What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00603/0028.


Navelbine 10 mg / ml concentrate for solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

NAVELBINE 10 mg/ml

concentrate for solution for infusion

Vinorelbine (as tartrate)

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 further questions, please ask your doctor or your pharmacist.
  • 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.

In this leaflet:

1. What Navelbine is and what it is used for
2. Before you use Navelbine
3. How to use Navelbine
4. Possible side effects
5. How to store Navelbine
6. Further information

1. What Navelbine is and what it is used for

Navelbine belongs to a family of medicines used to treat cancer called the vinca-alkaloid family.

Navelbine is used to treat some types of lung and breast cancer in patients over 18 years of age:

  • Non-small cell lung cancer
  • Advanced breast cancer that has not responded to other medicines.

It is not recommended for use by children under 18 years old.

2. Before you use Navelbine

Do not use Navelbine

  • If you are allergic (hypersensitive) to the active substance (vinorelbine), or to any of the related family of cancer drugs called the vinca alkaloids,
  • If you are allergic to any of the other ingredients of Navelbine (refer to section 6 in this leaflet),
  • If you are pregnant or think that you might be pregnant,
  • If you are breast feeding,
  • If you have a low white blood cell (neutrophils, leucocyte) count or a severe infection current or recent (within 2 weeks),
  • If you have a low platelet count (thrombocytopenia),
  • If you plan to receive a yellow fever vaccination or have just received one.

Take special care with Navelbine

Please inform your doctor if:

  • you have a history of heart attack or severe chest pain,
  • you have problems with your liver or you have received radiotherapy where the treatment field included the liver,
  • you have signs or symptoms of infection (such as fever, chills, joint pain, cough),
  • you take or have recently taken any other medicines including medicines obtained without prescription,
  • you plan to have a vaccination or have just had one,

Before and during your treatment with Navelbine, blood cell counts are performed to check that it is safe for you to receive treatment. 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 with other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without prescription.

Your doctor should take special attention if you are taking the following medicines:

  • medicines used to thin your blood (anticoagulants),
  • an anti-epileptic medicine called phenytoin,
  • antifungal medicines such as itraconazole and ketaconazole,
  • an anti-cancer medicine called mitomycin C,
  • medicines that impair your immune system such as ciclosporin and tacrolimus.

Many vaccines (live attenuated vaccines) are not recommended during treatment. Please inform your doctor if you require any vaccinations.

If you are given Navelbine as well as medicines that affect your bone marrow it may make some of the side effects worse.

Using Navelbine with food and drink

There are no known interactions with food and drink when using Navelbine. However, you should check with your doctor if taking alcohol is advisable for you.

Male fertility

Men being treated with Navelbine are advised not to father a child during treatment and for up to 3 months after the end of the treatment and to seek advice on conservation of sperm prior to treatment because Navelbine may alter male fertility.

Women of child-bearing potential

Women of child-bearing potential must use effective contraception (birth control) during treatment and for up to 3 months after the end of the treatment.

Pregnancy

  • Do not take Navelbine if you are pregnant or think that you might be pregnant.
  • If you have to start treatment with Navelbine and are pregnant or if pregnancy occurs during your treatment with Navelbine, you must immediately contact your doctor for advice.

Breast-feeding

  • Do not take Navelbine if you are breast feeding.
  • Breast-feeding must be discontinued if treatment with Navelbine is necessary.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

However, some of the possible side effects of Navelbine could affect your ability to drive or perform skilled tasks: see section 4; Possible side effects below for details. Therefore, it is recommended that you should not drive if you feel unwell or if your doctor has advised you not to drive.

3. How to use Navelbine

Navelbine should be prescribed by a qualified doctor who is experienced in the use of cancer treatments.

Navelbine is used in patients over 18 years old. It is not recommended for use by children under 18 years old.

Dosage

Before and during treatment with Navelbine your doctor will check your blood cell count. The results of your blood test will decide when you receive your treatment. The dose will depend on your height and weight and your general condition. Your doctor will calculate your body surface area and will determine the dose you should receive.

