Vincristine Sulphate 1mg/Ml Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vincristine Sulphate 1 mg/ml Injection
(5 mg/5 ml vial)
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 any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Vincristine Sulphate Injection is and what it is used for
2. Before you use Vincristine Sulphate Injection
3. How to use Vincristine Sulphate Inj ection
4. Possible side effects
5. How to store Vincristine Sulphate Injection
6. Further information
1. WHAT VINCRISTINE SULPHATE INJECTION IS AND WHAT IT IS USED FOR
Vincristine sulphate is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Vincristine Sulphate Injection is used in the treatment of cancers of the blood (eg. leukaemia or lymphomas), breast, head and neck or lung. It may be used to treat multiple myeloma (a cancer of plasma cells) and it may also be used in the treatment of some cancers in children. It may be used in a blood disorder known as idiopathic thrombocytopenic purpura (ITP) after other treatments have not been successful.
Vincristine Sulphate Injection may be given alone or in combination with other anticancer medicines.
2. BEFORE YOU USE VINCRISTINE SULPHATE INJECTION
Vincristine Sulphate Injection must never be injected intrathecally (into the spine).
Do not use Vincristine Sulphate Injection
• if you have shown signs of hypersensitivity (severe allergy) to vincristine, benzyl alcohol or mannitol in the past
• if you have Charcot-Marie-Tooth syndrome (disease which causes weakness in the leg muscles)
• if you have an infection that is not being treated
Tell your doctor if any of the above applies to you before this medicine is used.
Premature babies or babies less than 4 weeks old must not receive Vincristine Sulphate Injection 5 mg/5 ml (see ‘Important information about one of the ingredients of Vincristine Sulphate Injection’ below).
Take special care with Vincristine Sulphate Injection
• to make sure that this medicine is only given to you through a vein (it should not be given by any other route). If you notice any pain during, or soon after the injection is given, tell your doctor or nurse immediately
• if you have a mental or nervous system disorder
• if you have liver trouble
• if you have kidney cancer
• if you are having radiotherapy
• if you have breathing problems
• if you have a low white blood cell count, measured on blood test
• if you have an infection
Tell your doctor if any of the above applies to you before this medicine is used.
Special care is also needed if this medicine is given to the elderly or children between 4 weeks and 3 years old.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with vincristine sulphate.
Use of the following medicines may make the side effects of vincristine sulphate worse:
• isoniazid (medicine used to treat tuberculosis)
• mitomycin-C (anti-cancer medicine)
• itraconazole (a medicine used to treat fungal infections)
• L-asparaginase (used for treating some types of cancer)
• dactinomycin (used for treating some types of cancer)
• some anti-cancer drugs (eg containing platinum) that may cause problems with hearing or balance
• medicines which cause problems with passing water (urine). These should be stopped before you start treatment with vincristine
• medicines which cause problems with your nervous system e.g. walking difficulties, pins and needle or numbness
Phenytoin (medicine used to control fits) may not work as well when vincristine sulphate is used, so blood levels of phenytoin will need to be monitored.
Methotrexate used in the treatment of cancer may work better when used with vincristine.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.
Women of childbearing potential should use appropriate contraception methods during treatment with vincristine sulphate.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
Important information about one of the ingredients of Vincristine Sulphate Injection
This medicine contains benzyl alcohol. This means that this medicine must not be given to premature babies or neonates. It may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Vincristine Sulphate Injection contains Latex
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
3. HOW TO USE VINCRISTINE SULPHATE INJECTION
This medicine is given by infusion (drip) into a vein.
Vincristine sulphate is an irritant, if it accidentally gets into your eye tell your doctor or nurse immediately so that it may be washed out.
You may be given medicines to prevent constipation during treatment with vincristine sulphate.
Dosage
Your doctor will work out the correct dose of vincristine sulphate for you and how often it must be given.
The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using a blood sample.
Vincristine sulphate is usually given once a week.
