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ViraferonPeg (Peginterferon alfa-2b)

What ViraferonPeg is and what it is used for

The active substance in ViraferonPeg is a protein called peginterferon alfa-2b, which belongs to the class of medicines called interferons. Interferons are made by your body’s immune system to help fight infections and severe diseases. This medicine is injected into your body to work with your immune system. ViraferonPeg is used for the treatment of chronic hepatitis C, a viral infection of the liver.

ViraferonPeg is best used for this treatment in combination with ribavirin.

Adult patients:

The combination of ViraferonPeg and ribavirin is recommended for adults who have not previously been treated with these medicines. This includes adults also infected with clinically stable HrV (Human Immunodeficiency Virus). The combination can also be used to treat adults who have already failed treatment with an interferon alpha or peginterferon alpha in combination with ribavirin or interferon alpha alone.

If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe ViraferonPeg alone.

Children and adolescents:

ViraferonPeg is used in combination with ribavirin in children 3 years of age and older and adolescents who have not been treated previously for chronic hepatitis C.

Before you use ViraferonPeg

Do not use ViraferonPeg

You should tell your doctor before starting treatment if you or the child you are caring for:

  • are allergic (hypersensitive) to peginterferon alfa-2b or any of the other ingredients of ViraferonPeg (see section “What ViraferonPeg contains”).
  • are allergic (hypersensitive) to any interferon.
  • have had severe heart problems.
  • have heart disease that has not been well controlled during the past 6 months.
  • have severe medical conditions that leave you very weak.
  • have autoimmune hepatitis or any other problem with your immune system.
  • are taking medicine that suppresses (weakens) your immune system.
  • have advanced, uncontrolled liver disease (other than hepatitis C).
  • have thyroid disease that is not well controlled with medicines.
  • have epilepsy, a condition that causes convulsions (seizures, or “fits”). Children and adolescents must not use ViraferonPeg if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.

Reminder: Please also read the “Do not take” section of the Package Leaflet for ribavirin before using it in combination with ViraferonPeg.

Take special care with ViraferonPeg

Seek medical help immediately in case of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives).

You should tell your doctor before taking this medicine if you or the child you are caring for: have had a severe nervous or mental disorder.

The use of ViraferonPeg in children and adolescents with existence of or history of severe psychiatric conditions is not allowed .

  • have ever had depression or develop symptoms associated with depression (e.g. feelings of
  • sadness, dejection, etc) while on treatment with ViraferonPeg (see section 4 “POSSIBLE SIDE EFFECTS”).
  • have ever been treated for depression or any other nervous or mental disorder.
  • have ever had a heart attack or a heart problem.
  • have kidney disease, your doctor may prescribe a lower than usual dose and monitor your
  • kidney blood values regularly during treatment. If ViraferonPeg is used in combination with
  • ribavirin, your doctor should monitor you or the child you are caring for more carefully for
  • a decrease in red blood cell count.
  • have had liver problems (other than hepatitis C).
  • develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing.
  • are diabetic or have high blood pressure, your doctor may ask you or the child you are caring for to have an eye examination.
  • have had any serious illness affecting breathing or blood.
  • have psoriasis, it may become worse while you are using ViraferonPeg.
  • are planning to become pregnant, discuss this with your doctor before starting to use ViraferonPeg.
  • have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection. Be sure to discuss this with your doctor.

If you are also being treated for HIV (see section “Using other medicines”).

Reminder: Please read the “Take special care” section of the Package Leaflet for ribavirin before using it in combination with ViraferonPeg.

ViraferonPeg is not recommended for use in patients under the age of 3 years.

Teeth and mouth problems

These have been reported in patients receiving ViraferonPeg in combination with ribavirin. You may develop gum disease, which could lead to loss of teeth. You may develop a dry mouth or vomiting, both of which can damage your teeth. It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.

Eye problems

During treatment, some patients may experience eye problems, or loss of vision in rare instances. Your doctor should carry out an eye examination before starting your treatment. In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination. If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy. If your eye disorder becomes more severe or if you develop new eye disorders, your treatment will be discontinued.

While being treated with ViraferonPeg

Your doctor may advise to drink extra fluids to help prevent low blood pressure.

Your doctor will test your blood before you begin therapy and throughout the treatment to make sure that the therapy you are getting is safe and effective.

