PX610/5

Cosmegen® Lyovac Injection

500 mcg Powder for Solution for Injection (Dactinomycin)

•    Please read this leaflet carefully before you start to receive your medicine

•    It gives you important information about the medicine

•    If you want to know more, or are not sure about anything, ask your doctor or pharmacist

•    Keep this leaflet until you have finished receiving your medicine

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

Information in this leaflet:

1.    What Cosmegen Lyovac Injection is and what it is used for

-    What is in your medicine and how does it work?

-    Why do you need to be given this medicine?

2.    Before you take Cosmegen Lyovac Injection

-    When should this medicine not be used?

-    Before you take this medicine

-    Taking other medicines

3.    How to take Cosmegen Lyovac Injection

-    How will your medicine be given?

4.    Possible side effects

5.    How to store Cosmegen Lyovac Injection

6.    Further Information

1.    What Cosmegen Lyovac Injection is and what it is used for

What is in your medicine and how does it work?

The name of your medicine is Cosmegen Lyovac injection and its active ingredient is dactinomycin.

Dactinomycin belongs to a group of medicines called antibiotics.

It works by preventing the reproduction of cells, especially abnormal cells which are associated with some types of cancer.

It also prevents reproduction of normal cells that multiply quickly.

Why do you need to be given this medicine?

Your doctor has prescribed Cosmegen for you because you may suffer from one of the following conditions which your doctor should have explained to you:

•    Wilms' tumour (a type of kidney cancer which usually occurs in children)

•    Rhabdomyosarcoma (a rare cancer of the muscle)

•    Ewing's sarcoma (a type of bone cancer)

•    cancer of the testis and uterus

•    melanoma (a type of skin cancer).

Cosmegen may also be used in the treatment of other cancers.

Your doctor may prescribe radiotherapy as well as Cosmegen.

2.    Before you take Cosmegen Lyovac Injection

When should this medicine not be used?

You should not be given Cosmegen injection if:

•    you are allergic to dactinomycin or any of the ingredients in Cosmegen injection

•    you have chickenpox or shingles

•    you are, or think you may be, pregnant

•    you are planning to become pregnant

•    you are breast feeding.

If you think any of these apply to you, tell your doctor.

Before you take this medicine

There are other things regarding Cosmegen which you should know about. These are given below so that special care can be taken where needed.

Splashes or spills

Cosmegen is extremely harmful to soft tissue such as skin, and any leakage on to the skin will cause soft-tissue damage. Any spills or splashes of Cosmegen must be washed off immediately with lots of water or saline (salt water).

Medical attention should be sought immediately.

Radiation therapy

If you are receiving Cosmegen with radiation therapy your doctor will have to keep a close watch on you as there is an increased possibility of some other side effects.

Kidney, liver, bone marrow

Cosmegen may cause kidney, liver or bone marrow problems. This can result in a lower number of red and white blood cells and a lower number of platelets. Symptoms of lower red blood cells include tiredness, headaches, being short of breath when exercising, dizziness and looking pale. A lower number of white blood cells may make it harder for you to fight off infections. Symptoms of lower platelet counts include excessive bruising or a harder time to stop bleeding if you have a cut. Your doctor should assess these functions frequently.

Taking other medicines

Always tell your doctor or pharmacist if you are taking any other medicines, because using some medicines together can be harmful.

•    X-ray: You should tell your doctor if you received X-ray treatment

at any time. There is some information that, rarely, other tumours may occur following treatment with X-rays and medicines like Cosmegen.

•    Antibacterial medicines: Cosmegen may alter the results of tests that are done to measure the levels of antibacterial medicines.

Pregnancy and breast feeding

If you are pregnant, think you might be pregnant or are planning to become pregnant, tell your doctor immediately.

If you are breast feeding, you should not be given Cosmegen injection. Driving and operating machines

Cosmegen can cause some people to feel less alert. Make sure you are not affected before you drive or operate machinery.

3. How to take Cosmegen Lyovac Injection How will your medicine be given?

You will be given your Cosmegen injection by a doctor or nurse who is experienced in the use of cancer treatments.

The number of injections you need will depend upon your condition, your response to the medicine, any possible side effects, and whether you are having other treatments at the same time.

You may be given Cosmegen either as an injection (see below) or mixed with another solution as an infusion (a ‘drip') into your vein.

It must not be taken by mouth.

There are two ways of giving Cosmegen injection:

•    into a vein

•    directly into the site of the cancer.

The dosage is different for each method.

In these cases your doctor will calculate the doses required and will tell you how long your treatment might take. Your doctor will determine the correct dose and duration of the treatment depending on your type of cancer.

Dosage

Typical doses for injection into a vein:

•    Not more than 15 micrograms per kg of body weight for 5 days in adults and children, or

•    400-600 micrograms per square metre of body surface daily, for 5 days. Typical doses for giving Cosmegen directly into the site of the cancer:

•    For the legs or pelvis, 50 micrograms per kg bodyweight.

