Consumer medicine information

Plegridy

Peginterferon beta-1a

BRAND INFORMATION

Brand name

Plegridy

Active ingredient

Peginterferon beta-1a

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Plegridy.

SUMMARY CMI

PLEGRIDY®

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 PLEGRIDY?

PLEGRIDY contains the active ingredient peginterferon beta-1a (rch). PLEGRIDY is used to treat people with relapsing forms of Multiple Sclerosis (MS).
For more information, see Section 1. Why am I using PLEGRIDY? in the full CMI.

2. What should I know before I use PLEGRIDY?

Do not use if you have ever had an allergic reaction to PLEGRIDY 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 PLEGRIDY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PLEGRIDY 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 PLEGRIDY?

  • PLEGRIDY dose is gradually increased. The recommended starting dose is a single injection of PLEGRIDY 63 micrograms, followed by a single injection of PLEGRIDY 94 micrograms two weeks later. Full dose is 125 micrograms.
  • PLEGRIDY is injected under the skin (subcutaneously) every 14 days (two weeks).

More instructions can be found in Section 4. How do I use PLEGRIDY? in the full CMI.

5. What should I know while using PLEGRIDY?

Things you should do
  • Remind any doctor, dentist, MS nurse or pharmacist you visit that you are using PLEGRIDY.
  • Tell your doctor if you are pregnant or plan to become pregnant, or if you want to breastfeed.
  • If you are about to have any blood tests, tell your doctor that you are using PLEGRIDY, as it may interfere with the results of some tests.
Things you should not do
  • Do not stop using this medicine unless your doctor tells you to.
  • Do not use PLEGRIDY if you have severe depression or think about committing suicide.
  • Do not use PLEGRIDY if you are already pregnant.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how PLEGRIDY affects you.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
  • Alcohol may increase the risk of liver injury.
Looking after your medicine
  • Keep 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. PLEGRIDY can be kept out of the refrigerator between 2°C to 25°C for up to 30 days as long as it is kept away from light.

For more information, see Section 5. What should I know while using PLEGRIDY? in the full CMI.

6. Are there any side effects?

Common side effects include headache, muscles or joints pain, feeling sick or having flu, feeling cold or tired, nausea, vomiting, itch, injection site reactions.
Serious side effects may include seizure, allergic reaction, liver injury, depression, thoughts of hurting yourself or suicide.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

PLEGRIDY® (PLEGG-rih-dee)

Active ingredient(s): peginterferon beta-1a (rch)

Consumer Medicine Information (CMI)

This leaflet provides important information about using PLEGRIDY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PLEGRIDY.

Where to find information in this leaflet:

1. Why am I using PLEGRIDY?
2. What should I know before I use PLEGRIDY?
3. What if I am taking other medicines?
4. How do I use PLEGRIDY?
5. What should I know while using PLEGRIDY?
6. Are there any side effects?
7. Product details

1. Why am I using PLEGRIDY?

PLEGRIDY contains the active ingredient peginterferon beta-1a (rch). PLEGRIDY belongs to a group of medicines called interferons.

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 action of interferons in MS is unknown, it is thought that PLEGRIDY works by decreasing the unwanted immune reaction against myelin.

2. What should I know before I use PLEGRIDY?

Warnings

Do not use PLEGRIDY if:

  • you are allergic to interferon beta or peginterferon, or any of the 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
  • Always check the ingredients to make sure you can use this medicine.
  • If you have severe depression or think about committing suicide
  • If you are already pregnant

Check with your doctor if you:

have any other medical conditions such as:

  • allergies to any other medicines, foods, preservatives or dyes.
  • Depression or problems with your moods, or if you have ever considered committing suicide
  • A seizure, fit or convulsion
  • Liver problems
  • Bleeding problems, bruising easily, frequent infections
  • Heart problems
  • Thyroid problems
  • Bone marrow suppression.
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not start using PLEGRIDY if you are already pregnant.

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 are breastfeeding or intend 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.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with PLEGRIDY and affect how it works.

PLEGRIDY may interact with some other medicines that are broken down by the liver:

  • medicines to treat epilepsy
  • medicines to treat depression

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PLEGRIDY.

4. How do I 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

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.

The recommended starting dose is a single injection of PLEGRIDY 63 micrograms, followed by a single injection of PLEGRIDY 94 micrograms two weeks later.

You will be provided with an Administration Dose Pack containing your next injections.

The recommended third dose is a single injection of PLEGRIDY 125 micrograms (full dose), two weeks after the second dose.

Full doses of PLEGRIDY 125 micrograms are then recommended every 14 days (two weeks).

