AZACITIDINE SXP

AZACITIDINE SXP

Active ingredient: azacitidine

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Consumer Medicine Information (CMI)

This leaflet provides important information about using AZACITIDINE SXP. 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 SXP.

Where to find information in this leaflet:

1. Why am I being given AZACITIDINE SXP?
2. What should I know before I am given AZACITIDINE SXP?
3. What if I am taking other medicines?
4. How will I be given AZACITIDINE SXP?
5. What should I know while being given AZACITIDINE SXP?
6. Are there any side effects?
7. Product details

1. Why am I being given AZACITIDINE SXP?

AZACITIDINE SXP contains the active ingredient azacitidine. Azacitidine is an anti-cancer agent. It is used to prevent the growth of cancer cells.

AZACITIDINE SXP is used 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.

2. What should I know before I am given Azacitidine ANS?

Warnings

Do not use AZACITIDINE SXP if:

• you are allergic to azacitidine or any of the ingredients listed at the end of this leaflet
• always check the ingredients to make sure you can use this medicine

Check with your doctor if you have or have had:

• advanced liver cancer
• severe problems with your kidney function
• heart problems or lung disease
• allergies to any other medicines, foods, preservatives or dyes

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.

As with many medicines, AZACITIDINE SXP may harm your developing or breastfeeding baby.

Use an effective method of contraception during treatment with AZACITIDINE SXP and for up to three months after discontinuation of AZACITIDINE SXP.

Males: tell your doctor if your partner intends to become pregnant while you are using AZACITIDINE SXP or shortly after you have stopped using AZACITIDINE SXP.

Use barrier methods of contraception (e.g. condoms) during treatment and for up to three months after discontinuation of AZACITIDINE SXP.

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

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 AZACITIDINE SXP.

4. How will I be given AZACITIDINE SXP?

How much will be given

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

Your doctor will decide what dose of AZACITIDINE SXP, the 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 SXP per metre squared of body surface area.

AZACITIDINE SXP 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 SXP.

When you will be given AZACITIDINE SXP

It is very important that you continue to receive AZACITIDINE SXP for as long as your doctor prescribes it.

You will have blood tests before you begin treatment with AZACITIDINE SXP 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.

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

Your doctor will check your progress and may change your dose if necessary.

If you are older than 65 years, your doctor will give you regular blood tests described above but may also check your kidney function during your treatment with other tests.

If you are given too much AZACITIDINE SXP

It is unlikely that you will receive an overdose of AZACITIDINE SXP because a trained nurse or doctor will give it. If you think that you have been given too much AZACITIDINE SXP, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given Azacitidine SXP?

Things you should do

• Tell any other doctors, dentists, and pharmacists who are treating you that you are being treated with AZACITIDINE SXP
• 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 SXP affects you.

Looking after your medicine

The hospital will store AZACITIDINE SXP under the correct conditions.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any AZACITIDINE SXP that may be left over.

Do not use this medicine after the expiry date.

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.

Common 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 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 cold sores or bleeding from the gums red or purple, flat, pinhead spots pain chest pain

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

Serious side effects

What to do

Bleeding (including nosebleeds) or bruising in the absence of injury, or you are more tired than usual. AZACITIDINE SXP 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.

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital

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.

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital

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 AZACITIDINE SXP 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 SXP looks like

AZACITIDINE SXP is a white powder supplied in glass vials. (100 mg AUST R 395837).

Who distributes AZACITIDINE SXP

Southern XP Pty Ltd
5/112 Church Street
Hawthorn VIC 3122
Australia

Sponsor

Southern XP IP Pty Ltd
Unit 5/118 Church Street
Hawthorn VIC 3122

This leaflet was prepared in January 2024.