Vinorelbine 10 Mg/Ml Concentrate For Solution For Infusion
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.
•
doctor, or pharmacist or nurse.
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 •
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.)
•
pregnant
are not using effective contraception
cell) count or have (or have recently had) a severe infection
•
• 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 ofa doctor.
Before each administration ofVinorelbine, 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.
•
infection (fever, chills, joint pain, etc.) tell your doctor immediately. Other tests may be needed
•
treatment field includes the liver let your doctor know
•
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
•
you should tell your doctor before you receive this medicine
• 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.
• If you are of Japanese origin, as you may be more vulnerable for lung problems during treatment with Vinorelbine.
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 offungal 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, lapatinib
• Blood thinning medicines e.g. warfarin, lapatinib
• 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 treatmentwith 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
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 ofVinorelbine. You should be experienced in the handling and use ofcytotoxic agents and be familiarwith the SPCforVinorelbine. 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 ofVinorelbine 10 mg/ml concentratefor 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 ofsolution foradministration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.
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 ifthedrug 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 forsolution 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.
Vinorelbine is always administered intravenously pfter appropriate dilution.
Adults:
Vinorelbine is usually given once a week at the rate of 25-30mg/m2 per week.
lit may be by injection over a5to 10 minute period or py infusion over 20 to 30 minutes.
After being given the drug yourvein will be flushed with an isotonic solution so that the drug is dispersed.
Iln combination chemotherapy the usual dose is 25-30mg/m2. The frequency of administration is reduced. This may be for example day 1 and 5, every 3 weeks'
Ipatientswith impaired liverfunction:
.For patients with impaired liverfunction the dose may be reduced.
bhildren:
Vinorelbine is not recommended for use by children younger than 18 years.
^our doctor will perform regular tests to monitor your medical condition during yourtreatment and before each administration ofVinorelbine.
Ilfyou are given too much Vinorelbine
Your dose will be carefully calculated by the doctors and administered by trained staff so overdose is unlikely.
4. POSSIBLESIDEEFFECTS
Like all medicines, Vinorelbine can cause side effects, Although not everybody gets them.
iDefinition offrequency:
Very common: likely to affect more than 1 ofevery 10
Ipeople.
Common: likely to affect more than 1 of every 100 but less than 1 ofevery 10 people.
Uncommon: likely to affect more than 1 ofevery 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.
Very rare: likely to affect less than 1 of every 10,000
Ipeople.
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 your 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, ^welling ofyour 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 effects occur, contact your doctor as soon as [possible:
Very common: Low count of white blood cells, which pay increase the risk of infection. Low count of red blood cells (anaemia), which may make you feel tired. [Inflammation ofthe mouth or the gullet. Nausea and vomiting. Constipation. Hairloss. Oedema, tenderness, pain and/or rash on the injection site. Abnormal results ofliverfunction tests. Loss ofdeep 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.
Uncommon: Severe infections or blood I _
poisoning. Severe numbness (paraesthesia). Low blood pressure, high blood pressure, flushing and peripheral coldness.
Rare: Inflammation of the pancreas.
Paralytic intestinal blockage (ileus). Low | M
levelsofsodiumintheblood.Changesin
the activity of the heart (ECG changes). i
Injection site necrosis. Seriously low blood I
pressure or collapse. Skin reactions such
as rash, itch and hives. Lung disease
(interstitial pneumopathy).
Veryrare: 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 othervinca-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 ofwhite blood cells, a reduction in the number of both red and white blood cells - pancytopenia, 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. CONTENTSOFTHEPACKANDOTHER INFORMATION
What Vinorelbine contains
Each ml of concentrate for solution for infusion contains 10 mg ofvinorelbine base equivalent to 13.85 mg ofvinorelbine 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,
RiversideWay, Dartford, DA1 5BS, UK.
Manufacturer:
S.C. SINDAN PHARMA S.R.L.
11th Ion Mihalache Blvd, 011171 Bucharest, Romania
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 anothervein.
pisposalguidelines: 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.
^aste material may be disposed of by incineration.
Any unused product orwaste material should be ^isposed 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.
|/n 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 ofO.9% Sodium Chloride solution or by a short infusion (20-30 minutes) after dilution in 125 ml ofO.9% Sodium Chloride solution.
Administration should always be followed by a 0.9% |Sodium Chloride infusion to flush the vein.
Dose modifications:
suggested that the dose be reduced by 1/3 and the ,
haematological toxicity closely followed-up.
The dose limiting toxicity ofvinorelbine is mainly neutropenia. If the neutrophil count is <2000/mm3 and/or i platelet number is <75000/mm3, then the treatment I 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 protectfrom light. Do notfreeze.
The physicochemical and microbiological stability of the drug product after dilution in the recommended solutions, for infusion has been demonstrated for 24 hours at 2-8°C.| 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
Please refer to the SPC for further information.