DOXORUBICIN ACCORD

DOXORUBICIN ACCORD

Active ingredient(s): Doxorubicin hydrochloride

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Doxorubicin Accord. 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 Doxorubicin Accord.

Where to find information in this leaflet:

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

1. Why am I being given Doxorubicin Accord?

Doxorubicin Accord contains the active ingredient doxorubicin hydrochloride. It is used to treat many types of cancer. Doxorubicin Accord works by stopping cancer cells from growing and multiplying.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I am given Doxorubicin Accord?

Warnings

You must not be given Doxorubicin Accord if:

• you are allergic to doxorubicin and/or other anthracyclines or anthracenediones e.g. daunorubicin, epirubicin, mitozantrone, or any of the ingredients listed at the end of the CMI
• you have bone marrow suppression (reduced number of red or white blood cells or platelets) caused by previous treatment with other cancer medicines or radiation therapy, symptoms include tiredness, mouth ulcers or bleeding or bruising more easily than usual
• you have a generalised infection
• you have an irregular heart rate, poor blood flow to the heart or had a heart attack
• you have severe liver problems
• you have previously received treatment with the maximum dose of doxorubicin, daunorubicin or epirubicin
• you are pregnant or likely to become pregnant, as it may harm your developing baby
• you are breastfeeding, as it passes into breast milk and may affect your child

You must not be given Doxorubicin Accord infusion into the bladder if you have:

• a tumour of the bladder wall
• a urinary infection
• bladder inflammation
• a catheter in the bladder
• blood in your urine

Before you are given Doxorubicin Accord

Tell your doctor if you have any heart or liver problems.

You will be given a blood test and your heart will be monitored before you start treatment with Doxorubicin Accord.

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

Tell your doctor or pharmacist if you or your partner are pregnant or intend to become pregnant.

Men and women should use a reliable method of contraception (birth control).

Women of childbearing potential are advised to avoid becoming pregnant during treatment and to use effective contraceptive methods during treatment and for at least 6 months and 10 days after last dose.

Men with female partners of childbearing potential are advised to use effective contraception during treatment with doxorubicin and for at least 3 months and 10 days after last dose.

If you become pregnant while on treatment with Doxorubicin Accord, consult your doctor.

Nursing mothers are advised not to breastfeed while receiving Doxorubicin and for at least 10 days after last dose.

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.

Some medicines and Doxorubicin Accord may interfere with each other. These include:

• other cancer medicines, such as cyclophosphamide, paclitaxel, 6-mercaptopurine, sorafenib
• some medicines used to prevent blood clots, such as heparin
• propranolol and other medicines for your heart.
• inactivated vaccines
• verapamil used for high blood pressure, angina or irregular heart beat
• phenobarbitone and phenytoin used to treat epilepsy
• St. John’s Wort, a herbal supplement, used for mild anxiety and low mood
• cyclosporin used in transplant patients to prevent organ rejection

These medicines may be affected by Doxorubicin Accord, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Doxorubicin Accord given at the same time as radiation therapy may also cause unwanted effects.

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

Your doctor has more information on medicines to be careful with or avoid while using Doxorubicin Accord.

4. How will I be given Doxorubicin Accord?

How much will be given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight, liver function and the effect on your bone marrow of any previous treatment you may have had with x-ray or chemotherapy medicines.

Treatment is usually given once every 3 weeks, or on 3 successive days repeated every 4 weeks.

However, your doctor may give Doxorubicin Accord more or less frequently.

You will be given a blood test and your heart will be monitored before you start treatment with Doxorubicin Accord.

How it is given

Doxorubicin Accord is given by slow infusion into a vein or the bladder. If it is infused into the bladder, you will be asked not to urinate for one hour while Doxorubicin Accord is given.

If you receive too much Doxorubicin Accord

Since Doxorubicin Accord is usually given to you in hospital under the supervision of your doctor or nurse, it is very unlikely that you will be given too much of the medicine. If you think that you have been given too much Doxorubicin Accord.

You should immediately:

• contact your doctor or nurse
• phone the Poisons Information Centre (by calling 13 11 26)

5. What should I know while being given Doxorubicin Accord?

Things you must do

Keep all of your doctor’s appointments so your progress can be checked.

