Vinorelbine 10 Mg/ Ml Concentrate For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using
this medicine because it contains Important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, or pharmacist or nurse.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Vinorelbine is and what it is used for
2. What you need to know before you use Vinorelbine
3. How to use Vinorelbine
4. Possible side effects
5. How to store Vinorelbine
6. Contents of the pack and other information
1. WHAT VINORELBINE IS AND WHAT IT IS USED FOR
Vinorelbine belongs to a family of medicines used to treat cancer called the vinca alkaloid family. Vinorelbine is intended for the treatment of cancer, specifically advanced non small cell lung cancer and advanced breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINORELBINE
You should not be given Vinorelbine
• If you are allergic (hypersensitive) to vinorelbine, other vinca alkaloids, or to any of the other ingredients in the product or to any of the other ingredients in this medicine (listed in section 6.)
• If you are pregnant or think that you might be pregnant
• If you are breast-feeding
• If you are a woman of childbearing potential and are not using effective contraception
• If you have a low neutrophil (a type of white blood cell) count or have (or have recently had) a severe infection
• If you have severe decrease in blood platelets
• In combination with yellow fever vaccine
• If you have a severe liver disease not caused by cancer.
This medicine is strictly for intravenous use only and should not be injected into the spine.
Warnings and precautions
Vinorelbine will be given under the supervision of a doctor.
Before each administration of Vinorelbine, a blood test will be done. If the results are not satisfactory, your treatment may be delayed and further checks made until the results return to normal.
• If you have signs or symptoms that suggest an infection (fever, chills, joint pain, etc.) tell your doctor immediately. Other tests may be needed
• If you have received radiotherapy where the treatment field includes the liver let your doctor know
• All contact with the eye should be strictly avoided: There is a risk of severe irritation and corneal ulceration if eye contact occurs. If any contact with the eye occurs the eye should be immediately washed with saline/salt solution and an ophthalmologist should be contacted
• If you have a history of ischaemic heart disease you should tell your doctor before you receive this medicine
VINORELBINE 10 mg/ml-concentrate for solution for infusion
PLEASE DETACH BEFORE HANDING ABOVE
SECTION TO THE PATIENT
INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of information to assist in the administration of Vinorelbine. You should be experienced in the handling and use of cytotoxic agents and be familiar with the SPC for Vinorelbine. Reference should be made to guidelines on the safe handling of antineoplastic agents.
Preparation of Infusion
Vinorelbine 10 mg/ml concentrate for solution for infusion has a more or less yellow colouration which does not affect the quality of the product.
Handling guidelines: The preparation and administration of Vinorelbine 10 mg/ml concentrate for solution for infusion should be carried out only by trained staff and as with all cytotoxic agents, precautions should be taken to avoid exposing staff to Vinorelbine during pregnancy.
Preparation of solution for administration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.
• If you have impaired liver function
• If you need a vaccination. You should inform your doctor of the treatment before any vaccination
• If you receive a cancer medicine named Mitomycin C.
Men and women who are treated with Vinorelbine should use effective contraception during treatment. Men and women should BOTH read the information in the Pregnancy and Breast-feeding and Fertility section below.
Other medicines and Vinorelbine
Tell your doctor, or pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
This is especially important if you are using any of the medicines below:
• Other medicines which can affect the bone marrow e.g. cancer medicines
• Carbamazepine, phenytoin and phenobarbital (medicines for the treatment of epilepsy)
• Antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
• St John's Wort (Hypericum perforatum)
• Ketoconazole and itraconazole (medicines for the treatment of fungal infections)
• Antiviral medicines to treat HIV-infection e.g. ritonavir (HIV protease inhibitors)
• Nefazodone (a medicines used for the treatment of depression)
• Cyclosporine and tacrolimus (medicines which decrease the activity of the immune system)
• Other medicines for the treatment of cancer e.g. mitomycin C, cisplatin
• Blood thinning medicines e.g. warfarin
• Yellow fever vaccine and other live vaccines.
Pregnancy and breast-feeding
Vinorelbine should not be given to pregnant women, because it can cause serious birth defects.
If you are pregnant, think you may be pregnant or become pregnant, tell your doctor immediately. You should not receive Vinorelbine during pregnancy. Women of childbearing potential must use effective contraception whilst receiving treatment and for 3 months after treatment has finished.
