Consumer Information for: TOPOTECAN HYDROCHLORIDE FOR INJECTION

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Topotecan hydrochloride for Injection is used for the treatment of:

  • ovarian cancer (metastatic) after failure of initial or subsequent therapy.
  • sensitive small cell lung cancer after failure of first line chemotherapy (defined as recurrence at least 60 days after first line chemotherapy).
What it does

Topotecan hydrochloride for Injection helps destroy tumours. It acts on an enzyme (topoisomerase-I) to prevent growth of tumour cells.

When it should not be used

hydrochloride for Injection if:

  • you are hypersensitive (allergic) to topotecan or any of the other ingredients of Topotecan hydrochloride for Injection
  • you are pregnant or breast-feeding.
  • you have severe kidney disease.
  • results of your last blood test show that you are not able to receive Topotecan hydrochloride for Injection (severe bone marrow depression). Your doctor will tell you.
What the medicinal ingredient is

The medicinal ingredient is topotecan hydrochloride.

What the non-medicinal ingredients are

Topotecan hydrochloride, Lyophilized powder for injection:
The nonmedicinal ingredients consist of mannitol, tartaric acid, hydrochloric acid and sodium hydroxide.

Topotecan hydrochloride, Solution for injection:
The nonmedicinal ingredients consist of tartaric acid, hydrochloric acid, sodium hydroxide and water for injections.

What dosage form it comes in

Topotecan hydrochlorideLyophilized powder for injection:
Topotecan hydrochloride for injection is supplied as sterile powder in single-dose vials. Each vial contains 4 mg of topotecan. Before infusion the powder needs to be reconstituted and diluted.

Topotecan hydrochloride, Solution for injection:
Concentrate. Not for direct infusion, Dilute before use. Topotecan hydrochloride Injection (topotecan hydrochloride) is supplied as a sterile solution in single-dose vials. Each 1 ml vial contains 1 mg of topotecan. Each 4 ml vial contains 4 mg of topotecan. Before infusion the solution needs to be diluted.

Warnings and precautions

Serious Warnings and Precautions

Topotecan hydrochloride for Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.

Possible serious side effect includes:

  • a decrease in the number of cells produced in your bone marrow (bone marrow suppression), especially a type of white blood cells called neutrophils (neutropenia).
  • Bowel inflammation which may cause severe pain in your abdomen, with fever and a decrease in white blood cells which can potentially be fatal (neutropenic colitis).
  • Lung inflammation which may cause severe coughing, shortness of breath and fever which can potentially be fatal (interstitial lung disease).

BEFORE you use Topotecan hydrochloride for Injection talk to your doctor or pharmacist if:

  • you are hypersensitive (allergic) to topotecan or any of the other ingredients of Topotecan hydrochloride for Injection.
  • you are pregnant or breast-feeding. results of your last blood test show that you are not able to receive Topotecan hydrochloride for Injection, your doctor will tell you.
  • you have kidney disease.

Use of this medicine during Pregnancy and Breast Feeding
You should not be given Topotecan hydrochloride for Injection if you are pregnant or think you are pregnant.

Nursing Mothers
Do not breast-feed if you are receiving Topotecan Hydrochloride for Injection. You should not restart breastfeeding until the doctor tells you it is safe.

Use in Children
Use in children is not recommended as safety and effectiveness have not been established.

Effect on ability to drive and use machinery Topotecan hydrochloride for Injection may make you feel tired. Do not drive or operate any tools or machines if you feel tired or weak.

Interactions with this medication

It is important that your doctor know about all your medications so that you get the best possible treatment. Tell your doctor about all the medicines you are taking including those you have bought without a prescription.

Proper use of this medication

Usual dose

The dose of Topotecan hydrochloride for Injection which you will receive will be based on your body size (surface area) and the results of blood tests carried out before treatment.

The recommended dose of Topotecan hydrochloride for Injection is 1.5 mg / m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course. Prior to administration, Topotecan hydrochloride for Injection powder must be dissolved with water. The Topotecan hydrochloride for Injection solution will be diluted further using either Sodium Chloride solution or Dextrose solution. Topotecan hydrochloride for Injection should be diluted only in Polyethylene (PE) bags. A minimum of four courses of Topotecan hydrochloride for Injection is recommended.

Insufficient data are available in children to provide a dosage recommendation.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

Overdose

If you think you have been given too much Topotecan hydrochloride, contact your healthcare professional, hospital emergency department or regional Poison Control Centre right away, even if you do not have any symptoms.

Accidental overdosage may result in low blood pressure, fast heart rate and bleeding of the bowel.