Using other medicines

Please tell your doctor or pharmacist if you or the child you are caring for:

  • are taking or have recently taken any other medicines or vitamins/nutritional supplements, including medicines obtained without a prescription.
  • are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C Virus (HCV) and are being treated with an anti-HIV medicinal product(s) -[nucleoside reverse transcriptase inhibitor (NRTI), and/or highly active anti-retroviral therapy (HAART)]. Your doctor will monitor you for signs and symptoms of these conditions.

Taking ViraferonPeg in combination with ribavirin and an anti-HIV medicinal product(s) may increase the risk of lactic acidosis, liver failure, and blood abnormalities: reduction in number of red blood cells, white blood cells and blood clotting cells called platelets. Patients with advanced liver disease receiving HAART may be at increased risk of worsening liver function, therefore adding treatment with ViraferonPeg alone or in combination with ribavirin may increase their risk.

With zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work. Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse. If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed. Additionally, patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells). Therefore the use of zidovudine with ViraferonPeg and ribavirin combination therapy is not recommended. Reminder: Please read the “Taking other medicines” section of the Package Leaflet for ribavirin before using it in combination with ViraferonPeg.

Pregnancy and breast-feeding

Pregnancy:

Ask your doctor or pharmacist for advice before taking any medicine.

In studies in pregnant animals, interferons have sometimes caused miscarriage. The effect of ViraferonPeg on human pregnancy is not known. Girls or women of childbearing potential need to use effective birth control (two different methods) during the treatment with ViraferonPeg.

Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:

if you are a girl or a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped. You and your partner must each use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment. This should be discussed with your doctor.

if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom. If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. You and your partner must each use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment. This should be discussed with your doctor.

Breast-feeding:

It is not known whether this medicine is present in human milk. Therefore, do not breast-feed an infant if you are taking ViraferonPeg.

Reminder: Please read the “Pregnancy and breast-feeding” section of the Package Leaflet for ribavirin before using it in combination with ViraferonPeg.

Driving and using machines

Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking ViraferonPeg.

Important information about some of the ingredients of ViraferonPeg

This medicine contains sucrose. If you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially “sodium-free”.

How to use ViraferonPeg

General information about taking ViraferonPeg:

Your doctor has prescribed ViraferonPeg specifically for your current condition or the current condition of the child you are caring for; do not share this medicine with anyone else.

Your doctor has determined the correct dose of ViraferonPeg based on how much you or the child you are caring for weighs. If necessary, the dose may be changed during treatment.

ViraferonPeg is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under the skin. If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection. Detailed instructions for subcutaneous administration are provided at the end of this leaflet

Prepare the dose just before you intend to inject it and use it immediately. Look carefully at the solution you prepared before you use it. The solution should be clear and colourless.

Do not use the solution if it is discoloured (changed it’s colour from the original) or if there are bits of particles in the solution. Discard the ViraferonPeg pre-filled pen with any solution that is left in it after you give yourself the injection.

Inject ViraferonPeg once each week on the same day. Injecting it at the same time of day each week will help you not to forget to take it.

Always use ViraferonPeg exactly as your doctor has told you. Do not exceed the recommended dosage, and take it for as long as prescribed.

Combination treatment with ribavirin

Adults:

ViraferonPeg, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week. If you have kidney disease, your dose may be lower, depending upon your kidney function.

Ribavirin capsules are taken every day, morning and evening with food.The usual dose of ribavirin,according to how much you weigh, is shown in the table below:

  1. Look for the line that shows how much you weigh.
  2. Read across on the same line to see how many hard capsules to take. Reminder: If your doctor’s instructions are different from the amounts in the below table, follow your doctor’s instructions.
  3. If you have any questions about the dose, ask your doctor.
Ribavirin hard capsule for oral use – dose based on body weight
If the adult weighs (kg) Usual daily ribavirin dose Number of 200 mg capsules
<65 800 mg 2 capsules in the morning and 2 capsules in the evening
65-80 1,000 mg 2 capsules in the morning and 3 capsules in the evening
81 – 105 1,200 mg 3 capsules in the morning and 3 capsules in the evening
> 105 1,400 mg 3 capsules in the morning and 4 capsules in the evening

For patients using this treatment for the first time, the usual length of treatment is up to one year.

Please read ribavirin Package Leaflet before you begin combination treatment with ViraferonPeg.

If you are co-infected with HCV/HIV, you should continue treatment for 48 weeks.