Use the record table printed on the inside lid of the Pack to keep a track of your injection dates.

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.

When to use PLEGRIDY

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 inject PLEGRIDY Pen

Many people with MS learn to give themselves the injection or have it given by a carer.

Self-injection needs to be taught and practiced. 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.

Keep referring to the leaflet for detailed instructions on how to use PLEGRIDY.

You can obtain more information from your doctor, pharmacist or the MS Society in your State, or by telephoning 1800 852 289 in Australia or 0800 852 289 in NZ.

If you forget to use PLEGRIDY

PLEGRIDY should be used regularly at the same time every 14 days. If you miss your dose at the usual time, 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 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 use too much PLEGRIDY

If you think that you have used too much PLEGRIDY, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26 in Australia, or 0800 POISON or 0800 764 766 in New-Zealand), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PLEGRIDY?

Things you should do

Call your doctor straight away if you:

  • 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.

Remind any doctor, dentist or pharmacist you visit that you are using PLEGRIDY.

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.

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 should not do

  • Do not stop using PLEGRIDY or change the dosage, without checking with your doctor.
  • Do not give PLEGRIDY to anyone else, even if they appear to have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PLEGRIDY affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the risk of liver injury.

Looking after your medicine

  • 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).

Heat and dampness can destroy some medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

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.

Getting rid of any unwanted medicine

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.

If you no longer need to use this medicine or it is out of date, or is damaged or looks differently than it should, take it to any pharmacy for safe disposal.

If you are not sure whether you should use this medicine, talk to your doctor or pharmacist.

Do not use this medicine after the expiry date.

6. Are there any side effects?

PLEGRIDY helps most people with MS but it may have unwanted effects in a few people.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, MS nurse or pharmacist to answer any further questions you may have about side effects.

Less serious side effects

Less serious side effectsWhat to do
Nervous system-related:
  • Headache
  • Feeling weak and tired (asthenia)
Muscles and joints related:
  • Muscle pain
  • Pain in your joints, arms, legs or neck (arthralgia)
Skin related:
  • Itchy skin (pruritus)
Digestion system related:
  • Feeling or being sick (nausea or vomiting)
Non-specific effect on the body:
  • Fever, chills, feeling cold
Speak to your doctor or MS nurse if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Liver-related
  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Itching all over
  • Feeling sick, being sick (nausea and vomiting), loss of appetite
  • Tiredness, sleepiness, confusion
  • Bleeding more easily than normal, easy bruising of the skin
  • Dark coloured urine, and pale stools
Psychiatric-related:
  • Depression, thoughts of hurting yourself or suicide
  • New mood changes
Allergic reaction related:
  • 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.
Nervous system-related:
  • Seizure (fit)
  • Weakness
  • Tiredness (lethargy)
  • Confusion
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Flu-like symptoms

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.

Three simple ways to help reduce the impact of flu-like symptoms:

  1. Consider the timing of your PLEGRIDY injection. The start and end of flu-like symptoms are different for every patient. On average, flu-like symptoms begin approximately 10 hours after injection and last for about 17 hours.
  2. Take paracetamol or ibuprofen half an hour before your PLEGRIDY injection. Speak to your doctor or pharmacist about how much to take and how long to take it.
  3. If you have a fever, drink plenty of water to keep you hydrated.

Injection site reactions

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 or pharmacist if you notice anything else that may be making you feel unwell.

Some side effects (such as decreased blood cell counts, or changed liver function) can only be found when your doctor does tests from time to time to check your progress.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PLEGRIDY contains

Active ingredient
(main ingredient)		peginterferon beta-1a (rch)
Other ingredients
(inactive ingredients)		Sodium acetate trihydrate
Glacial acetic acid
L-arginine hydrochloride
Polysorbate 20
Water for injections
Potential allergensNone

Do not take this medicine if you are allergic to any of these ingredients.

What PLEGRIDY looks like

The PLEGRIDY pre-filled syringe Titration Pack holds 2 ready to use syringes. Each Titration Pack for PLEGRIDY syringe contains a clear, colourless liquid (0.5 mL) containing either 63 or 94 micrograms of peginterferon beta-1a.

The PLEGRIDY pre-filled syringe Administration Dose Pack holds 2 ready to use syringes. Each Administration Dose Pack syringe contains a clear, colourless liquid (0.5 mL) 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, colourless liquid (0.5 mL) 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, colourless liquid (0.5 mL) containing 125 micrograms of peginterferon beta-1a.

Every pen has a pre-attached needle and is ready to inject.

