Vinorelbine Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Metastatic Breast Cancer (Breast Cancer, Metastatic), Non-Small Cell Lung Cancer|
|Class:||Antineoplastic detoxifying agents, Mitotic inhibitors|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||Vinorelbine tartrate, Water for Injection, Sodium Hydroxide|
About this Medication
What the Medication is Used For
Vinorelbine Injection, USP is indicated in the treatment of
- advanced non-small cell lung cancer;
- metastatic breast cancer.
What it DoesSlows or stops the growth of cancer cells in your body.
When it Should not be Used
Vinorelbine is contraindicated in patients
- with known hypersensitivity to vinorelbine;
- who have drug-induced severe reductions in the number of circulating platelets and/or white blood cells.
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
Water for Injection. Sodium Hydroxide may be used forpH adjustment. No other preservatives or other additivesare present.
Vial stoppers do not contain natural rubber latex.
What Dosage Forms It Comes In
Solution - 10 mg vinorelbine per mL.
Warnings and Precautions
BEFORE you use Vinorelbine Injection, USP talk to yourdoctor or pharmacist if:
- you have had prior irradiation or chemotherapy;
- you have liver problems
- you have pre-existing neuropathy
- you are pregnant or plan to become pregnant
- you are nursing
Vinorelbine can cause blisters; it can produceinflammation at the site of injection. The major acutetoxicities of vinorelbine are related to bone marrowtoxicity and nerve function.
Interacitons With This Medication
Drugs that may interact with Vinorelbine Injection, USPinclude mitomycin, cisplatin, paclitaxel. Prior orconcomitant radiation therapy may result inradiosensitising effects.
Proper Use of This Medication
This preparation is for intravenous administration only —fatal if given intrathecally. It should be administered byindividuals experienced in the administration of cancerchemotherapeutic drugs.
Blood counts should be taken prior to each dose. Thedosage should be reduced or the drug discontinued uponevidence of abnormal depression of the bone marrow.
It is extremely important that the intravenous needle orcatheter be properly positioned before any vinorelbine isinjected. Leakage into surrounding tissue may causeconsiderable irritation, local tissue necrosis and/orthrombophlebitis. If this occurs, the injection should bediscontinued immediately and any remaining portion ofthe dose should then be introduced into another vein. Theapplication of moderate heat to the area of leakage in theform of a warm compress applied for 15 to 20 minutes atleast four times per day for the first 24 to 48 hours, inaddition to rest and elevation of the affected site for 48 –72 hours, has been reported to help disperse drug andminimize discomfort.
As with other toxic compounds, caution should beexercised in handling and preparing the solution ofvinorelbine. Skin reactions may occur with accidentalexposure. The use of gloves is recommended. If thesolution of vinorelbine contacts the skin or mucosa,immediately wash the skin or mucosa thoroughly withsoap and water. Care should be taken to avoid accidentalcontamination of the eye with vinorelbine. If thishappens, the eye should be immediately and thoroughlywashed with a large volume of irrigation solution (wateror sodium chloride).
The usual initial dose of Vinorelbine Injection, USP is30 mg/m2 administered weekly. The dose may be adjustedby the doctor according to blood and liver conditions.
Vinorelbine Injection must be diluted in either a syringeor i.v. bag using one of the recommended solutions. Thesolution will be prepared by the practitioner. The dilutedvinorelbine should be administered over 6 to 10 minutesinto the side port of a free-flowing i.v. followed byflushing with at least 75 to 125 mL of one of thesolutions.
In the event of overdosage, contact your doctor, hospitalemergency department or regional Poison Control Centre.
Side Effects and What to do About Them
Injection site reactions (redness, pain, and veindiscoloration) occurred in approximately one-third of allpatients.
The most common side effects of chemotherapy medicine(including vinorelbine) are hair loss, increased risk ofinfection, nausea, vomiting, fatigue, and mouth sores.
Acute shortness of breath and severe bronchospasm havebeen reported. Bronchodilators, steroids and/or oxygenhave produced symptomatic relief.
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|
|Thinned of brittle hair||✓|
|Sore throat or mouth pain||✓|
|Loss of appetite||✓|
|Unusual bleeding or bruising||✓|
|Redness pain, or swelling at the site of injection||✓|
|Shortness of breath||✓|
|Abnormal burning and tingling||✓|
|Change in bowel habits for more than 2 days||✓|
This is not a complete list of side effects. For anyunexpected effects while taking Vinorelbine Injection,USP, contact your doctor or pharmacist.
How to Store It
Store Vinorelbine Injection, USP vials between 2 °C and8 °C in the original package. Protect from light andfreezing. Single-dose vials. Discard unused portion.
Vinorelbine Injection is initially clear and colourless topale yellow, but may develop a slightly darker yellow tolight amber colour in time. This does not indicate achange which should preclude its use.
Reporting Side Effects
You can help improve the safe use of health products forCanadians by reporting serious and unexpected side effectsto Health Canada. Your report may help to identify newside effects and change the product safety information.
3 ways to report
- Online at hc-sc.gc.ca
- 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
NOTE: Contact your health professional if you needinformation about how to manage your side effects. TheCanada Vigilance Program does not provide medicaladvice.
This document plus the full product monograph, preparedfor health professionals can be obtained by contacting thesponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.