SOVALDI sofosbuvir 400 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
21-02-2022
Summary of Product characteristics
(SPC)
21-02-2022
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
sofosbuvir
Available from:
Gilead Sciences Pty Ltd
INN (International Name):
sofosbuvir
Authorization status:
Registered
Patient Information leaflet
Sovaldi® CMI FEB 2022 v6.0
1
SOVALDI®
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 SOVALDI?
Sovaldi contains the active ingredient sofosbuvir. SOVALDI is given
with other medicines to treat hepatitis C virus (HCV)
infection in adults 18 years and older.
For more information, see Section 1. Why am I using Sovaldi? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SOVALDI?
Do not use if you have ever had an allergic reaction to Sovaldi 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
Sovaldi?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sovaldi 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 SOVALDI?
The usual dose is one Sovaldi tablet orally, once daily. Sovaldi
tablets can be taken with or without food.
More instructions can be found in Section 4. How do I use SOVALDI?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SOVALDI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sovaldi.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Sovaldi to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Sovaldi
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your Sovaldi tablets in the bottle with the cap tightly closed
until you take them.
•
Store Sovaldi in a cool, dry place where it stays below 30 °C.
For more information, see Section 5. What should I know while using
[insert medicine]? in the full CMI.
6.
ARE THERE ANY SIDE EFFE
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Summary of Product characteristics
SOVALDI Product Information v7.0 – (16 February 2022)
1
AUSTRALIAN PI – SOVALDI
® (SOFOSBUVIR)
1
NAME OF THE MEDICINE
SOVALDI (400 mg sofosbuvir)
tablets.
The active substance in SOVALDI tablets is sofosbuvir.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOVALDI is available as 400 mg tablets, which contain 400 mg
sofosbuvir and are yellow,
capsule shaped, film coated with “GSI” on one side and “7977”
on the other side. For the full
list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each SOVALDI tablet is film-coated and yellow in colour. The tablets
are capsule shaped
debossed with “GSI” on one side and the number “7977” on the
other side. The tablets are
supplied in bottles with child resistant closures.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SOVALDI is indicated for the treatment of adults with chronic
hepatitis C (CHC) infection as
a component of a combination antiviral treatment regimen.
(see 5.1 Pharmacodynamic Properties, Clinical Trials and 4.2 Dose and
method of
administration section for detailed information on the studied
combinations, dose regimens,
and treatment durations for different subgroups of CHC patients).
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage of SOVALDI tablets is 400 mg once daily taken
orally with or
without food.
SOVALDI should be used in combination with other agents. The
recommended treatment
regimen and duration for SOVALDI combination therapy is provided in
Table 1 and Figure
1.
SOVALDI Product Information v7.0 – (16 February 2022)
2
TABLE 1
RECOMMENDED TREATMENT REGIMENS AND DURATION FOR SOVALDI
COMBINATION THERAPY FOR ADULTS
DURATION
SOVALDI DOSE
(DAILY)
PEGINTERFERON
ALFA DOSE
RIBAVIRIN
DOSE
(DAILY)
Patients with genotype 1,
4, 5 or 6 CHC
12 weeks
a,b
400 mg
See
peginterferon
alfa product
information
c
See ribavirin
product
information
d
Patients with genotype 2
CHC
12 weeks
NA
<75 kg =
1000 mg
c
≥75 kg =
1200 mg
c
Patients with genotype 3
CHC
16 weeks
e
Patients with CHC
awaiting liver
transplant
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