Intron A is an alfa interferon used to treat some viral infections and certain types of cancer. It cannot be taken by mouth since it would be broken down by enzymes in the gut. It must therefore be administered by injection. The dose is measured in International Units (IU).

Powder vials contain either 3, 5 or 10 million IU of interferon alfa-2b(rbe).They also contain the following inactive ingredients: glycine, sodium phosphate dibasic, sodium phosphate monobasic and human albumin.

Product Licence Holder: Schering-Plough Ltd, Welwyn Garden City, Hertfordshire AL7 1TW.

Manufactured by: Schering-Plough (Briny) Co., Innishannon, County Cork, Ireland.

Intron A is used to treat a n umber of different cancers and viral infections. These are:

Hairy Cell Leukaemia: a very rare type of cancer of the blood

Chronic myelogenous leukaemia: a cancer of the blood

Multiple myeloma: a cancer of the bone marrow

Non-Hodgkin's Lymphoma: a cancer of the lymph glands

AlDS-related Kaposi's sarcoma: a rare skin tumour which can develop in patients with AIDS.

Hepatitis B: a viral infection of the liver

Chronic Hepatitis C/Non-A, Non-B: a viral infection of the liver

Condylomata acuminata: genital warts caused by a viral infection

Your doctor will explain to you which of these conditions you have.

You should not be treated if you:

• are allergic to any of the ingredients in Intron A
• have a severe heart complaint
• have severe kidney disease
• have epilepsy, or other nervous system problems
• have thyroid disease (unless you are taking treatment for it)

Children are not normally treated with Intron A unless the doctor thinks that it is essential.

You should not take Intron A if you have certain types of long-term liver disease e.g. cirrhosis (check with your doctor if you are not sure).

At intervals whilst receiving Intron A therapy and prior to starting treatment your blood will be tested. In addition, if you are being treated for Hepatitis B you may also need a special liver test (a liver biopsy).

If you are pregnant or breast-feeding a baby you should only be treated with Intron A if you have discussed with your doctor whether the benefits of the medicine for you, the mother, outweigh any possible risks to the child. If you are of child-bearing age, you should use contraceptives during treatment.

If you have any of the following illnesses before treatment, or develop them whilst on treatment, you r doctor may need to reduce your dose of Intron A, or you may need extra treatment to control them. Your doctor will decide by watching the signs and symptoms carefully, doing tests if necessary. In some cases it may be necessary to stop Intron A altogether.

• chest problems or pneumonia
• diabetes
• problems with blood clotting
• liver conditions
• low blood pressure
• a heart attack or irregular heart beat
• depression, confusion, unconsciousness
• thyroid problems
• psoriasis

If you notice any changes in your eyesight whilst you are taking Intron A, you should tell your doctor as he may wish to perform an eye examination.

Sleeping tablets, medicines taken for anxiety (sedatives) and strong pain killers should not be taken during treatment unless you have checked with your doctor first. You can take 1-2 paracetamol 500 mg tablets, 30 minutes before injection if you need to, but remember not to exceed 8 tablets in any 24 hours.

Certain asthma drugs, called theophylline or aminophylline, may need a change in dosage during Intron A treatment

The dose you are given depends on how big you are. It varies with your body surface area. Technically, this is measured in square metres (m2), but actually it is worked out from your weight and height.

There are also different doses according to the disease being treated. Sometimes doctors prescribe different doses to those shown below. For example, your doctor may prescribe you a different dose of Intron A if you are already taking another medicine to treat your disease. If this applies to you, you can discuss it with your doctor, if you have not already done so.

Usually by subcutaneous injection. This means Intron A is injected with a short needle into the fatty tissue just under the skin. It is given either daily or three times a week on every other day, for example, on Mondays, Wednesdays and Fridays. For genital warts, the injection is made directly into the base of the wart. A local anaesthetic may be administered if it is uncomfortable.

Disease treated Dose

Hairy Cell Leukaemia: 2 million lU/m2 3 times a week

for 6 months or more by

subcutaneous injection

Chronic 4 to 5 million IU/m² daily until

myelogenous the disease is under control

leukaemia: then 3 times a week by

subcutaneous injection

Multiple myeloma 3 million IU/m² 3 times a week

maintenance therapy: by subcutaneous injection

Non-Hodgkin's 5 million IU 3 times a week for

Lymphoma: 18 months by subcutaneous

injection

AlDS-related Usually 30 million IU/m² 3 to 5

Kaposi's sarcoma: times a week by subcutaneous

injection or by injection into

times a week for 4 to 6 months

by subcutaneous injection.

Chronic Hepatitis C/ Usually 3 million IU 3 times a

Non-A, Non-B: week for up to 18 months, by

subcutaneous injection.

Condylomata acuminata: 1 million IU injected into the

base of each wart 3 times a

week for 3 weeks. As many as

5 warts can be treated at one

time. The total dose each week

should not be more than 15

million IU. If you have more

than 5 warts, a further course

of treatment may be needed.

Contact your doctor as soon as possible.