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)

Who distributes PLEGRIDY

PLEGRIDY is supplied in Australia by:

Biogen Australia Pty Ltd
Level 4
2 Banfield Road
Macquarie Park NSW 2113
Australia

It is supplied in New Zealand by:

Biogen NZ Biopharma Limited
Auckland
New Zealand

This leaflet was prepared in May 2023.

Published by MIMS July 2023

BRAND INFORMATION

Brand name

Plegridy

Active ingredient

Peginterferon beta-1a

Schedule

S4

 

1 Name of Medicine

Peginterferon beta-1a (rch).

2 Qualitative and Quantitative Composition

Pre-filled pen.

A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 63 micrograms, 94 micrograms, or 125 micrograms of peginterferon beta-1a. The glass syringe is contained within a single-use, disposable, injection device (pre-filled pen).

Pre-filled syringe.

A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 63 micrograms, 94 micrograms or 125 micrograms of peginterferon beta-1a.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Plegridy is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see Section 5.1 Pharmacodynamic Properties).

4.2 Dose and Method of Administration

Plegridy is administered subcutaneously using a single use pre-filled pen or single use pre-filled syringe.
The recommended dosage of Plegridy is 125 micrograms injected subcutaneously every 2 weeks.

Treatment initiation.

It is generally recommended that patients start treatment with 63 micrograms at dose 1 (day 0), increasing to 94 micrograms at dose 2 (day 14), reaching the full dose of 125 micrograms by dose 3 (day 28) and continuing with the full dose (125 micrograms) every 14 days (2 weeks) thereafter (see Table 1).
A titration pack is available containing the 63 micrograms (dose 1, orange label) and 94 micrograms (dose 2, blue label) syringes/ pens.
It is recommended that a health care professional trains patients in the proper technique for self administering subcutaneous injections using the pre-filled pen/ syringe. Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections include abdomen, arm, and thigh.
If a dose of Plegridy is missed, it should be administered as soon as possible.
If 7 days or more to the next planned dose: Patients should administer their missed dose immediately. Treatment can then continue with the next scheduled dose as planned.
If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of Plegridy within 7 days of each other.
Each Plegridy pre-filled pen/ syringe is provided with the needle pre-attached. Pre-filled pens/ syringes are for single use only and should be discarded after use.
Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment.

Children and adolescents.

The safety and efficacy of Plegridy in patients below 18 years of age has not been studied.

Dosage adjustment in renal impairment.

No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease (see Section 4.4 Special Warnings and Precautions for Use; Section 5.2 Pharmacokinetic Properties).

Dosage adjustment in hepatic impairment.

Plegridy has not been studied in patients with hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use; Section 5.2 Pharmacokinetic Properties).

Dosage adjustment in the elderly.

The safety and efficacy of Plegridy in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.

4.3 Contraindications

Plegridy is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of the formulation.
The initiation of treatment is contraindicated during pregnancy, and in patients with current severe depression and/or suicidal ideation.

4.4 Special Warnings and Precautions for Use

Hepatic injury.

Hepatic injury, including elevated serum hepatic transaminase levels, hepatitis, and autoimmune hepatitis, and rare cases of severe hepatic failure, has been reported with interferon beta. Elevations in hepatic enzymes, noninfectious hepatitis and hepatic injury have been observed with the use of Plegridy. Patients should be monitored for signs of hepatic injury. Withdrawal of treatment with Plegridy should be considered if hepatic transaminase levels significantly increase or if they are associated with clinical symptoms such as jaundice (see Section 4.8 Adverse Effects (Undesirable Effects)).

Depression and suicidal ideation.

Depression and suicidal ideation have been reported to occur with increased frequency in patients receiving interferon beta. Patients treated with Plegridy should be advised to report immediately any symptoms of depression and/or suicidal ideation to their prescribing physician. Patients exhibiting depression should be monitored closely during therapy with Plegridy and treated appropriately. If a patient develops depression or other severe psychiatric symptoms, cessation of Plegridy therapy should be considered (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).

Anaphylactic and hypersensitivity reactions.

Serious hypersensitivity reactions, including cases of anaphylaxis, have been reported as a rare complication of treatment with interferon beta, including Plegridy. Patients should be advised to discontinue Plegridy and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity. Treatment should not be restarted (see Section 4.8 Adverse Effects (Undesirable Effects)).

Injection site reactions.

Injection site reactions, including injection site necrosis, have been reported with the use of subcutaneous interferon beta. One patient treated with Plegridy in clinical trials experienced an injection site necrosis. Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis (see Section 4.8 Adverse Effects (Undesirable Effects)).

Decreased peripheral blood counts.

Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta. Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with Plegridy. Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see Section 4.8 Adverse Effects (Undesirable Effects)).

