Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Navelbine 10 mg / ml concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Vinorelbine tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Navelbine contains the active substance Vinorelbine (as tartrate) and 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, and advanced breast cancer that has not responded to other medicines, in patients over 18 years of age. 2.
What you need to know before you take it
Navelbine Do not use Navelbine • If you are allergic to Vinorelbine, or to any of the related family of cancer drugs called the vinca alkaloids, or any of the other ingredients of this medicine, (listed in section 6), • 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. Warnings and precautions Talk to your doctor or pharmacist before you are given Navelbine 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 plan to have a vaccination. Many vaccines (live attenuated vaccines) are not recommended during treatment,
• • •
your liver function is not normal. If your liver function test shows that you have severe liver impairment your doctor will want to monitor this when you are receiving vinorelbine, you are pregnant, you are of Japanese ethnicity because you will be more sensitive to vinorelbine and may experience some chest problems whilst receiving treatment with vinorelbine.
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. Children and adolescents It is not recommended for use by children under 18 years old. Other medicines and Navelbine Tell 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, anti-tuberculosis medicine called rifampicin, antifungal medicines such as itraconazole and ketaconazole, anti-cancer medicines called mitomycin C or lapatinib, medicines that impair your immune system such as ciclosporin and tacrolimus. Many vaccines (live attenuated vaccines) are not recommended during treatment, especially in patients who already have weakened immune systems. Please inform your doctor if you require any vaccinations. If you are given Navelbine as well as medicines (such as Cisplatin) that affect your bone marrow it may make some of the side effects worse. Pregnancy, breast-feeding and fertility If you are pregnant, think you are pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine because there are potential risks for the infant. You should not breast-feed if you are given Navelbine. If you are a woman of child-bearing potential, you must use an effective contraception (birth control) during treatment and for 7 months after the end of treatment. If you are a man being treated with Navelbine, you are advised not to father a child during treatment and for 4 months after the end of treatment, and to seek advice on conservation of sperm prior to treatment because Navelbine may alter your fertility. You must use an effective contraception during treatment and for 4 months after the end of treatment. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
However, as in all cases you should not drive if you feel unwell or if your doctor has advised you not to drive. 3.
How to take it
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 determine the dose you should receive, how often and for how long. 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 are given more Navelbine than you should Your dose of Navelbine is carefully monitored and checked by your doctor and pharmacist. However, 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. Immediately contact your doctor, while you are being given Navelbine, if you develop any of the following symptoms:
- A chest pain, breathlessness and fainting, which can be a symptom of a clot in a blood vessel in the lungs (pulmonary embolism).
- Headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as posterior reversible encephalopathy syndrome.
- Cough, fever and chills which may be signs of a major infection or a general infection (septicemia) that can be severe.
- Severe constipation with abdominal pain when your bowels have not been open for several days.
- Severe dizziness, lightheadedness when you stand up, it may be signs of severely reduced blood pressure.
- Severe chest pain which is not normal for you, the symptoms may be due to disturbance in your heart function following insufficient blood flow, so called ischemic heart disease such as for example angina pectoris and myocardial infarction (sometimes with fatal outcome).
- Difficulty in breathing, which may be the symptom of a condition known as acute respiratory distress syndrome and can be severe and life-threatening.
–
Dizziness, decreased blood pressure, rash affecting your whole body, or swelling of the eyelids, face, lips or throat which may be signs of an allergic reaction.