As Intron A is usually given daily or 3 times a week, it

is usually more convenient to have injections at home.

You can give subcutaneous injections yourself. These

injections are simple to do and you will be shown

how to do them. Sometimes a relative, friend or

community nurse could do them for you.

1. Wash hands.
2. On a clean dry surface collate items required for injection:

• syringe
• transfer needle (green)
• injection needle (grey)
• *1 ampoule of sterile water
• *Correct dose vial of Intron A (this should be stored in the refrigerator at 2-8 C)
• 2 alcohol swabs
• 1 plaster.
• check expiry date on these

1. Remove syringe and transfer needle from packaging, attach needle to syringe (taking care not to touch the end of the syringe or inside hub of needle). Leave needle guard in place and place on one side.
2. Flip plastic top from top of Intron A vial.
3. Clean the rubber top of vial with alcohol swab.
4. Snap off the top of water vial - protect hands by wrapping ampoule in the alcohol swab wrapper.
5. Remove the needle guard, check the syringe plunger moves easily. Draw up 1 ml of water.
6. Gently inject the sterile water through the rubber bung directing it down the side of the vial to avoid making bubbles.
7. Remove syringe and needle.
8. Make sure the powder dissolves in the water by gently shaking the vial from side to side. Allow any bubbles to settle. The solution should be colourless to pale yellow. Do not use if there are particles present in the solution.
9. Turn the vial upside down and insert the transfer needle through the rubber bung. Keeping the needle tip in the solution, draw back the syringe plunger until all the liquid is in the syringe. Withdraw needle from vial, replace the guard.
10. Hold the syringe with the needle pointing upwards and gently tap any air bubbles to the top. Expel the air by pushing the plunger of the syringe making sure you don't squirt out any of the solution.
11. Remove transfer needle and attach grey needle, with needle guard still in place.

1. Wash hands and ensure that the place you are going to inject is clean and dry.
2. Hold syringe like a pencil and remove needle guard.
3. Pinch the skin firmly where you are going to inject. This traps some of the fatty area beneath it. Before injecting, wipe the designated area with an alcohol swab.
4. With the syringe straight up or at a slight angle

5. Gently push the plunger to inject the Intron A.
6. Pull the needle straight out, pressing on the area gently, but firmly, with cotton wool/gauze swab to arrest any bleeding which may occur.
7. Dispose of syringe, needles and glass waste immediately into "sharps" bin, which may be obtained by sending the enclosed reply-paid card.

Inject your recommended dose as soon as you remember and then carry on as normal.

Like all drugs, Intron A has side effects. Although a lot of different side effects have been seen, you should remember that most of them only rarely occur. Side effects are generally dose related and get better when treatment is stopped.

The most common side effects are "flu-like" symptoms, such as fever, fatigue and headache. These symptoms are similar to those experienced when you catch flu and the body produces interferon naturally to fight off the virus. The feverish symptoms are most likely to occur 2 to 6 hours after the first few injections. After 2 weeks or so they are likely to disappear. Injecting Intron A about 2 hours before bedtime and taking 1-2 paracetamol 500 mg tablets 30 minutes before the injection and again when you go to bed will help alleviate the symptoms. Remember not to take more than 8 tablets in any 24 hour period.

You may go on feeling tired after the first few weeks of Intron A therapy. If this is the case, take plenty of rest and pace your activities. You may also suffer from nausea and lose your appetite.

You may occasionally suffer from some less common side-effects, such as: vomiting, diarrhoea, joint pain and weakness, sleepiness, dizziness, dry mouth, hair loss, back pain, depression, increased sweating, taste alteration, irritability, difficulty sleeping, confusion, difficulty in concentrating and low blood pressure.

The following side-effects only occur rarely in a few patients being treated with Intron A: abdominal pain, rash, nervousness, problems at the site of injection e.g. inflammation or redness, Herpes simplex e.g. cold sores, itching, eye pain, anxiety, nose bleeds, coughing, sore throat, chest problems, pneumonia, inflammation of the lungs, drowsiness, loss of weight, swelling of the face, difficulty breathing, indigestion, irregular heart beat, high blood pressure, increased appetite, decreased sex drive, bleeding of the gums, problems with your eyesight. Intron A may also have an effect on the thyroid gland and cause high blood sugar. If you are having laboratory tests performed on your blood and urine, Intron A may cause abnormal results. Very rarely, a few people have had fits after having high doses of Intron A.

If you think you are suffering from these, or any other side effects, you should tell your doctor.

Intron A powder should be stored in a refrigerator at

2-8°C but can be stored at room temperature (below ! 25°C) for short periods e.g. when travelling long distances, but solutions which have been made up from the powder should be stored at 2-8 C in a refrigerator. You may keep the solution for 24 hours when you store it in a refrigerator. Do not use the solution after this time.

Do not use Intron A after the expiry date which is stamped on the label.

If there is anything you do not understand:

You will see from this leaflet that Intron A is quite a

complex medicine. If there is anything you do not

understand, ask your doctor to explain it.