Roferon -A (Interferon alfa-2a)
Roferon -A
3 million international units (MIU)
solution for injection in pre-filled syringe
4.5 million international units (MIU) solution for injection in pre-filled syringe
6 million international units (MIU) solution for injection in pre-filled syringe
9 million international units (MIU) solution for injection in pre-filled syringe
Interferon alfa-2a
1. WHAT ROFERON-A IS AND WHAT IT IS USED FOR
Roferon-A contains an antiviral agent called interferon alfa-2a which is similar to a natural substance produced by the body to protect against viral infections, tumors and foreign substances that may invade the body. Once Roferon-A has detected and attacked a foreign substance, it alters it by slowing, blocking, or changing its growth or function.
Roferon-A is used to treat the following:
• Viral infections, such as chronic hepatitis B and C.
• Cancers of the blood (cutaneous T-cell lymphoma, hairy cell leukaemia and chronic myelogenous leukaemia).
• Some other forms of cancer (renal cell carcinoma, AIDS-related Kaposi’s sarcoma, follicular non-Hodgkin’s lymphoma and malignant melanoma).
If you are not sure why you have been prescribed Roferon-A, you should discuss your illness and its treatment with your doctor.
2. BEFORE YOU USE ROFERON-A
Do not use Roferon-A:
• if you are allergic (hypersensitive) to interferon alfa-2a or any of the other ingredients of Roferon-A.
• if you suffer or have suffered from heart disease.
• if you have a severe kidney or liver condition.
• if you have a liver disease or liver cirrhosis
• if you have a bone marrow disorder.
• if you suffer from seizures e.g. epilepsy and/or other central nervous system disorders.
• if you are or have recently been treated with medication for chronic liver disease that weakens your immune response.
Roferon-A is not recommended for use in children except on the advice of your doctor. ‘Gasping syndrome’ (a serious condition in children up to 3 years old), has been linked with benzyl alcohol. Benzyl alcohol is an inactive ingredient in Roferon-A. Roferon-A is therefore not a suitable medicine for young children (including premature babies, newborns or infants).
For some diseases, Roferon-A may be used in combination with other drugs. In such cases any additional restrictions on the use of Roferon-A will be explained to you by your doctor.
Take special care with Roferon-A: Tell your doctor:
• if you have mental problems (psychiatric difficulties) or have ever had a mental (psychiatric) illness.
• if you have psoriasis (a disease of recurring dry, patchy, scaly skin lesions).
• if you have kidney, heart or liver problems.
• if you have ever had an autoimmune disease, e.g. thyroid problems, vasculitis (inflammation of the blood vessels).
• if you have had an organ transplant (such as kidney) or bone marrow transplant, or have one planned in the near future.
• if you are or may be pregnant.
• if you have a low blood cell count.
• if you have diabetes (a disease resulting from high sugar level in your blood).
• if you have any other problems with your blood .
• if you are being treated for chronic hepatitis C.
• if you are also infected with HIV and being treated with anti-HIV medicinal products.
• if you are taking any other medicines (including those not prescribed by your doctor).
Tell your doctor if you have a blood disorder or suffer from diabetes. Your doctor may take samples of your blood at intervals to check its composition, which may change during treatment. If needed your doctor may adjust the dose of your treatment with Roferon-A and any other treatments you are receiving at the same time.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. The effects of those drugs could either be increased, decreased, or altered when administered concomitantly with interferons. In particular the plasma concentration of theophylline, an asthma drug from the xanthine family, can be increased when it is administered concomitantly with interferon and may request a dosage adjustment.
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 Roferon-A and Ribavirin may increase your risk of lactic acidosis or liver failure. Your doctor will monitor you for signs and symptoms of these conditions. Please read the Ribavirin Package Leaflet.
Tests and investigations:
If you are going to have a blood test, you should tell the doctor or nurse performing the test that you are taking Roferon-A. In some uncommon or rare cases, Roferon-A may affect the results of these tests.