Very common side effects (may affect more than 1 in 10 people) Nausea; vomiting, constipation A decrease in red blood cells which can make the skin pale and cause weakness or breathlessness A decrease in white blood cells which makes you more vulnerable to infection Weakness of lower extremities Loss of some reflex reactions, occasionally difference in the perception of touch Hair loss, normally not severe for long treatment Inflammation or sores in the mouth or throat Reactions at the site where NAVELBINE was administered such as redness, burning pain, vein discoloration, inflammation of the veins Liver disorders (abnormal liver test). Common side effects (may affect up to 1 in 10 people): A decrease in platelets which can increase the risk of bleeding or bruising Joint pain Jaw pain Muscle pain Tiredness (asthenia, fatigue) Fever Pain at different sites in your body such as chest pain and pain where your tumour is Diarrhoea Infections at different sites. Uncommon side effects (may affect up to 1 in 100 people): Severe difficulties with your body movements and sense of touch Dizziness Sudden feeling of heat and skin redness of the face and neck Feeling cold in the hands and feet Difficulty in breathing or wheezing (dyspnoea and bronchospasm) Blood infection (sepsis) with symptoms such as high fever and deterioration in general health High blood pressure. Rare side effects (may affect up to 1 in 1 000 people): Heart attack (ischemic heart disease, angina pectoris, myocardial infarction, sometimes fatal) Lung toxicity (inflammation and fibrosis, sometimes fatal) Severe abdominal and back pain (inflammation in pancreas) Low blood levels of sodium in your blood (which can cause symptoms of tiredness, confusion, muscle twitching and unconsciousness) Ulcers at the injection site where the NAVELBINE was given (local necrosis) Skin rashes on your body such as rashes and eruptions (generalized cutaneous reactions).
Very rare side effects (may affect up to 1 in 10 000 people) Irregular heartbeat (tachycardia), palpitations, heart rhythm disorders. Not known: frequency cannot be estimated from the available data Abdominal pain, gastrointestinal bleeding Heart failure which can cause shortness of breath and ankle swelling Redness of hands and feet (erythema) 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) Lack of muscle control may be associated with abnormal gait, speech changes and abnormalities in eyes movement (ataxia) Headache Chills with fever Cough Loss of appetite Weight loss Darker colour of skin that follows the path of veins. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme; website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
Navelbine Keep out of the sight and reach 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. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. Navelbine will be diluted and stored by hospital staff. 6.
Contents of the pack and other information
What Navelbine contains • The active substance is Vinorelbine (as tartrate). Each 1 ml of solution contains 10 mg of vinorelbine. •
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 1 ml, 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 Fareva Pau Fareva Pau 1 Avenue du Béarn 64320 Idron FRANCE
For any information on this product 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, call, free of charge: 0800 198 5000 (UK only): 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 12/2023
——————————————————————————————————————————–The following information is intended for medical or healthcare professionals only: Below is a summary of information to assist in the preparation and administration of Navelbine 10mg/ml concentrate for solution for infusion. The preparation and administration of Navelbine should be carried out by trained staff and as with all cytotoxic agents, precautions should be taken to avoid exposing staff during pregnancy. PREPARATION GUIDE NAVELBINE 10mg/ml concentrate for solution for infusion Vinorelbine (as tartrate) Read this guide prior to the preparation and administration of Navelbine
1.
PRESENTATION
Navelbine is a concentrate for solution for infusion. It is a clear colourless to pale yellow solution with a pH of 3.3 – 3.8 in clear glass vials containing 10 mg per 1 ml, 40 mg per 4 ml and 50 mg per 5 ml of vinorelbine (as tartrate). These are supplied in boxes containing 10 vials.
2.
RECOMMENDATION FOR SAFE HANDLING
Procedures for proper handling and disposal of anticancer drugs should be considered. As with other cytotoxic compounds, caution should be exercised in handling and preparing the Navelbine solution: •
Suitable eye protection, disposable gloves, face mask and disposable apron should be worn.
•
Eventual spillage or leakage should be mopped up.
•
All contact with the eye should be strictly avoided. Immediate liberal washing of the eye with sodium chloride 9 mg/ml (0.9 %) solution for injection should be undertaken if any contact occurs.
•
On completion, any exposed surface should be thoroughly cleaned and hands and face washed.
Preparation of the solution for infusion For single use only, discard any unused contents Navelbine must be diluted prior to administration in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection.
Navelbine should not be diluted in alkaline solutions as there is a risk of precipitation. After diluting Navelbine in sodium chloride 9 mg/ml (0.9 %) solution for injection or in glucose solution for injection 5%, chemical and physical in-use stability has been demonstrated for 8 days at room temperature (20oC ± 5oC) or in the refrigerator (2oC – 8oC) protected from light, in neutral glass bottle, PVC and vinyl acetate bags. There is no content / container incompatibility between Navelbine and infusion sets with PVC tubing. From a microbiological point of view, the product should be used immediately. If not used immediately, in -use storage times and conditions prior to use are under the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless preparation has taken place in controlled and validated aseptic conditions.