You should not breast-feed while you are being treated with Vinorelbine. Do not restart breast-feeding until your doctor tells you it is safe to do so.
Fertility
If you are a man, you should avoid fathering a child during treatment with Vinorelbine and for 6 months after treatment has stopped. There is also a risk that treatment with Vinorelbine will lead to male infertility and you may wish to seek advice about sperm storage before treatment starts.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery. However, if you think you are affected you should not drive or operate machinery until you feel better.
3. HOW TO USE VINORELBINE
Vinorelbine will always be given by a healthcare professional.
Vinorelbine is always administered intravenously after appropriate dilution. ^
Suitable eye protection, disposable gloves, face mask and disposable apron should be worn.
Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).
Eventual spillage or leakage should be mopped up wearing protective gloves. All contact with the eye should be strictly avoided: risk of severe irritation and even corneal ulceration if the drug is sprayed underpressure. Immediate liberal washing of the eye with 0.9% Sodium Chloride solution should be undertaken if any contact occurs. On completion, any exposed surface should be thoroughly cleaned and hands and face washed.
Vinorelbine 10 mg/ml concentrate for solution for infusion may be administered by slow bolus (5-10 minutes) after dilution in 20-50 ml of 0.9% Sodium Chloride solution or by a short infusion (20-30 minutes) after dilution in 125 ml of 0.9% Sodium Chloride solution.
Administration should always be followed by a 0.9% Sodium Chloride infusion to flush the vein.
Vinorelbine 10 mg/ml concentrate for solution for infusion must only be given intravenously: it is very important to make sure that the cannula is accurately placed in the vein before starting to infuse the solution.
Adults:
Vinorelbine is usually given once a week at the rate of 25-30mg/m2 per week.
,lt may be by injection over a 5 to 10 minute period or by infusion over 20 to 30 minutes.
kfter being given the drug your vein will be flushed .with an isotonic solution so that the drug is dispersed.
.In combination chemotherapy the usual dose is 25-Q0mg/m2. The frequency of administration is reduced. .This may be for example day 1 and 5, every 3 weeks'
.Patients with impaired liver function:
For patients with impaired liver function the dose may .be reduced.
.Children:
Vinorelbine is not recommended for use by children .younger than 18 years.
.Your doctor will perform regular tests to monitor your medical condition during your treatment and before each administration of Vinorelbine.
If you are given too much Vinorelbine
Your dose will be carefully calculated by the doctors and administered by trained staff so overdose is lunlikely.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Vinorelbine can cause side effects, ^although not everybody gets them.
Definition of frequency:
k/ery common: likely to affect more than 1 of every 10 people.
ICommon: likely to affect more than 1 of every 100 but less than 1 of every 10 people.
Illncommon: likely to affect more than 1 of every 1,000 but less than 1 of every 100 people.
|Rare: likely to affect more than 1 of every 10,000 but
less than 1 of every 1,000 people.
k/ery rare: likely to affect less than 1 of every 10,000
people.
frequency not known: the frequency has not been established.
Serious side effects - if any of the following side Effects occur, immediately contact your doctor:
Uncommon: Shortness of breath, narrowing of the Airways (bronchospasm).
Rare: Chest pain which may spread to the back of ^our neck and arm, due to lack of blood supply to the heart (angina pectoris). Heart attack (myocardial |infarction), Lung disease.
Not known: Widespread and very serious allergic (reactions. Symptoms may include sudden wheezing, swelling of your lips, tongue and throat or body, (difficulties to swallow, rash, light-headedness, fainting (anaphylaxis/anaphylactic shock/anaphylactoid Reaction).
These are very serious side effects. You may need (immediate medical care.
Other side effects - if any of the following side ^ffects occur, contact your doctor as soon as possible:
(Very common: Low count of white blood cells, which may increase the risk of infection. Low count of red (blood cells (anaemia), which may make you feel tired. Inflammation of the mouth or the gullet. Nausea and ^omiting. Constipation. Hair loss. Oedema, tenderness, pain and/or rash on the injection site, ^bnormal results of liver function tests. Loss of deep tendon reflexes. Weakness of the lower extremities. Common: Pain in muscles and joints, including jaw pain. Changes in kidney function (increased creatinine values). Symptoms of infection e.g. fever, pain. Diarrhoea. Low count of blood platelets (risk of bleeding). Weakness, fatigue, fever, pain in different locations.
iUncommon: Severe infections or blood poisoning. Severe numbness (paraesthesia). Low blood pressure, high blood pressure, flushing and peripheral
If the drug extravasates during intravenous administration, a substantial local reaction may occur. In this case, the injection should be stopped and the rest of (the dose should be administered in another vein.
