EPCLUSA sofosbuvir 400 mg / velpatasvir 100 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

velpatasvir, Quantity: 100 mg; sofosbuvir, Quantity: 400 mg

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

sofosbuvir,velpatasvir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; copovidone; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide red; macrogol 4000; polyvinyl alcohol

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EPCLUSA is indicated for the treatment of chronic hepatitis C virus (HCV) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 Dose and method of administration section for the recommended regimens for different patient subgroups).

Product summary:

Visual Identification: Pink, diamond-shaped, film coated tablets, debossed with "GSI" on one side and "7916" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-12-19

Patient Information leaflet

Epclusa® CMI FEB 2022 v5.0
1
EPCLUSA®
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.
1.
WHY AM I USING EPCLUSA?
Epclusa contains the active ingredients sofosbuvir and velpatasvir in
a single tablet. Epclusa is used to treat hepatitis C virus
infection in adults and children 12 years of age and older and
weighing 30 kg or more.
For more information, see Section 1. Why am I using Epclusa? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPCLUSA?
Do not use if you have ever had an allergic reaction to sofosbuvir,
velpatasvir or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF 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 use
Epclusa?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Epclusa and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE EPCLUSA?
The usual dose is one Epclusa tablet orally, once daily. Epclusa
tablets can be taken with or without food.
More instructions can be found in Section 4. How do I use Epclusa?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EPCLUSA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Epclusa
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Epclusa to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Epclusa affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your Epclusa tablets in the bottle with the cap tightly closed
until you take them.
•
Store Epclusa in a cool, dry place where it stays below 30 °C.
For more information, see Section 5. What sho

Summary of Product characteristics

EPCLUSA Product Information v7.0– (10 February 2022)
1
AUSTRALIAN PI – EPCLUSA
® (SOFOSBUVIR/VELPATASVIR)
1
NAME OF THE MEDICINE
EPCLUSA (sofosbuvir/velpatasvir 400 mg/100 mg)
tablets.
The active substances in EPCLUSA tablets are sofosbuvir and
velpatasvir.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EPCLUSA is available as a fixed-dose combination tablet. Each tablet
contains 100 mg
velpatasvir and 400 mg sofosbuvir. EPCLUSA tablets are pink,
diamond-shaped, film coated
tablets, debossed with “GSI” on one side and “7916” on the
other side.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each EPCLUSA tablet is film-coated and pink in colour. The tablets are
diamond shaped
debossed with “GSI” on one side and the number “7916” on the
other side. The tablets are
supplied in bottles with child-resistant closures.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
EPCLUSA is indicated for the treatment of chronic hepatitis C virus
(HCV) infection
(genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients ≥ 12
years of age and weighing
≥ 30 kg.
(see 4.2 Dose and method of administration section for the recommended
regimens for
different patient subgroups).
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of EPCLUSA in adults is one tablet, taken orally,
once daily with or
without food
_. _
Table 1 provides the recommended treatment regimen based on adult
patient population.
TABLE 1
RECOMMENDED TREATMENT REGIMEN REGARDLESS OF HCV GENOTYPE
ADULT PATIENT POPULATION
RECOMMENDED TREATMENT REGIMEN
Patients without cirrhosis and patients with
compensated cirrhosis
EPCLUSA for 12 weeks
Patients with decompensated cirrhosis
EPCLUSA + ribavirin
a
for 12 weeks
a.
In patients with decompensated cirrhosis, the ribavirin starting dose
should be 600mg daily, with dose adjustment
according to tolerance.
EPCLUSA Product Information v7.0– (10 February 2022)
2
SPECIAL POPULATIONS
PAEDIATRICS
In paediatric patients ≥ 12 years of age and weighing ≥ 30