Dosage and instructions for use STRICTLY INTRAVENOUS ADMINISTRATION AFTER APPROPRIATE DILUTION Intra-thecal administration of Navelbine may be fatal. The use of intrathecal route is contra-indicated. •
It is recommended to infuse Navelbine over 6 – 10 minutes after dilution in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection.
•
After administration the vein should be thoroughly flushed with at least 250 ml of saline solution.
•
Navelbine must be given strictly intravenously. It is very important to make sure that the cannula is accurately placed in the vein before starting to infuse Navelbine.
•
If the drug extravasates into the surrounding tissue during the administration considerable local irritation may occur. In this case, the administration should be stopped, the vein flushed with normal saline solution and the remaining dose administered in another vein. The management of any extravasation should be according to local hospital guidelines and policies.
•
Do not infuse concomitantly with another cytotoxic agent. It should be given as the first drug where the patient is treated with combination chemotherapy due to the risk of venous irritation.
Storage Unopened vials should be stored in a refrigerator at a temperature of 2oC – 8oC in the original package in order to protect from light. • The product should not be frozen as this could adversely affect the product. • An expiry date is stated on both the vial and outer box and refers to the last day of that month. • Do not use the product after this date.
Navelbine will be diluted and stored by hospital staff. 3.
PROCEDURE FOR PROPER DISPOSAL
Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic drugs.
4. FURTHER INFORMATION Please refer to SmPC.
Frequently asked questions about Navelbine 10 mg / ml concentrate for solution for infusion
How do I take Navelbine 10 mg / ml concentrate for solution for infusion?
Navelbine 10 mg / ml concentrate for solution for infusion comes as infusion containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Navelbine 10 mg / ml concentrate for solution for infusion?
The active substance in Navelbine 10 mg / ml concentrate for solution for infusion is vinorelbine tartrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Navelbine 10 mg / ml concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Navelbine 10 mg / ml concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: vinorelbine tartrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
- As a single agent or in combination for the first line treatment of stage 3 or 4 non-small cell lung cancer.
- Treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.
4.2. Posology and method of administration
Strictly intravenous administration after appropriate dilution.
Intra-thecal administration of Navelbine may be fatal.
Navelbine must only be administered by the intravenous route as an infusion over 6 – 10 minutes.
Instructions for use and handling: see section 6.6.
Administration
- It is recommended to infuse Navelbine over 6 to 10 minutes after dilution in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection.
- Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.
- The infusion time of 6 to 10 minutes must be followed as the risk of venous irritation is increased if the infusion exposure time is increased.
- It is vital to ensure that the cannula is accurately placed in the vein before starting to infuse Navelbine. If the drug extravasates into the surrounding tissue during the administration considerable local irritation may occur. In this case, the administration should be stopped, the vein flushed with 0.9 % sodium chloride solution and the remaining dose administered in another vein.
The management of any extravasation should be according to local hospital guidelines and policies.
Advanced non-small cell lung cancer and advanced breast cancer
- In monotherapy the usual dose given is 25 - 30 mg/m² once weekly.
- In combination chemotherapy the usual dose (25 - 30 mg/m²) is usually maintained, while the frequency of administration is reduced e.g. day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol.
Administration in the elderly
Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine, (see section 5.2).
Administration in patients with liver insufficiency
The pharmacokinetics of Navelbine is not modified in patients presenting with moderate or severe liver impairment. Nevertheless, as a precautionary measure a reduced dose of 20mg/m2 and close monitoring of haematological parameters is recommended in patients with severe liver impairment, (see sections 4.4, 5.2).
Administration in patients with renal insufficiency
Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Navelbine in patients with renal insufficiency, (see sections 4.4, 5.2).
Administration in children
Safety and efficacy in children have not been established and administration is therefore not recommended, (see section 5.1).
4.3. Contraindications
• Known hypersensitivity to vinorelbine or other vinca alkaloids, or to any of the excipients.
• Neutrophil count < 1500/mm3 or severe infection current or recent (within 2 weeks)
• Platelet count < 100000/mm3
• In combination with yellow fever vaccine, (see section 4.5)
• Lactation, (see section 4.6).
