How does it work?

Roferon-A injection contains the active ingredient interferon alfa-2b, which is a type of medicine called an immunomodulator.

Interferons are a family of small protein molecules that are produced naturally by cells in response to viral infections or various synthetic and biological inducers. Three major classes of interferons have been identified: alfa, beta and gamma. They work in a complicated way that is not fully understood, but are thought to boost the immune system, causing it to attack infected or abnormal cells.

Interferons can be used to treat a range of diseases. Interferon alfa can be used in the treatment of various cancers, such as leukaemias, lymphomas and other types of cancers (eg skin, bone marrow). It works by preventing abnormal or malignant cells from increasing in numbers.

Interferon alfa can also be used to treat chronic hepatitis B and C, which are caused by the hepatitis B and C viruses. It works by helping to prevent these viruses from multiplying in the liver cells.

What is it used for?

• Chronic hepatitis B
• Chronic hepatitis C (preferably in combination with ribavirin)
• Hairy cell leukaemia
• A form of skin cancer called Kaposi's sarcoma, in people with AIDS whose CD4 count is greater than 250/mm³
• Cancer of the blood called chronic myeloid leukaemia or CML in people who have the Philadelphia-chromosome
• A type of cancer of the lymph nodes that first appears on the skin (cutaneous T-cell lymphoma)
• Cancer of the lymph nodes (follicular non-Hodgkins lymphoma)
• Advanced kidney cancer
• Skin cancer (malignant melanoma), used after surgery to remove the cancer

Warning!

• This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• This medicine can cause flu-like symptoms such as aches and pains, fever, chills, sweating, headache, fatigue and nausea. These tend to be worse at the start of treatment and improve with continued treatment. You may want to take a medicine to reduce these symptoms, for example, paracetamol, aspirin or ibuprofen, before the injection and for 24 hours after the injection. Ask your doctor or pharmacist for advice.
• This medicine has been associated with psychiatric side effects, particularly depression, that can occur at any time during treatment and even after treatment has finished. You should discuss this with your doctor before starting treatment. It is important to talk to your doctor immediately if you have any distressing thoughts or feelings, thoughts about suicide or self-harm, mood changes, confusion, agressive behaviour or any other unusual change in behaviour while having treatment with this medicine. It may be necessary to stop treatment.
• This medicine has rarely been associated with side effects on the eyes. You should have an eye examination before starting treatment. Tell your doctor if you experience any disturbances in your vision during treatment.
• This medicine may rarely decrease the number of blood cells in your blood. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• During treatment with this medicine you will need to have regular blood tests. This is to monitor things such as your liver function, thyroid function and the levels of blood cells and lipids in your blood.
• Your ability to become pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• History of depression or other psychiatric disorders
• People who have recently had an organ transplant, eg kidney or bone marrow transplant, and are taking immunosuppressant medicines to prevent transplant rejection
• Diabetes
• High blood pressure (hypertension)
• Decreased kidney function
• Decreased liver function
• Heart disease
• Decreased blood cell production by the bone marrow, causing lower than normal levels of blood cells in the blood
• History of disease caused by the immune system attacking the body's own tissues (autoimmune disease, eg autoimmune hepatitis)
• Overactive or underactive thyroid gland
• Psoriasis
• Sarcoidosis

Not to be used in

• Premature babies, newborn babies, infants or young children. This medicine is also not recommended for older children.
• Severe heart disease
• Severely decreased kidney function
• Severely decreased liver function
• Severely decreased blood cell production by the bone marrow, causing lower than normal levels of blood cells in the blood
• Uncontrolled epilepsy
• People with chronic hepatitis who have liver cirrhosis, or who are being or have recently been treated with immunosuppressive medicines
• AIDS patients with CD4 counts less than 250/mm³, or those with a history of opportunistic infections

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established. It should only be used during pregnancy if the expected benefit to the mother is greater than any possible risk to the foetus. Women who could get pregnant should use effective methods of contraception to prevent pregnancy while having treatment with this medicine. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. The manufacturer states that it should not be used during breastfeeding. Alternatively, breastfeeding can be stopped during treatment. This decision will depend on the importance of the medicine to the mother. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Cold or flu-like symptoms
• Loss of appetite
• Headache
• Fatigue
• Feeling of weakness
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
• Hair loss (alopecia)
• Disturbance in the components of the blood
• Depression
• Anxiety
• Disturbances in behaviour
• Difficulty in sleeping (insomnia)
• Dizziness
• Pins and needles sensations
• Numbness
• Visual disturbances
• Increase or decrease in blood pressure
• Skin reactions such as rash and itch
• Local pain and swelling at the site of injection
• Heart problems such as irregular heart beats and fluid retention
• Liver, kidney or lung disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.

This medicine should not be used in AIDS patients who are taking protease inhibitors or reverse transcriptase inhibitors (except zidovudine).

The may be an increased risk of side effects if this medicine is used in combination with cancer chemotherapy or other treatments that can have effects on the blood cells.

Interferon alfa may increase the blood levels of the following medicines:

• theophylline
• zidovudine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain interferon alfa-2a as the active ingredient.