Pegasys® (peginterferon alfa-2a)

What is it?

Pegasys is used for the treatment of chronic hepatitis C, which is a viral infection of the liver. Pegasys is presented as a solution for injection in a vial (1 ml) available in packs containing 1 or 4 single dose vials. Pegasys is also supplied in prefilled syringes (0.5 ml) in packs containing 1 or 4 prefilled syringes. The active substance is peginterferon alfa-2a (conjugation of recombinant interferon alfa-2a with bis-[monomethoxy polyethylene glycol] of a molecular mass, Mn, of 40,000), 135 or 180 micrograms in a single dose vial or prefilled syringe.

Pegasys is sometimes used for this treatment in combination with ribavirin. If you receive combination therapy of Pegasys and ribavirin, you should also read the ribavirin package leaflet.

Before you take it

Do not use Pegasys if:

you are allergic to peginterferon alfa-2a, to any interferon or any of the other ingredients of Pegasys.
you have ever had a heart attack or suffer from other heart disease.
you have ever suffered from severe nervous or mental disorder.
if you have, so called autoimmune hepatitis.
if you have advanced liver disease (e.g. your skin has become yellow).
the patient is a child less than 3 years old.
you are pregnant or breast-feeding.

Take special care with Pegasys:

Tell your doctor:

if you are planning on becoming pregnant, discuss this with your doctor before starting to use Pegasys. (see Pregnancy).
if you have psoriasis, it may get worse during treatment with Pegasys.
if you have a problem with your liver other than hepatitis C.
if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination
if you notice a change in your vision.
when receiving Pegasys, you may temporarily have a greater risk of getting an infection. Check with your doctor if you think you are getting an infection (such as pneumonia).
if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while on this medication, seek medical help immediately.
if you have thyroid disease that is not well controlled with medicines.
if you have ever had depression or develop symptoms associated with depression while on treatment with Pegasys (e.g. feelings of sadness, dejection , etc).
if you have ever had anaemia.
if you are coinfected with HIV and treated with anti HIV medicinal products.

Pregnancy:

Do not use Pegasys during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding:

Do not breast-feed an infant if you are being treated with Pegasys. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Do not drive or use machinery if you feel drowsy, tired, or confused while taking Pegasys.

Taking other medicines:

Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

How to take it?

Always take Pegasys as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor has prescribed Pegasys specifically for you and your current condition; do not share this medicine with anyone else.

Pegasys dosing:

Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it. If necessary, the dose may be changed during treatment. Do not exceed the recommended dose. Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week for at least 6 months and possibly 1 year. Pegasys injection is normally taken at bedtime. Pegasys is intended for subcutaneous use (under the skin). This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh. If you are injecting this medicine yourself, you will be instructed how to give the injection. Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.

Combination therapy with ribavirin:

In the case of combination therapy with Pegasys and ribavirin, please refer to the dosing regimen recommended by your doctor.

If you use more Pegasys than you should:

Contact your doctor or pharmacist as soon as possible.

If you forget to take Pegasys:

If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible. Take your next injection on the regularly scheduled day. If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible. Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week. As an example: Your regular weekly Pegasys injection is on Monday. You remember on Friday that you forgot to take your injection on Monday (4 days late).You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday (5 days after your Friday dose). Your next injection will be on the Monday, 5 days later after the Wednesday injection. You are now back on your regularly scheduled day and should continue your injections every Monday. If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day. Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys. Do not take a double dose to make up for forgotten individual doses.

Possible side effects

Like all medicines, Pegasys can have side effects. Although not all of the unwanted effects may occur, they may need medical attention if they do. During treatment your doctor will take blood samples regularly to check for changes in your blood cells and in liver function.

Check with your doctor immediately if any of the following side effects occur:

Severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool or urine; severe nosebleed; fever or chills; problems with your eyesight.

The most common side effects with the combination of Pegasys and ribavirin are flu-like symptoms such as aches and pains, nausea, and diarrhoea; inability to sleep, loss of hair, irritability, injection site irritation and skin reactions.

Other common side effects are inability to concentrate, weight loss, anxiety, poor memory, increased sweating, mood/emotion changes and back pain.

Less common side effects are dry mouth, mouth sores, numbness or tingling, decreased sexual desire, sleepiness, tremors, anemia, palpitations, eye irritation, sinus congestion, airway infection, taste disturbance, flatulence and swollen glands.

When Pegasys is used alone, some of these effects are less likely to occur. If you notice any side effects not mentioned here, please inform your doctor or pharmacist.

Storing it

Keep out of the reach and sight of children.
Store at 2-8 degrees centigrade (in a refrigerator). Do not freeze. Store in the original package in order to protect from light.
Do not use after the expiry date stated on the label.
Do not use Pegasys if the vial or packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.

How to self-inject Pegasys from single dose vials

The following instructions explain how to use Pegasys single dose vials to inject yourself. Please read the instructions carefully and follow them step by step. Your doctor or his/her assistant will instruct you on how to give the injections.

Getting Ready

Wash your hand carefully before handling any of the items.

Collect the necessary items before beginning:

Included in the pack:

a vial of Pegasys solution for injection

Not included in the pack:

a 1 ml syringe
a long needle to withdraw Pegasys from the vial
a short needle for the subcutaneous injection
a cleansing swab
small bandage or sterile gauze
an adhesive bandage
a container for the waste material

Measuring the dose of Pegasys

Remove the protective cap from the Pegasys vial.
Clean the rubber top of the vial with a cleansing swab.
You can save the swab to clean the skin area where you will inject Pegasys.
Remove the syringe from the wrapping. Do not touch the tip of the syringe.
Take the long needle and place it firmly on to the tip of the syringe.
Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Insert the needle through the rubber top of the Pegasys vial.
Hold the vial and syringe in one hand and turn the vial and the syringe upside down.

With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution. Your other hand will be free to move the plunger of the syringe.
Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe.
Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe.
Take the short needle and place it firmly on to the tip of the syringe.
Remove the needle guard from the syringe needle.
Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back. To remove air bubbles from the syringe, hold the syringe with the needle pointing up. Tap the syringe gently to bring the bubbles to the top. Push the plunger up slowly to the correct dose. Replace the needle guard and place the syringe in a horizontal position until ready for use.
Allow the solution to reach room temperature before injection or warm the syringe between your palms.
Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present. You are now ready to inject the dose.

Injecting the solution

Select the injection site in the abdomen or thigh (except your navel or waistline). Change your injection site each time.
Clean and disinfect the skin where the injection is to be made with the cleansing swab.
Wait for the area to dry.
Remove the needle guard.
With one hand, pinch a fold of loose skin. With your other hand hold the syringe as you would a pencil.
Insert the needle into the pinched skin at an angle of 45 to 90 degrees.
Inject the solution by gently pushing the plunger all the way down.
Pull the needle straight out of the skin.
Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Do not massage the injection site. If there is bleeding, cover with an adhesive bandage.

Disposal of the injection materials

The syringe, needle and all injection materials are intended for single use and must be discarded after the injection. Dispose of the syringe and needle safely in a closed container. Ask your doctor, hospital or pharmacist for an appropriate container.

Further information

For any additional information about this medicinal product, please contact your doctor or pharmacist.