HARVONI

Main information

  • Trade name:
  • HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222848
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222848

HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Gilead Sciences Pty Ltd

Postal Address

Level 6 / 417 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

13/05/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle

Product Type

Single Medicine Product

Effective date

11/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 30

degrees Celsius

Not recorded

Store at room

temperature

Pack Size/Poison information

Pack Size

Poison Schedule

28 Tablets, Bottle

(S4) Prescription Only Medicine

Components

1. HARVONI ledipasvir/sofosbuvir 90 mg/400 mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Film coated, orange, diamond shaped tablet with "GSI" on one side and

"7985" on the other side

Active Ingredients

ledipasvir acetone solvate

95.9 mg

sofosbuvir

400 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:49:22 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

HARVONI Consumer Medicine Information v3.0 – 02 DECEMBER 2016

Harvoni

Tablets

ledipasvir /sofosbuvir 90 mg/400 mg tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about HARVONI tablets.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be available.

The latest Consumer Medicine

Information is available from your

pharmacist or doctor and may

contain important information about

the medicine and its use of which

you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking HARVONI

against the benefits it is expected to

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

This medicine has been prescribed

for you personally and you should

not pass it on to others. It may harm

them, even if their symptoms are the

same as yours.

What HARVONI is

used for

HARVONI is used to treat hepatitis

C virus infection in adults of 18

years and older.

Hepatitis C is a virus that infects the

liver.

How HARVONI works

HARVONI is one tablet that contains

two active substances, ledipasvir and

sofosbuvir. This medicine works by

lowering the amount of hepatitis C

virus in your body and may lead to a

cure of your HCV infection over a

number of weeks.

HARVONI is sometimes taken with

another medicine, ribavirin.

Cure means the HCV virus is cleared

from your blood (remains at an

undetectable level) when measured 3

months after finishing all treatment.

HARVONI does not protect

against re-infection with the HCV

virus if cure has been achieved.

Ask your doctor if you have any

questions about why HARVONI

has been prescribed for you.

Use in children

HARVONI is for adults. HARVONI

has not been studied in children

under the age of 18.

Before you take

HARVONI

When you must not take it

Together with your doctor, you need

to decide whether HARVONI is right

for you.

Do not take HARVONI if you are

allergic to:

ledipasvir,

sofosbuvir or

any of the other ingredients of

HARVONI. The ingredients of

HARVONI are in the product

description section of this

leaflet.

Some people are allergic to

medicines. If you have any of the

following symptoms soon after

taking your medicine, DO NOT

TAKE ANY MORE HARVONI and

tell your doctor IMMEDIATELY or

go to the accident and emergency

department at your nearest hospital:

Skin troubles such as lumpy skin

rash or “hives”

Swelling of the face, lips, mouth

or throat which may cause

difficulty in swallowing or

breathing

Wheezing, chest pain or tightness

Fainting

These are very serious effects. If you

have them, you may have a serious

allergic reaction. You may need

urgent medical attention or

hospitalisation. Hypersensitivity

reactions are very rare.

Ask your doctor or pharmacist if

you don’t understand anything in

this list.

Do not take HARVONI if you are

taking any medicine other than

HARVONI that contains

sofosbuvir.

If you are pregnant, think you may

be pregnant or are planning to

have a baby, ask your doctor or

pharmacist for advice before

taking this medicine. You should

not breast feed during treatment

with HARVONI.

Do not take HARVONI after the

expiry or “use by” date (EXP)

printed on the bottle.

If you take it after the expiry date has

passed, it may not work as well.

HARVONI Consumer Medicine Information v3.0 – 02 DECEMBER 2016

Do not take HARVONI if the

packaging is torn or shows signs of

tampering.

Before you start to take it

Tell your doctor if you are allergic

to foods, dyes, preservatives or any

other medicines.

Tell your doctor if you have, or

have had, any of the following

medical conditions:

Have liver problems, other than

hepatitis C

Have a current or previous

infection with the hepatitis B

virus, since your doctor may

want to monitor you more

closely.