Thrombotic microangiopathy.

Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome have been reported with interferon beta products, including fatal cases. Monitoring of early symptoms in all patients e.g. new onset hypertension, impaired renal function and thrombocytopenia is recommended. Prompt treatment is required and discontinuation of treatment with interferon is recommended.

Nephrotic syndrome.

Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with interferon should be considered.

Seizure.

Seizures have been associated with the use of interferon beta. Caution should be exercised when administering Plegridy to patients with pre-existing seizure disorder (see Section 4.8 Adverse Effects (Undesirable Effects)).

Cardiac disease.

Worsening of cardiac disease has been reported in patients receiving interferon beta. The incidence of cardiovascular events was similar between Plegridy (125 micrograms every 2 weeks) and placebo treatment groups (7% in each group). Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment. Plegridy does not have any known direct acting cardiac toxicity; however, symptoms of the flu-like syndrome seen with Plegridy therapy may prove stressful to patients with cardiac conditions.

Endocrine disorders.

Hypothyroidism and hyperthyroidism have been observed with the use of interferon beta products. Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.

Autoimmune disorders.

Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta. In clinical studies, the incidence of autoimmune disorders was less than 1% in both Plegridy and placebo treatment groups. If patients develop a new autoimmune disorder, consider stopping Plegridy.

Immunogenicity.

Immunogenicity to Plegridy was evaluated in relapsing multiple sclerosis patients for a minimum of one year and up to two years. Less than 1% of patients (5/715) developed persistent treatment emergent neutralising antibodies to interferon beta-1a. Persistent treatment emergent antibodies to the PEG moiety were also seen in 3% (18/681) of patients. In general, neutralising antibodies have the potential to reduce clinical efficacy. In the ADVANCE study, the development of antibodies against the interferon or PEG moiety of Plegridy had no discernible impact on the pharmacodynamic response, safety, or clinical efficacy, although the analysis was limited by the low immunogenicity incidence.

Use in hepatic impairment.

It is recommended that liver function tests be undertaken prior to initiation of treatment with Plegridy and monitored periodically thereafter. Caution should be used and close monitoring considered when administering Plegridy to patients with severe hepatic impairment. Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other drugs or hepatotoxic agents (e.g. alcohol) associated with hepatic injury (see Section 4.8 Adverse Effects (Undesirable Effects); Section 5.2 Pharmacokinetic Properties).

Use in renal impairment.

No dose adjustment is necessary for Plegridy in patients with mild to severe renal impairment, or end stage renal disease.
The pharmacokinetics of Plegridy were assessed in a single dose study in healthy volunteers and subjects with mild, moderate, and severe renal impairment as well as patients with end stage renal disease. No clinically important differences in pharmacokinetic profiles were identified based on renal function (see Section 5.2 Pharmacokinetic Properties).

Use in the elderly.

The safety and effectiveness of Plegridy in patients aged 65 and over have not been established.

Paediatric use.

The safety and effectiveness of Plegridy in patients below the age of 18 have not been studied.

Effects on laboratory tests.

Laboratory abnormalities are associated with the use of interferons. Complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during Plegridy therapy. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No formal drug interaction studies have been conducted with Plegridy. Patients who experienced a relapse in the study could receive standard therapy with corticosteroids. Interferons have been reported to reduce the activity of hepatic cytochrome P450 dependent enzymes in humans and animals. Caution should be exercised when Plegridy is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. antiepileptics and some classes of antidepressants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The weekly subcutaneous administration of peginterferon beta-1a at 170 times the clinical exposure (based on serum AUC) to sexually mature female rhesus monkeys over the course of one menstrual cycle (up to 5 weeks), resulted in menstrual irregularities, anovulation, and decreased serum progesterone. This is consistent with the effects observed with non-pegylated interferon beta. These effects were reversible after discontinuation of drug. The significance of these non-clinical effects to humans is unknown.
(Category D)
Initiation of treatment is contraindicated during pregnancy (see Section 4.3 Contraindications).
Peginterferon beta-1a has not been tested for reproductive toxicity in pregnant animals. Non-pegylated interferon beta-1a has shown no evidence of teratogenicity in pregnant animals. Similar results have been obtained with other interferons.
Non-pegylated interferon beta-1a was not teratogenic in rhesus monkeys at doses up to 50 micrograms (10 million IU)/kg SC. Abortifacient activity was evident at this dose but not at 1.25 micrograms (0.25 million IU)/kg. Patients should be advised of the abortifacient potential of interferon beta observed in animal studies.
There are no adequate and well-controlled studies in pregnant women. Women of child-bearing potential should take appropriate contraceptive measures during treatment. If a patient becomes or plans to become pregnant whilst on therapy, they should be informed of the potential hazards to the fetus. Plegridy should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
 It is not known whether Plegridy is excreted in human milk. Because of the potential for serious adverse reactions in breast-feeding infants, a decision should be made either to discontinue breast-feeding or Plegridy therapy.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
The most common adverse drug reactions (ADRs; incidence ≥ 10%, and ≥ 2% compared to placebo) for Plegridy 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
The most commonly reported adverse events leading to discontinuation in patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks was influenza-like illness (< 1%).