4.4. Special warnings and precautions for use
Special warnings
Navelbine should be administered under the supervision of a physician experienced in the use of chemotherapy.
Since inhibition of the hematopoietic system is the main risk associated with Navelbine, close haematological monitoring should be undertaken during treatment (determination of haemoglobin level and the leucocyte, neutrophil and platelet counts on the day of each new administration).
The dose limiting adverse reaction is mainly neutropenia. This effect is non-cumulative, having its nadir between 7 and 14 days after the administration and is rapidly reversible within 5 to 7 days. If the neutrophil count is below 1500/mm3 and/or the platelet count is below 100000/mm3, then the treatment should be delayed until recovery.
If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out.
Special precautions for use
Special care should be taken when prescribing for patients with history of ischemic heart disease (see section 4.8).
The pharmacokinetics of Navelbine is not modified in patients presenting moderate or severe liver impairment. For dosage adjustment in this specific patient group, see section 4.2.
As there is a low level of renal excretion there is no pharmacokinetic rationale for reducing the dose of Navelbine in patients with impaired kidney function (see section 4.2).
Navelbine should not be given concomitantly with radiotherapy if the treatment field includes the liver.
This product is specifically contra-indicated with yellow fever vaccine and its concomitant use with other live attenuated vaccines is not recommended.
Caution must be exercised when combining Navelbine and strong inhibitors or inducers of CYP3A4 (see section 4.5- Interactions specific to vinorelbine), and its combination with phenytoin (like all cytotoxics) and with itraconazole (like all vinca-alkaloids) is not recommended.
All contact with the eyes should be strictly avoided: there is a risk of severe irritation and even corneal ulceration if the drug is sprayed under pressure. Immediate washing of the eye with sodium chloride 9mg/ml (0.9%) solution for injection should be undertaken if any contact occurs.
Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome (ARDS) occurring with the use of Navelbine intravenous pharmaceutical form has been reported. The mean time to onset of ARDS after vinorelbine administration was one week (range 3 to 8 days).
The infusion must be immediately interrupted in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity.
Interstitial lung disease has been reported more frequently in the Japanese population. Special attention should be exercised for this specific population.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use contraindicated
Yellow fever vaccine: as with all cytotoxics, risk of fatal generalised vaccine disease, (see section 4.3).
Concomitant use not recommended
Live attenuated vaccines: (for yellow fever vaccine, see concomitant use contraindicated) as with all cytotoxics, risk of generalised vaccine disease, possibly fatal. This risk is increased in patients already immunodepressed by their underlying disease. It is recommended to use an inactivated vaccine when one exists (e.g., poliomyelitis), (see section 4.4).
Phenytoin: as with all cytotoxics, risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption by cytotoxic drug or loss of efficacy of the cytotoxic drug due to increased hepatic metabolism by phenytoin.
Itraconazole: as with all vinca-alkaloids, increased neurotoxicity of vinca-alkaloids due to the decrease of their hepatic metabolism.
Concomitant use to take into consideration
Cisplatin: There is no mutual pharmacokinetic interaction when combining Navelbine with cisplatin over several cycles of treatment. However, the incidence of granulocytopenia associated with Navelbine use in combination with cisplatin is higher than associated with Navelbine single agent.
Mitomycin C: risk of bronchospam and dyspnoea are increased, in rare case an interstitial pneumonitis was observed.
Ciclosporin, tacrolimus: excessive immunodepression with risk of lymphoproliferation.
As vinca alkaloids are known substrates for P_glycoprotein, and in the absence of specific study, caution should be exercised when combining Navelbine with strong modulators of this membrane transporter.
The combination of Navelbine with other drugs with known bone marrow toxicity is likely to exacerbate the myelosuppressive adverse effects.
As CYP3A4 is mainly involved in the metabolism of vinorelbine, combination with strong inhibitors of this isoenzyme (e.g., azole antifungals such as ketoconazole and itraconazole) could increase blood concentrations of vinorelbine and combination with strong inducers of this isoenzyme (e.g., rifampicin, phenytoin) could decrease blood concentrations of vinorelbine.
