PLEGRIDY

Main information

  • Trade name:
  • PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen TITRATION
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection pre-filled pen TITRATION
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214200
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214200

PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for

injection pre-filled pen TITRATION PACK

ARTG entry for

Medicine Registered

Sponsor

Biogen Australia Pty Ltd

Postal Address

PO Box 380,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/11/2014

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. PLEGRIDY peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection

pre-filled pen TITRATION PACK

Product Type

Composite Pack

Effective date

14/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

PLEGRIDY is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) (see CLINICAL TRIALS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Not recorded

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x peginterferon beta 1-a 94 microgram/0.5 mL pre-filled pen

(S4) Prescription Only Medicine

1 x peginterferon beta 1-a 63 microgram/0.5 mL pre-filled pen

(S4) Prescription Only Medicine

Components

1. PLEGRIDY peginterferon beta 1-a (rch) 63 microgram/0.5 mL solution for injection pre-filled pen

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

A clear, colorless liquid, essentially free of visible particles

Active Ingredients

peginterferon beta-1a

63 microgram

2. PLEGRIDY peginterferon beta 1-a (rch) 94 microgram/0.5 mL solution for injection pre-filled pen

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

A clear, colorless liquid, essentially free of visible particles

Active Ingredients

peginterferon beta-1a

94 microgram

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:31:16 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

© 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 2 of

Produced at 26.11.2017 at 10:31:16 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

PLEGRIDY

®

(PLEGG-rih-dee)

peginterferon beta-1a (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Plegridy.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Plegridy

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.

You may need to read it again.

What Plegridy is used

for

Plegridy is a prescription medicine

used to treat people with relapsing

forms of Multiple Sclerosis (MS). It

is not known if PLEGRIDY is safe

and effective in people under 18 or

over 65 years of age.

The cause of MS is not yet known.

MS affects the brain and spinal cord.

In MS, the body's immune system

reacts against its own myelin (the

'insulation' surrounding nerve fibres).

In relapsing forms of MS, people

have 'exacerbations' from time to

time (e.g. blurred vision, weakness in

the legs or arms, or loss of control of

bowel or bladder function). They are

followed by periods of recovery.

Recovery may be complete or

incomplete. If it is incomplete there

is 'progression of disability'.

Plegridy belongs to a group of

medicines called interferons. The

active substance in Plegridy is

peginterferon beta-1a. Peginterferon

beta-1a is a long-acting form of

interferon. Interferons exist naturally

in the body to help fight viral

infections and regulate the body's

immunity.

Although the exact mechanism of

interferons in MS is unknown, it is

thought that Plegridy works by

decreasing the unwanted immune

reaction against myelin.

Ask your doctor if you have any

questions about why this Plegridy

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

Plegridy is available only with a

doctor's prescription.

Use only for the person for whom

it has been prescribed.

Before you use

Plegridy

When you must not use it

Do not use Plegridy if you have an

allergy to:

interferon beta, peginterferon

beta-1a or any other interferon

any of the other ingredients listed

at the end of this leaflet

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin

Do not use Plegridy:

If you have severe depression or

think about committing suicide

If you are already pregnant

Do not use Plegridy after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

Do not use Plegridy if the medicine

is coloured, cloudy, or contains

floating particles. If it has expired or

is damaged or looks differently than

it should, return it to your pharmacist

for disposal.

If you are not sure whether you

should use this medicine, talk to your

doctor or pharmacist.

Before you use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had:

Depression or problems with your

moods, or if you have ever

considered committing suicide

A seizure, fit or convulsion

Liver problems

Bleeding problems

A problem with your heart

Thyroid problems

Bone marrow suppression

Do not start using Plegridy if you

are already pregnant.

PLEGRIDY

If you could get pregnant, you need

to use contraception while you use

Plegridy.

Tell your doctor:

If you are pregnant or plan to

become pregnant

If you want to breastfeed

Your doctor can discuss with you the

risks and benefits involved.

If you have not told your doctor

about any of the above, tell them

before you start using Plegridy.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Plegridy may interact with some

other medicines that are broken down

by the liver:

medicines to treat epilepsy

medicines to treat depression

Ask your doctor, nurse or

pharmacist if you have any

questions about medicines to be

careful with or avoid while using

Plegridy.

How to use Plegridy

Follow all directions given to you

by your doctor, MS nurse or

pharmacist carefully.

They may differ from the

information contained in this leaflet.

How much to use

Plegridy is only to be injected once

every 14 days (two weeks).

Plegridy is injected under the skin

(subcutaneously). Try to use Plegridy

at the same time on the same day

every time you inject.

How to use it

Starting Plegridy

If you are new to Plegridy your

doctor or MS nurse may advise you

to gradually increase your dose so

that you can adjust to the effects of

Plegridy before taking the full dose.

