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
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:
- 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.
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 pregnant or think that you might be pregnant
- If you are breast feeding
- If you have a low white blood cell (neutrophil) count or a severe infection
- If you have a low platelet count (thrombocytopenia)
- If you have a low blood 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)
- 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.
Live attenuated vaccines (e.g. Measles vaccine, Mumps vaccine, Rubella vaccine…) and yellow fever vaccines are not recommended with Navelbine as they may increase the risk of life-threatening vaccine disease.
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.
The effects of anti-cancer drugs on the unborn child are not fully known. Navelbine is one of the anti-cancer drugs which are known to have adverse effects in pregnant animals.
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.
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 who will take into account any other medicines you are being given.
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 5 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, 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.
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
(can occur in more than 1 in 10 patients treated)
• Feeling sick (nausea), vomiting
If this becomes uncontrollable, immediately contact your doctor. 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).
If your temperature reaches 38°C or higher, immediately contact your doctor.
• A fall in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness
If this symptom becomes severe, immediately contact your doctor for treatment.
• Loss of some reflex reactions, occasionally difference in the perception of touch.
• Weakness of the lower extremities
If these symptoms become severe, immediately contact your doctor for treatment.
• Inflammation or sores in the mouth or throat (stomatitis)
• Constipation. If you have abdominal pain or if you do not have a bowel movement for several days
Immediately contact your doctor if you experience any of these side effects.
• Abnormal liver test
Your doctor should check your liver function when you are receiving chemotherapy.
• 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)
Ask your doctor for advice if these symptoms persist. These are possible symptoms when receiving chemotherapy.
Common side effects
(can occur in less than 1 in 10 patients treated)
• Tiredness, 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.
• A fall in platelets which increases the risk of bleeding or bruising (thrombocytopenia).
• Diarrhoea, joint pain (arthralgia), jaw pain, muscle pain (myalgia)
If these symptoms become severe, immediately contact your doctor.
Uncommon side effects
(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 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)
Immediately contact your doctor if you experience any of these side effects.
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.
Effects on your nervous system:
• Severe difficulties with your body movements and sense of touch (severe paresthesias)
Immediately contact your doctor if you experience any of these side effects.
Rare side effects
(can occur in less than 1 in 1,000 patients treated)
Effects on your blood:
• Severe hyponatremia which is when there are low blood levels of sodium in your blood (which can cause symptoms of tiredness, confusion, muscle twitching and coma)
Immediately contact your doctor if you experience any of these side effects.
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).
Immediately contact your doctor if you experience any of these side effects.
Effects on your respiratory system:
• If you are receiving another cancer drug called mitomycin C, you may experience breathing difficulties (interstitial pneumopathies).
Immediately contact your doctor if you experience any of these side effects.
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)
Immediately contact your doctor if you experience any of these side effects.
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
(can occur in less than 1 in 10,000 patients treated)
• Irregular heartbeats (tachycardia, palpitation, and heart rhythm disorders)
• Life threatening infections in your body such as severe fever, chest infections and infections at other sites in your body (septicaemia)
Immediately contact your doctor if you experience any of these side effects.
Other side effects have been reported:
- 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).
- Low sodium level due to an overproduction of a hormone causing fluide retention and resulting in weakness, tiredness or confusion (Syndrome of Inappropriate Antidiuretic Hormone secretion SIADH)
- Loss of appetite (anorexia).
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.
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.
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 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
Manufacturer
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 July 2009
No comments:
Post a Comment