Pregnancy
Do not use Roferon-A if you are pregnant, think you may be pregnant, or are planning to become pregnant, unless your doctor tells you to. This is because Roferon-A may affect your baby. It is important that you and your partner use an effective method of birth control (contraception) while you are being treated with Roferon-A.
When Roferon-A is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur as ribavirin can be very damaging to an unborn baby:
if you are a woman of childbearing age who is taking Roferon-A in combination with ribavirin, you must have a negative pregnancy test before treatment, each month during therapy 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 the treatment and for 4 months after stopping treatment. This can be discussed with your doctor.
if you are a man who is taking Roferon- A in combination with ribavirin, do not have sex with a pregnant women 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 7 months after treatment has stopped. You and your partner must each use an effective contraceptive during the time you are taking the treatment and for the 7 months after stopping treatment. This can be discussed with you doctor.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. It is not known whether this product is present in human milk. Therefore, discuss with your doctor whether you should suspend breast-feeding or discontinue Roferon-A. In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Driving and using machines
Do not drive or use machinery if you feel drowsy, tired or confused while using Roferon-A.
Important information about some of the ingredients of Roferon-A
Roferon-A contains benzyl alcohol therefore it must not be given to premature babies or newborns. It may cause toxic or allergic reactions in infants and children up to 3 years old.
The product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially “sodium free”.
3.HOW TO USE ROFERON-A
Always use Roferon-A exactly as your doctor has told you.
Roferon-A can be given by your doctor or nurse, or your doctor or nurse may teach you how to inject yourself with Roferon-A. Do not try to inject yourself with Roferon-A unless you have received training. You should check with your doctor or nurse if you are not sure.
Roferon-A pre-filled syringes are used to give an injection beneath your skin (subcutaneous). See section 7 “How to inject Roferon-A” for detailed instructions.
The pre-filled syringes are for single use only.
Roferon-A dosing
Your doctor will decide the best dose for you. The amount of Roferon-A you need will depend on why
you are being treated and the side effects you suffer.
Your dose should not normally be more than 36 Million International Units (MIU) per day.
If you think the effect of your medicine is too weak or too strong talk to your doctor. Do not change the amount you take before talking to your doctor.
Usual Initial Dosage
Hairy Cell Leukaemia
3 MIU daily for 16 – 24 weeks.
Chronic Myelogenous Leukaemia
The dose will normally be increased from 3 MIU to 9 MIU taken once a day over an initial treatment period of 12 weeks.
Cutaneous T-Cell Lymphoma
The dose will normally be increased from 3 MIU to 18 MIU taken once a day over an initial treatment period of 12 weeks.
ALDS-related Kaposi’s Sarcoma
The dose will normally be increased from 3 MIU to 18 MIU taken once a day to a maximum of 36 MIU over an initial treatment period of 10 – 12 weeks.
Renal Cell Carcinoma
Combination with vinblastine
The dose will normally be increased from 3 MIU to 18 MIU taken three times a
week over an initial treatment period of 12 weeks.
Combination with bevacizumab (Avastin)
9 MIU under the skin (subcutaneously) three times a week until your disease
progresses or for up to 1 year.
Chronic Hepatitis B
2.5 – 5 MlU/square metre body surface area three times a week for 4 – 6 months.
Chronic Hepatitis C
3-6 MIU three times a week for 6 months.
FollicularNon-Hodgkin’sLymphoma (with chemotherapy)
6 MlU/square metre body surface area from day 22 to day 26 of each 28-day cycle
Malignant Melanoma
3 MIU three times a week for 18 months.
If you respond well to initial treatment with Roferon-A, your doctor may decide that you should continue treatment for a longer period of time (maintenance therapy) and will change your dosage accordingly.
Combination therapy with Ribavirin in chronic hepatitis C
When taking Roferon-A and Ribavirin at the same time, please follow the dosage regimen recommended by your doctor.
