Viraferon - patient leaflet, side effects, dosage

WHAT VIRAFERON IS AND WHAT IT IS USED FOR

2. BEFORE YOU USE VIRAFER

• – if you have psoriasis, it may get worse during treatment with Viraferon.

• – when receiving Viraferon, you may temporarily have a greater risk of getting an infection. Check with your doctor if you think you are getting an infection.

• – if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor.

• – if you notice unusual bleeding or bruising check with your doctor immediately.

• – if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medication seek medical help immediately.

• - if you are also being treated for HIV, please see Using other medicines.

• - if you 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.

Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Viraferon and ribavirin combination therapy. In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Viraferon with ribavirin. You should brush your teeth thoroughly twice daily and have regular dental examinations. In addition some patients may experience vomiting. If you have this reaction, be sure to rinse your mouth thoroughly afterwards.

During the one year of treatment, many children did not grow or gain weight as much as expected. However, during the 6 months after treatment, this trend was generally reversed, although a few children did not return to their previous rate of growth within the first year after completing treatment.

Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure.

Tell your doctor if you have ever been treated for dep unconsciousness; thoughts of suicide or attempted sui

Using other medicines

Viraferon will add to the effects of substances that slow down your nervous system, possibly causing drowsiness. Therefore, check with your doctor or pharmacist about drinking alcoholic beverages, or taking sleeping pills, sedatives or strong pain medications.

Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medication you are taking, or have taken recently, even those not prescribed, as the dose of some medications may have to be adjusted while you are treated with Viraferon.

Patients who also have HIV infection: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment. If you are receiving HAART, the addition of Viraferon and ribavirin may increase your risk of lactic acidosis and of liver failure. Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also). Additionally, patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Viraferon with food and drink

While being treated with Viraferon, your doctor may want you to drink extra fluids to help prevent low blood pressure.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. In studies in pregnant animals, interferons have sometimes caused miscarriage. The effect on human pregnancy is not known.

If you are prescribed Viraferon in combination with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur:

• – if you are a girl or a woman of childbearing age, 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 contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment. This can 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. This will lessen the chance for ribavirin to be left in the woman’s body. If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. This can be discussed with your doctor. If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment. This can be discussed with your doctor.

It is not known whether this product is present in human milk. Therefore, do not breast-feed an infant if you are taking Viraferon. In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products. <7?

Driving and using machines

Do not drive or use machinery if you become drowsy, tired, or confused from this medicine.

Important information about some of the ingredients of Viraferon

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repe­atedly receive human plasma-derived albumin.

This medicine contains human albumin solution as an excipient. When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time you receive a dose of Viraferon the name and batch number of the product are recorded in order to maintain a record of the batches used.

3. HOW TO USE VIRAFERON

Your doctor has prescribed Viraferon specifically for you and your current condition; do not share this medicine with anyone else.

Your doctor has determined the exact dosage for administration of Viraferon according to your individual needs. The dosage will vary according to the disease being treated.

If you are injecting Viraferon yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive. Dosages that are to be administered 3 times a week are best given every other day.

The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:

Chronic hepatitis B: 5 to 10 million IU 3 times a week (every other day) injected subcutaneously (under the skin).

Chronic hepatitis C: Adults - 3 million IU 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin or alone. Children 3 years of age and older and adolescents - 3 million IU/m2 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin (Please also see ribavirin package leaflet).

Your doctor may prescribe a different dose of Viraferon alone or in combination with other medicines (e.g. ribavirin). If you are prescribed Viraferon in combination with another medicine, please refer also to the Package Leaflet of the medicine to be used in combination. Your doctor will determine the exact dosage schedule and regimen according to your needs. If you have the impression that the effect of Viraferon is too strong or too weak, talk to your doctor or pharmacist.

Subcutaneous use:

Viraferon is usually intended for subcutaneous use. This means that Viraferon is injected with a short 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 with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).

One dose of Viraferon is given on each scheduled day. Viraferon is given three times a week, every other day, for example on Monday, Wednesday, and Friday. Interferons may cause unusual tiredness; if you are injecting this medicine yourself, or giving it to a child, use it at bedtime.

Use Viraferon exactly as prescribed by your doctor. Do not exceed the recommended dosage, and take Viraferon for as long as prescribed.

If you use more Viraferon than you should

Contact your doctor or healthcare professional as soon as possible.

If you forget to take Viraferon

If you are self-administering treatment, or if you are the caregiver of a child taking Viraferon in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual. Do not take a double dose to make up for a forgotten dose. If you are scheduled to inject this product every day, and you accidentally missed a full day’s dose, continue treatment at the usual dose the following day. Contact your doctor or pharmacist if needed.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Viraferon 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.

Some people get depressed when taking Viraferon alone or in combination treatment with ribavirin, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.