Clinical trials.

In clinical studies (Study 1 and 2/ ADVANCE, ATTAIN), a total of 1468 patients with relapsing multiple sclerosis received Plegridy for up to 278 weeks (65 months), with an overall exposure equivalent to 4217 person-years. A total of 1285 patients received at least 1 year, 1124 patients received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with Plegridy. The experience in the extension study ATTAIN (all patients received Plegridy; treatment was for up to 4 years in ATTAIN) was consistent with the experience in the 1-year placebo-controlled phase of the ADVANCE study.
Table 2 summarises ADRs from 512 patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks and 500 patients who received placebo for up to 48 weeks.
The adverse reactions are presented as MedDRA preferred terms under the MedDRA system organ class (SOC).
Description of selected adverse events.

Flu-like symptoms.

Influenza-like illness was experienced by 47% of patients receiving Plegridy 125 micrograms every 2 weeks and 13% of patients receiving placebo. The incidence of flu-like symptoms (e.g. influenza-like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain, pyrexia) was highest during the initiation of treatment and generally decreased over the first 6 months.
Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity. None were considered serious in nature. Less than 1% of patients who received Plegridy during the placebo-controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms.
An open-label study in patients switching from interferon beta therapy to Plegridy evaluated the onset and duration of prophylactically treated flu-like symptoms. Patients were taking prophylactic and concurrent analgesics and/or antipyretics. Approximately 90% of patients had at least 1 occurrence of flu-like symptoms in the first 8 weeks and approximately 90% of patients reported no new or worsening of flu-like symptoms during the transition with either treatment for the first 8 weeks after switching to Plegridy. Symptoms were generally mild with the median time of onset of 10 hours (interquartile range, 7 to 16 hours) following injection and the median duration was 17 hours (interquartile range, 12 to 22 hours).

Injection site reactions.

Injection site reactions (e.g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received Plegridy 125 micrograms every 2 weeks compared to 11% of patients receiving placebo. Injection site erythema was the most commonly reported injection site reaction. Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity. One patient out of 1468 patients who received Plegridy in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.

Hepatic transaminase abnormalities.

The incidence of hepatic transaminase increases was greater in patients receiving Plegridy compared to placebo. The majority of enzyme elevations were < 3 times the upper limit of normal (ULN). Elevations of alanine aminotransferase and aspartate aminotransferase (> 5 times ULN) were reported in 1% and < 1% of placebo-treated patients and 2% and < 1% of patients treated with Plegridy respectively. Elevations of serum hepatic transaminases combined with elevated bilirubin were observed in two patients who had pre-existing liver test abnormalities prior to receiving Plegridy in the clinical trials. Both cases resolved following discontinuation of Plegridy.

Haematological disorders.

Decreases in white blood cell counts of < 3.0 x 109/L were observed in 7% of patients receiving Plegridy and in 1% receiving placebo. Mean white blood cell counts remained within normal limits in patients treated with Plegridy. Decreases in white blood cell counts were not associated with an increased risk of infections or serious infections. The incidence of potentially clinically significant decreases in lymphocyte counts (< 0.5 x 109/L) (< 1%), neutrophil counts (≤ 1.0 x 109/L) (< 1%), platelet counts (≤ 100 x 109/L) (≤ 1%) was similar in Plegridy-treated patients compared to placebo-treated patients. Two serious cases were reported in patients treated with Plegridy: one patient (< 1%) experienced severe thrombocytopenia (platelet count < 10 x 109/L), another patient (< 1%) experienced severe neutropenia (neutrophil count < 0.5 x 109/L). In both patients, cell counts recovered after discontinuation of Plegridy. Compared to placebo, there were no significant differences observed in red blood cell counts in patients treated with Plegridy.

Hypersensitivity reactions.

Hypersensitivity events were reported in 16% of patients treated with Plegridy 125 micrograms every 2 weeks and 14% of patients who received placebo. Less than 1% of Plegridy-treated patients experienced a serious hypersensitivity event (e.g. angioedema, urticaria) and they recovered promptly after treatment with anti-histamines and/or corticosteroids.

