TYBOST 150 mg cobicistat tablets, bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

cobicistat, Quantity: 150 mg

Disponible desde:

Gilead Sciences Pty Ltd

Designación común internacional (DCI):

Cobicistat

formulario farmacéutico:

Tablet

Composición:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sunset yellow FCF aluminium lake; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Vía de administración:

Oral

Unidades en paquete:

30 Tablets, Bottle

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

TYBOST is indicated as a pharmacokinetic enhancer of appropriate HIV-1 protease inhibitors in adults (See Dosage and Administration).

Resumen del producto:

Visual Identification: Tablet, film-coated, orange in colour, debossed with 'GSI' on one side and plain faced on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estado de Autorización:

Licence status A

Fecha de autorización:

2013-10-23

Información para el usuario

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

Ficha técnica

TYBOST Product Information v10.0 – (24 August 2021)
Page 1
AUSTRALIA PRODUCT INFORMATION - TYBOST
® COBICISTAT TABLETS
1
NAME OF THE MEDICINE
TYBOST (cobicistat).
Cobicistat is one of the active substances in the single tablet
regimens; STRIBILD
®
, GENVOYA
®
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of cobicistat.
_ _
Cobicistat is a white to pale yellow solid.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TYBOST is indicated as a pharmacokinetic enhancer of appropriate HIV-1
protease inhibitors in
adults (see Section 4.2 Dose and method of administration).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
TYBOST must be coadministered with atazanavir or darunavir. The
recommended dose of
TYBOST is one tablet, once daily taken orally with food.
The recommended dose of TYBOST and that of the coadministered protease
inhibitor, atazanavir
or darunavir, are presented in Table 1. As TYBOST is used in
combination with atazanavir or
darunavir, also consult the Product Information for atazanavir or
darunavir.
TABLE 1.
RECOMMENDED DOSING REGIMENS
DOSE OF TYBOST
DOSE OF RECOMMENDED HIV-1 PROTEASE INHIBITOR
150 mg once daily
Atazanavir 300 mg once daily
Darunavir 800 mg once daily
TYBOST is not recommended for use with HIV-1 protease inhibitors other
than those presented
in Table 1.
TYBOST Product Information v10.0 – (24 August 2021)
Page 2
DOSAGE ADJUSTMENT
_Renal impairment_
No dose adjustment of TYBOST is required in patients with renal
impairment, including those with
severe renal impairment (see Section 5.1 Pharmacodynamic properties).
TYBOST has been shown to decrease estimated creatinine clearance due
to inhibition of tubular
secretion of creatinine without affecting actual renal glomerular
function. This effect