NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
NAVELBINE INJECTION
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
Why do I need Navelbine®IV?
Navelbine Injection contains the active ingredient vinorelbine tartrate. Navelbine Injection is used to treat lung cancer and advanced breast cancer. For more information, see Section 1. Why do I need Navelbine®IV? in the full CMI.
What should I know before I am given Navelbine®IV?
Do not use if you have ever had an allergic reaction to or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given Navelbine Injection? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with Navelbine Injection and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
How is Navelbine Injection given?
Navelbine Injection is given as a slow injection into your veins, usually with an infusion (drip). Navelbine Injection must only be given by a doctor or nurse.
More instructions can be found in Section 4. How is Navelbine Injection given? in the full CMI.
What should I know while I am given Navelbine Injection?
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Things you should do
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Tell your doctor or nurse immediately if you feel any pain or discomfort during the injection.
Keep all appointments with your doctor to check on your progress and monitor side effects.
If you become pregnant while taking Navelbine Injection, tell your doctor immediately.
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Things you should not do
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You should not breast-feed while you are being treated with Navelbine Injection.
Do not use if you have or have had an infection or high temperature in the last 2 weeks
Do not use if you are currently receiving radiation therapy.
Do not use if you have recently had a yellow fever vaccination or plan to have one.
Do not use if you have severe liver problems or if you have a reduced number of platelets of red blood cells.
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Driving or using machines
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Be careful driving or operating machinery until you know how Navelbine Injection affects you.
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Drinking alcohol
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Fatigue is a common side effect of Navelbine Injection. Drinking alcohol may make the tiredness worse.
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Looking after your medicine
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If you are storing Navelbine Injection at home:
Store Navelbine Injection in the refrigerator (2 to 8°C). Do not freeze it.
Keep away from light and where children cannot reach.
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For more information, see Section 5. What should I know while I am given Navelbine Injection? in the full CMI.
Are there any side effects?
Common side effects include nausea, vomiting, diarrhoea, unusual tiredness, weakness, sleepiness, drowsiness or lack of energy, unusual hair loss, constipation, aching muscles, chest pain, jaw pain, painful swollen joints, injection site reactions, shortness of breath and high or low blood pressure. Serious side effects include difficulty breathing, pain in bladder or back, blood in urine, chest pain, fast or irregular heartbeat, rash, itching or hives on the skin, swelling of the feet and ankles, face, lips, tongue or other parts of the body.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient(s): vinorelbine tartrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Navelbine Injection.You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Navelbine Injection.
Where to find information in this leaflet:
1. Why do I need Navelbine Injection?
2. What should I know before I am given Navelbine Injection?
3. What if I am taking other medicines?
4. How is Navelbine Injection given?
5. What should I know while I am given Navelbine Injection?
6. Are there any side effects?
7. Product details
Why am I using Navelbine Injection?
Navelbine Injection contains the active ingredient vinorelbine tartrate. Vinorelbine belongs to a family of medicines called vinca alkaloids.
Navelbine Injection belongs to a group of medicines called antineoplastic or cytotoxic medicines.You may also hear of these medicines being called chemotherapy.
Navelbine Injection contains the medicine, vinorelbine which belongs to a family of medicines called vinca alkaloids.
Navelbine Injection is used treat lung cancer and advanced breast cancer.
Navelbine Injection may be used on its own or in combination with other medicines to treat cancer. Navelbine Injection works by stopping cancer cells from growing and multiplying causing the cells to die.
Navelbine Injection is not recommended for use in children as there is no information on its effects in children.
What should I know before I am given Navelbine Injection?
Warnings
Do not use Navelbine Injection if:
you are allergic to vinorelbine; or to the other vinca alkaloids, (vinblastine, vincristine, vindesine, vinflunine); or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Navelbine Injection may include:
shortness of breath
wheezing, difficulty breathing or a tight feeling in your chest
swelling of the face, lips, tongue or other parts of the body
rash, itching, hives or flushed, red skin.
dizziness or lightheadedness.
Navelbine Injection should not be administered if you are pregnant or intend to becomepregnant.
Like most medicines used to treat cancer, Navelbine Injection is not recommended for use in pregnancy.Navelbine Injection may affect your developing baby if you take it during pregnancy.If there is a need to consider Navelbine Injection during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Do not breastfeed while being treated with Navelbine Injection.
Navelbine Injection may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.