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

If any of the following side effects happen, stop taking Viraferon and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Viraferon. You may need urgent medical attention or hospitalisation. These very serious side effects are very rare.

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

• chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.

These may signal serious side effects that may need urgent medical attention. Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.

At the beginning of treatment with Viraferon, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors. Your doctor may recommend that you take paracetamol if you develop these symptoms.

Other side effects that may occur include:

Very commonly reported side effects (at least 1 in every 10 patients):

pain, swelling and redness or skin damage at site of injection, hair loss, dizziness, changes in appetite, stomach or abdominal pains, diarrhoea, nausea (feeling sick), viral infection, depression, emotional lability, insomnia, anxiety, sore throat and painful swallowing, fatigue, chills/rigors, fever, flu-like reaction, feeling of general discomfort, headaches, weight loss, vomiting, irritability, weakness, mood swings, coughing (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, musculoskeletal pain, changes in laboratory blood values including decreased white blood cell count. Some children have had a decrease in their rate of growth (height and weight).

Commonly reported side effects (at least 1 in every 100 patients, but less than 1 in every 10 patients): thirst, dehydration, high blood pressure, migraines, swollen glands, flushing, menstrual problems, decreased sexual drive, vaginal problem, breast pain, pain in testicle, problems with thyroid gland, red gums, dry mouth, red or sore mouth or tongue, tooth ache or tooth disorder, herpes simplex (fever blisters), taste change, upset stomach, dyspepsia (heartburn), constipation, enlargement of liver (liver problems, sometimes severe), loose stools, bedwetting in children, inflammation of the sinuses, bronchitis, eye pain, problem with your tear ducts, conjunctivitis (“pink eye”), agitation, sleepiness, sleepwalking, problem with behaviour, nervousness, stuffy or runny nose, sneezing, rapid breathing, pale or reddened skin, bruising, fingers and toes very sensitive to cold, problem with skin or nails, psoriasis (new or worsened), increased sweating, increased need to pass urine, fine shaking movements, decreased sensitivity to touch, arthritis.

Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia

Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia. Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported. This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.

Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported. Loss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses. Cases of stroke (cerebrovascular events) have been reported. Check with your doctor immediately if you have any of these symptoms.

Periodontal (affecting gums) and dental disorders, altered mental status, loss of consciousness, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported, but their frequency is unknown.

Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with Viraferon use.

Other side effects not listed above may also occur in some patients. 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.

5. HOW TO STORE VIRAFERON

Keep out of the reach and sight of children.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

For short term travelling, the non-reconstituted product can be kept out of the refrigerator at or below 25°C for a period up to four weeks before use. If the product is not used during this four-week period, it should be discarded.

The solution should be used immediately after reconstitution. If not used immediately, it must be stored at 2°C – 8°C in the refrigerator and used within 24 hours.

Do not use Viraferon after the expiry date which is stated on the package.

Do not use Viraferon if you notice changes in the appearance of Viraferon.

Any unused product must be discarded after withdrawal of the dose.

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.

• 6. FURTHER INFORMATION

What Viraferon contains

• – The active substance is recombinant interferon alfa-2b, 1 million IU/ml.

• – The other ingredients are glycine, disodium phosphate anhydrous, sodium dihydrogen phosphate

monohydrate, and human albumin solution.

• – Solvent: water for injections 1 ml/ampoule

What Viraferon looks like and contents of the pack

Viraferon is presented as a powder and solvent for solution for injection

The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule with 1 injection syringe, 2 injection needles and 1 cleansing swab.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

SP Europe

73, rue de Stalle

B-1180 Bruxelles

Belgium

For any information about this medicinal product, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgiqu­e/Belgien

Rue de Stalle/Stallestraat 73

B-1180 Bruxelles/Brus­sel/Brüssel

Tél/Tel: + 32-(0)2 370 92 11

Tél/Tel: + 32-(0)2 370 92 11

Tel: + 420 221771250

Tel: + 356–21 23 21 75

Nederland

Maarssenbroeksedijk 4

NL-3542 DN Utrecht

Tel: + 31-(0)800 778 78 78

Norge

Pb. 398

N-1326 Lysaker

Tlf: + 47 67 16 64 50

Lietuva

Kçstucio g. 65/40

LT-08124 Vilnius Tel. + 370 52 101868

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HOW TO SELF INJECT VIRAFERON

The following instructions explain how to inject Viraferon yourself. Please read the instructions carefully and follow them step by step. Your doctor or his/her assistant will instruct you how to self-inject Viraferon. Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of selfinjection.

Preparation

Collect necessary items before you begin:

• – a vial of Viraferon powder for injection;

• – an ampoule of solvent for Viraferon (water for injections 1 ml);

• – a 2 ml syringe;

• – a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the Viraferon powder vial;

• – a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection;

• – a cleansing swab.