Have severe kidney problems or

if you are on haemodialysis as

the effects of HARVONI on

patients with severe kidney

problems have not been fully

tested

Have any other medical condition

Tell your doctor if you:

Are pregnant or planning to

become pregnant. Please speak

to your doctor if you are unsure.

HARVONI may be used with

ribavirin. Ribavirin can damage

your unborn baby. It is therefore

absolutely essential that you

(and your partner) take all

precautions not to get pregnant if

you are taking ribavirin. You

and your partner must use an

effective birth control method

during ribavirin treatment and

during the 6 months after

completing ribavirin treatment.

It is very important that you read

the “Pregnancy” section in the

ribavirin product information

very carefully

Are breastfeeding or plan to

breast-feed. It is not known

whether ledipasvir or sofosbuvir,

the two active substances of

HARVONI, pass into human

breast milk

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

HARVONI.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines

including any that you buy without

a prescription from your

pharmacy, supermarket or health

food shop.

Some medicines and HARVONI

may interfere with each other.

Tell your doctor if you take any of

the following medicines:

amiodarone used to treat heart

conditions

digoxin used to treat heart

conditions

rosuvastatin used to treat high

cholesterol

tipranavir used to treat HIV

infection

tenofovir disoproxil fumarate

used to treat HIV infection

rifampicin, rifapentine, rifabutin

(antibiotics used to treat

infections, including

tuberculosis);

St. John’s Wort (Hypericum

perforatum – herbal medicine

used to treat depression);

carbamazepine, phenytoin

(medicines used to treat epilepsy

and prevent seizures).

HARVONI may interact with these

medicines. As a result, the amounts

of HARVONI or other medicines in

your blood may be affected. This

may stop your medicines from

working properly, or make any side

effects worse. In some cases your

doctor may need to give you a

different medicine or adjust the dose

of medicine you are taking.

Take any medicines used to treat

stomach ulcers, heartburn or

acid reflux, such as:

antacids (e.g. aluminium

hydroxide or magnesium

hydroxide)

Proton pump inhibitors (e.g.

omeprazole)

H2-antagonists (e.g.

famotidine)

These medicines can decrease the

amount of ledipasvir in your blood.

If you are taking one of these

medicines your doctor will either

give you a different medicine for

stomach ulcers, heartburn or acid

reflux, or recommend how and when

you take that medicine.

If you are taking an antacid,

take it at least 4 hours

before or at least 4 hours

after HARVONI.

If you are taking a proton

pump inhibitor, take it at

the same time as

HARVONI or up to 2

hours after taking

HARVONI. Do not take

before HARVONI.

If you are taking an H

antagonist, your doctor

may give you a different

medicine or adjust the dose

of the medicine you are

taking.

It is very important to let your doctor

or pharmacist know what

medications, herbal supplements, or

vitamins you are taking.

Know the medicines you take. Keep

a list of medicines and show it to

your doctor and pharmacist when

you get a new medicine. Your

doctor and your pharmacist can tell

you if you can take these medicines

with HARVONI. Do not start any

new medicines while you are taking

HARVONI without first talking with

your doctor or pharmacist.

Your doctor and pharmacist may

have more information on medicines

to be careful with or to avoid while

taking HARVONI

.

HARVONI Consumer Medicine Information v3.0 – 02 DECEMBER 2016

How to take HARVONI

Follow all directions given to you

by your doctor or pharmacist

carefully.

How much to take

The usual dose is one HARVONI

tablet orally, once daily. Never

change the dose on your own. Do

not stop this medicine unless your

doctor tells you to stop.

How to take it

HARVONI tablets can be taken with

or without food.

When to take it

Take HARVONI at about the same

time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

If you forget to take it

Do not miss a dose of HARVONI.

If you forget to take HARVONI,

take your missed dose right away

unless it is almost time for your

next dose.

Do not take a double dose to make

up for a forgotten dose. Continue

with your regular dosing schedule.

Do not stop taking HARVONI

unless your doctor tells you to. It

is very important that you

complete the full course of

treatment to give the medicines the

best chance to cure your

hepatitis C virus infection.