If you are given too much or too little Vincristine Sulphate Injection
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines, vincristine sulphate can have side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
• pain or swelling at the injection site during or immediately after the injection
• severe chest pains possibly radiating to the jaw or arm, sweating, breathlessness and nausea
• severe breathing problems or shortness of breath
These are serious side effects. You may need urgent medical attention. All of these serious side effects are rare.
If any of the following happen, tell your doctor as soon as possible:
• convulsions (fits)
• deafness or hearing loss
• worsening eyesight
• pain (may involve the jaw, throat, neck, bones or muscles)
• dizziness
• fever, sore throat, skin rashes, or sores on your body and mouth ulcers (may indicate a drop in white blood cells)
• significant weight loss
• numbness or pins and needles
• difficulty in walking
• muscle weakness or muscle wasting
• difficulty with speech
• unusual eye movements
• problems with passing water (more or less urine than normal, or pain when passing urine)
• mild breathing problems
• raised or lowered blood pressure
• headache
• tiredness
• unexpected bruises
• stomach cramps, constipation or diarrhoea
• being sick or feeling sick
• hair loss
• missed periods
soreness around the injection site after the injection
Vincristine sulphate may lead to changes in your blood cells. Your doctor may take blood samples to monitor for these and also to check how well your liver is working.
There have been reports of other malignancies (cancers) occurring at a later date after vincristine has been used in combination with other anti-cancer drugs. This happens rarely.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Effects on fertility
Treatment with vincristine sulphate may permanently reduce fertility in men and women. Tell your doctor if you have concerns.
5. HOW TO STORE VINCRISTINE SULPHATE INJECTION
Keep out of the reach and sight of children Expiry
This medicine must not be used after the expiry date which is stated on the vial label and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
Store in a refrigerator (2°C - 8 °C). The vials should be kept in the outer carton, in order to protect from light.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Vincristine Sulphate Injection contains
The active substance is vincristine sulphate. Each millilitre (ml) of solution contains 1 milligram (mg) of vincristine sulphate.
The other ingredients are mannitol, benzyl alcohol and Water for Injections.
What Vincristine Sulphate Injection looks like and contents of the pack Vincristine Sulphate Injection is a colourless solution which comes in glass containers called vials.
It may be supplied in packs containing 5 x 5 mg/5 ml vials.
Marketing authorisation holder and manufacturer responsible for batch release in Europe
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Manufacturer
Hospira Australia Pty Ltd,1-5, 7-23 and 25-39 Lexia Place, MULGRAVE VIC 3170, Australia
This leaflet was last revised in April 2016
Vincristine Sulphate 1 mg/ml Injection The following information is intended for medical or healthcare professionals
only
Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Vincristine Sulphate Injection should not be mixed with any other drug and should not be diluted in solutions that raise or lower the pH outside the range 3.5 to 5.5. Furosemide both in syringe and injected sequentially into Y-site with no flush between, results in immediate precipitation.
Instructions for use preparation is for intravenous use only. Fatal if given by any other route.
It should only be administered by individuals experienced in vincristine administration.
It is recommended to infuse vincristine sulphate over 5 to 10minutes after dilution in a 50 ml infusion bag with Sodium Chloride 9 mg/ml (0.9%) Solution for Injection.
After administration the vein must be flushed through thoroughly.
Care should be taken to avoid extravasation. If leakage into surrounding tissue should occur it may cause considerable irritation. The injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage may help to disperse the drug and are thought to minimise discomfort and the possibility of cellulitis.
Cytotoxic Handling Guidelines
Administration: Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.
Preparation: Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of preparation.
Operations such as reconstitution of powder and transfer to syringes should be carried out only in the designated area.
The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.
Pregnant personnel are advised not to handle chemotherapeutic agents.
Contamination: In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of skin. Medical advice should be sought if the eyes are affected.
In the event of spillage, operators should put on gloves and mop the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and then seal it.
Disposal: Syringes, containers, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated.
The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.