If you previously relapsed or have not responded to interferon alpha-2b with or without ribavirin,you should continue treatment for one year. This will be determined based on your response after the first 12 weeks of therapy.

Children 3 years of age and older and adolescents:

The dose is determined by a calculation accounting for both height and weight for ViraferonPeg

and by body weight for ribavirin. Ribavirin should be taken morning and evening with food. The

duration of treatment is up to 1 year based on the doctor’s judgement for you or the child you are caring for.

ViraferonPeg alone

Adults

ViraferonPeg, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year. If you have kidney disease, your dose may be lower, depending upon your kidney function.

ViraferonPeg alone was not studied in HCV/HIV co-infected patients.

All patients

If you are injecting ViraferonPeg yourself, please be sure that the dose that has been prescribed is clearly provided on the package of medicine you receive.

If you have the impression that the effect of ViraferonPeg is too strong or too weak, talk to your doctor or pharmacist or the doctor or pharmacist of the child you are caring for.

If you use more ViraferonPeg than you should

Tell your doctor or healthcare professional or the doctor or healthcare professional of the child you are caring for as soon as possible.

If you forget to take ViraferonPeg

Take/administer the dose of ViraferonPeg in combination with ribavirin as soon as you remember unless it is very close to your next injection. If it is very close to your next injection, you should not make up for the forgotten dose and, then continue your treatment as usual.

Contact your doctor or pharmacist or the doctor or pharmacist of the child you are carting for if needed.

Possible side effects

Like all medicines, ViraferonPeg can cause side effects, although not everybody gets them. Although not all of these side effects may occur, they may need medical attention if they do. When ViraferonPeg is used alone, some of these effects are less likely to occur, and some have not occurred at all.

Psychiatric and central nervous system:

Some people get depressed when taking ViraferonPeg alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. Ask a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.

Children and adolescents are particularly prone to develop depression when being treated with ViraferonPeg and ribavirin. Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.

Growth and development (children and adolescents):

With up to one year of treatment with ViraferonPeg in combination with ribavirin, some children and

adolescents did not grow or gain weight as much as expected. Some children did not reach their projected height within 1-5 years after completing treatment.

Contact your doctor immediately if you notice any of the following side effects occurring during treatment:

  • chest pain; changes in the way your heart beats,
  • breathing problems (including shortness of breath),
  • confusion, feeling depressed, wanting to harm yourself or others, hallucinations, convulsion (“fit”),
  • trouble sleeping, thinking or concentrating; difficulty remaining alert, numbness or tingling
  • feeling, dizziness,
  • severe stomach pain or cramps; blood or clots in stool (or black, tarry stool),
  • pain in your lower back or side; difficulty or inability to pass urine,
  • fever or chills beginning after a few weeks of treatment,
  • painful or inflamed muscles (sometimes severe),
  • problems with your eyes or your eyesight or hearing,
  • severe or painful reddening of your skin or mucous membrane,
  • severe bleeding from your nose, gums or any other part of your body.

Possible side effects listed below are grouped by frequency of occurrence:

Very common       (affects at least 1 user in 10)
Common              (affects at least 1 but less than 10 users in 100)
Uncommon          (affects at least 1 but less than 10 users in 1,000)
Rare                     (affects at least 1 but less that 10 users in 10,000)
Very rare              (affects less than 1 user in 10,000)
Not known           (frequency cannot be estimated from the available data)

Side effects that have been reported in adults with ViraferonPeg alone or in combination with ribavirin capsules include:

Very commonly reported side effects:

  • feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or
  • nervous, difficulty concentrating, mood swings,
  • headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection,
  • weakness,
  • difficult breathing, pharyngitis (sore throat), coughing,
  • stomach pain, vomiting, nausea, diarrhoea, loss of appetite, loss of weight, dry mouth,
  • hair loss, itching, dry skin, rash, irritation or redness (and rarely, skin damage) at the site of injection,
  • decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections),
  • pain in joints and muscles, muscle and bone pain.

