Vinorelbine Ebewe®

Vinorelbine Ebewe®

Active ingredient(s): Vinorelbine tartrate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Vinorelbine Ebewe. 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 Vinorelbine Ebewe.

Where to find information in this leaflet:

1. Why am I using Vinorelbine Ebewe?
2. What should I know before I use Vinorelbine Ebewe?
3. What if I am taking other medicines?
4. How do I use Vinorelbine Ebewe?
5. What should I know while using Vinorelbine Ebewe?
6. Are there any side effects?
7. Product details

1. Why am I using Vinorelbine Ebewe?

Vinorelbine Ebewe contains the active ingredient vinorelbine tartrate. Vinorelbine belongs to a family of medicines called vinca alkaloids.

Vinorelbine Ebewe belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these medicines being called chemotherapy.

Vinorelbine Ebewe is used treat lung cancer and advanced breast cancer.

Vinorelbine Ebewe may be used on its own or in combination with other medicines to treat cancer. Vinorelbine Ebewe works by stopping cancer cells from growing and multiplying causing the cells to die.

2. What should I know before I use Vinorelbine Ebewe?

Warnings

Do not use Vinorelbine Ebewe 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 Vinorelbine Ebewe 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
• 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.

Check with your doctor if you:

• have allergies to any other medicines or 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. Vinorelbine Ebewe 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 Vinorelbine Ebewe.

Vinorelbine Ebewe 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

Vinorelbine Ebewe should not be administered if you are pregnant or intend to become pregnant.

Check with your doctor if you are pregnant or intend to become pregnant.

Like most medicines used to treat cancer, Vinorelbine Ebewe is not recommended for use during pregnancy.

Vinorelbine Ebewe 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 Vinorelbine Ebewe for three months after your last dose of Vinorelbine Ebewe.

Men being treated with Vinorelbine Ebewe 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 Vinorelbine Ebewe.

If there is a need to consider Vinorelbine Ebewe during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Do not breastfeed while being treated with Vinorelbine Ebewe.

Vinorelbine Ebewe may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not breastfeed while being treated with Vinorelbine Ebewe.

Use in Children

Vinorelbine Ebewe is not recommended for use in children as there is no information on its effects in children.

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 Vinorelbine Ebewe 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 Vinorelbine Ebewe 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 Vinorelbine Ebewe.

If you have not told your doctor about any of the above, do so before you begin treatment with Vinorelbine Ebewe.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Vinorelbine Ebewe.

4. How do I use Vinorelbine Ebewe?

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.
• Vinorelbine Ebewe may be given alone or in combination with other drugs.
• Several courses of Vinorelbine Ebewe therapy may be needed depending on your response to treatment.
• Vinorelbine Ebewe reduces the number of white blood cells in the body. Your doctor will check these levels regularly. Further doses of Vinorelbine Ebewe may be delayed until your blood cell numbers return to acceptable levels.

How to use Vinorelbine Ebewe

• Vinorelbine Ebewe is given as a slow infusion (drip) into your veins.
• Vinorelbine Ebewe must only be given by a doctor or nurse.

How to long to use Vinorelbine Ebewe

Vinorelbine Ebewe 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 Vinorelbine Ebewe

Tell your doctor as soon as possible if you realise that you have missed an appointment for receiving your dose of Vinorelbine Ebewe.

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 Vinorelbine Ebewe

As Vinorelbine Ebewe 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 Vinorelbine Ebewe, 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 Vinorelbine Ebewe?

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 Vinorelbine Ebewe 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 Vinorelbine Ebewe.
• If you become pregnant while taking Vinorelbine Ebewe, tell your doctor immediately.
• Vinorelbine Ebewe 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 Vinorelbine Ebewe.

Remind any doctor, dentist or pharmacist you visit that you are having treatment with Vinorelbine Ebewe.

Things you should not do

• You should not breast-feed while you are being treated with Vinorelbine Ebewe. Breastfeeding must be discontinued before starting treatment with Vinorelbine Ebewe.
• 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 Vinorelbine Ebewe.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Vinorelbine Ebewe 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 Vinorelbine Ebewe. Make sure you know how Vinorelbine Ebewe 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

Vinorelbine Ebewe is usually stored in the hospital, or at the pharmacy. However, if you are storing at home:

• Store Vinorelbine Ebewe in the refrigerator (2 to 8°C).
  Do not freeze it.
• Protect Vinorelbine Ebewe 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 Vinorelbine Ebewe, or it has passed its expiry date, return any leftover vials to your pharmacist. Do not dispose of Vinorelbine Ebewe 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

Less serious side effects

What to do

Pain related aching muscles, muscle tenderness or weakness, not caused by exercise pain, including pain at the tumour site jaw pain painful swollen joints Skin related skin rash unusual hair loss or thinning Head and neurology related unusual tiredness, weakness, sleepiness, drowsiness or lack of energy Gastrointestinal/Gut related nausea vomiting diarrhoea constipation upset stomach Infection related fever

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

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/ Gut 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.

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.

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 Vinorelbine Ebewe contains

Active ingredient (main ingredient)	Vinorelbine tartrate
Other ingredients (inactive ingredients)	water for injections nitrogen

Vinorelbine Ebewe does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Vial stopper is not made with natural rubber latex.

Do not take this medicine if you are allergic to any of these ingredients.

What Vinorelbine Ebewe looks like

Vinorelbine Ebewe – clear, colourless to pale yellow solution. It comes in a clear glass vial with a rubber stopper and a cap. Each vial is packed in a carton.

10 mg in 1 mL injection: AUST R 126693 (vial)

50 mg in 5 mL injection: AUST R 99724 (vial)

Who distributes Vinorelbine Ebewe

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was prepared in February 2022.