Azacitidine Sandoz

Azacitidine Sandoz

Active ingredient(s): Azacitidine

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Azacitidine Sandoz. 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 Azacitidine Sandoz.

Where to find information in this leaflet:

1. Why am I using Azacitidine Sandoz?
2. What should I know before I use Azacitidine Sandoz?
3. What if I am taking other medicines?
4. How do I use Azacitidine Sandoz?
5. What should I know while using Azacitidine Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Azacitidine Sandoz?

Azacitidine Sandoz contains the active ingredient azacitidine.

Azacitidine Sandoz is an anti-cancer agent. Azacitidine Sandoz prevents the growth of cancer cells. Azacitidine Sandoz has been prescribed by your doctor for the treatment of myelodysplastic syndrome (MDS). Myelodysplastic syndrome is a blood disorder in which the bone marrow is not working normally and does not produce enough mature blood cells.

This causes a lack of healthy blood cells that can function properly in the body.

Ask your doctor if you have any questions about how Azacitidine Sandoz works, or why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason. Azacitidine Sandoz will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood.

2. What should I know before I use Azacitidine Sandoz?

Warnings

Do not use Azacitidine Sandoz if:

• you are allergic to azacitidine, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
  – shortness of breath
  – wheezing or difficulty breathing
  – swelling of the face, lips, tongue or other parts of the body
  – rash, itching or hives on the skin.
• If you have advanced liver cancer.
• If you are pregnant.
• If you have severe problems with your kidney function.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any allergies to any other medicines, foods, preservatives or dyes.
• have had any heart problems or lung disease.

You will have blood tests before you begin treatment with Azacitidine Sandoz and at the start of each period of treatment (called a ‘cycle’). This is to check that you have enough blood cells and that your liver and kidneys are working properly. If you are older than 65 years, your doctor will give you the regular blood tests described above but may also check your kidney function during your treatment with other tests.

Azacitidine can cause a serious immune reaction called ‘differentiation syndrome’.

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

Women

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

Avoid becoming pregnant while receiving Azacitidine Sandoz but if you do, tell your doctor immediately. Use an effective method of contraception during treatment with Azacitidine Sandoz and for up to six (6) months after discontinuation of Azacitidine Sandoz.

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

Do not breast-feed while you are receiving Azacitidine Sandoz but if you do, tell your doctor immediately.

It is not known if azacitidine is excreted in human milk.

Men

Do not father a child while receiving treatment with Azacitidine Sandoz. Use barrier methods of contraception (e.g. condoms) during treatment and for up to three (3) months after discontinuation of Azacitidine Sandoz, if your partner is of childbearing potential.

Talk to your doctor if you wish to conserve your sperm before having this treatment.

Children under 18 years

Do not give Azacitidine Sandoz to children (under 18 years).

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.

4. How do I use Azacitidine Sandoz?

How much to use

Your doctor will choose the correct dose of Azacitidine Sandoz for you.

• Your dose will depend on your general condition and your height and weight.
• Your dose will be calculated based on your body surface area, with the usual dose of 75 mg Azacitidine Sandoz per metre squared of body surface area.
• Your doctor will check your progress and may change your dose if necessary.

Azacitidine Sandoz can cause nausea and vomiting. To stop you from getting sick (nausea and vomiting), your doctor may give you another medicine at the start of each treatment cycle with Azacitidine Sandoz.

If you have any further questions on the use of Azacitidine Sandoz, ask your doctor or pharmacist.

When to use Azacitidine Sandoz

Initially, Azacitidine Sandoz will be given daily for 7 days. 21 days later, you will have Azacitidine Sandoz for another 7 days. This is called a ‘cycle’. The cycle is repeated every 28 days for a minimum of 6 cycles.

How to use Azacitidine Sandoz

Azacitidine Sandoz will be given to you as an injection under the skin (subcutaneously i.e. under the skin on your thigh, abdomen or upper arm) or as an intravenous infusion by a doctor or a nurse.

5. What should I know while using Azacitidine Sandoz?

Things you should do

Remind any other doctors, dentists, and pharmacists who are treating you that you are being treated with Azacitidine Sandoz.

Tell your doctor immediately if you stop passing urine or if you are passing less urine than normal.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being treated with this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all your doctor’s appointments so that your progress can be checked. Your doctor will do some tests e.g. blood tests, at regular intervals to make sure the medicine is working and to prevent any unwanted side effects.

Driving or using machines

Be careful driving or operating machinery until you know how Azacitidine Sandoz affects you.

Looking after your medicine

Your doctor or pharmacist is responsible for storing Azacitidine Sandoz. They are also responsible for disposing of any unused Azacitidine Sandoz correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them 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.

Less serious side effects

Less serious side effects

What to do

Sore throat or trouble swallowing; feeling of tension in the nose, cheeks or behind your eyes; runny or blocked nose. Trouble sleeping; feeling tired or lacking energy; dizziness; headache; anxiety; or feeling confused. Loss of appetite, decreased weight, constipation, stomach pain, indigestion. Cold sores or bleeding from the gums. Red or purple, flat, pinhead spots under the skin; itching; rash; bruising, redness of the skin; soreness and swelling at the injection site; unusual hair loss or thinning. Muscle or joint pain Chest pain.

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

Serious side effects

Serious side effects

What to do

Bleeding (including nosebleeds) or bruising in the absence of injury, or you are more tired than usual. Azacitidine Sandoz can reduce the number of red blood cells that carry oxygen around the body and can also reduce the number of platelets, which are responsible for making the blood clot appropriately. Pain in one or both eyes, changes in vision. This could be due to bleeding in your eyes. Blood in the urine

Tell your doctor as soon as possible if you notice any of these serious side effects.

Very serious side effects

Very serious side effects

What to do

Shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash; itching or hives on the skin. These could be symptoms of an allergic reaction. A sudden severe headache; weakness or numbness in the face, arm or leg; changes in vision; trouble speaking or understanding speech; or loss of coordination. These could be signs of bleeding in the brain (a type of stroke). Fever; chills; shortness of breath; cough; phlegm; or occasionally coughing up blood. These could be symptoms of pneumonia (a serious lung infection). Fever; severe chills; hot, tender and red skin; rapid breathing; rapid pulse; confusion; nausea; vomiting; diarrhoea; pain or burning when you urinate; sore mouth or throat; or mouth ulcers. These could be symptoms of sepsis (blood infection) or other frequent infections. Vomiting blood or material that looks like coffee grounds; bleeding from the back passage; black sticky bowel motions (stools); or bloody diarrhoea. These could be signs of bleeding in your gut. Fever, cough, difficulty breathing, rash, decreased urine, low blood pressure hypotension), swelling of the arms or legs and rapid weight gain. These could be symptoms of a serious immune reaction (differentiation syndrome).

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

Some of these side effects (for example, high blood pressure) can only be found when your doctor does tests from time to time to check your progress.

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 Azacitidine Sandoz contains

Active ingredient (main ingredient)	Azacitidine
Other ingredients (inactive ingredients)	Mannitol

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

What Azacitidine Sandoz looks like

Azacitidine Sandoz is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine. (AUST R 338376).

Who distributes Azacitidine Sandoz

Sandoz Pty Ltd
Level 15, 100 Pacific Highway
North Sydney NSW 2060
Australia
Tel: 1800 726 369

This leaflet was revised in November 2023.