Harvoni

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ledipasvir 90mg;  ;  ; Sofosbuvir 400mg;  ;  ;  

Available from:

Gilead Sciences (NZ)

INN (International Name):

Ledipasvir 90 mg

Dosage:

90mg/400mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ledipasvir 90mg     Sofosbuvir 400mg       Excipient: Colloidal silicon dioxide Copovidone Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 85F13912

Prescription type:

Prescription

Manufactured by:

Esteve Quimica SA

Therapeutic indications:

HARVONI is indicated for the treatment of chronic hepatitis C (CHC) infection in adults and in pediatric patients 12 years of age and older or weighing at least 35 kg with genotype 1, 4, 5 or 6 without cirrhosis or with compensated cirrhosis.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 100 mL, white, HDPE with PP child resistant cap, in outer carton - 28 tablets - 60 months from date of manufacture stored at or below 30°C

Authorization date:

2014-05-09

Patient Information leaflet

Harvoni® CMI MAY 2022 v 8.0
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 Data Sheet v9.0 – (30 May 2022) Page 1 of 37
NEW ZEALAND DATA SHEET
1 HARVONI
® (LEDIPASVIR 90 MG, SOFOSBUVIR 400 MG) TABLETS)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ledipasvir 90 mg and sofosbuvir 400 mg)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
HARVONI tablets are orange diamond shaped debossed with “GSI” on
one side and the number
“7985” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HARVONI is indicated for the treatment of chronic hepatitis C (CHC)
infection in adults and in
paediatric patients 12 years of age and older or weighing at least 35
kg with genotype 1, 4, 5 or 6
without cirrhosis or with compensated cirrhosis.
4.2 DOSE AND METHOD OF ADMINISTRATION
4.2.1 Adults
The recommended dose of HARVONI tablets in adults is one tablet, taken
orally, once daily with
or without food.
Table 1 provides the recommended treatment duration of HARVONI and the
recommended use of
co-administered medicinal product for certain subgroups.
HARVONI Data Sheet v9.0 – (30 May 2022) Page 2 of 37
TABLE 1
RECOMMENDED TREATMENT DURATION FOR HARVONI IN ADULT PATIENTS AND THE
RECOMMENDED USE OF CO ADMINISTERED RIBAVIRIN IN CERTAIN SUBGROUPS
PATIENT POPULATION*
TREATMENT
DURATION
PATIENTS WITH GENOTYPE 1, 2, 4, 5 OR 6 CHC MONO-INFECTED AND HCV/HIV-1
CO-INFECTED PATIENTS
Treatment-naïve without cirrhosis
HARVONI
8 or 12 weeks
a
Treatment-naïve with cirrhosis
HARVONI
12 weeks
Treatment-experienced
b
without cirrhosis
HARVONI
12 weeks
Treatment-experienced
b
with cirrhosis
HARVONI
12 or 24 weeks
c
Liver transplant recipients with compensated liver
disease
HARVONI + ribavirin
12 Weeks
PATIENTS WITH GENOTYPE 3 CHC
Treatment-naïve with and without cirrhosis
HARVONI + ribavirin
12 weeks
*
Includes patients co-infected with human immunodeficiency virus (HIV)
a.
HARVONI for 8 weeks can be considered for treatment-naïve,
non-cirrhotic patients with baseline HCV RNA <6 million
IU/mL
b.
Treatment-experienced patients who have failed treatment wit