Commonly reported side effects:

  • decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, excess of uric acid (as in gout) in the blood, low calcium level in the blood, decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors), swollen glands (swollen lymph nodes), thirst, changed behaviour or aggressive behaviour (sometimes directed against others), agitation, nervousness, feeling sleepy, trouble sleeping, unusual dreams, lack of interest in activities, lack of interest in sex, erectile problem, increased appetite, confusion, shaky hands, poor coordination, vertigo (spinning feeling), numbness, pain or tingling feeling, increased or decreased sensitivity to touch, tense muscles, limb pain, arthritis, migraine, increased sweating, eye pain or infection, blurred vision, dry or teary eyes, changes in hearing/loss of hearing, ringing in ears, sinusitis, respiratory infections, stuffy or runny nose, difficulty in speaking, nosebleed, cold sores (herpes simplex), fungal or bacterial infections, ear infection/earache, indigestion (stomach upset), heartburn, redness or sores in mouth, burning sensation on tongue, red or bleeding gums, constipation, intestinal gas (flatus), bloating, hemorrhoids, sore tongue, change in taste, tooth problem, excessive loss of body water, enlarged liver, psoriasis, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin disorders, puffy face, puffy hands or feet, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), acne, hives, abnormal hair texture, nail disorder, pain at the site of injection, difficult, irregular or no menstrual period, abnormally heavy and prolonged menstrual period, problem affecting ovary or vagina, pain in breast, sexual problem, irritation of prostate gland, increased need to pass urine, chest pain, pain on the right side around your ribs, feeling unwell, low or high blood pressure, feeling faint, flushing, palpitations (pounding heart beat), rapid heart rate.

Uncommonly reported side effects:

  • suicide, attempted suicide, thoughts about threatening the life of yourself, panic attack,
  • delusions, hallucination,
  • hypersensitivity reaction to the medication, heart attack, inflammation of the pancreas, pain in bone and diabetes mellitus,
  • cotton wool spots (white deposits on the retina).

Rarely reported side effects:

  • diabetic ketoacidosis (medical emergency due to build-up of ketone bodies in the blood as a result of out-of-control diabetes),
  • seizures (convulsions) and bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement),
  • eye problems including changes in vision, damage to the retina, obstruction of the retinal
  • artery, inflammation of the optic nerve, swelling of the eye,
  • congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems,
  • sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and
  • swelling, skin lesions and swollen glands).

Very rarely reported side effects:

  • aplastic anaemia, stroke (cerebrovascular events), toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin).
  • Loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients treated at high doses.

The following side effects have occurred with ViraferonPeg alone or in combination with

  • ribavirin, but their frequency is unknown:
  • pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells). This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
  • facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania (excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), thoughts about threatening the life of others.

If you are an HCV/HIV co-infected adult patient receiving HAART, the addition of ViraferonPeg and ribavirin may increase your risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).

The following other side effects (not listed above) have occurred with the combination of ViraferonPeg and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART:

  • oral candidiasis (oral thrush),
  • defective metabolism of fat,
  • CD4 lymphocytes decreased,
  • appetite decreased,
  • back pain,
  • hepatitis,
  • limb pain,
  • and various laboratory blood values abnormalities.

The following effects have occurred with the combination of ViraferonPeg/ribavirin in children and adolescents:

Very commonly reported side effects:

  • loss of appetite, dizziness, headache, vomiting, nausea, stomach pain,
  • hair loss, dry skin, pain in joints and muscles, redness at the site of injection,
  • feeling irritable, tired feeling, feeling unwell, pain, chills, fever, flu-like symptoms,
  • weakness, decrease in rate of growth (height and weight for age), decreases in red blood cells that may cause fatigue, shortness of breath, dizziness.

Commonly reported side effects:

  • fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection, coughing, throat pain, feeling cold, eye pain, decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms, wanting or attempting to harm yourself, aggressive behaviour, agitation, anger, mood changes, nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.
  • changes in taste, diarrhoea, stomach upset, oral pain, fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed, sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), acne, back pain, muscle and bone pain, limb pain, dryness, pain, rash, irritation or itching at the site of injection.

Uncommonly reported side effects:

  • painful or difficult urination, urinary frequency, the presence of excess protein in the urine,
  • painful menstruation, itchy anal area (pinworms or ascarids), inflammation of the lining membrane of the stomach and the intestines, inflamed gums, enlarged liver, abnormal behaviour, emotional disorder, fear, nightmare, tremor, decreased sensitivity to touch,   numbness or tingling feeling, pain radiating along the course of one or more nerves, drowsiness, bleeding of the mucous membrane that lines the inner surface of the eyelids, itchy eyes, eye pain, blurred vision, intolerance to light, low blood pressure, paleness, nasal discomfort, runny nose, wheezing, difficult breathing, chest pain or discomfort, redness, swelling, pain of skin, shingles, skin sensitive to sunlight, rash with raised spotted lesions, skin discolouration, peeling of skin, shortening of muscle tissue, muscle twitching, facial pain, bruising.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store ViraferonPeg

Keep out of the reach and sight of children.

