Consumer medicine information

Topotecan Agila powder for injection

topotecan (as hydrochloride)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Topotecan Ascen. 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 possible risks of Topotecan Agila against the expected benefits.

If you have any concerns about this medicine talk to your doctor or pharmacist. Keep this leaflet until you have finished treatment with Topotecan Agila. You may need to read it again.

What Topotecan Agila is used for

Topotecan Agila contains topotecan hydrochloride as the active ingredient.

Topotecan Agila is an anti-cancer medicine. It works by killing cancer cells and preventing cancer cells from reproducing.

Topotecan Agila is used to treat patients with ovarian cancer, small cell lung cancer and cervical cancer.

Your doctor may have prescribed Topotecan Agila for another reason. Ask your doctor if you have any questions about why Topotecan Agila has been prescribed for you.

Before receiving Topotecan Agila

When you must not be given it

You must not receive Topotecan Agila if:

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

Before you are given it

Before you receive Topotecan Agila tell your doctor if:

  • you have any kidney problems.
    The dosage of Topotecan Agila 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 Agila may cause a reduction in blood cells which may increase the risk of bleeding.
    – fever or other symptoms of infection. Topotecan Agila may decrease your body’s ability to fight infection.
    – recent exposure to chickenpox or shingles (Herpes zoster).

Treatment with Topotecan Agila 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 Agila might affect your ability to have children.

Taking other medicines with Topotecan Agila:

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

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when receiving Topotecan Agila with other medicines.

How Topotecan Agila is given

How much is given

Your doctor will decide the dosage of Topotecan Agila to be given to you. The dosage you receive is based on your height and weight.

How Topotecan Agila is given

Your doctor or nurse will inject the necessary dose of Topotecan Agila.

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

Topotecan Agila is given once daily for five days for the treatment of ovarian and small cell lung cancer and once every day for three days for cervical 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 Agila you will need.

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

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


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 Agila.

While you are receiving Topotecan Agila

Things you must do

Follow your doctor’s directions regarding treatment with Topotecan Agila. 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 Agila 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 Agila.

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 Agila 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, nurse or pharmacist as soon as possible if you do not feel well while you are receiving Topotecan Agila. Like most anti-cancer drugs, Topotecan Agila 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. Some side effects may need medical treatment.

Topotecan Agila 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 or certain types of cancer. Discuss these possible effects with your treating doctor.

Like many anticancer medicines, Topotecan Agila 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 Agila 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 Agila 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 Agila.

After being given Zoledronic Acid Agila Concentrated injection


Topotecan Agila is an anti-cancer medicine which requires special care in handling and preparation.

It should be given to your pharmacist, doctor or nurse as soon as possible.

Topotecan Agila is usually stored at the hospital or at the pharmacy.

If you need to store Topotecan Agila always:

  • Keep the pack in a cool dry place where the temperature stays below 25°C.
  • Do not leave it in the car on a hot day.
  • Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep all medicines out of the reach of children, such as in a locked cupboard.


If your doctor tells you to stop using Topotecan Agila return any left over vials to your pharmacist.

Product Description

What it looks like

Topotecan Agila powder for injection is supplied as glass vials containing yellow/greenish powder.

Other ingredients:
Topotecan Agila powder for injection also contains the inactive ingredients

  • tartaric acid,
  • mannitol,
  • hydrochloric acid and
  • sodium hydroxide.


Topotecan Agila is only available if prescribed by a doctor.

Topotecan Agila powder for injection 4mg vials contain topotecan hydrochloride equivalent to 4mg of topotecan.


Topotecan Agila is supplied by:
Agila Australasia Pty Ltd
8-12 Ordish Road
Dandenong South, VIC 3175

Australian Registration Number:
Topotecan Agila powder for injection 4 mg/vial is AUST R 178006.

This leaflet was created in November 2012.

Doc ID: 3.AL.M.1.0

Published by MIMS April 2015