An increased incidence of grade 3/4 neutropenia has been suggested when intravenous vinorelbine and lapatinib were associated in one clinical phase I study. In this study, the recommended dose of intravenous form of vinorelbine in a 3-weekly schedule on day 1 and day 8 was 22.5 mg/m2 when combined with daily lapatinib 1000 mg. This type of combination should be administered with caution.
Anticoagulant treatment: Due to the increase of thrombotic risk in case of tumoural diseases, the use of anticoagulative treatment is frequent. The high intra-individual variability of the coagulability during diseases, and the eventuality of interaction between oral anticoagulants and anticancer chemotherapy required, if it is decided to treat the patient with oral anticoagulants, to increase frequency of the INR (International Normalised Ratio) monitoring.
4.6. Fertility, pregnancy and lactation
Pregnancy:
There are insufficient data available on the use of vinorelbine in pregnant women. Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3). On the basis of the results of animal studies and the pharmacological action of the medicinal product, there is a potential risk of embryonic and foetal abnormalities.
Navelbine should therefore not be used during pregnancy, unless the individual awaited benefit clearly outweighs the potential risks. If pregnancy occurs during treatment, the patient should be informed about the risks for the unborn child and be monitored carefully. The possibility of genetic counselling should be considered.
Women of child-bearing potential / contraception in males and females
Due to the genotoxic potential of vinorelbine (see section 5.3), women of child-bearing potential should use effective contraception during therapy with vinorelbine and for 7 months after treatment.
Men should use effective contraception during treatment with vinorelbine and for 4 months after treatment.
As vinorelbine is genotoxic, genetic counselling is also recommended for those wishing to conceive after therapy.
Lactation:
It is unknown whether Navelbine is excreted in human breast milk. The excretion of Navelbine in milk has not been studied in animal studies. A risk to the suckling child cannot be excluded therefore breast feeding must be discontinued before starting treatment with Navelbine, (see section 4.3).
Fertility:
Men being treated with Navelbine are advised not to father a child during treatment and for 4 months after treatment. Prior to treatment, advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with vinorelbine.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. On the basis of the vinorelbine pharmacodynamic profile, Navelbine is unlikely to impair the ability to drive or operate machinery. However, caution is necessary in patients treated with Navelbine considering some side effects of the drug, (see section 4.8).
4.8. Undesirable effects
Adverse reactions reported as more than isolated cases are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), according to the MedDRA frequency convention and system organ classification.
The most commonly reported adverse drug reactions are bone marrow depression with neutropenia, anaemia, neurologic disorders, gastrointestinal toxicity with nausea, vomiting, stomatitis and constipation, transient elevations of liver function tests, alopecia and local phlebitis.
Additional adverse reactions pooled from Post Marketing experience and clinical trials have been added according to the MedDRA classification with the frequency Not known.
Detailed Adverse reactions information:
Reactions were described using the W.H.O classification (grade 1 = G1; grade 2 = G2; grade 3 = G3; grade 4 = G4; grade 1-4 = G1-4; grade 1-2 = G1-2; grade 3-4 = G3-4).
Infections and infestations
Common:
Infection bacterial, viral or fungal at different localization (respiratory, urinary, GI tract…) mild to moderate and usually reversible with an appropriate treatment.
Uncommon:
Severe sepsis sometimes with other organ failure.
Septicaemia.
Very rare:
Complicated septicaemia and sometimes fatal.
Not known:
Neutropenic sepsis.
Neutropenic infection G3-4.
Blood and lymphatic system disorders
Very Common:
Bone marrow depression resulting mainly in neutropenia (G3: 24.3%; G4: 27.8%), reversible within 5 to 7 days and non-cumulative over time.
Anaemia (G3-4: 7.4%).
Common:
Thrombocytopenia (G3-4: 2.5%) may occur but are seldom severe.
Not known:
Febrile neutropenia.
Pancytopenia.
Leucopenia G1-4.
Immune system disorders
Not known:
Systemic allergic reactions as anaphylaxis, anaphylactic shock or anaphylactoid type reaction.
Endocrine disorders
Not known:
Inappropriate antidiuretic hormone secretion (SIADH).
Metabolism and nutrition disorders
Rare:
Severe hyponatraemia.
Not known:
Anorexia.
