Vinorelbine 10mg/ml Concentrate For Solution For Infusion
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Vinorelbine is and what it is used for
- 2. Before you use Vinorelbine
- 3. How to use Vinorelbine
- 4. Possible side effects
- 5. How to store Vinorelbine
- 6. Further information
What Vinorelbine Is And What It Is Used For
Vinorelbine is used in the treatment of cancer and belongs to a group of medicines known as Vinca alkaloids.
Vinorelbine is used to treat certain types of lung cancer and breast cancer.
Before You Use Vinorelbine
Do not use Vinorelbine
- if you are allergic (hypersensitive) to vinorelbine or other Vinca alkaloids
- if you have or recently had serious infection or severe decrease in white blood cells (neutropenia)
- if you have severe decrease in blood platelets.
- if you are pregnant
- if you are breast-feeding
- if you are a women of childbearing potential not using effective contraception
- if you have a severe liver disease not caused by cancer
- in combination with yellow fever vaccine
This medicine is strictly for intravenous use only and should not be injected into the spine.
Take special care with Vinorelbine
- if you have had a heart disease involving lack of blood supply to the heart (ischaemic heart disease, angina)
- if you are having radiotherapy and the treatment field includes the liver
- if you present signs or symptoms suggestive of infection (such as fever, chills, sore throat), let your doctor know immediately, so that he/she can carry out any tests which may be needed
- if you have impaired liver function
- if you need a vaccination. You should inform your doctor of the treatment before any vaccination.
- if you receive a cancer medicine named mitomycin C
Vinorelbine must not get into contact with the eye as there is a risk of severe irritation and even corneal ulceration. If this occurs, immediately rinse the eye with normal saline solution and contact an ophthalmologist.
Men and women who are treated with Vinorelbine should use an effective contraception during treatment. Men and women should BOTH read the information under pregnancy and breast-feeding below.
Before each administration of Vinorelbine, 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 and further checks made until these values return to normal.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are using any of the following medicines:
- other medicines which can affect the bone marrow e.g. cancer medicines
- carbamazepine, phenytoin and phenobarbital (medicines for the treatment of epilepsy)
- antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
- St John’s Wort (Hypericum perforatum)
- ketoconazole and itraconazole (medicines for the treatment of fungal infections)
- antiviral medicines to treat HIV-infection e.g. ritonavir (HIV protease inhibitors).
- nefazodon (medicines for the treatment of depression)
- cyclosporine and tacrolimus (medicine which decrease the activity of the immune system)
- verapamil, quinidine (medicines for the treatment of heart diseases)
- other medicines for the treatment of cancer e.g. mitomycin C, cisplatin
- blood thinning medicines e.g. warfarin
- yellow fever vaccine and other live vaccines
Pregnancy and breast-feeding
Vinorelbine should not be given to pregnant women, because it can cause serious birth defects.
If you are a woman of childbearing age you must use an effective method of contraception during treatment. If pregnancy occurs during your treatment you must immediately inform your doctor. If you are or become pregnant during treatment with Vinorelbine, genetic counselling is recommended.
If you are a man, you should avoid fathering a child during treatment with Vinorelbine and for 6 months after treatment has stopped. There is also a risk that treatment with Vinorelbine will lead to male infertility and you may wish to seek advice about sperm storage before the treatment starts.
You must discontinue breast-feeding before treatment with Vinorelbine starts as it is not known whether it might pass into breast milk thereby affecting the baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed.
How To Use Vinorelbine
Vinorelbine will be given to you under the supervision of a doctor specialized in this type of treatment.
The dosage depends on the condition you are being treated for, your response to the therapy and other medication you are being given. Your general condition and your response to the treatment will be closely observed before, during and after the vinorelbine treatment.
The usual dosage of vinorelbine is 25-30mg/metres squared of body surface area given once a week.
The medicine should be diluted before use with a solution of sodium chloride or glucose and given into a vein as an injection over 5-10 minutes or by infusion (drip) over 20-30 minutes. Following your treatment, a solution of sodium chloride will be used to flush the vein.
Dosage will be reduced if you have severe liver problems.
The safety and efficacy in children have not been determined.
If you use more Vinorelbine than you should
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.
Possible Side Effects
Like all medicines, Vinorelbine can cause side effects, although not everybody gets them.
Frequency:
Very common: likely to affect more than 1 of every 10 people.
Common: likely to affect more than 1 of every 100 but less than 1 of every 10 people.
Uncommon: likely to affect more than 1 of every 1,000 but less than 1 of every 100 people.
Rare: likely to affect more than 1 of every 10,000 but less than 1 of every 1,000 people.
Very rare: likely to affect less than 1 of every 10,000 people.
Serious side effects – if any of the following side effects occur, immediately contact your doctor:
Common: Narrowing of the airways (bronchospasm), shortness of breath, respiratory reactions due to allergy.
Rare: Chest pain which spreads to the back of the neck and arm, due to lack of blood supply to the heart. Heart attack, lung disease.
These are very serious side effects. You may need immediate medical care.
Other side effects – if any of the following side effects occur, contact your doctor as soon as possible:
Very common: Low count of white blood cells, which may increase the risk of infection. Low count of red blood cells (anaemia), which may make you feel tired. Inflammation of the mouth or the gullet. Nausea and vomiting. Anorexia (decreased appetite), constipation, diarrhoea. Hair loss. Oedema, tenderness, pain and/or rash on the injection site. Fatigue, fever, pain, weakness, abnormal results of liver function tests, loss of deep tendon reflexes.
Common: Numbness (paraesthesia). Pain in joints and muscles. Increased creatinine values (change in renal function). Symptoms of infection e.g. fever, pain. Skin reactions. Low count of a special type of white blood cells, which can cause fever. Low count of blood platelets (risk of bleeding).
Rare: Inflammation of the pancreas, paralytic intestinal blockage (ileus). Weakness of lower extremities. Low levels of sodium in the blood. Changes in the activity of the heart (ECG changes). Jaw pain. Injection site necrosis.
Very rare: Guillain-Barrés syndrome (inflammation in peripheral nerves which may cause weakness). SIADH syndrome, which may include symptoms of increased weight, nausea (feeling sick), vomiting, muscle cramps, confusion and seizures (fits).
As changes in the blood may occur, your doctor may order blood samples to be taken to control this (low count of white blood cells, anaemia and/or low count of blood platelets, influence on the liver- or kidney function and the electrolyte balance in your body).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Vinorelbine
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C). DO NOT FREEZE. Keep the vial in the outer carton in order to protect from light.
Do not use Vinorelbine after the expiry date which is stated on the vial label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Vinorelbine contains
The active substance is vinorelbine. One ml concentrate for solution for infusion contains 10 mg vinorelbine (as tartrate).
Each 1ml vial contains 10mg of vinorelbine (as tartrate).
Each 5ml vial contains 50mg of vinorelbine (as tartrate).
The other ingredient is water for injections.
What Vinorelbine looks like and contents of the pack
Vinorelbine 10mg/ml Concentrate For Solution For Infusion is a clear, colourless to slightly yellow solution.
Pack-sizes:
1 x 1ml vial
10 x 1ml vial
1 x 5ml vial
10 x 5ml vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturers
This leaflet was last revised in October 2008
If you would like a leaflet with larger text, please contact 01271 311257.
SINPL022
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