Vinorelbine Tartrate for Injection (Teva Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

$What the medication is used for:

VINORELBINE TARTRATE FOR INJECTION has been prescribed to you for the treatment of lung and/or breast cancer.

What it does:

Vinorelbine interferes with the growth of rapidly dividing cells, like cancer cells, and eventually causes cell death.

When it should not be used:

VINORELBINE TARTRATE FOR INJECTION should not be used if you:

• are allergic to vinorelbine tartrate or

• have severe granulocytopenia (reduced number of white

  blood cells) or severe thrombocytopenia (reduced number of platelets. Platelets help to form blood clots).

What the medicinal ingredient is:

Vinorelbine Tartrate

What the nonmedicinal ingredients are:

Water for Injection

What dosage forms it comes in:

Injection 10 mg/mL

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• The preparation and administration of VINORELBINE

  TARTRATE FOR INJECTION (vinorelbine tartrate) is only carried out by trained healthcare professionals

• Before each administration of VINORELBINE

  TARTRATE FOR INJECTION, a blood sample will be taken for analysis of its components

• If the results of this analysis are not satisfactory, your treatment may be delayed or the dose reduced and further checks may be made

  BEFORE you use VINORELBINE TARTRATE FOR INJECTION talk to your doctor or pharmacist if:

  $ you have any other medical problems, especially any infections such as chickenpox (including recent exposure) or Herpes zoster (shingles)

  $ you are taking any medications, prescription and non- prescription medicines

  $ you have had any other therapy for cancer including other drugs or radiation therapy.

  $ you are pregnant or if you intend to have children.

  Vinorelbine may cause birth defects if either the male or female is receiving it at the time of conception or if it is taken during pregnancy

  $ you intend to breast-feed during treatment with vinorelbine. Vinorelbine may cause serious side effects in nursing babies.

  $ you have ever had any unusual or allergic reaction to vinorelbine

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all medications that you are taking. It is especially important that your doctor knows if you are taking mitomycin, cisplatin or paclitaxel.

You may experience radiosensitivity effects if you take vinorelbine tartrate injection prior or along with radiation therapy.

PROPER USE OF THIS MEDICATION

VINORELBINE TARTRATE FOR INJECTION is for intravenous administration only. It should be administered by individuals experienced in the administration of cancer chemotherapeutic drugs.

Usual dose:

The dose of vinorelbine will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, your body size, and whether or not other medicines are also being taken.

Overdose:

In the case of an overdose your doctor will stop the therapy and treat the symptoms. You may have to have additional medical treatment.

Missed Dose:

Your doctor will set the times at which you are to receive this medicine. It is important not to miss a dose. Let your prescriber or health care professional know if you are unable to keep an appointment. Contact your doctor as soon as possible.

IMPORTANT: PLEASE READ

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Any medicine may have unwanted effects. Tell your doctor about any unusual sign or symptom whether listed or not.

Some side-effects that have been reported following treatment with vinorelbine tartrate are listed below.

• Constipation, rarely becoming intestinal obstruction
• Diarrhea
• Nausea and occasionally vomiting.

• Breathing difficulties or skin reaction as a result of an

  allergic reaction.

• Alopecia (hair loss).
• Jaw pain.

• A burning feeling and inflammation at the site of

  injection may occur. VINORELBINE TARTRATE FOR INJECTION is a vesicant (can cause skin blistering) and can produce phlebitis (inflammation of a vein) or extravasation (escape of drug and or blood, from a vessel into the surrounding tissue) injury. If you notice pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional immediately.

• Decrease in white blood cells, red blood cells and

  platelets. The major toxicities of vinorelbine tartrate are related to bone marrow toxicity, specifically granulocytopenia (decrease in white blood cells) with increased susceptibility to infection. Contact your doctor immediately if you experience fever or chills.

• Neuropathy (suppression of some reflex reactions or

  altered touch awareness).

• Asthenia (The lack or loss of strength and energy,

  weakness)

This is not a complete list of side effects. For any unexpected effects while taking VINORELBINE TARTRATE FOR INJECTION, contact your doctor or pharmacist.

HOW TO STORE IT

Store VINORELBINE TARTRATE FOR INJECTION vials in refrigerator (2°C to 8°C) in the original package protected from light. Do not freeze.

Keep Out of the Reach of Children.

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:

-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, Ontario

  K1A 0K9

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 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 found by contacting the sponsor, Teva Canada Limited at:

1-800-268-4127 ext. 1255005

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: March 20, 2014