CISPLATIN ACCORD

CISPLATIN ACCORD

Active ingredient: cisplatin

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Cisplatin 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 Cisplatin Accord.

Where to find information in this leaflet:

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

1. Why am I using Cisplatin Accord?

Cisplatin Accord contains the active ingredient cisplatin. Cisplatin belongs to a group of anticancer medicines known as the platinum complexes. Cisplatin works by preventing the growth of cancer cells and eventually destroying them.

Cisplatin Accord is used for the treatment of:

• ovarian cancer
• cancer of the testes
• cancer of the bladder
• cancer of the head and neck

Your doctor, however, may prescribe Cisplatin Accord for another purpose.

2. What should I know before I use Cisplatin Accord?

Warnings

Do not use Cisplatin Accord if:

• you are allergic to cisplatin, carboplatin, other medicines containing platinum 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:

• allergies to any other medicines, foods, preservatives or dyes.
• kidney disease or poor kidney function
• a low blood count, abnormal or heavy bleeding
• hearing problems
• any sort of infection (e.g. sinusitis), tooth abscess, etc.
• abnormal or heavy bleeding
• bleeding gums
• unusual tiredness
• severe nausea and vomiting
• numbness or weakness of the arms and legs
• dizziness or being light-headed, especially on standing up
• problems with your sight
• fits
• muscle weakness
• a problem with blood clots forming in your blood vessels, such as painful inflammation of the veins (thrombophlebitis) or blockage of blood vessels in the legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism)

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, Cisplatin Accord may harm your developing or breastfeeding baby.

Birth control should be used during treatment with cisplatin and for at least 26 weeks after you stop treatment (at least 31 weeks if have kidney disease). You must tell your doctor immediately if you think you are pregnant.

Males: Tell your doctor or pharmacist if your partner intends to become pregnant while you are being give cisplatin, or shortly after you have stopped treatment.

It is recommended that you use effective contraception while you are using cisplatin and for at least 14 weeks after you stop treatment (at least 19 weeks if you have kidney disease).Cisplatin may have a prolonged effect on fertility in males and females. Your doctor should discuss this issue with you before you begin therapy with cisplatin.

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 Cisplatin Accord may interfere with each other.

• other anticancer drugs, such as paclitaxel and ifosfamide
• antibiotics, such as aminoglycoside antibiotics, used to treat infection
• fluid tablets, such as loop diuretics, used to treat fluid build up
• lithium, used to treat bipolar disorder or schizophrenia
• anticonvulsants, used to treat seizures
• anticoagulants, used to prevent blood clots

Do not have any immunisations (vaccinations) without your doctor’s approval while you are being treated with cisplatin.

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

4. How do I use Cisplatin Accord?

How much to use

Cisplatin Accord should only be administered by trained professionals, with appropriate handling, in a hospital or clinic environment.

Cisplatin Accord is for single use in one patient only. Any unused residue should be discarded.

Cisplatin Accord may be given as a single intravenous infusion or slow intravenous infusion.

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys, liver and ears are working, and whether other medicines are being given at the same time.

Additional fluid is given before and after your dose of cisplatin. This is to make sure that you do not lose too much water and cause problems with your kidneys.

When to use Cisplatin Accord

It is very important that you continue to receive Cisplatin Accord for as long as your doctor prescribes it. Be sure to keep all your doctor’s appointments.

If you use too much Cisplatin Accord

It is very unlikely that you will receive an overdose of Cisplatin Accord because a trained nurse or doctor will give it. If you think that you have been given too much Cisplatin Accord, 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 using Cisplatin Accord?

Things you should do

• Be sure to keep all your doctor’s appointments.
• You will have blood and other tests from time to time to check on your progress and detect any unwanted side effects.
• Tell all the doctors, dentists, and pharmacists who are treating you that you are being given Cisplatin Accord.
• If you are about to be started on any new medicine, tell your doctor or pharmacist that you are being given Cisplatin Accord.
• If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given Cisplatin Accord.
• If you become pregnant while taking this medicine, tell your doctor immediately

Driving or using machines

Be careful driving or operating machinery until you know how Cisplatin Accord affects you.

This medicine may cause dizziness, light-headedness or problems with movement in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol dizziness or light-headedness may be worse.

Looking after your medicine

The hospital will store Cisplatin Accord under the correct conditions.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any Cisplatin 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.

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

If you are over 65 years of age you may have an increased chance of getting side effects.

Common side effects

Common side effects	What to do
nausea or vomiting pain or redness at site of injection hair loss, especially of the scalp tiredness	Speak to your doctor if you have any of these common side effects and they worry you

Temporary loss of hair, particularly that on the scalp is a less common but upsetting side effect of cisplatin and occurs in a small number of patients (about 2 patients per 100 treated). The severity of hair loss will depend on the dose of cisplatin given. It is more common when other anticancer medicines are used together with cisplatin.

Serious side effects

Serious side effects	What to do
muscle aches or pains bursts of pain that run down the back into the arms and legs hearing loss or ringing in the ears (tinnitus).	Call your doctor as soon as possible

Very Serious side effects

Very Serious side effects

What to do

flushing, swelling of the face, wheezing, fast heartbeat, a rash, dizziness or feeling light-headed fever and chills, sore throat, sweats or feel generally unwell blurred vision, changes in colour or blindness reduced urination, swelling of the feet or lower legs bleeding, unusual bruising, bleeding gums, blood in the urine or stools, or pinpoint red spots seizures, slurred speech and loss of taste and memory problems with movement or reduced reflexes, and leg weakness shaking or tremors, foot spasms muscle cramps or twitching paralysis or numbness of the face, arm or leg, tingling or a loss of sensation in the hands or feet irregular and/or rapid heartbeat severe nausea or vomiting

Call your doctor immediately 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 Cisplatin Accord contains

Active ingredient (main ingredient)	cisplatin
Other ingredients (inactive ingredients)	Sodium chloride Sodium hydroxide Hydrochloric acid water for injections

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

Cisplatin Accord does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

Cisplatin Accord is not addictive.

What Cisplatin Accord looks like

Cisplatin Accord is a is a clear colourless to pale yellow solution supplied in a vial in single packs.

(10 mg/10 mL: AUST R 286790, 25 mg/25 mL: AUST R 286793, 50 mg/50 mL: AUST R 286786, 100 mg/100 mL AUST R 286791).

Who distributes Cisplatin Accord

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

This leaflet was prepared in January 2022.