Do not use ViraferonPeg after the expiry date which is stated on the carton.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Use the reconstituted solution (solution you prepared by mixing the powder and the liquid in the pre-filled pen) immediately or within 24 hours when stored in a refrigerator (2°C – 8°C).

Do not use ViraferonPeg if you notice discolouration of the powder, which should be white. The reconstituted solution should be clear and colourless. Do not use if it is discoloured or if bits of particles- are present. After administering the dose, discard the ViraferonPeg pre-filled pen and any unused solution contained in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What ViraferonPeg contains

The active substance is peginterferon alfa-2b. Each pre-filled pen contains 50 micrograms, 80 micrograms, 100 micrograms, 120 micrograms and 150 micrograms of peginterferon alfa-2b in 0.5 ml of solution when reconstituted as recommended.

The other ingredients are:

  • Powder : disodium phosphate, anhydrous, sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80;
  • Solvent : water for injections.

What ViraferonPeg looks like and contents of the pack

ViraferonPeg is a powder and solvent (liquid) for solution for injection in a pre-filled pen.

The white powder and the  clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.

ViraferonPeg 50 micrograms, 80 micrograms, 100 micrograms, 120 micrograms and 150 micrograms are available in different pack sizes:

  1. 1 pen containing powder and solvent for solution for injection, 1 injection needle and 2 cleansing swabs;
  2. 4 pens containing powder and solvent for solution for injection, 4 injection needles and 8 cleansing swabs;
  3. 6 pens containing powder and solvent for solution for injection, 6 injection needles and 12 cleansing swabs;
  4. 12 pens containing powder and solvent for solution for injection, 12 injection needles and 24 cleansing swabs.

Not all pack sizes may be marketed.

How to use the ViraferonPeg pre-filled pen

The following instructions explain how to inject yourself with the single use ViraferonPeg pre-filled pen. Please read all of the instructions carefully before attempting to use the pen and follow them step by step.

Your doctor or his/her assistant will show you how to self-inject with the ViraferonPeg pre-filled pen. Do not attempt to inject yourself unless you are sure you understand everything fully.

The ViraferonPeg pre-filled pen should be used by one person only and must not be shared. Use the injection needle and cleansing swabs provided in the pack only for the ViraferonPeg pre-filled pen. Make sure that the pen is at room temperature before you use it. Your doctor will have told you what dose you need to take for your treatment.

Note: The colour of the dosing button is different for each strength of the ViraferonPeg pre-filled pen.

Preparation:

  • Find a clean, well-lit, non-slip flat working surface and get together all of the supplies you will need for the injection. All of the supplies you will need are in the ViraferonPeg pack. The pack contains: ViraferonPeg pre-filled pen one disposable injection needle two cleansing swabs, and dosing tray
  • The ViraferonPeg pre-filled pen should be stored in the refrigerator, but take it out and allow it to come to room temperature before you use it. Before taking the ViraferonPeg pre-filled pen out of its carton, check the expiration date printed on the carton. Do not use if the expiration date has passed.
  • Take the ViraferonPeg pre-filled pen out of the carton. Look in the window of the pen and make sure there is a white, to off-white tablet that is whole, or in pieces, or powdered. This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected.
  • Wash your hands thoroughly with soap and water, rinse, and towel dry. It is important to keep your work area, your hands, and the injection site clean to lessen the risk of infection.

Please follow the 3 major steps below to use the pen.