You will be provided with a Titration

Pack containing your first two

injections. For further details on use,

please follow the instructions

provided with the Titration Pack.

Use the record table printed on the

inside lid of the Titration Pack to

keep a track of your injection dates.

Many people with MS learn to give

themselves the injection or have it

given by a carer.

Self-injection needs to be taught and

practised. It is important that a

qualified health care professional

supervises your first injection.

Your doctor may teach you to self-

inject or arrange for an MS nurse to

do so.

After being taught to self-inject, you

should refer to the leaflet in the pack

for step-by-step instructions about

how to prepare and inject Plegridy.

How long to use it

The positive effects of Plegridy are

not seen immediately. They occur

with long-term treatment. It is

important to continue treatment with

Plegridy unless your doctor tells you

to stop.

If you forget to take it

Inject as soon as you remember

and then resume your regular

dosing schedule. However, never

inject more than once in a 7-day

period.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist or MS nurse for some

hints.

If you take too much

(overdose)

Immediately telephone the Poisons

Information Centre (telephone

Australia 13 11 26 or New Zealand

0800 POISON or 0800 764 766), if

you think that you or anyone else

may have used too much Plegridy.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are using

Plegridy

Things you must do

If you become pregnant while on

treatment with Plegridy,

immediately tell your doctor.

If you are a female of childbearing

age and are sexually active, you

should use birth control during

treatment with Plegridy.

If you have new or worsening

depression or suicidal thoughts,

immediately tell your doctor:

This could include feeling hopeless

or bad about yourself, thoughts of

hurting yourself or suicide,

irritability (getting upset easily),

nervousness, or new or worsening

anxiety.

Always talk to your doctor or

pharmacist before taking any other

medicine while you are using

Plegridy.

If he or she recommends that you

take a medication to reduce

symptoms of pain and inflammation,

follow their advice carefully. Do not

take more than the recommended

dose.

Tell any other doctors, dentists and

pharmacists who treat you that you

are using this medicine.

If you are about to have any blood

tests, tell your doctor that you are

using Plegridy.

It may interfere with the results of

some tests.

PLEGRIDY

Keep all your doctor's

appointments so that your progress

can be checked.

Your doctor may do blood tests

before you start treatment and from

time to time to monitor your progress

and prevent unwanted side effects.

Things you must not do

Do not give Plegridy to anyone

else, even if they appear to have the

same condition as you.

Do not stop using Plegridy or

change the dosage, without

checking with your doctor.

Talk about this with your doctor or

pharmacist if you want more

information.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Plegridy.

Plegridy helps most people with MS

but it may have unwanted effects in a

few people. All medicines have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you get

some side effects.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

Ask your doctor, MS nurse or

pharmacist to answer any

questions you may have.

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital if any of the

following happen:

Yellowing of your skin or the

whites of your eyes (jaundice)

Itching all over

Feeling sick, being sick (nausea

and vomiting)

Easy bruising of the skin

Loss of appetite, tiredness,

sleepiness, confusion,

Bleeding more easily than

normal,

Dark coloured urine, and pale

stools.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

The most common side effect is to

feel 'flu-like' symptoms, e.g.

headache, tiredness, muscle aches,

joint pain, shivering and fever. Your

doctor or MS nurse may advise you

to gradually increase your dose of

Plegridy during the first month of

treatment to help reduce these

symptoms. These side effects

generally occur less often as therapy

continues.

To help further reduce these

symptoms, your doctor may advise

you to take a medication to reduce

pain and inflammation before your

injection and for up to one day

afterwards.

You may get reactions around the

place you inject. These usually get

less over time. Reactions such as

redness, itching or pain are very

common. Swelling, bruising, warmth

or rash at the injection site is

common.

To reduce injection site reactions,

read and follow the advice given in

the "Instructions for Use" at the end

of the pack insert.

Tell your doctor, nurse or

pharmacist if you notice any of the

following and they worry you:

Headache

Muscle pain

Pain in your joints, arms, legs or

neck (arthralgia)

Chills, feeling cold

Feeling weak and tired (asthenia)

Feeling or being sick (nausea or

vomiting)

Itchy skin (pruritus)

Increase in body temperature

The above list includes the more

common side effects of Plegridy, or

these effects might be related to your

general health or the MS process, or

to a combination of these.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may occur in some people.

Some side effects can only be found

when your doctor does tests from

time to time to check your progress.

After using Plegridy

Storage

Keep your Plegridy in its original

pack until it is time to use it.

Keep Plegridy in the refrigerator

at 2°C to 8°C. Do not freeze.

If necessary, you can keep Plegridy

out of the refrigerator for up to 30

days as long as it is kept away from

light. If out of the refrigerator, store

the carton in a cool dry place where

the temperature stays between 2°C to

25°C.

