Patient Medication Information: uses, side effects, how to take - Vinorelbine Injection, USP (Generic Medical Partners)
ABOUT THIS MEDICATION
What the medication is used for:
VINORELBINE INJECTION, USP 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 INJECTION, USP 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
|
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. 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 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:
| If you think you have taken too much VINORELBINE INJECTION, USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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.
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 INJECTION, USP 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)
| 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 finger tips 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.
HOW TO STORE IT
Store VINORELBINE INJECTION, USP vials in refrigerator (2°C to 8°C) in the original package protected from light. Do not freeze.
Keep out of the sight and reach of children.
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:
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 found by contacting the sponsor, Generic Medical Partners Inc. at:
1.416.444.4GMP (1.416.444.4467)
Generic Medical Partners Inc.,
251 Consumers Road, Suite 1200
Toronto, Ontario,
M2J 4R3
