HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sofosbuvir, Quantity: 400 mg; ledipasvir acetone solvate, Quantity: 95.9 mg (Equivalent: ledipasvir, Qty 90 mg)

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

ledipasvir acetone solvate,sofosbuvir

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

28 Tablets, Bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

HARVONI (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis C (CHC) infection in adults. (see PRECAUTIONS and CLINICAL TRIALS sections for information on the available data for HCV patients of each genotype, see DOSAGE AND ADMINISTRATION section for recommended regimens and treatment durations for different patient subgroups).

Product summary:

Visual Identification: Film coated, orange, diamond shaped tablet with "GSI" on one side and "7985" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 72 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-05-13

Patient Information leaflet

Harvoni® CMI FEB 2022 v 6.0
1
HARVONI®
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. [Include if
applicable]
1.
WHY AM I USING HARVONI?
Harvoni contains the active ingredients sofosbuvir and ledipsavir.
Harvoni is used to treat hepatitis C virus (HCV) infection in
adults 18 years and older.
For more information, see Section 1. Why am I using Harvoni? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HARVONI?
Do not use if you have ever had an allergic reaction to Harvoni 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
Harvoni?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Harvoni 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 HARVONI?
The usual dose is one Harvoni tablet orally, once daily. Harvoni
tablets can be taken with or without food.
More instructions can be found in Section 4. How do I use HARVONI?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HARVONI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Harvoni.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Harvoni 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 Harvoni
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your Harvoni tablets in the bottle with the cap tightly closed
until you take them.
•
Store Harvoni in a cool, dry place where it stays below 30 °

Summary of Product characteristics

HARVONI Product Information v11.0 – (10 February 2022)
1
AUSTRALIAN PI – HARVONI
® (LEDIPASVIR/SOFOSBUVIR)
1
NAME OF THE MEDICINE
HARVONI (ledipasvir/sofosbuvir 90 mg/400 mg) tablets.
The active substances in HARVONI tablets are ledipasvir and sofosbuvir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HARVONI is available as a fixed-dose combination tablet. Each tablet
contains 90 mg
ledipasvir and 400 mg sofosbuvir and are orange diamond shaped, film
coated with “GSI” on
one side and “7985” on the other side. For the full list of
excipients, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Each HARVONI tablet is film-coated and orange in colour. The tablets
are diamond shaped
debossed with “GSI” on one side and the number “7985” on the
other side. The tablets are
supplied in bottles with child resistant closures.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HARVONI (ledipasvir/sofosbuvir fixed-dose combination) is indicated
for the treatment of
chronic hepatitis C (CHC) infection in adults.
(see 4.4 Special warnings and precautions for use and 5.1
Pharmacodynamic properties,
Clinical Trials sections for information on the available data for HCV
patients of each
genotype, see 4.2 Dose and method of administration section for
recommended regimens and
treatment durations for different patient subgroups).
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of HARVONI tablets is one tablet, taken orally,
once daily with or
without food.
The recommended treatment regimen and duration for HARVONI is provided
in Table 1.
For patients with HCV/HIV-1 co-infection, follow the dosage
recommendations in Table 1.
HARVONI Product Information v11.0 – (10 February 2022)
2
TABLE 1
RECOMMENDED TREATMENT REGIMEN AND DURATION FOR HARVONI
(INCLUDING THE CO-ADMINISTRATION OF RIBAVIRIN FOR CERTAIN SUBGROUPS)
HCV GENOTYPE
PATIENT POPULATION
TREATMENT REGIMEN AND
DURATION
Genotype 1
Treatment-naïve without cirrhosis
HARVONI 8 or 12 weeks
a
Treatment-naïve with cirrhosis
HARVONI 12 weeks
Trea tm