•    For the arms, 35 micrograms per kg bodyweight.

Your doctor will advise you of the method and number of injections and courses you require.

If you miss a dose or are given too much

Your response to the medicine and your condition will be monitored by your doctor, who will determine if changes to your treatment are needed.

If you are confused or concerned about the number of doses you have received, or think you may have been given too much medicine, talk to your doctor immediately.

4. Possible side effects

As with all medicines, Cosmegen may cause side effects in some patients. However, these side effects are usually reversible once your treatment has stopped.

Seek urgent medical attention if you experience:

•    serious bacterial infection in the bloodstream or body tissues (sepsis including neutropenic sepsis), which can lead to death. Symptoms include shivering, hot and cold, a sudden chill, diarrhoea. At the early stage the patient will be warm and alert and not look unwell. However, they can deteriorate rapidly and death can follow

•    blisters and/or a rash that join together to cover a large portion of the body resulting in severe peeling of the skin, flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of skin to die, peel, and shed

•    facial or tongue swelling, hives, skin pain that may be accompanied by fever, chills, aching muscles and generally feeling unwell

•    evenly distributed red patches and rash primarily on the arms and legs

See your doctor immediately if you experience:

•    liver problems (such as liver failure, hepatitis (irritated liver caused by a virus), a painful enlarged liver, fluid retention)

•    a lowering of the red blood cells which can cause tiredness (which may be severe)

•    a lowering of white blood cells which can make you more prone to infections

•    a lowering of platelets which can make you more prone to bleeding Other side effects may include (especially in the first few hours after receiving Cosmegen):

•    Vomiting

•    Nausea (feeling ill)

•    Generally feeling unwell

Apart from nausea and vomiting, side effects do not usually start until a few days after your treatment has stopped and may continue for one to two weeks afterwards.

Other possible side effects are listed below.

General side effects may include:

•    infections

•    kidney problems

•    fever

•    slowing down of growth

•    inflammation of the rectum

•    fertility problems

•    muscle pain

•    tiredness, feeling generally unwell

Side effects of the Lungs:

•    inflammation of the lungs

Side effects of the Mouth:

•    difficulty swallowing, sore mouth or throat, mouth ulcers or sores, cracked lips

•    spasm of the hands or feet and tingling around the mouth and vocal cords (due to low calcium levels in the blood)

Side effects on the stomach and intestine (gut):

•    stomach ulcers, pains in stomach, diarrhoea

•    loss of appetite

•    inflammation of the rectum

Side effects on the skin and soft tissues:

•    any leakage on the skin will cause soft tissue damage

•    blistering or reddening of the skin

•    skin rashes

•    acne

•    flare up of rashes

•    increased darkness in skin which has previously been exposed to radiation treatment

•    hair loss

If you are receiving Cosmegen directly into the site of the cancer damage to the skin and soft tissues may occur from leaks. The side effects from leaks are:

•    blood clots

•    damage to soft tissue

•    infections

•    problems with wound healing

•    blistering or reddening of the skin

•    swelling of affected area

•    in rare and severe cases, an affected arm can pull inwards and become stiff contracture)

Any spills or splashes of Cosmegen must be washed off immediately with lots of water or saline (salt water).

There is some information that, rarely, other tumours may occur following treatment with X-rays and medicines like Cosmegen.

Your doctor will monitor you carefully and frequently for your response to treatment, but if you experience any of the above effects, especially fever or bleeding, or you have any other unusual symptoms or feelings or concerns, you should talk to your doctor.

5.    How to store your medicine

•    Keep your medicine out of the reach and sight of children

•    Do not store above 25°C

•    Do not freeze

•    Keep the vial in the outer carton in order to protect from light

•    Discard open unused product immediately.

REMEMBER,

•    Cosmegen should not be given after the expiry date, which is clearly marked on the pack

•    Cosmegen is for YOU only. NEVER give it to anyone else

•    It may harm others, even if their symptoms are the same as yours.

6.    Further Information What Cosmegen contains

•    The active ingredient is dactinomycin. Each vial contains 500 micrograms (0.5 mg) of dactinomycin as the active substance.

•    The other ingredient is mannitol

Contents of the pack

Cosmegen is supplied as a yellow-orange powder in a glass vial. Each vial contains 500 micrograms of dactinomycin. It also contains mannitol E421. It is made up into a clear, gold-coloured liquid by adding sterile water to the powder in the vial.

Marketing Authorisation Holder

The Marketing Authorisation is held by Orphan Europe SARL, Immeuble Le Wilson, 70 avenue du General de Gaulle, 92800 Puteaux - France.

Manufacturer

Cosmegen is made by Almac Pharma Services Limited, Seagoe Industrial Estate, Craigavon, Co. Armagh, BT63 5UA, U.K.

RECORDATI GROUP

® Registered Trademark

Date revised: November 2013    PX610/5