Disposal guidelines: all sharps should be placed in an appropriate container and all other disposable items and cleaning materials in a sealed plastic bag which should be incinerated with other clinical waste.
k/Vaste material may be disposed of by incineration. Any unused product or waste material should be disposed of in accordance with local requirements.
Administration and Dosage
Strictly by intravenous injection through an infusion line: FATAL if given by other routes.
The use of intrathecal route is contra-indicated.
\ln adults:
Vinorelbine 10 mg/ml concentrate for solution for infusion (is usually given at 25-30mg/m2 weekly.
Vinorelbine 10 mg/ml concentrate for solution for infusion may be administered by slow bolus (5-10 minutes) after dilution in 20-50 ml of 0.9% Sodium Chloride solution or .by a short infusion (20-30 minutes) after dilution in 125 ml of 0.9% Sodium Chloride solution.
Administration should always be followed by a 0.9% podium Chloride infusion to flush the vein.
Rare: Inflammation of the pancreas.
Paralytic intestinal blockage (ileus). Low
levels of sodium in the blood. Changes in
the activity of the heart (ECG changes). I
Injection site necrosis. Seriously low blood
pressure or collapse. Skin reactions such
as rash, itch and hives. Lung disease m
Very rare: Guillain-Barris syndrome
(inflammation in peripheral nerves which
may cause weakness). Blood poisoning
which may be life threatening. Strong heartbeat, rapid
heartbeat, heart rhythm disorders.
Not known: SIADH syndrome, which may include symptoms of increased weight. Decreased appetite (anorexia). Redness (erythema) of hands and feet.
As with other vinca-alkaloids vinorelbine is a moderate blister agent.
As changes in the blood may occur, your doctor may order blood samples to be taken to control this (low count of white blood cells, anaemia and/or low count of blood platelets, influence on the liver- or kidney function and the electrolyte balance in your body).
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE VINORELBINE
This medicine will be stored in the pharmacy and made up in a special area before the doctor or nurse gives it to you.
It will be stored in a refrigerator (2°C - 8°C).
The vial should be kept in the outer carton in order to protect from light.
An expiry date is given on the outer carton and the vial label. It should not be used after this date.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vinorelbine contains
Each ml of concentrate for solution for infusion contains 10 mg of vinorelbine base equivalent to 13.85 mg of vinorelbine tartrate.
The other ingredient is water for injections.
What Vinorelbine looks like and contents of the pack
Vinorelbine 10 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellow solution.
Each 1 ml vial contains a total content of 10mg Vinorelbine (as tartrate).
Each 5 ml vial contains a total content of 50mg Vinorelbine (as tartrate).
Vinorelbine 10 mg/ml concentrate for solution for infusion has to be diluted before being given to you.
Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
S.C. SINDAN PHARMA S.R.L.
11th Ion Mihalache Blvd, 011171 Bucharest, Romania
This leaflet was revised in October 2013
Dose modifications:
In patients with massive liver metastases (i.e. >75% of i liver volume replaced by the tumour), it is empirically ' suggested that the dose be reduced by 1/3 and the , haematological toxicity closely followed-up.
There is no pharmacokinetic rationale for reducing vinorelbine dose in patients with impaired kidney function.
The dose limiting toxicity of vinorelbine is mainly neutropenia. If the neutrophil count is <2000/mm3 and/or i platelet number is <75000/mm3, then the treatment ' should be delayed until recovery. Drug administration is . expected to be delayed by 1 week in about 35% of treatment courses.
Storage
Store in a refrigerator (2°C - 8°C). Keep the vial in the outer] carton in orderto protect from light. Do not freeze.
The physicochemical and microbiological stability of thJ drug product after dilution in the recommended solutions for infusion has been demonstrated for 24 hours at 2-8°C.I From the microbiological point of view, the product must be used immediately after dilution. Other in-use time periods] and other in-use storage conditions are the responsibility of the user.
An expiry date is given on the outer carton and vial label i of the product. It should not be used after this date. I