Patient Medication Information: uses, side effects, how to take - Vinorelbine Injection, USP (Fresenius Kabi Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Vinorelbine Injection, USP has been prescribed to you for the treatment of lung cancer 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 Injection, USP should not be used if you:
- are allergic to vinorelbine tartrate or
- who 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 important nonmedicinal ingredients are:
Vinorelbine Injection, USP: Water for Injection.
No other preservatives or other additives are present.
Vial stoppers do not contain natural rubber latex.
What dosage forms it comes in:
Solution - 10 mg vinorelbine per mL.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
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BEFORE you use Vinorelbine Injection, USP 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;
- 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 Injection, USP 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.
| In the event of overdosage contact your doctor hospital emergency department or regional Poison Control Centre. |
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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.
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 is a vesicant (can cause skin blistering) and can produce phlebitis (inflammation of a vein) or extravasation (escape off vesicant 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)
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Common | Fever, chills | √ | |||
| Diarrhea and Constipation | √ | ||||
| Numbness of fingertips and toes | √ | ||||
| At injection site | |||||
| Pain | √ | ||||
| Swelling | √ | ||||
| Burning | √ | ||||
This is not a complete list of side effects. For any unexpected effects while taking Vinorelbine Injection, USP, contact your doctor or pharmacist.
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. |
HOW TO STORE IT
Store Vinorelbine Injection, USP vials refrigerated at 2°C to 8°C in the original package. Protect from light and freezing. Single-dose vials. Discard unused portion.
Vinorelbine Injection, USP is initially clear and colourless to pale yellow, but may develop a slightly darker yellow to light amber colour in time. This does not indicate a change which should preclude its use.
MORE INFORMATION
If you want more information about Vinorelbine Injection, USP:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer's website (https://www.fresenius-kabi.com/en-ca), or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8