Frequency of administration.

Normally Navelbine is scheduled once a week. The frequency will be determined by your doctor.

Duration of treatment.

The duration of your treatment is decided by your doctor.

Method and route of administration

  • Navelbine must be diluted before administration
  • Navelbine must only be administered into a vein. It will be given by an infusion into one of your veins. It will take between 6 to 10 minutes.
  • After administration the vein will be rinsed thoroughly with a sterile solution.

If you use more Navelbine than you should

Your dose of Navelbine is carefully monitored and checked by your doctor and pharmacist. However, although you will have received the correct amount of chemotherapy your body may sometimes react giving severe symptoms. Some of these symptoms may develop as signs of an infection (such as fever, chills, cough, joint pain). You may also become severely constipated. You must immediately contact your doctor if any of these severe symptoms occur.

If you stop using Navelbine

Your doctor will decide when you should stop your treatment. However, if you want to stop your treatment earlier, you should discuss other options with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Navelbine can cause side effects, although not everybody gets them.

While taking Navelbine, if you develop any of the following symptoms you should contact your doctor immediately:

  • signs of a major infection such as cough, fever and chills,
  • severe constipation with abdominal pain when your bowels have not been open for several days,
  • severe dizziness, light-headedness when you stand up,
  • severe chest pain which is not normal for you,
  • signs of allergy such as itching, shortness of breath.

Below is a list of side effects that have occurred in some people following treatment with Navelbine. This list is classified according to the decreasing frequency of side effects occurrence.

Very common side effects What should you do?

(can occur in more than 1 in 10 patients treated)

  • Feeling sick (nausea)
  • Vomiting

Immediately contact your doctor if this becomes uncontrollable. These side effects may be controlled with standard anti-sickness therapy.

  • A fall in white blood cells which makes you more vulnerable to infection. This can commonly cause bacterial, viral or fungal infections in your body (respiratory, urinary, gastro-intestinal systems and possibly others).

Immediately contact your doctor, especially if your temperature reaches 38°C or higher.

  • A fall in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness
  • Weakness of the lower extremeties
  • Loss of some reflex reactions, occasionally difference in the perception of touch
  • Constipation. If you have abdominal pain or if you do not have a bowel movement for several days

Immediately contact your doctor for treatment, should these symptoms become severe.

  • Hair loss (alopecia).

Reactions at the site where Navelbine was administered such as

  • Redness (erythema)
  • Burning pain
  • Vein discolouration
    Inflammation of the veins (local phlebitis)

Immediately contact your doctor for treatment, should these symptoms become severe.

These are possible symptoms when receiving chemotherapy.

  • Inflammation or sores in the mouth or throat (stomatitis)

Immediately contact your doctor.

Abnormal liver test

Your doctor should check your liver function when you are receiving chemotherapy.

Common side effects What should you do?

(can occur in less than 1 in 10 patients treated)

  • A fall in platelets which can increase the risk of bleeding or bruising (thrombocytopenia).
  • Joint pain (arthralgia)
  • Jaw pain
  • Muscle pain (myalgia)

Immediately contact your doctor for treatment, should these symptoms become severe.

  • Tiredness (asthenia, fatigue)
  • Fever
  • Pain at different sites in your body such as chest pain and pain where the tumour is

If the symptoms persist or if your temperature reaches 38°C or higher, ask your doctor for advice.

These symptoms are expected when receiving chemotherapy.

  • Diarrhoea

Immediately contact your doctor

Uncommon side effects What should you do?

(can occur in less than 1 in 100 patients treated)

Effects on your blood:

  • Severe signs of a major infection such as cough, fever, chills and blood infection.

Immediately contact your doctor if you experience any of these side effects.

