topotecan (as hydrochloride) powder for injection vial
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you start taking Hycamtin capsules.
This leaflet answers some of the common questions about Hycamtin (topotecan). It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine
may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You
can also download the most up to date leaflet from www.novartis.com.au.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the possible risks of Hycamtin 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 Hycamtin.
You may need to read it again.
What Hycamtin is used for
Hycamtin contains topotecan hydrochloride as the active ingredient.
Hycamtin is an anti-cancer medicine. It works by killing cancer cells and preventing cancer cells from reproducing. Hycamtin
is used to treat patients with ovarian cancer, small cell lung cancer and cervical cancer.
Your doctor may have prescribed Hycamtin for another reason.
This medicine is available only with a doctor's prescription.
Hycamtin is not addictive.
Before receiving Hycamtin
You must not receive Hycamtin 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 Hycamtin, do not restart until the doctor tells you it is safe to do so.
you have very low blood count.
the expiry date printed on the pack has passed
the packaging is torn or shows signs of tampering.
Tell your doctor if
Before you receive Hycamtin, tell your doctor if you have any:
kidney problems; the dosage of Hycamtin may need to be reduced.
other medical problems. In particular tell your doctor if you have any of the following:
bleeding or bruising; Hycamtin may cause a reduction in blood cells which may increase the risk of bleeding.
fever or other symptoms of infection; Hycamtin may decrease your body's ability to fight infection.
recent exposure to chickenpox or shingles (Herpes zoster).
Treatment with Hycamtin 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 Hycamtin might affect your ability to have children.
Taking other medicines
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 Hycamtin with other medicines.
How Hycamtin is given
How much is given
Your doctor will decide the dosage of Hycamtin to be given to you. The dosage you receive is based on your height and weight.
How Hycamtin is given
Your doctor or nurse will inject the necessary dose of Hycamtin.
Hycamtin is given into the vein by an intravenous drip over a 30 minute period.
Hycamtin 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 Hycamtin you will need.
If you have any concerns about Hycamtin, 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 Hycamtin.
While you are receiving Hycamtin
Things you must do
Follow your doctor's directions regarding treatment with Hycamtin.
Remember to keep your appointments with your doctor. If you miss an appointment contact your doctor for instructions.
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.
Hycamtin 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 Hycamtin.
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.
Hycamtin may lower your body's resistance to infection. Some vaccines may cause illness in people with decreased resistance
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.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are receiving Hycamtin.
Like most anti-cancer drugs, Hycamtin 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.
Hycamtin 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, Hycamtin 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 Hycamtin 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.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
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
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 Hycamtin 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 Hycamtin.
Hycamtin 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.
Hycamtin is usually stored at the hospital or at the pharmacy.
If you need to store Hycamtin:
always keep the pack in a cool dry place where the temperature stays below 30°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 Hycamtin, return any leftover vials to your pharmacist.
What it looks like
Hycamtin is supplied as glass vials containing a yellow powder.
Hycamtin also contains the inactive ingredients:
tartaric acid (E334)
hydrochloric acid (E507), and
sodium hydroxide (E524).
Hycamtin is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road,
Macquarie Park NSW 2113
Telephone 1 800 671 203
® Registered Trademark
Hycamtin Australian Registration Number:
AUST R 58598 Hycamtin topotecan (as hydrochloride) 4mg powder for injection vial.
This leaflet was prepared in
For internal use only
(hycinj020615c based on PI hycinj020615i)