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.
1. Why am I using Navelbine IV?
2. What should I know before I use 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 use Navelbine IV? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Navelbine IV?
Navelbine IV is given as a slow infusion (drip) into your veins. Navelbine IV must
only be given by a doctor or nurse.
More instructions can be found in Section
4. How do I use Navelbine IV? in the full CMI.
5. What should I know while using Navelbine IV?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Navelbine IV.
Keep all appointments with your doctor to check on your progress and monitor side
effects.
If you become pregnant while taking Navelbine IV, 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 IV.
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 IV affects
you.
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Drinking alcohol
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Fatigue is a common side effect of Navelbine IV. Drinking alcohol may make the tiredness
worse.
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Looking after your medicine
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If you are storing Navelbine IV at home:
Store Navelbine IV in the refrigerator (2 to 8°C). Do not freeze it.
Keep away from light and where children cannot reach
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6. 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.
Active ingredient(s):
vinorelbine tartrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Navelbine IV. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Navelbine IV.
Where to find information in this leaflet:
1. Why am I using Navelbine IV?
Navelbine IV contains the active ingredient vinorelbine tartrate. Vinorelbine belongs to a family of medicines called vinca alkaloids.
Navelbine IV belongs to a group of medicines called antineoplastic or cytotoxic medicines.
You may also hear of these medicines being called chemotherapy.
Navelbine IV contains the medicine, vinorelbine which belongs to a family of medicines
called vinca alkaloids.
Navelbine IV is used treat lung cancer and advanced breast cancer.
Navelbine IV may be used on its own or in combination with other medicines to treat
cancer. Navelbine IV works by stopping cancer cells from growing and multiplying causing
the cells to die.
Navelbine IV is not recommended for use in children as there is no information on
its effects in children.
2. What should I know before I use Navelbine IV?
Warnings
Do not use Navelbine IV 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 IV 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 of lightheadedness
you have or have had an infection or high temperature in the last 2 weeks. Your doctor
may decide to delay your treatment until the infection has gone.
you have recently had a yellow fever vaccination or plan to have one.
you are currently receiving radiation therapy to your liver.
you have, or had any of the following medical conditions:
severe liver problems
a reduced number of white blood cells (known as neutropenia) which you may notice
as frequent infections such as fever, severe chills, sore throat or mouth ulcers
a reduced number of platelets (blood cells which help the blood to clot) which you
may notice as bleeding or bruising more easily than normal.
Navelbine IV should not be administered if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, Navelbine IV is not recommended for use
in pregnancy. Navelbine IV may affect your developing baby if you take it during pregnancy.
If there is a need to consider Navelbine IV during your pregnancy, your doctor will
discuss with you the benefits and risks of using it.
Do not breastfeed while being treated with Navelbine IV.
Navelbine IV 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 infections
such 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 IV 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 IV.
Navelbine IV 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 IV is not recommended for use
during pregnancy. Navelbine IV 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 IV and for three months after your last dose
of Navelbine IV.
Men being treated with Navelbine IV 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 IV.
If there is a need to consider Navelbine IV 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 IV.
3. 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 IV 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 IV 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 IV.
If you have not told your doctor about any of the above, do so before you begin treatment
with Navelbine IV.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Navelbine IV.
4. How do I take Navelbine IV?
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 IV may be given alone or in combination with other drugs.
Several courses of Navelbine IV therapy may be needed depending on your response to
treatment.
Navelbine IV reduces the number of white blood cells in the body. Your doctor will
check these levels regularly. Further doses of Navelbine IV may be delayed until your
blood cell numbers return to acceptable levels.
How to use
Navelbine IV is given as a slow infusion (drip) into your veins.
Navelbine IV must only be given by a doctor or nurse.
How long it is given
Navelbine IV 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 IV
Tell your doctor as soon as possible if you realise that you have missed an appointment
for receiving your dose of Navelbine IV.
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 IV
As Navelbine IV 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 IV, tell your doctor, nurse, or pharmacist.
You should immediately:
phone the Poisons Information Centre
(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.
5. What should I know while using Navelbine IV?
Things you should do
Tell your doctor or nurse immediately if you feel any pain or discomfort during the
infusion.
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 IV 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 IV.
If you become pregnant while taking Navelbine IV, tell your doctor immediately. Navelbine
IV 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, or
if you get a fever, chills, cough, hoarse throat, lower back or side pain or find
it 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. Check with
your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail 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 IV.
Remind any doctor, dentist or pharmacist you visit that you are having treatment with
Navelbine IV.
Things you should not do
You should not breast-feed while you are being treated with Navelbine IV. Breastfeeding
must be discontinued before starting treatment with Navelbine IV.
Men being treated with Navelbine IV 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 IV.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Navelbine
IV 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 IV.
Make sure you know how Navelbine IV 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 IV is usually stored in the hospital, or at the pharmacy. However, if you
are storing at home:
Store Navelbine IV in the refrigerator (2 to 8°C). Do not freeze it.
Protect Navelbine IV 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 IV, or it has passed its expiry
date, return any leftover vials to your pharmacist. Do not dispose of Navelbine IV
via wastewater or household waste. This will help to protect the environment.
6. 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 worry
you.
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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)
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 your
nearest 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 you
feel 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 stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Navelbine IV 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 IV 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 IV looks like
Navelbine IV 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.
10mg/1mL: AUST R 62246
50mg/5mL: AUST R 62248
Who distributes Navelbine IV
Pierre Fabre Australia Pty Limited
Level 7, 32 Walker St
North Sydney NSW 2060
This leaflet was prepared in July 2021