It is also important to inform your doctor if you have any infection or fever before, during or after treatment with Doxorubicin Accord, as it will lower your ability to fight infection.

Tell your doctor or nurse immediately if stinging, burning or pain develops at the injection site.

Tell any other doctors, dentists, and pharmacists who treat you that you are being given Doxorubicin Accord.

Doxorubicin Accord is known to be very powerful at lowering the number of white blood cells and platelets in your blood. This means that you have an increased chance of getting an infection or bleeding.

Take the following precautions to reduce your risk of infection or bleeding:

• Avoid people who have infections. Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it painful or difficult to urinate
• Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist, nurse or pharmacist may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work
• Be careful not to cut yourself when you are using sharp objects such as a razor or nail cutters
• Avoid contact sports or other situations where you may bruise or get injured.
• Avoid vaccination with certain vaccines. Your doctor or pharmacist will tell you what vaccines to avoid

Your doctor will monitor the effects of Doxorubicin Accord on your blood, liver and heart regularly by giving you tests.

If you become pregnant while you are being given Doxorubicin Accord, tell your doctor immediately.

Driving or using machines

Be careful driving or operating machinery or doing jobs that require you to be alert until you know how Doxorubicin Accord affects you.

Looking after your medicine

The hospital will store Doxorubicin Accord under the correct conditions.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any Doxorubicin Accord 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.

Tell your doctor or nurse as soon as possible if you do not feel well while Doxorubicin Accord is being given to you.

Common side effects

Common side effects

What to do

nausea and vomiting. This may be expected 3-6 hours after Doxorubicin Accord is given and may last for several hours diarrhoea, dehydration, flushing of the face, abdominal pain loss of appetite may be expected for 24 hours following each treatment with Doxorubicin Accord. This may occasionally last for several days Doxorubicin Accord may colour your urine red for 1-2 days after treatment. This is no cause for alarm a burning sensation in the mouth, throat, food pipe, rectum or vagina may occur usually 5 to 10 days after treatment with Doxorubicin Accord. This pain will normally subside within 10 days hair loss is expected 1 to 2 weeks after beginning treatment with Doxorubicin Accord. You may lose all your hair, but after treatment is stopped, your hair is expected to grow back. Male patients may notice lack of beard growth during treatment skin infections, blisters, itchy skin bleeding or easy bruising permanent darkening of areas on the skin, nail beds, and the inside of the mouth discharge with itching of the eyes and crusty eyelids, dry eyes excess tears redness or pins and needles on the palms of your hands and soles of your feet drowsiness, unusual tiredness, weakness, feeling unwell, hot flushes, shock painful swelling of joints (gout) weight gain. infertility in both men and women women may stop menstruating. Regular menstruation usually returns a few months after treatment is stopped in premenopausal women, although premature menopause can occur. men may permanently experience a low sperm count or remain infertile. Sometimes male fertility may return several years after stopping Doxorubicin Accord therapy

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

Serious side effects

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, light-headedness or back pain swelling and redness of skin along the vein in which Doxorubicin Accord is injected infections, fever, sweats, severe chills, bruising more easily than normal fatigue, chest pain, palpitations, shortness of breath or swelling in the feet or legs due to fluid build-up. Doxorubicin Accord may also affect heart muscle and function. Your doctor will monitor your heart regularly before, during and after treatment. bleeding or ulceration of the bowel blood poisoning kidney problems blockage of a blood vessel caused by a clot leukaemia

Call your doctor straight away if you have any of these side effects

If you are given Doxorubicin Accord into the bladder, tell your doctor as soon as possible if you develop the following temporary side effects:

• cystitis (pain in the bladder or back, blood in urine)
• difficulty passing urine or an increased frequency of passing urine

Other side effects not listed above may occur in some people. Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

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.

Doxorubicin Accord is not addictive.

What Doxorubicin Accord contains

Active ingredient (main ingredient)	doxorubicin
Other ingredients (inactive ingredients)	sodium chloride water for injections

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

What Doxorubicin Accord looks like

Doxorubicin Accord injection is a clear red solution in a glass vial. (10 mg/5 mL: AUST R 174249, 200 mg/100 mL: AUST R 174248)

Who distributes Doxorubicin Accord

Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia

This leaflet was prepared in November 2022.