Effects on your nervous system:

  • Severe difficulties with your body movements and sense of touch (severe paresthesias)

Effects on your heart and blood vessels:

  • Reduced blood pressure (hypotension with symptoms such as dizziness or feeling faint)
  • Raised blood pressure (hypertension) with symptom such as a headache.
  • A sudden feeling of heat and skin redness of the face and neck (flushing)
  • Feeling cold in the hands and feet (peripheral coldness)

Effects on your respiratory system:

  • Difficulty in breathing or wheezing (dyspnoea and bronchospasm)

Immediately contact your doctor if you experience any of these side effects.

Rare side effects What should you do?

(can occur in less than 1 in 1,000 patients treated)

Effects on your heart and blood vessels

  • Severe chest pain, heart attack (ischaemic heart disease, angina pectoris, myocardial infarction)
  • Severe drop in blood pressure causing dizziness, fainting (severe hypotension, collapse).

Effects on your respiratory system:

  • If you are receiving another cancer drug called mitomycin C, you may experience breathing difficulties (interstitial pneumonopathy).

Effects on your blood:

  • Severe hyponatraemia which is when there are low blood levels of sodium in your blood (which can cause symptoms of tiredness, confusion, muscle twitching and coma),

Effects on your gastrointestinal system:

  • Severe constipation with abdominal pain when your bowels have not been open for several days (paralytic ileus)
  • Severe abdominal and back pain (pancreatitis)

Allergic reaction effects

  • Skin rashes on your body such as rashes and eruptions (generalised cutaneous reactions)
  • Ulcer at the injection site where the Navelbine was given (local necrosis).

Immediately contact your doctor if you experience any of these side effects.

Very rare side effects What should you do?

(can occur in less than 1 in 10,000 patients treated)

  • Life threatening infection in your body such as severe fever, chest infection and infections at other sites in your body (septicaemia)
  • Irregular heartbeat (tachycardia, palpitation, and heart rhythm disorders)

Immediately contact your doctor if you experience any of these side effects.

Other side effects have been reported with a “not known” frequency:

  • Generalised allergic reactions. These are serious reactions which can cause severe difficulty in breathing, dizziness, rash affecting your whole body, swelling of the eyelids, face lips, throat (anaphylactic shock, anaphylaxis, anaphylactoid type reactions).
  • A fall in white blood cell count with fever (febrile neutropenia), a general infection in combination with a fall in white blood cell count (neutropenic sepsis).
  • Low sodium level due to an overproduction of a hormone causing fluid retention and resulting in weakness, tiredness or confusion (Syndrome of Inappropriate Antidiuretic Hormone secretion SIADH).
  • Loss of appetite (anorexia).
  • Skin redness (erythema) on the hands and feet.

Do not be alarmed by this list. If you suffer from any of these side effects or if you have any other unusual symptom or feelings, you should contact your doctor as soon as possible.

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.

5. How to store Navelbine

Keep out of the reach and sight of children.

Do not use Navelbine after the expiry date which is stated on the vial and box (after Exp). The expiry date refers to the last day of that month.

Navelbine will be diluted and stored by hospital staff.

6. FURTHER INFORMATION

What Navelbine contains

  • The active substance is Vinorelbine (as tartrate). Each 1 ml of solution contains 10 mg of vinorelbine as vinorelbine tartrate.
  • The other ingredient is water for injection.

What Navelbine looks like and contents of the pack

Navelbine is a clear colourless to pale yellow solution.

This medicinal product is a concentrate for solution for infusion, in clear glass vials of 1, 4 or 5 ml. Navelbine is available as:

Box of 10 vials of 1ml,

Box of 10 vials of 4 ml,

Box of 10 vials of 5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pierre Fabre Limited
250 Longwater Avenue
Green Park
Reading
RG2 6GP
United Kingdom

Manufacturer

Pierre Fabre Médicament Production
Avenue du Bearn - BP 9097
F-64320 - Pau Idron - Bizanos
FRANCE

For any information on this product please contact Pierre Fabre Limited; Phone: 0800 085 5292

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only): Please be ready to give the following information:

Product Name Reference Number

NAVELBINE 10mg/ml concentrate for solution for infusion 00603/0028

This is a service provided by the Royal National Institute of the Blind.

This leaflet was last approved in Dec 2016