Patient Medication Information: uses, side effects, how to take - Vinorelbine Injection
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 does:
Slows 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:
Vinorelbine tartrate
What the important nonmedicinal ingredients are:
Water for Injection. Sodium Hydroxide may be used for pH adjustment. 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
BEFORE you use Vinorelbine Injection, USP talk to your doctor 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 produce inflammation at the site of injection. The major acute toxicities of vinorelbine are related to bone marrow toxicity and nerve function.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Vinorelbine Injection, USP include mitomycin, cisplatin, paclitaxel. Prior or concomitant radiation therapy may result in radiosensitising effects.
PROPER USE OF THIS MEDICATION
This preparation is for intravenous administration only — fatal if given intrathecally. It should be administered by individuals experienced in the administration of cancer chemotherapeutic drugs.
Blood counts should be taken prior to each dose. The dosage should be reduced or the drug discontinued upon evidence of abnormal depression of the bone marrow.
It is extremely important that the intravenous needle or catheter be properly positioned before any vinorelbine is injected. Leakage into surrounding tissue may cause considerable irritation, local tissue necrosis and/or thrombophlebitis. If this occurs, the injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein. The application of moderate heat to the area of leakage in the form of a warm compress applied for 15 to 20 minutes at least four times per day for the first 24 to 48 hours, in addition to rest and elevation of the affected site for 48 –72 hours, has been reported to help disperse drug and minimize discomfort.
As with other toxic compounds, caution should be exercised in handling and preparing the solution of vinorelbine. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of vinorelbine contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. Care should be taken to avoid accidental contamination of the eye with vinorelbine. If this happens, the eye should be immediately and thoroughly washed with a large volume of irrigation solution (water or sodium chloride).
Usual dose:
The usual initial dose of Vinorelbine Injection, USP is 30 mg/m2 administered weekly. The dose may be adjusted by the doctor according to blood and liver conditions.
Vinorelbine Injection must be diluted in either a syringe or i.v. bag using one of the recommended solutions. The solution will be prepared by the practitioner. The diluted vinorelbine should be administered over 6 to 10 minutes into the side port of a free-flowing i.v. followed by flushing with at least 75 to 125 mL of one of the solutions.
Overdose:
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre. IMPORTANT: PLEASE READ
Vinorelbine-PM-ENG-v2.0 Page 34 of 34
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Injection site reactions (redness, pain, and vein discoloration) occurred in approximately one-third of all patients.
The most common side effects of chemotherapy medicine (including vinorelbine) are hair loss, increased risk of infection, nausea, vomiting, fatigue, and mouth sores.
Acute shortness of breath and severe bronchospasm have been reported. Bronchodilators, steroids and/or oxygen have 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 | ||
| Common | |||
| Nausea | √ | ||
| Vomiting | √ | ||
| Thinned or brittle hair | √ | ||
| Constipation | √ | ||
| Diarrhea | √ | ||
| Fatigue, weakness | √ | ||
| Sore throat or mouth pain | √ | ||
| Loss of appetite | √ | ||
| Rash | √ | ||
| Unusual bleeding or bruising | √ | ||
| Redness pain, or swelling at the site of injection | √ | ||
| Fever | √ | ||
| Chills | √ | ||
| Shortness of breath | √ | ||
| Cough | √ | ||
| Abnormal burning and tingling | √ | ||
| Change in bowel habits for more than 2 days | √ | ||
| Chest pain | √ | ||
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 between 2 °C and 8 °C in the original package. Protect from light and freezing. Single-dose vials. Discard unused portion.
Vinorelbine Injection 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.
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:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- 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 Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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 obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.
Fresenius Kabi Canada Ltd.
45 Vogell Rd, Suite 200
Richmond Hill, ON L4B 3P6