Side effects and what to do about them

Like all medicines, Topotecan hydrochloride for Injection can have side effects. The most common side effects with Topotecan hydrochloride for Injection are:

  • a temporary reduction in the amount of new blood cells produced by your body, particularly of a type of white blood cell which is important for your body to prevent and fight off an infection. In approximately 1 in 20 patients a serious infection is caught during treatment which can be fatal. If at any time during treatment you feel unwell or develop a temperature you should contact your doctor immediately.
  • you may become temporarily anaemic and tired or take longer for a minor injury to stop bleeding. The reduction in the amount of blood cells (lasts for only a few days), starting from approximately day 8 of each treatment cycle and lasting for about a week. In most cases the level of blood cells return to normal in time for the next cycle of treatment.
  • Gastrointestinal perforations (including lifethreatening and fatal cases) have been reported with Topotecan hydrochloride for Injection-treated patients. Your doctor will monitor you for the possibility of GI perforation if you experience symptoms of severe stomach pain, nausea, vomiting and/or bloody stool and will discontinue Topotecan hydrochloride for Injection if you have an intestinal perforation.

Other possible side effects are:

  • nausea (feeling sick or queasy or having the urge to throw up)
  • vomiting (throwing up)
  • diarrhea (frequent and watery bowel movements)
  • fever
  • hair loss
  • stomach pain
  • constipation
  • swelling and pain of the mouth, tongue or gums
  • fatigue (tiredness)
  • weakness
  • anorexia (weight loss and loss of appetite)
  • feeling unwell
  • headache
  • coughing
  • shortness of breath
  • yellow skin (jaundice)
  • rash
  • itching sensation mild pain and inflammation at the site of injection.

Severe allergic reactions have been reported rarely.

  • lung inflammation (interstitial lung disease) has been reported rarely. Signs include difficulty in breathing, severe cough and fever.

Several of these effects may occur during your treatment. If you notice any of these, or any other effects not mentioned in this leaflet between courses or when you leave hospital/after treatment has finished, tell your doctor, nurse or pharmacist.

Serious side effects, how often they happen and what to do about them
Side Effect/Symptom Talk with your Doctor immediately
Very Common
Any sign of fever or infection, or any unexpected bruising or bleeding. ✔
Common
Serious infection; local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be caused by a urinary infection) ✔
Uncommon
Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate, and collapse. ✔
Rare
Severe bleeding. ✔
Severe abdominal pain, fever and diarrhoea (rarely with blood).

These could be signs of bowel inflammation (colitis)		 ✔
Severe cough, shortness of breath, fever (interstitial lung disease). You are at increased risk if you have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. ✔
Frequency not known (events from spontaneous reports)
Severe stomach pain, nausea, vomiting of blood, black or bloody stools. (Possible symptoms of gastrointestinal perforation). ✔
Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, bloody stool which could be signs and symptoms of inflammation of the inner lining of the mouth, stomach and / or gut (mucosal inflammation). ✔

This is not a complete list of side effects. For any unexpected effects while taking Topotecan hydrochloride for Injection, contact your doctor or pharmacist.
How to store

Lyophilized powder for injection
Unopened vials of Topotecan hydrochloride for Injection are stable until the date indicated on the package when stored between 15º and 30ºC (59º and 86ºF) and protected from light in the original package.

Reconstituted Solutions
Vials which have been reconstituted with Water for Injection are stable for up to 24 hours when refrigerated at 2-8ºC or stored at 20-30ºC (68-86ºF) at normal laboratory conditions.

However, since the vials contain no preservative, it is recommended that the product should be used immediately after reconstitution. If not used immediately, the reconstituted solution should be stored in a refrigerator at 2-8ºC and discarded after 24 hours.

Diluted solutions
Topotecan hydrochloride for Injection should be diluted only in Polyethylene (PE) bags. Reconstituted vials of Topotecan hydrochloride diluted for infusion are stable for up to 24 hours at approximately 20 to 25ºC (68 to 77ºF) and ambient lighting conditions. If not used immediately, the diluted solution should be stored in a refrigerator between 2-8ºC in line with good pharmaceutical practice.

Solution for injection
Unopened vials of Topotecan hydrochloride, Solution for Injection are stable until the date indicated on the package when stored between 15º and 30ºC (59º and 86ºF) and protected from light in the original package.

Diluted solutions
Diluted solution of Topotecan hydrochloride Injection are stable for up to 30 days at approximately 20o to 25°C (68° to 77oF) or 2 to 8°C.

Keep out of reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Topotecan hydrochloride for Injection:

This leaflet was prepared by:
            Accord Healthcare Inc.
            3535 boul. St. Charles suite 704
            Kirkland, QC, H9H 5B9
            Canada

Last revised: May 9, 20

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