Step 1: Mix the medicine

Key points:

  • Before you mix the ViraferonPeg, make sure it is at room temperature. It is important that you keep the ViraferonPeg pre-filled pen upright (Dosing button down) (as shown in figure 1).
  • Place the ViraferonPeg pre-filled pen upright in the holder of the tray provided in the pack (the dosing button will be on the bottom) on a hard, flat, non-slip surface. You may want to hold the pen using the grip.
  • To mix the powder and the liquid, keep the ViraferonPeg pre-filled pen upright in the dosing tray and press the top half of the pen downward toward the hard, flat, non-slip surface until you hear the pen click.
  • Once you have heard the click, you will notice in the window that both dark stoppers are now touching. The dosing button should be flush with the pen body.
  • Wait for several seconds to let the powder dissolve.
  • Gently turn the pen upside down twice. DO NOT SHAKE THE PEN.
  • Keep the ViraferonPeg pre-filled pen upright, with the dosing button down. Then, look through the pen window to see that the mixed ViraferonPeg solution is competely dissolved. If there is still foam, wait until it settles.
  • The solution should be clear and colourless before use. Do not use the solution if it is discoloured, not clear, or contains particles.
  • Before attaching the needle, it is normal to see some small bubbles in the pre-filled pen window, near the top of the solution.
  • Place the pen back into the holder in the tray with the dosing button on the bottom.

Step 2: Attach the needle

  • Keeping the pen upright in the tray holder, wipe the rubber membrane of the ViraferonPeg pre-filled pen with one cleansing swab.
  • Take the injection needle provided in the tray and remove its protective paper tab, but DO NOT remove either the outer cap or the yellow inner cap from the injection needle.
  • Keeping the pen upright in the tray holder, FIRMLY push the injection needle straight onto the pen rubber membrane (figure 2) and screw it securely in place, in a clockwise direction.
  • Keep the ViraferonPeg pre-filled pen UPRIGHT (Dosing button down) and keep both needle caps on until you are ready to inject.
  • Screwing the needle into place, “primes” the needle and allows the extra liquid and air in the pen to be removed. NOTE : You may see some liquid trickle out from under the cap, as the air has been expelled out of the pen. This is normal.
  • Wait about 5 seconds for this process to finish.
  • The dark stoppers move up and you will no longer see the fluid in the window once the needle is successfully primed (figure 3).
  • Check through the window to be sure that the two stoppers are together. If they are not together, do not use this pen because you may not be able to dial your dose (figure 3).
  • Take the pen from the tray holder.
  • Holding the pen firmly, pull the dosing button out as far as it will go, until you see a dark ring on the pen. The dosing button should be easy to pull out without too much force being needed (figure 4).
  • NOTE: Do not push the dosing button back in at this time. You will push it in when you are ready to self-inject the ViraferonPeg.
  • Turn the dosing button until your prescribed dose is in line with the dosing tab. The button should turn easily without too much force being needed (figure 5). If you have trouble dialing your dose, check to make sure the dosing button has been pulled out as far as it will go.
  • NOTE: If you cannot easily pull out the dosing button or dial the dose, do not use excessive force and do not use this pen because it may not deliver the correct dose.
  • Carefully lay the pen down on a hard, flat, non-slip surface. DO NOT remove either of the needle caps and DO NOT push the dosing button in until you are ready to self-inject the ViraferonPeg dose.

Step 3: Inject the ViraferonPeg solution

  • Select the injection site. Your doctor will have told you which sites to use (e.g., thigh or abdomen). The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen. Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection. You should use a different site each time you inject ViraferonPeg to avoid soreness at any one site. Do not inject ViraferonPeg into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
  • Clean the injection site skin with the second cleansing swab provided, and wait for the area to dry.
  • Pull off the outer needle cap (figure 6).
  • There may be some liquid around the inner needle cap. Don’t worry, this is normal. This liquid is not part of your dose, it is extra.
  • Once the injection site is dry, pull off the yellow inner needle cap carefully exposing the injection needle. You are now ready to inject.
  • Hold the ViraferonPeg pre-filled pen with your fingers wrapped around the pen body barrel and your thumb on the dosing button (figure 7).
  • With your other hand, pinch a fold of loose skin in the area you have cleaned for injection.
  • Insert the needle into the pinched skin at an angle of 45° to 90°.
  • Press the dosing button down slowly and firmly until the button can no longer move.
  • Keep your thumb pressed down on the dosing button for an additional 5 seconds to ensure that you get the complete dose.
  • Remove the needle from your skin.
  • Gently press the injection site with a small bandage or sterile gauze if necessary for a few seconds.
  • Do not massage the injection site. If there is bleeding, cover with an adhesive bandage.
  • Discard the ViraferonPeg pre-filled pen with the needle safely in a closed rigid container. After 2 hours, check the injection site for redness, swelling, or tenderness.
  • If you have a skin reaction and it doesn’t clear up in a few days, contact your health care professional.
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