Consumer medicine information

Atgam®

Atgam^®

Active ingredient(s): Equine antithymocyte immunoglobulin

Consumer Medicine Information (CMI)

This leaflet provides important information about treatment with Atgam. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Atgam.

Where to find information in this leaflet:

1. Why am I being treated with Atgam?
2. What should I know before treatment with Atgam?
3. What if I am taking other medicines?
4. How is Atgam given?
5. What should I know during treatment with Atgam?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Atgam?

Atgam contains the active ingredient, equine antithymocyte immunoglobulin (a type of horse protein used to help control your body’s immune system response to foreign protein).

Atgam is used after a kidney transplant to stop your body’s immune system from rejecting the new kidney.

Your doctor may prescribe Atgam for another purpose.

2. What should I know before treatment with Atgam?

Warnings

Do not use Atgam if you are allergic to Atgam/equine antithymocyte immunoglobulin or other horse proteins (equine gamma globulins) or any of the ingredients listed at the end of this leaflet.

Check with your doctor if you

have previously been treated with Atgam
have had an allergic reaction to similar types of products.

Before being treated with Atgam, your doctor usually will do a skin test to see if you are likely to have an allergic reaction to Atgam.

It is possible for products developed from horse or human blood to carry infectious diseases like viral hepatitis and AIDS.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children

There has been limited use of Atgam in children. It has been safely used in a small number of children who have had kidney, liver or bone marrow transplants and aplastic anaemia (anaemia due to the absence of bone marrow).

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Atgam.

4. How is Atgam given?

How much will be given

Your doctor will decide what dose of Atgam you need and when you should start treatment with Atgam.

Your doctor will usually give you other medicines when you are given Atgam. These medicines are also used to reduce your immune response to the new kidney.

If you use too much Atgam

Atgam will be given under medical supervision so an overdose is unlikely.

5. What should I know during treatment with Atgam?

Things you should do

Keep follow up appointments with your doctor or clinic.

Have any blood tests requested by your doctor.

Remind any doctor or dentist you visit that you are using Atgam.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Atgam affects you.

Atgam may cause dizziness, faintness, convulsion, confusion in some people

Drinking alcohol

No information available.

Looking after your medicine

Atgam is stored in a hospital which is responsible for storing and disposing of any unused product correctly.

6. Are there any side effects?

All medicines can have side effects. Most side effects are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Side effects

What to do

Fever, chills, sore mouth or throat
Reappearance of cold sores, eye or genital infections
Generally feeling unwell or tired
Cough
Hiccups or hiccoughs
Nosebleed
Pain, swelling or redness at injection site
Sweating, night sweats
Stomach pain/discomfort or stomach upset
Loss of appetite
Nausea, vomiting
Diarrhoea
Constipation
Skin rash, itchiness
Confusion or disorientation
Headache
Low or high blood pressure
Shortness of breath, swelling of the feet or legs
Signs and symptoms suggestive of a blood disorder such as bruising easily or unexplained bruises, bleeding very easily
Problems with your liver, kidney or blood showing as abnormal blood test results

Speak to your doctor if you have any of these side effects and they worry you.

Side effects

What to do

Shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body; feeling lightheaded or dizzy; skin rash, itching, hives (anaphylaxis)
Fast or slow heart rate
Warmth, tenderness, pain or swelling in the leg or under the skin
Purplish, bulging veins seen through the skin (similar to varicose veins)
Painful joints, chest and/or back pain
Swelling or pain in the leg, aching, tenderness or weakness in muscles
Tingling or numbness in hands and feet
Paralysis
Abnormal involuntary movement or tremor, rigidity
Muscle spasms around the voice box
Swelling around the eyes
Breathlessness especially with exercise or exertion
Sharp chest pain when breathing
Fever, headache, stiff neck, vomiting, light sensitivity, drowsiness or confusion
Convulsions
Surgical wound that does not heal
Swollen lymph nodes
Painful red areas, large blisters and peeling skin
Light coloured stool, blood in stools
Lower back or side pain, dark urine, blood in urine, changes in frequency or volume of urination

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Atgam contains

Active ingredient (main ingredient)	equine antithymocyte immunoglobulin
Other ingredients (inactive ingredients)	glycine, Water for Injections, sodium hydroxide and hydrochloric acid.

Atgam does not contain any preservatives.

Do not take this medicine if you are allergic to any of these ingredients.

What Atgam looks like

Atgam is sterile, transparent to milky solution which is colourless or faintly pink or brown. It may develop a slight granular or flaky deposit during storage. It is supplied in 5 mL ampoules. Each ampoule is for single use only.

Australian Registration Number: Aust R 12282.