Depression and suicidal ideation.

The overall incidence of adverse events related to depression and suicidal ideation was 8% for both Plegridy 125 micrograms every 2 weeks and placebo groups. The incidence of serious events related to depression and suicidal ideation were similar and low (< 1%) in both Plegridy 125 micrograms every 2 weeks and placebo-treated patients.

Seizure.

The incidence of seizure events was low and comparable in patients receiving Plegridy (125 micrograms every 2 weeks) and placebo (< 1% in each group).

Post-marketing experience.

Suspected adverse reactions reported in post-marketing experience that are not already included under Clinical trials are shown in Table 3.

Hepatic injury.

In post marketing experience, noninfectious hepatitis (including serious hepatitis) cases have been reported following Plegridy administration (see Section 4.4 Special Warnings and Precautions for Use).

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
No case of overdose has been reported. In case of overdosage, appropriate supportive treatment should be given.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Plegridy is interferon beta-1a conjugated to a single, linear 20 kDa methoxy poly(ethylene glycol) molecule to the alpha-amino group of the N-terminal amino acid residue.
Interferons are a family of naturally occurring proteins that are induced by cells in response to biological and chemical stimuli, and mediate numerous cellular responses that have been classified as antiviral, antiproliferative, and immunomodulatory in nature.
The pharmacological properties of Plegridy are consistent with those of interferon beta-1a and are believed to be mediated by the protein portion of the molecule.
A definitive mechanism of action of Plegridy in multiple sclerosis is not known. However, as the biological effects of Plegridy are consistent with those of non-pegylated interferon beta-1a, the mechanism of action of Plegridy is likely to be similar. Plegridy binds to the type I interferon receptor on the surface of cells and elicits a cascade of intracellular events leading to the regulation of interferon-responsive gene expression. These genes, and their gene products, are believed to mediate the efficacy of Plegridy in multiple sclerosis.
As an interferon beta, Plegridy modulates immune responses that are believed to play a role in the pathogenesis of multiple sclerosis. While the pathogenesis of the disease is complex and multifaceted, Plegridy may act at several levels including up-regulation of anti-inflammatory cytokines (e.g. IL-4, IL-10, IL-27), down-regulation of pro-inflammatory cytokines (e.g. IL-2, IL-12, IFN-γ, TNF-α) and inhibiting the migration of activated T cells across the blood brain barrier; however additional mechanisms have been proposed.
Pharmacodynamic responses were evaluated by measuring the induction of interferon-responsive genes including those encoding 2',5'-oligoadenylate synthetase (2',5'-OAS), myxovirus resistance protein A (MxA), and several chemokines and cytokines, as well as the gene product neopterin (D-erythro-1, 2, 3,-trihydroxypropylpterin), a product of the interferon-inducible enzyme, GTP-cyclohydrolase I. Gene induction in healthy human subjects was greater in terms of peak level and exposure (area under the effect curve) for Plegridy compared to non-pegylated interferon beta-1a (IM) when both were given at equivalent doses as measured by in vitro activity in a cytopathic effect assay (6 MIU). The duration of this response was sustained and prolonged for Plegridy, with elevations detected up to 15 days compared to 4 days for non-pegylated interferon beta-1a. Increased concentrations of neopterin were observed in both healthy subjects and multiple sclerosis patients treated with Plegridy, with a sustained and prolonged elevation over 10 days compared to 5 days observed for non-pegylated interferon beta-1a. Neopterin concentrations return to baseline within the two-week dosing interval.

Clinical trials.

