MAVIRET glecaprevir/pibrentasvir 100 mg/40 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glecaprevir, Quantity: 100 mg; pibrentasvir, Quantity: 40 mg

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: propylene glycol monocaprylate; tocofersolan; croscarmellose sodium; sodium stearylfumarate; copovidone; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; iron oxide red; macrogol 3350

Administration route:

Oral

Units in package:

84

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MAVIRET is indicated for the treatment of adult and paediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV GT1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors (see 4.2 DOSE AND METHOD OF ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES ? Clinical trials).

Product summary:

Visual Identification: MAVIRET 100 mg/40 mg tablets are pink-coloured, film-coated, oblong biconvex shaped, and debossed with "NXT" on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-01-16

Patient Information leaflet

MAVIRET
®
M
A
V
I
R
E
T
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I TAKING MAVIRET?
Maviret contains the active ingredients glecaprevir and pibrentasvir.
Maviret is used to treat chronic hepatitis C.
For more information, see Section 1. Why am I taking Maviret? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE MAVIRET?
Check the list of ingredients at the end of this CMI. Do not take
Maviret if you have ever had an allergic reaction to any of them.
There are certain medicines that should not be taken together with
Maviret.
Talk to your doctor before you take this medicine if he/she is not
aware that you have any other medical conditions, take any other
medicines, or are pregnant or plan to become pregnant or are
breastfeeding.
For more information, see Section 2. What should I know before I take
Maviret? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Maviret and affect how it works.
Maviret may interfere with other medicines and affect how they
work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE MAVIRET?
TABLETS
•
Take 3 tablets all together, once every day. Take the tablets with
food.
•
Do not break, crush or chew the tablets. Swallow them whole with a
full glass of water.
GRAULES
Mix the required amount of granules with recommended food. Take this
once a day, before or after a snack or meal.
More instructions can be found in Section 4. How do I take Maviret? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING MAVIRET?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you become pregnant while taking
Maviret.
•
Keep all your doctor’s appointments so that your progress can be
checked.
•
Remind any doctor or dentist you vis

Summary of Product characteristics

MAVIRET PI
Version 11
14 September 2022
Page 1 of 37
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PI – MAVIRET
® (GLECAPREVIR / PIBRENTASVIR) TABLETS AND GRANULES
1
NAME OF THE MEDICINE
Glecaprevir and pibrentasvir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glecaprevir is a white to off-white crystalline powder with a
solubility of less than 0.1 to 0.3
mg/mL across a pH range of 2-7 at 37

C and is practically insoluble in water, but is sparingly
soluble in ethanol.
Pibrentasvir is a white to off-white to light yellow crystalline
powder with a solubility of less
than 0.1 mg/mL across a pH range of 1-7 at 37

C and is practically insoluble in water, but is
freely soluble in ethanol.
Tablets
MAVIRET is a fixed-dose combination tablet containing glecaprevir 100
mg and pibrentasvir
40 mg.
Granules
MAVIRET granules in sachets are a fixed-dose combination product
containing glecaprevir
50 mg and pibrentasvir 20 mg.
Both MAVIRET tablets and granules do not contain gluten. Both MAVIRET
tablets and
granules contain lactose.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets
MAVIRET
immediate
release
tablets
are
pink-coloured,
film-coated,
oblong
biconvex
shaped, and debossed with “NXT” on one side.


MAVIRET PI
Version 11
14 September 2022
Page 2 of 37
Granules
MAVIRET granules are available as pink granules (glecaprevir) and
yellow granules
(pibrentasvir). Both granules are round and biconvex.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAVIRET is indicated for the treatment of adult and paediatric
patients 3 years and older
with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6
infection with or without
compensated cirrhosis. This includes patients with HCV GT1 infection
who were previously
treated with either a regimen of an NS