Check with your doctor if you:
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
if you have, or have had, any of the following medical conditions:
heart problems (including chest pain and heart attack)
liver problems
a low white blood cell count which you may notice as signs of frequent infectionssuch as fever, severe chills, sore throat or mouth ulcers
lung problems, including asthma
take any medicines for any other condition or treatments for cancer, including radiation therapy.Navelbine Injection must not be administered if you are currently receiving radiation therapy to your liver.
if you have recently had or plan to have a vaccination.Live attenuated vaccines (eg. measles vaccine, mumps vaccine, rubella vaccine) are not recommended while having Navelbine Injection.
Navelbine Injection is a potent cytotoxic drug that results in a decrease in blood cells.Your blood count will be carefully monitored before and during your treatment
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, Navelbine Injection is not recommended for use during pregnancy.Navelbine Injection may affect your developing baby if you take it during pregnancy.
If you are a fertile man or woman, you should use an effective method of contraception during your treatment with Navelbine Injection and for three months after your last dose of Navelbine Injection.
Men being treated with Navelbine Injection are advised not to father a child during and up to a minimum of 3 months after treatment.Prior to treatment, men are advised to seek advice on conserving sperm due to the chance of irreversible fertility resulting from treatment with Navelbine Injection.
If there is a need to consider Navelbine Injection during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not breastfeed while being treated with Navelbine Injection.
What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Navelbine Injection and affect how it works. These include:
medicines used to prevent blood clots (anticoagulants) eg. phenindione, warfarin heparin
phenytoin, a medicine used to treat epilepsy
cyclosporin, tacrolimus, medicines which lower your immunity
itraconazole and ketoconazole, medicines used to treat fungal infections
mitomycin, lapatinib, medicines used to treat cancer
medicines with known bone marrow toxicity (causing a reduced number of red or white blood cells or platelets)
other medicines used to treat cancer such as cisplatin
ritonavir, a medicine used to treat AIDS
rifampicin, a medicine used to treat tuberculosis.
These medicines may be affected by Navelbine Injection or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines.Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while having Navelbine Injection.
If you have not told your doctor about any of the above, do so before you begin treatment with Navelbine Injection.
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Navelbine Injection.
How is Navelbine Injection given?
How much to take
Your doctor will decide what dose you will receive.This depends on your body surface area, your condition and factors such as your liver function and whether you are receiving any other chemotherapy medicines. Your doctor may adjust your dose during treatment.
Navelbine Injection may be given alone or in combination with other drugs.
Several courses of Navelbine Injection therapy may be needed depending on your response to treatment.
Navelbine Injection reduces the number of white blood cells in the body.Your doctor will check these levels regularly.Further doses of Navelbine Injection may be delayed until your blood cell numbers return to acceptable levels.
How to use
Navelbine Injection is given as a slow injection into your veins, usually with an infusion (drip).
Navelbine Injection must only be given by a doctor or nurse.
How long it is given
Navelbine Injection is usually given every week, but it may be given less often if you are also having other medicines to treat cancer. Your doctor will decide how many doses you will need.
If you forget to use Navelbine Injection
Tell your doctor as soon as possible if you realise that you have missed an appointment for receiving your dose of Navelbine Injection.
If you have problems remembering when your next dose is due, use a diary or calendar or ask a friend to remind you.
If you use too much Navelbine Injection
As Navelbine Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects while or after being given Navelbine Injection, tell your doctor, nurse or pharmacist.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
What should I know while I am given Navelbine Injection?
Things you should do
Tell your doctor or nurse immediately if you feel any pain or discomfort during the injection.
Keep all appointments with your doctor. Your doctor may want to do some blood and other tests from time to time to check on your progress and monitor any unwanted side effects.
Keep follow up appointments with your doctor. It is important to have your follow-up doses of Navelbine Injection at the appropriate times to get the best effects from your treatments.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are having treatment with Navelbine Injection.
If you become pregnant while taking Navelbine Injection, tell your doctor immediately. Navelbine Injection can lower the number of white blood cells and platelets in your blood.This means that you have an increased chance of getting an infection or bleeding.
Take the following precautions to reduce your risk of infection or bleeding:
Check with your doctor immediately if you think you may be getting an infection, orif you get a fever, chills, cough, hoarse throat, lower back or side pain or findit painful or difficult to urinate;
Avoid people who have infections.
Be careful when using a toothbrush, toothpick or dental floss.Your doctor, dentist,nurse or pharmacist may recommend other ways to clean your teeth and gums.Checkwith your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor ornail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Call your doctor straight away if you
are feeling unwell after taking Navelbine Injection.