The efficacy and safety of Plegridy were assessed from the first year of a 2-year randomised, double-blind, clinical study in patients with relapsing remitting multiple sclerosis (the ADVANCE study). Efficacy results were derived from the placebo-controlled first year of the study. At study entry 1512 patients were randomised and dosed to 125 micrograms Plegridy injected subcutaneously every 2 (n = 512) or 4 (n = 500) weeks versus placebo (n = 500). At the end of the first year, patients who received placebo were randomised to Plegridy every 2 or every 4 weeks while the patients randomised to Plegridy in the first year remained on their original dose assignment.
The study enrolled patients who had experienced at least two relapses within the prior three years including at least one in the year prior to randomisation and had an Expanded Disability Status Scale (EDSS) score ranging from 0 to 5. Neurological evaluations were performed at baseline, every 12 weeks and at time of suspected relapse. Brain MRI evaluations were performed at baseline, weeks 24 and 48. The primary endpoint was the annualised relapse rate (ARR) over one year. Secondary endpoints included the proportion of subjects relapsing, new or newly enlarging T2 hyperintense lesions and time to confirmed disability progression, defined as at least a 1 point increase from baseline EDSS ≥ 1 or 1.5 point increase for patients with baseline EDSS of 0, sustained for 12 weeks.
The mean age of the study population was 37 years, the mean disease duration was 3.6 years and the mean EDSS at baseline was 2.46. The majority of the patients were female (71%). Plegridy had a statistically significant effect on the primary and all secondary endpoints.
Plegridy every two weeks reduced the ARR by 36% compared to placebo (p = 0.0007) at one year (Table 4). There was a consistent reduction of the ARR noted in subgroups defined by demographic and baseline disease characteristics. Plegridy reduced the proportion of subjects who relapsed by 39% (p = 0.0003), the proportion of subjects with sustained disability progression by 38% (p = 0.0383), the number of new or newly enlarging T2 lesions by 67% (p < 0.0001), the number of Gd enhancing lesions by 86% (p < 0.0001) and the number of T1 hypointense lesions by 53% (p < 0.0001). A treatment effect was observed as early as six months, with the Plegridy group demonstrating a 61% reduction (p < 0.0001) in new or newly enlarging T2 lesions as compared with placebo.
Across relapse and MRI endpoints Plegridy 125 micrograms every two weeks showed a numerically greater treatment effect over the Plegridy every four weeks dosing regimen.

ADVANCE, year 2.

Results over 2 years confirmed that efficacy was maintained beyond the placebo-controlled first year of the study. Patients who continued treatment with Plegridy for 2 years (438 of 512, or 85.5% of patients) had an annualised relapse rate of 0.230 (95% CI = 0.183, 0.291) in year 1 and a rate of 0.178 (95% CI = 0.136, 0.233) in year 2. In this population, the proportion of subjects who had 12 week disability progression was 0.061 in year 1 and 0.034 in year 2. In the ATTAIN extension study (continued treatment up to 4 years), efficacy was maintained with long-term treatment.
Results for this study are shown in Table 4 and Figure 1.

5.2 Pharmacokinetic Properties

The serum half-life of Plegridy peginterferon beta-1a is prolonged compared with non-pegylated interferon beta-1a. Serum concentration of peginterferon beta-1a was dose-proportional in the range of 63-188 micrograms as observed in a single dose and a multiple dose study in healthy subjects. Pharmacokinetics observed in multiple sclerosis patients were consistent with those seen in healthy subjects.

Absorption.

Following subcutaneous administration of peginterferon beta-1a in multiple sclerosis patients, the peak concentration was reached between 1-1.5 days post-dose. The observed Cmax (mean ± SE) was 280 ± 79 picogram/mL following repeat dosing of 125 micrograms every two weeks and the AUC over the 14 day dosing interval was 35 ± 6 nanogram.hr/mL.
Subcutaneous peginterferon beta-1a resulted in approximately 4, 9, and 13-fold higher exposure (AUC168h) values and approximately 2, 3.5 and 5-fold higher Cmax, following single doses of 63 (6 MIU), 125 (12 MIU), and 188 (18 MIU) micrograms respectively, compared to intramuscular administration of 30 (6 MIU) micrograms non-pegylated beta-1a.

Distribution.

Following repeat dosing of 125 microgram doses every two weeks by subcutaneous administration in multiple sclerosis patients, peginterferon beta-1a was widely distributed with a volume of distribution of 479 ± 105 L (mean ± SE).

Biotransformation and elimination.

Clearance mechanisms for Plegridy include catabolism and excretion. The major pathway of elimination of peginterferon beta-1a is renal. Renal elimination is postulated to be a major excretory pathway for the PEG moiety. Other potential minor routes of elimination for the PEG moiety include hepatic metabolism and biliary excretion.
The process of covalently conjugating a PEG moiety to a protein can alter the in vivo properties of the unmodified protein, including decreased renal clearance and decreased proteolysis thus extending the circulating half-life. Accordingly, the half-life (t1/2) of peginterferon beta-1a is approximately 2-fold longer than non-pegylated interferon beta-1a in healthy volunteers. In multiple sclerosis patients, the t1/2 (mean ± SE) of peginterferon beta-1a was 78 ± 15 hours at steady state. The mean steady-state clearance of peginterferon beta-1a was 4.1 ± 0.4 L/hr.

Special populations.

Elderly (> 65 years).

Clinical experience in patients aged above 65 years is limited. However, results from a population pharmacokinetic analysis suggest that age does not impact peginterferon beta-1a clearance.

Gender.

No gender effect on the pharmacokinetics of peginterferon beta-1a was found in a population pharmacokinetic analysis.

Race.