Other important instructions
Your doctor will tell you when to stop using Roferon-A. Some illnesses may require treatment over a
period of several years.
If you use more Roferon-A than you should:
Contact your doctor, pharmacist or nearest hospital immediately.
If you forget to use Roferon-A:
Do not take a double dose to make up for a forgotten dose.
If you stop using Roferon-A:
Contact your doctor or pharmacist as soon as possible.
If you have further questions on the use of this product, ask your doctor or pharmacist.
4.POSSIBLE SIDE EFFECTS
Like all medicines, Roferon-A can cause side effects, although not everybody gets them.
Important side effects to look out for:
Tell your doctor straight away if you notice any of the following serious side effects. You may need urgent medical treatment:
• If you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while on this medication.
• If you notice a decrease in your sight during or after treatment with Roferon-A.
• If you develop any signs of depression (such as sadness, feeling worthless or thoughts of suicide) during your Roferon-A treatment.
Other possible side effects:
It is common to experience flu-like symptoms such as tiredness, chills, muscle or joint pain, headache, sweating and fever. These effects can usually be reduced by taking paracetamol. Your doctor will advise you on the dose you should take. These kinds of symptoms usually lessen with continued therapy.
Infections:
Pneumonia, cold sores and genital herpes occur rarely.
Blood and lymphatic system disorders:
Changes in blood cell counts have been reported, including:
• Lower numbers of red blood cells (anaemia). The signs include feeling tired, pale skin and being short of breath.
• Lower numbers of platelets. The signs include small bruises on the body or bleeding.
• Lower white cell counts. The signs include increased number of infections.
Changes in platelet and red blood cell counts are more likely to occur if you are undergoing cancer treatments, including chemotherapy, or have decreased bone marrow activity. The make-up of your blood will usually become more normal after discontinuing Roferon-A.
Immune system and endocrine disorders:
Autoimmune conditions (where the body attacks its own cells), such as arthritis, hypersensitivity reactions including wheals, swelling of the face, lips and throat, wheezing and allergic type reactions, such as a rash, have been reported rarely.
Sarcoidosis (a disease that results from inflammation of tissues of the body) has been very rarely reported. Sarcoidosis can affect almost any body organ, but most often starts in the lungs or lymph nodes.
Rarely, abnormal functioning of the thyroid gland has been reported.
Gastrointestinal, metabolism and nutrition disorders:
Anorexia (an eating disorder causing weight loss) and nausea are side effects which occur frequently. Bitter taste, dry mouth and weight loss may occur less frequently. Other side effects which may affect the stomach and bowel, such as stomach pains, diarrhoea, vomiting, heartburn, constipation and flatulence (wind), have been observed less frequently. In rare cases, the pancreas may work abnormally. In very rare cases, worsening or return of a peptic ulcer and intestinal bleeding have occurred.
Low blood calcium, electrolyte imbalance (abnormal blood test results for sodium and other elements), dehydration and, very rarely, diabetes (a disease resulting from high blood sugar) and hypertriglyceridaemia (high levels of some lipids/fats in the blood) have been reported.
Nervous system and psychiatric disorders:
Headache, dizziness, pins and needles, trembling, numbness, sleep disturbances, nervousness, anxiety states, forgetfulness, drowsiness, confusion, changed or abnormal behaviour, depression and suicidal behaviour have occurred. You should tell your doctor if you experience any symptoms of depression.
Rarely, vertigo, transient or temporary impotence (male sexual dysfunction), convulsions (fits), stroke and coma have been reported.
Eye disorders:
Conjunctivitis, eye discharge, visual disturbances, such as blurred vision and, very rarely, loss of eyesight, have been reported.
Cardiac, vascular and respiratory disorders:
Temporary low or high blood pressure, irregular heart beat, slowing of the heart rate, palpitations, chest pain and heart attack have been observed in patients using Roferon-A. Build-up of fluid in the lungs (which may cause breathing problems) and a bluish discolouration of the skin or lips (caused by a lack of oxygen in the blood) have also been reported. Serious heart and lung problems occur rarely.