Remind any doctor, dentist or pharmacist you visit that you are having treatment with Navelbine Injection.
Things you should not do
You should not breast-feed while you are being treated with Navelbine Injection.Breastfeeding must be discontinued before starting treatment with Navelbine Injection.
Men being treated with Navelbine Injection are advised not to father a child during and up to a minimum of 3 months after treatment.Prior to treatment, men are advised to seek advice on conserving sperm due to the chance of irreversible fertility resulting from treatment with Navelbine Injection.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NavelbineInjection affects you.
If you experience symptoms that affect your ability to concentrate and react, do not drive a car or operate machinery.Fatigue is a common side effect of Navelbine Injection. Make sure you know how Navelbine Injection affects you before you drive a car, operate machinery or do anything else that could be dangerous if you are feeling tired.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol may make the tiredness worse.
Looking after your medicine
Navelbine Injection is usually stored in the hospital, or at the pharmacy. However, if you are storing at home:
Store Navelbine Injection in the refrigerator (2 to 8°C). Do not freeze it.
Protect Navelbine Injection from light
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor stops your treatment with Navelbine Injection, or it has passed its expiry date, return any leftover vials to your pharmacist. Do not dispose of Navelbine Injection via wastewater or household waste.This will help to protect the environment.
Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Pain Related
aching muscles, muscle tenderness or weakness, not caused by exercise
pain, including pain at the tumour site
jaw pain
painful swollen joints
Problems with skin and hair
skin rash
unusual hair loss or thinning
Head and neurology related
unusual tiredness, weakness, sleepiness, drowsiness or lack of energy
Gastrointestinal upset
nausea
vomiting
diarrhoea
constipation
upset stomach
Infection related
fever
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious Side effects
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Serious side effects
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What to do
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Breathing problems:
difficulty breathing, short of breath
breathlessness, which may be very severe and usually worse on lying down
Head and neurology related
tiredness, headaches, being short of breath when exercising, dizziness and looking pale (symptoms of a decreased number of red blood cells)
numbness + tingling of fingers and toes
lack of muscle control, which may be associated with abnormal gait, and speech changes
weakness of legs or feet
Infection related:
frequent infections such as fever, severe chills, sore throat or mouth ulcers (symptoms of a lack of white blood cells)
sore mouth
Bleeding related:
bleeding or bruising more easily than normal or nosebleeds (symptoms of a low blood platelet count)
blood infection (sepsis) with symptoms such as a high fever and deterioration in general health;
Eye problems:
changes in your vision
Gastrointestinal problems:
stomach pain with bloating, gut cramps and vomiting which may be symptoms of the small bowel not working properly
severe upper stomach pain
Skin related:
irritation, pain, swelling or colouring of the skin around the needle or along the vein during the infusion
Liver disease related:
weakness, tiredness, loss of appetite, weight loss or stomach pain that may be symptoms of liver disease.
Urinary related:
pain or burning feeling when passing urine
pain in bladder or back, blood in urine
Heart related:
chest pain
palpitations, fast or irregular heart beat;
severe chest pain which is not normal for you, the symptoms may be due to disturbance in the heart function following insufficient blood flow, so called ischemic heart disease such as for example angina pectoris and myocardial infarction (sometimes with fatal outcome)palpitations, fast or irregular heart beat,
Allergy related:
rash, itching or hives on the skin
swelling of the feet and ankles, face, lips, tongue or other parts of the body.
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stoptaking any of your medicines.
Product details
This medicine is only available with a doctor’s prescription.
What Navelbine Injection contains
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Active ingredient
(main ingredient)
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vinorelbine tartrate
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Other ingredients
(inactive ingredients)
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water for injection
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Potential allergens
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No
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Navelbine Injection does not contain lactose, sucrose, gluten, tartrazine or any other azodyes.
Do not take this medicine if you are allergic to any of these ingredients.
What Navelbine Injection looks like
Navelbine Injection is a clear, colourless to pale yellow solution. It comes in a clear glass vial with a rubber stopper and royal blue cap. Each vial is packed in a carton.
Australian Registration Number:
10mg/1mL: 62246
50mg/5mL: 62248
Who distributes Navelbine Injection
Pierre Fabre Australia Pty Limited
Suite 901, 1 Elizabeth Plaza
North Sydney NSW 2060
This leaflet was prepared in August 2020
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