Race had no effect on the pharmacokinetics of peginterferon beta-1a in a population pharmacokinetic analysis.

Renal impairment.

A single dose study in healthy subjects (creatinine clearance > 80 mL/minute) and subjects with various degree of renal impairment showed a fractional increase in AUC336h (30%, 40% and 53%) and Cmax (27%, 26% and 42%) in subjects with mild (creatinine clearance 50 to ≤ 80 mL/minute), moderate (creatinine clearance 30 to < 50 mL/minute), and severe (creatinine clearance < 30 mL/minute) renal impairment respectively, compared to subjects with normal renal function (creatinine clearance > 80 mL/minute). Subjects with end stage renal disease requiring haemodialysis 2-3 times weekly showed similar AUC336h and Cmax as compared to subjects with normal renal function. Each haemodialysis reduced peginterferon beta-1a concentration by approximately 24%, suggesting that haemodialysis partially removes peginterferon beta-1a from systemic circulation.

Hepatic impairment.

The pharmacokinetics of peginterferon beta-1a have not been evaluated in patients with hepatic insufficiency.

5.3 Preclinical Safety Data

Genotoxicity.

Peginterferon beta-1a was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test and was not clastogenic in an in vitro assay in human lymphocytes.

Carcinogenicity.

Peginterferon beta-1a has not been tested for carcinogenicity in animals.

Toxicology.

Human interferon beta-1a is pharmacologically active in rhesus monkeys. Due to the immunogenicity of human interferons in rhesus monkeys, the studies were limited to five weeks duration. Exposure to peginterferon beta-1a by subcutaneous administration up to 325 times the clinical exposure, based on serum AUC, produced no signs of toxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Plegridy also contains sodium acetate trihydrate, glacial acetic acid, L-arginine hydrochloride, and polysorbate 20 in water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store in the closed original carton to protect from light until ready for injection. Store in a refrigerator between 2 to 8°C. Do not freeze. Discard if frozen. The formulation is preservative-free.
When no refrigerator is available, Plegridy may be stored protected from light between 2°C to 25°C for a maximum of 30 days in total.
Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm Plegridy.
Plegridy can be removed from and returned to the refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days, at a temperature that does not exceed 2°C to 25°C, protected from light.

6.5 Nature and Contents of Container

Plegridy is produced by recombinant DNA technology and is manufactured in three strengths, 63 micrograms, 94 micrograms, and 125 micrograms. Plegridy is supplied as pre-filled pen and pre-filled syringe.

Pre-filled pen.

Plegridy is formulated as a sterile clear liquid for subcutaneous injection. Each unit of Plegridy is stored in a 1 mL Type I glass syringe with a latex free bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe. A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 63 micrograms, 94 micrograms, or 125 micrograms of peginterferon beta-1a. The glass syringe is contained within a single-use, disposable, injection device (prefilled pen).
The Plegridy pre-filled pen Titration Pack holds 2 ready to use pens. Each Titration Pack for Plegridy pen contains a clear, colourless liquid (0.5 mL) containing either 63 or 94 micrograms of peginterferon beta-1a.
The Plegridy pre-filled pen Administration Dose Pack holds 2 or 6 ready to use pens. Each Administration Dose Pack pen contains a clear, colorless liquid (0.5 mL) containing 125 micrograms of peginterferon beta-1a.

Pre-filled syringe.

Plegridy is formulated as a sterile clear liquid for subcutaneous injection. Each unit of Plegridy is stored in a 1 mL Type I glass syringe with a latex free bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe. A single pre-filled syringe contains 0.5 mL of solution of Plegridy containing 63 micrograms, 94 micrograms or 125 micrograms of peginterferon beta-1a.
The Plegridy pre-filled syringe Titration Pack holds 2 ready to use syringes. Each Titration Pack for Plegridy syringe contains a clear, colorless liquid (0.5 mL) containing either 63 or 94 micrograms of peginterferon beta-1a.
The Plegridy pre-filled syringe Administration Dose Pack holds 2 or 6 ready to use syringes. Each Administration Dose Pack syringe contains a clear, colorless liquid (0.5 mL) containing 125 micrograms of peginterferon beta-1a.
Not all pack sizes are being distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Peginterferon beta-1a (rch) is recombinant interferon beta-1a conjugated to 20 kDa methoxy poly(ethylene glycol) using an -O-2-methylpropionaldehyde linker. It is expressed in mammalian cells and has the same sequence as naturally occurring human interferon beta. The 20 kDa mPEG-O-2-methylpropionaldehyde is attached to the a-amino group of the N-terminal amino acid residue using reductive amination chemistry.

CAS number.

The CAS Registry Number is 1211327-92-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes