Patient Medication Information: uses, side effects, how to take - PMS-Topotecan
ABOUT THIS MEDICATION
What the medication is used for:
pms-TOPOTECAN (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:
pms-TOPOTECAN helps destroy tumors. It acts on an enzyme (topoisomerase-I) to prevent growth of tumor cells.
When it should not be used:
Do not take pms-TOPOTECAN if:
- you are hypersensitive (allergic) to topotecan or any of the other ingredients of pms-TOPOTECAN.
- 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 pms-TOPOTECAN (severe bone marrow depression). Your doctor will tell you.
What the medicinal ingredient is:
The medicinal ingredient is topotecan hydrochloride.
What the nonmedicinal ingredients are:
The nonmedicinal ingredients consist of Hydrochloric Acid, Mannitol, Sodium Hydroxide, and Tartaric Acid.
What dosage forms it comes in:
pms-TOPOTECAN for injection is supplied as sterile powder in single-dose vials. Each vial contains 1 mg or 4 mg of topotecan. Before infusion the powder needs to be reconstituted and diluted.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
pms-TOPOTECAN should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Possible serious side effect includes:
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BEFORE you use pms-TOPOTECAN talk to your doctor or pharmacist if:
- you are hypersensitive (allergic) to topotecan or any of the other ingredients of pms-TOPOTECAN.
- you are pregnant or breast-feeding.
- results of your last blood test show that you are not able to receive pms-TOPOTECAN, your doctor will tell you.
- you have kidney disease.
Use of this medicine during Pregnancy and Breast Feeding
You should not be given pms-TOPOTECAN if you are pregnant or think you are pregnant.
Nursing Mothers
Do not breast-feed if you are receiving pms-TOPOTECAN. 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 pms-TOPOTECAN 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 pms-TOPOTECAN 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 pms-TOPOTECAN 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, pms-TOPOTECAN powder must be dissolved with water. The pms-TOPOTECAN solution will be diluted further using either Sodium Chloride solution or Dextrose solution. A minimum of four courses of pms-TOPOTECAN 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 pms-TOPOTECAN, 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, pms-TOPOTECAN can have side effects. The most common side effects with pms-TOPOTECAN 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 anemic 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 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 | ||||
|---|---|---|---|---|
| Frequency | Side Effect/Symptom | Talk with your Doctor immediately | ||
Very Common | Any sign of fever or infection, or any unexpected bruising or bleeding. | X | ||
| 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). | X | ||
| Uncommon | Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate, and collapse | X | ||
| Rare | Severe bleeding. | X | ||
Severe abdominal pain, fever and diarrhea (rarely with blood). These could be signs of bowel inflammation (colitis) | X | |||
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. | X | |||
This is not a complete list of side effects. For any unexpected effects while taking pms-TOPOTECAN contact your doctor or pharmacist.
HOW TO STORE IT
Unopened vials of pms-TOPOTECAN are stable until the date indicated on the package when stored between 15 ºC and 30ºC 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 5ºC or stored at 30ºC.
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 and discarded after 24 hours.
Diluted solutions
Reconstituted vials of pms-TOPOTECAN diluted for infusion are stable for up to 24 hours at approximately 20 ºC to 25ºC and ambient lighting conditions. If not used immediately, the diluted solution should be stored in a refrigerator in line with good pharmaceutical practice.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of the side effects, contact your health professional. 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 Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montreal, Canada
H4P 2T4