Breathlessness, cough and vasculitis (inflammation of the blood vessels) have been reported rarely.
Liver and kidney disorders:
Sometimes, mild effects on your liver may occur, but these will not normally require a change in dosage. In rare cases, Roferon-A may cause the liver to work less well than usual and may result in severe liver abnormalities, including liver failure and hepatitis.
Urine tests may show protein and increased cell counts in your urine. In rare cases, kidney failure or worsening of kidney function may occur, mainly in cancer patients who already suffer from kidney disease.
Skin and mucous membranes:
Increased sweating, rash, dryness or itching of your skin, psoriasis or worsening of psoriasis, runny nose and nose bleeds may occur. Hair thinning or hair loss sometimes occurs, but this is usually reversible on completion of treatment.
You may get a slight reaction around the area of skin where you are injected with Roferon-A. In very rare cases this may cause a dead patch of skin around the injection site.
Musculoskeletal disorders:
Muscle and joint pain, rarely systemic lupus eryfhematosus, arthritis.
Other side effects:
Flu-like illness, tiredness, fever, loss of appetite, chest pain.
Your doctor may decide to combine your Roferon-A treatment with other medicines. In such cases you
may experience additional undesirable effects. Where these occur, they will be explained to you by your
doctor.
Some changes may occur in your blood which your doctor will check for.
If any of the above 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 ROFERON-A
Keep out of the reach and sight of children.
Do not use Roferon-A after the expiry date, which is stated on the carton and on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not use Roferon-A if you notice that the solution is cloudy, if it has floating particles or if the medicine is any colour besides colourless to slightly yellowish.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Roferon-A contains
• The active substance is interferon alfa-2a, 3 MIU/0.5 ml, 4.5 MIU/0.5ml, 6 MIU/0.5ml and 9 MIU/0.5ml.
• The other ingredients are ammonium acetate, sodium chloride, benzyl alcohol (10 mg/1 ml), polysorbate 80, glacial acetic acid, sodium hydroxide and water for injections
What Roferon-A looks like and the contents of the pack
Roferon-A is a solution for injection (0.5 ml in pre-filled syringes).
Pack sizes: Packs of 1, 5,6, 12 or 30. Not all pack sizes may be marketed. The solution is clear, colourless to slightly yellowish.
7. HOW TO INJECT ROFERON-A
Illustrated instructions for subcutaneous injection using Roferon -A pre-filled syringe
Syringe with solution for injection Needle for subcutaneous injection
Important: Let the solution warm to room temperature before use (administration).
1
Take the needle from the box. Take off the rear cap from the needle. Then, take the syringe from the box and take off the protective cap. Push the needle onto the syringe. Pull off the shield from the needle (see figure 1).
2
Hold the syringe with the needle pointing up. Carefully push out any air by slowly pushing the plunger in.
3
Roferon-A can be injected either into the thigh or into the lower abdomen.
It is recommended that a new site be chosen for each injection
4
Before injecting yourself, clean the injection site with an alcohol swab.
5
Using your thumb and index finger, pinch up a fold of skin and insert the needle as far as it will go at an angle of 45 degrees (see figure 5).
Pull back the plunger of the syringe slightly.
If blood appears in the syringe, the needle has entered a blood vessel. If this happens you cannot inject the Roferon-A.
Discard the unused syringe and needle and start again with a new injection at a different site with a new syringe and needle.
6
Applying steady pressure, inject the contents of the Roferon-A pre-filled syringe beneath the skin until the syringe is completely empty.
7
To remove syringe, press the alcohol swab lightly on injection site and withdraw needle at a low angle.
The pre-filled syringes are for single use only. You should discard any unused product or waste material. Ask your doctor or pharmacist for future advice.
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