Consumer medicine information

Topotecan Kabi

Topotecan hydrochloride powder for injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Topotecan Kabi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Topotecan Kabi against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or health care professional.

Keep this leaflet. You may need to read it again.

What Topotecan Kabi is used for

Topotecan Kabi contains topotecan hydrochloride as the active ingredient.

Topotecan is an anti-cancer medicine. It works by killing cancer cells and preventing cancer cells from reproducing. Topotecan is used to treat patients with:

  • ovarian cancer
  • small cell lung cancer

Your doctor will be able to tell you about the specific condition for which you have been prescribed topotecan. Ask your doctor or health care professional if you have any questions why it has been prescribed for you. Topotecan is only available on a prescription from your doctor.

Before you are given Topotecan Kabi

When you must not receive it

Do not use Topotecan Kabi if:

  • You have had an allergic reaction to topotecan hydrochloride or any of the ingredients contained in this medicine.
  • You are, or think you may be pregnant or if you intend to become pregnant.
  • You are breastfeeding. If you have been breastfeeding prior to receiving topotecan, do not restart until your doctor tells you it is safe to do so.
  • You have very low blood counts.
  • The expiry date printed on the pack has expired.
  • The packaging is torn or shows signs of tampering.

If you are not sure whether any of these apply to you, check with your doctor.

Before you are given it

Tell your doctor if:

  • you have kidney problems. The dosage of topotecan may need to be reduced
  • you have any liver problems
  • you have any other medical problems. In particular tell your doctor if you have any of the following:
    – bleeding or bruising. Topotecan may cause a reduction in blood cells which may increase the risk of bleeding.
    – fever or other symptoms of infection. Topotecan may decrease the ability of your body to fight infection.
    – recent exposure to chickenpox or shingles (Herpes zoster)
    Treatment with topotecan may increase the severity of these infections.

Many medicines used to treat cancer may impair your ability to have children in the future. Talk to your doctor if you are concerned about how topotecan may affect your ability to have children.

Taking other medicines

Tell your doctor or health care professional if you are taking any other medicines or have taken other medicines recently, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular mention if you are receiving any other medicines to treat cancer.

Some medicines may be affected by topotecan, or may affect how it works.

Your doctor or health care professional will advise you about continuing to take other medicines while you are receiving topotecan. You may need different amounts of your medicine, or you may need to use different medicines.

How Topotecan Kabi is given

How much will be given

Your doctor will decide what dose you will receive. This depends on factors such as your height and weight.

How it is given

Your doctor or nurse will inject the necessary dose of topotecan.

Topotecan is given into the vein by an intravenous drip over a 30 minute period.

Topotecan is given once daily for five days for the treatment of ovarian and small cell lung cancer. This is usually repeated every three weeks from the start of each course. This may vary depending on the results of your blood tests. Your doctor will decide how many courses of topotecan you will need.

It is important to follow your doctor’s directions regarding treatment with topotecan. Remember to keep all appointments for treatment. If you miss an appointment contact your doctor for instructions.

If you have any concerns about topotecan, talk to your doctor or pharmacist.

If you take too much (overdose)

In the event of suspected overdose you will be monitored by your doctor and treated for any unwanted side effects that may occur. There is no antidote for an overdose of topotecan.

While you are being given Topotecan Kabi

Things you must do

Follow your doctor’s directions regarding treatment with topotecan.

Remember to keep your appointments with your doctor. It is very important that your doctor checks your progress at regular visits.

Remember to have your blood tests regularly, as instructed by your doctor. Topotecan may cause a reduction in blood cells which may make you prone to infection and bleeding.

Tell your doctor immediately if you experience a fever or any other symptoms of infection or any bleeding or bruising.

If you see another doctor or dentist for treatment, tell them that you are being treated with topotecan.

Do not have any vaccinations without your treating doctor’s approval. In addition, avoid contact with anyone who has recently received the oral polio vaccine. Topotecan may lower your body’s resistance to infection. Some vaccines may cause illness in people with decreased resistance to infection.

If you experience low blood counts, there are precautions you can take to reduce the risk of infection or bleeding:

  • avoid people with infections.
  • take care when using a toothbrush, dental floss or toothpick. Your doctor, dentist or nurse may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
  • take care not to cut yourself when using sharp objects such as a safety razor or nail cutters.
  • avoid contact sports or other situations where bruising or injury could occur.

Side Effects

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

Like other medicines that treat cancer, topotecan may cause some unwanted side effects. Some side effects will have symptoms that you will notice. Your doctor may check for others by doing certain tests. You may need medical treatment for some side effects.

Topotecan may cause other unwanted effects that may not occur until months or years after it is given. These delayed effects may include a decreased ability to have children. Discuss these possible effects with your treating doctor.

Like many anticancer medicines, topotecan may cause you to feel sick or be sick. You will be prescribed medicines to help prevent these side effects.

The most common side effects with topotecan are infections. Blood disorders are also common, where reduced levels of certain blood cells may cause anaemia, reduced resistance to infections and increased bruising or bleeding. Your doctor will monitor your blood tests for these side effects.

Tell your doctor or nurse immediately if you notice any of the following:

  • fever, chills, sore throat, cough, lower back or side pain, painful or difficult urination
  • black, tarry bowel motions, blood in your urine or bowel motions, pinpoint red spots on your skin or any other unusual bleeding or bruising.

Tell your doctor or nurse if you notice any of the following that are troublesome or ongoing:

  • feeling sick, being sick, diarrhoea, constipation, sore mouth, pains in the stomach
  • pain and swelling at the site of injection
  • fatigue, weakness, loss of appetite, feeling generally unwell
  • headache, dizziness, pins and needles sensation, decreased feeling or sensitivity of the skin, numbness or weakness in the arms or legs, loss of movement
  • pain and inflammation at the site of injection

Other side effects that may occur:

  • temporary loss of hair (including eyebrows, eyelashes and pubic hair) about 2 to 3 weeks after commencing treatment. Normal hair growth should return after treatment with topotecan has ended.

Your doctor, nurse or pharmacist may be able to tell you about ways to prevent or reduce some of these side effects.

Remember you should tell your doctor, nurse or pharmacist as soon as possible if any of these, or any other side effects not listed occur during or between treatments with topotecan.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Topotecan Kabi


Topotecan is an anti-cancer medicine which requires special care in handling and preparation. Topotecan Kabi should be stored in the hospital pharmacy or on the ward. The injection should be stored in a cool dry place, protected from light where the temperature stays below 25°C.

If you need to store the medicine ensure that it is kept out of the reach of children, such as in a locked cupboard. If your doctor tells you to stop using topotecan, return any unused vials to your pharmacist.

It must not be used after the expiry date (Exp) printed on the vial.

Product Description

What it looks like

Topotecan Kabi is supplied in a glass vial containing a yellow powder.

Topotecan Kabi 4 mg contains the active ingredient Topotecan hydrochloride, in a quantity equivalent to 4 mg of Topotecan.

Topotecan Kabi also contains the inactive ingredients mannitol, tartaric acid, sodium hydroxide and hydrochloric acid.


Topotecan Kabi is supplied in Australia by:
Fresenius Kabi Australia Pty Limited
964 Pacific Highway
Pymble NSW 2073
Telephone: (02) 9391 5555

Australian Registration Number

Topotecan Kabi 4 mg Powder for Injection AUST R 170123

® = Registered Trademark

This leaflet was prepared in 19 Jan 2011.

Published by MIMS January 2015