Do not change your dose or stop

taking HARVONI without first

talking to your doctor.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to use your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre:

131126 (Australia) and

0800 764 766 (New Zealand) or go

to the Accident and Emergency

department at your nearest

hospital if you think you or anyone

else may have taken too many

HARVONI tablets. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are taking

HARVONI

Things you must do

Tell all doctors and pharmacists

who are treating you that you are

taking HARVONI.

Tell your doctor as soon as possible

if there is any worsening of your

condition.

Things you must not do

Do not give HARVONI to anyone

else, even if they have the same

condition as you.

Do not stop taking HARVONI or

change the dose without checking

with your doctor.

It is important not to suddenly stop

taking your HARVONI tablets,

unless advised to do so by your

doctor.

Do not breastfeed. See “Before

you take it”.

Things to be careful of

Be careful driving or operating

machinery until you know how

HARVONI affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

HARVONI.

HARVONI helps most people with

Hepatitis C virus infection, but it

may have unwanted side effects in a

few people. All medicines can have

side effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the side

effects. Do not be alarmed by these

lists of possible side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

tiredness

headache

nausea

trouble sleeping (insomnia)

cough, shortness of breath

rash, itchy skin

feeling irritable

Tell your doctor as soon as possible

if you have any problems while

taking HARVONI, even if you do

not think the problems are

connected with the medicine or are

not listed in this leaflet.

Tell your doctor immediately if

you or your family notice any of

the following side effects:

signs of allergy such as rash or

hives on the skin; swelling of the

face, lips, tongue or other parts

of the body; wheezing or

difficulty breathing

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some people.

HARVONI Consumer Medicine Information v3.0 – 02 DECEMBER 2016

After taking HARVONI

Storage

Keep your HARVONI where young

children cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Keep HARVONI tablets in a cool,

dry place where it stays below

30 °C.

Do not store HARVONI or any other

medicine in a bathroom or near a

sink. Do not leave HARVONI in the

car or on a window sill – heat and

dampness can destroy some

medicines.

Keep your HARVONI tablets in

the bottle with the cap tightly

closed until you take them. If you

take HARVONI tablets out of their

pack they may not keep well.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

HARVONI tablets are diamond-

shaped and orange in colour. Each

tablet has “GSI” on one side and

“7985” on the other side of the tablet.

HARVONI tablets are supplied in

bottles containing 28 tablets.

Ingredients

Active Ingredients: ledipasvir and

sofosbuvir

Inactive Ingredients: silicon dioxide,

copovidone, croscarmellose sodium,

lactose, magnesium stearate and

microcrystalline cellulose.

Film-coating:

polyvinyl alcohol,

macrogol 3350, titanium dioxide,

purified talc, and sunset yellow FCF

aluminium lake.

Sponsor

Australia

Gilead Sciences Pty Ltd

Level 6, 417 St Kilda Road

Melbourne, Victoria 3004

New Zealand

c/- PricewaterhouseCoopers

Level 8 Pricewaterhousecoopers

Tower

188 Quay Street

Auckland 1010

This leaflet was prepared in

December 2016.

HARVONI, 7985 and GSI are

trademarks of Gilead Sciences, Inc. or

one of its related companies. Other

brands listed are trademarks of their

respective owners and are not trademarks

of Gilead Sciences, Inc.

AUST R 222848

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

10-7-2018

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Active substance: sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4482 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2798/T/51

Europe -DG Health and Food Safety

11-6-2018

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Active substance: ledipasvir/sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3759 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3850/T/67

Europe -DG Health and Food Safety

11-6-2018

Vosevi (Gilead Sciences Ireland UC)

Vosevi (Gilead Sciences Ireland UC)

Vosevi (Active substance: sofosbuvir / velpatasvir / voxilaprevir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3775 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4350/T/15

Europe -DG Health and Food Safety

30-5-2018

Epclusa (Gilead Sciences Ireland UC)

Epclusa (Gilead Sciences Ireland UC)

Epclusa (Active substance: sofosbuvir/velpatasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3452 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4210/T/27

Europe -DG Health and Food Safety