Do not use any Plegridy that has

been out of the refrigerator for

more than 30 days (refer to

Disposal below).

Do not store Plegridy or any other

medicine in the bathroom or near a

sink. Do not leave it on a windowsill

or in the car. Heat and dampness can

destroy some medicines.

Keep Plegridy where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Please read the package insert

carefully for full details, including

safe disposal of needles and

syringes after use.

If your doctor tells you to stop using

Plegridy or the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

PLEGRIDY

Product description

What it looks like

The Plegridy pre-filled syringe

Titration Pack holds 2 ready to use

syringes. Each Titration Pack for

Plegridy syringe contains a clear,

colorless liquid (0.5ml) containing

either 63 or 94 micrograms of

peginterferon beta-1a.

The Plegridy prefilled syringe

Administration Dose Pack holds 2

ready to use syringes. Each

Administration Dose Pack syringe

contains a clear, colorless liquid

(0.5ml) containing 125 micrograms

of peginterferon beta-1a.

Every syringe has a pre-attached

needle and is ready to inject.

The Plegridy pre-filled pen Titration

Pack holds 2 ready to use pens. Each

Titration Pack for Plegridy pen

contains a clear, colorless liquid

(0.5ml) containing either 63 or 94

micrograms of peginterferon beta-1a.

The Plegridy pre-filled pen

Administration Dose Pack holds 2

ready to use pens. Each

Administration Dose Pack pen

contains a clear, colorless liquid

(0.5ml) containing 125 micrograms

of peginterferon beta-1a.

Every pen has a pre-attached needle

and is ready to inject.

Ingredients

Plegridy is available in 3 strengths:

63 micrograms, 94 micrograms, and

125 micrograms.

Active Ingredient:

peginterferon beta-1a (rch)

It also contains:

Sodium acetate trihydrate

Glacial acetic acid

L-arginine hydrochloride

Polysorbate 20

Water for injections

Further information

You can obtain more information

from your doctor, pharmacist or the

MS Society in your State, or by

telephoning 1800 852 289 in

Australia.

Supplier

Plegridy is supplied in Australia

by:

Biogen Australia Pty Ltd

ABN 30 095 760 115

Level 3

123 Epping Road

North Ryde NSW 2113

Australia

Australian registration

numbers

Plegridy 63 microgram/0.5 mL and

94 microgram/0.5 mL:

AUST R 214198 (pre-filled syringe)

AUST R 214200 (pre-filled pen)

Plegridy 125 microgram/0.5 mL:

AUST R 214199 (pre-filled syringe)

AUST R 214197 (pre-filled pen)

Date of preparation

This leaflet was prepared in June

2016.

PLEGRIDY

is a registered

trademark of Biogen MA Inc.

PLEGRIDY

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Avonex (Biogen Netherlands B.V.)

Avonex (Biogen Netherlands B.V.)

Avonex (Active substance: Interferon Beta - 1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5392 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/102/T/178

Europe -DG Health and Food Safety

2-8-2018

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Active substance: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene) - Transfer of orphan designation - Commission Decision (2018)5288 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/024/16/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5035 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/13/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

23-7-2018

Plegridy (Biogen Netherlands B.V.)

Plegridy (Biogen Netherlands B.V.)

Plegridy (Active substance: peginterferon beta-1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4881 of Mon, 23 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2827/T/49

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

17-7-2018

Rebif (Merck Serono Europe Limited)

Rebif (Merck Serono Europe Limited)

Rebif (Active substance: Interferon beta-1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4780 of Tue, 17 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/136/T/135

Europe -DG Health and Food Safety

11-7-2018

Betaferon (Bayer AG)

Betaferon (Bayer AG)

Betaferon (Active substance: Interferon beta-1b) - Centralised - Yearly update - Commission Decision (2018)4527 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Fertavid (Merck Sharp and Dohme B.V.)

Fertavid (Merck Sharp and Dohme B.V.)

Fertavid (Active substance: follitropin beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4474 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1042/T/39

Europe -DG Health and Food Safety

10-7-2018

Puregon (Merck Sharp and Dohme B.V.)

Puregon (Merck Sharp and Dohme B.V.)

Puregon (Active substance: follitropin beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4479 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/86/T/97

Europe -DG Health and Food Safety

29-6-2018

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Active substance: Interferon beta) - Amendment of orphan designation - Commission Decision (2018)4186 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/17

Europe -DG Health and Food Safety

6-6-2018

Zinbryta (Biogen Idec Limited)

Zinbryta (Biogen Idec Limited)

Zinbryta (Active substance: daclizumab beta) - PSUSA - Modification - Commission Decision (2018)3696 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3862/PSUSA/10518/201705

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety