What Topotecan Hydrochloride for Injection is used for and how to use it
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Topotecan Hydrochloride for Injection - Consumer Medicine Information

Manufacture: Fresenius Kabi USA, LLC
Country: United States
Condition: Ovarian Cancer, Small Cell Lung Cancer
Class: Miscellaneous antineoplastics
Form: Intravenous (IV), Powder
Ingredients: Topotecan hydrochloride, Mannitol, Tartaric acid, Hydrochloric acid, Sodium hydroxide

About This Medication

What the Medication is Used For

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

When it Should not be Used

Do not take topotecan hydrochloride if:

  • you are hypersensitive (allergic) to topotecan or any of the other ingredients of Topotecan 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 (severe bone marrow depression). Your doctor will tell you.

What the Medicinal Ingredient Is

The medicinal ingredient is topotecan hydrochloride.

What the Important Nonmedicinal Ingredients Are

The nonmedicinal ingredients consist of mannitol, tartaric acid, hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.

What Dosage Forms it Comes In

Topotecan for Injection (topotecan hydrochloride) 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.

Warnings and Precautions

Serious Warnings and Precautions

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

Possible serious side effects include:

  • 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).
  • Pain in your abdomen, possibly severe, with fever and a decrease in white blood cells (neutropenic colitis).
  • Lung inflammation which may cause severe coughing, shortness of breath and fever (interstitial lung disease).

BEFORE you use topotecan hydrochloride talk to your doctor or pharmacist if:

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

Nursing Mothers

Do not breast-feed if you are receiving topotecan hydrochloride. You should not restart breast-feeding 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 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 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 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 powder must be dissolved with water. The topotecan solution will be diluted further using either Sodium Chloride solution or Dextrose solution. A minimum of four courses of Topotecan 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

In the event you accidentally take more doses than prescribed, you should immediately contact your doctor, your hospital emergency department or the nearest poison centre.

Side Effects and What to do About Them

Like all medicines, topotecan hydrochloride can have side effects. The most common side effects with topotecan hydrochloride 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.

Other possible side effects are:

  • nausea (feeling sick)
  • vomiting
  • diarrhea
  • 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
  • hyperbilirubinaemia (high levels of bilirubin in the blood)
  • rash
  • itching
  • 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

Frequency Side Effect/Symptom Talk with yourstrong>doctor immediately
Very common Any sign of fever or infection, or any unexpected bruising or bleeding X
Common Serious infection X
Uncommon Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate X
Rare Severe bleeding X
Severe abdominal pain X
Severe cough, shortness of breath, fever (interstitial lung disease) X

This is not a complete list of side effects. For any unexpected effects while taking topotecan hydrochloride contact your doctor or pharmacist.

How to Store It

Unopened vials of Topotecan for Injection are stable until the date indicated on the package, when stored between 15°C and 30°C and protected from light in the original package.

Reconstituted Solutions

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 between 2 °C and 8 °C or stored at room temperature between 15 ºC and 30 ºC and discarded after 24 hours.

Diluted Solutions

Reconstituted vials of Topotecan for Injection diluted for infusion are stable up to 24 hours at room temperature between 15 ºC and 30 ºC with ambient lighting conditions. If not used immediately, the diluted solution should be stored in a refrigerator between 2 °C and 8 °C, up to 24 hours, and in line with good pharmaceutical practice.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to:Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 71-877-821-7724.