Nervous system disorders
Very common:
Neurologic disorders (G 3-4: 2.7%) including loss of deep tendon reflexes.
Weakness of the lower extremities has been reported after a prolonged chemotherapy.
Uncommon:
Severe paraesthesias with sensory and motor symptoms are infrequent. These effects are generally reversible.
Not Known:
Headache
Dizziness
Ataxia
Posterior reversible encephalopathy syndrome
Cardiac disorders
Rare:
Ischemic heart disease (angina pectoris, myocardial infarction sometimes fatal).
Very rare:
Tachycardia, palpitation and heart rhythm disorders.
Not known:
Heart failure.
Vascular disorders
Uncommon:
Arterial hypotension, arterial hypertension, flushing and peripheral coldness.
Rare:
Severe hypotension, collapse.
Respiratory, thoracic and mediastinal disorders
Uncommon:
Dyspnoea and bronchospasm may occur in association with Navelbine treatment as with other vinca alkaloids.
Rare:
Interstitial pneumopathy sometimes fatal has been reported.
Not known:
Cough G1-2.
Acute respiratory distress syndrome sometimes fatal.
Pulmonary embolism
Gastrointestinal disorders
Very Common:
Stomatitis (G1-4: 15% with Navelbine as single agent).
Nausea and vomiting (G 1-2: 30.4% and G 3-4: 2.2%). Anti-emetic therapy may reduce their occurrence.
Constipation is the main symptom (G 3-4: 2.7%) which rarely progresses to paralytic ileus with Navelbine as single agent and (G3-4: 4.1%) with the combination of Navelbine and other chemotherapeutic agents.
Common:
Diarrhoea usually mild to moderate may occur.
Rare:
Paralytic ileus, treatment may be resumed after recovery of normal bowel mobility.
Pancreatitis have been reported.
Not known:
Gastrointestinal bleeding.
Severe diarrhoea.
Abdominal pain.
Hepatobiliary disorders
Very common:
Transient elevations of liver function tests (G 1-2) without clinical symptoms were reported (SGOT in 27.6% and SGPT in 29.3%).
Not known:
Hepatic disorder.
Skin and subcutaneous tissue disorders
Very common:
Alopecia, usually mild in nature, may occur (G3-4: 4.1% with Navelbine as single chemotherapeutic agent).
Rare:
Generalized cutaneous reactions have been reported with Navelbine.
Not known:
Palmar-plantar erythrodysesthesia syndrome.
Skin hyperpigmentation (serpentine supravenous hyperpigmentation).
Musculoskeletal and connective tissue disorders
Common:
Arthralgia including jaw pain and myalgia.
General disorders and administration site conditions
Very common:
Reactions at the injection site may include erythema, burning pain, vein discoloration and local phlebitis (G 3- 4: 3.7% with Navelbine as single chemotherapeutic agent).
Common:
Asthenia, fatigue, fever, pain at different locations including chest pain and pain at the tumour site have been experienced by patients receiving Navelbine therapy.
Rare:
Local necrosis has been observed. Proper positioning of the intravenous needle or catheter and bolus injection followed by liberal flushing of the vein can limit these effects.
Not known:
Chills G1-2
Investigations
Not known:
Weight loss
For the oral formulation of Navelbine the following additional Adverse Drug Reactions were reported: taste disorder, visual impairment, insomnia, dysphagia, oesophagitis, weight gain, dysuria, other genitourinary symptoms.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Overdosage with Navelbine could produce bone marrow hypoplasia sometimes associated with infection, fever and paralytic ileus.
Emergency procedure
General supportive measures together with blood transfusion, growth factors and broad spectrum antibiotic therapy should be instituted as deemed necessary by the physician.
Antidote
There is no known antidote for overdosage of Navelbine.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VINORELBINA TEVA 10 mg/ml prescriptionVINORELBINUM · injection / infusion
- VINORELBINA ACCORD 10 mg/ml prescriptionVINORELBINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- NavelbineVinorelbinum · injection / infusion
- NavirelVinorelbinum · injection / infusion
- NeocitecVinorelbinum · injection / infusion
- Vinorelbine AccordVinorelbinum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Navelbine 10 mg / ml concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.