinetic enhancer of appropriate HIV-1 protease inhibitors in adults

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2013-11-04

Patient Information leaflet

TYBOST Consumer Medicine Information v5.0 – (2 November 2016) Page 1
of 4
TYBOST
® TABLETS (150 MG COBICISTAT)
_Cobicistat _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
This leaflet answers some of the
common questions about TYBOST
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR
YOU PERSONALLY AND YOU SHOULD NOT
PASS IT ON TO OTHERS.
It may harm them, even if their
symptoms are the same as yours.
MEDICINES ARE SOMETIMES PRESCRIBED
FOR CONDITIONS THAT ARE NOT MENTIONED
IN THIS LEAFLET.
DO NOT USE TYBOST FOR A CONDITION
FOR WHICH IT WAS NOT PRESCRIBED.
KEEP THIS LEAFLET WITH YOUR TYBOST
MEDICINE.
You may need to read it again.
WHAT IS TYBOST
_HOW TYBOST WORKS _
TYBOST contains the active substance
cobicistat.
TYBOST is a type of medicine called a
pharmacokinetic enhancer (or
“booster”), which is used with one of
the two following medicines for the
treatment of HIV:

Reyataz
(atazanavir) and

Prezista
(darunavir).

TYBOST helps increase the levels of
these HIV medicines in your body.
_USE IN CHILDREN _
TYBOST is for adults. TYBOST has
not been studied in children under the
age of 18 or adults aged 65 and over.
DOES TYBOST CURE HIV
OR AIDS
TYBOST DOES NOT TREAT HIV INFECTION
OR AIDS; IT HELPS IMPROVE THE EFFECT OF
THE HIV MEDICINES:

Reyataz (atazanavir) and

Prezista (darunavir).
The long-term effects of TYBOST are
not known at this time. People taking
TYBOST may still get opportunistic
infections or other conditions that
happen with HIV infection.
Opportunistic infections are infections
that develop because the immune system
is weak.
Some of these conditions are:

pneumonia,

herpes virus infections, and

Mycobacterium avium complex
(MAC) infection.
THIS MEDICINE IS

Summary of Product characteristics

TYBOST Data Sheet v3.0 – (17 January 2017) Page 1 of 21
DATA SHEET
TYBOST
® (COBICISTAT) 150 MG TABLETS
NAME OF THE MEDICINE
TYBOST (cobicistat) 150 mg
tablets.
The active substance in TYBOST tablets is cobicistat.
Cobicistat is a mechanism-based inhibitor of cytochrome P-450 (CYP)
enzymes of the CYP3A
family. Cobicistat is one of the active substances in the single
tablet regimens; STRIBILD
®
,
GENVOYA.
DESCRIPTION
_COBICISTAT: _
the chemical name for cobicistat is 1,3-Thiazol-5-ylmethyl [(2
_R_
,5
_R_
)-5-{[(2
_S_
)-2-
[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4-
yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a
molecular formula of
C
40
H
53
N
7
O
5
S
2
and a molecular weight of 776.0. It has the following structural
formula:
H
N
N
H
O
O
N
S
O
N
H
N
O
O
N
N
S
CAS registry number: 1004316-88-4
Cobicistat is a white to pale yellow solid with a solubility of 0.1
mg/mL in water at 20 °C. The
partition coefficient (
_log p_
) for cobicistat is 4.3 and the pKa is 6.4.
TYBOST
tablets each contain 150 mg of cobicistat and the following
ingredients as excipients:
_Tablet _
_core: _
cellulose-microcrystalline
(E460),
silicon
dioxide,
croscarmellose
sodium,
magnesium stearate (E572).
_Film-coating: _
Sunset yellow FCF (FD&C yellow #6) aluminum
lake (E110), polyethylene glycol, polyvinyl alcohol, talc (E553B),
titanium dioxide (E171),
yellow iron oxide (E172).
Each TYBOST tablet is round, film-coated and orange in colour. Each
tablet is debossed with
‘GSI’ on one side and plain faced on the other side. The tablets
are supplied in bottles with child
resistant closures.
TYBOST Data Sheet v3.0 – (17 January 2017) Page 2 of 21
PHARMACOLOGY
_Pharmacotherapeutic group:_
all other therapeutic products, ATC code: V03AX03.
_ _
MECHANISM OF ACTION
Cobicistat
is
a
selective,
mechanism-based
inhibitor
of
cytochromes
P450
of
the
CYP3A
subfamily. Inhibition of CYP3A-mediated metabolism by cobicistat
enhances the systemic
exposure of CYP3A substrates, such as atazanavir or dar