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VINCRISTINE SULFATE SOLUTION FOR INJECTION

Active substance(s): VINCRISTINE SULFATE / VINCRISTINE SULFATE

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Hepatic impairment
In patients with hepatic impairment or with a
direct serum bilirubin value above
3 mg/100 ml a reduction of 50% of the dose
of vincristine sulfate is recommended.
Because of the hepatic metabolism and
biliary excretion of vincristine, reduced doses

Elderly
The normal adult dose is still appropriate
in the elderly

Posology
Extreme care must be used in calculating and
administering the dose to be injected,
because overdose can have severe and even
fatal results. When used as monotherapy,
the dose should be administered at 1 week
intervals. In combination with other
antineoplastic agents, the dosing frequency
depends on the protocol.
The usual dose for adults is 1.4 mg/m²
(maximum of 2 mg) once a week.
Children can tolerate a higher dose:
1.5-2.0 mg/m² once per week. For children
weighing 10 kg or less, the usual starting
dose is 0.05 mg/kg once a week.

VINCRISTINE SULFATE SHOULD ONLY BE
ADMINISTERED INTRAVENOUSLY. FATAL IF
GIVEN BY OTHER ROUTES

4. Posology and method of administration

Clear colourless solution or slightly yellow
solution, free of particles other than gas
bubbles.
The pH is 3.5 – 5.5 and osmolality is
approximately 600 mOsm/l.

Solution for injection.

3. PHARMACEUTICAL FORM

For a full list of excipients, see section 5.

1 ml of solution contains 1 mg vincristine
sulfate

Each vial of 1 ml contains 1 mg of Vincristine
sulfate.
Each vial of 2 ml contains 2 mg of Vincristine
sulfate.
Each vial of 5 ml contains 5 mg of Vincristine
sulfate.

2. QUALITATIVE AND QUANTITATIVE
COMPOSITION

Vincristine sulfate, solution for injection
1 mg/ml.

1. NAME OF THE MEDICINAL PRODUCT

The following information is intended for
medical or healthcare professionals only:

(Please note this is a Prescriber Information
Leaflet NOT the SPC. For full details
regarding this product please refer to the
SPC.)

PREPARATION GUIDE FOR USE WITH
VINCRISTINE SULFATE,
SOLUTION FOR INJECTION
1MG/ML

93.134.016-D

From a microbiological point of view, the
diluted solution should be used immediately.
If not used immediately, in-use storage times

After dilution
Chemical and physical in-use stability of the
solution prepared for injection or infusion
has been demonstrated for 48 hours at
2-8 ºC or 24 hours at 15 to 25 °C when
diluted to a concentration range of
0.01 mg/ml to 0.1 mg/ml in 9 mg/ml (0.9%)
sodium chloride solution for infusion or in
50 mg/ml (5%) glucose solution for infusion.

Vial before opening
24 months

7. Shelf life

In the absence of compatibility studies, this
medicinal product must not be mixed with
other medicinal products.

6. Incompatibilities

Mannitol.
Sulfuric acid (for pH adjustment).
Sodium hydroxide (for pH adjustment).
Water for injections.

5. List of excipients

The dose should not be increased beyond the
level which produces therapeutic benefit. In
general, individual doses should not exceed 2
mg; and white cell counts should be carried
out before and after giving each dose.

Intrathecal administration of vincristine
results in fatal neurotoxicity. Vincristine
sulfate can be administered intravenously via
an infusion or as a bolus injection of at least
1 minute via the line of a running infusion.
Caution: it is extremely important that the
needle be properly positioned in the vein
before any drug is injected.
Care should be taken to avoid infiltration of
subcutaneous tissues. Extravasation during
intravenous administration of vincristine
sulfate can cause considerable irritation. In
order to prevent vascular irritation, the vein
should be flushed well after the
administration of vincristine sulfate.
The dose of vincristine sulfate should be
calculated and administered with extreme
care, because overdose can have severe and
even fatal results.

Method of administration
Vincristine sulfate should only be used under
strict supervision of physicians experienced in
the treatment with cytotoxic products.

In case of severe neurotoxicity, vincristine
sulfate should not be administered,
particularly in case of paresis. When the
complaints decrease after discontinuation of
the administration of vincristine sulfate, the
treatment may be resumed with 50% of the
dose.

are recommended in patients with
obstructive jaundice or other hepatic
impairment. Patients with liver disease
sufficient to decrease biliary excretion may
experience an increase in the severity of side
effects.

Use
Vincristine sulfate is usually used together
with other medicines to treat:
• acute lymphocytic leukaemia, which is a
fast-growing cancer in which the body
produces a large number of immature
white blood cells
• Hodgkin's disease, which is a cancer of
the lymphatic vessel system
• non-Hodgkin's lymphoma, which is a
cancer of the lymph nodes not due to
Hodgkin's disease
• lung cancer (small cell)
• rhabdomyosarcoma, which is a cancer of
the muscles
• Ewing's sarcoma, which is a type of bone
cancer
• haematomas (internal bleeding) with
reduced number of platelets (idiopathic
thrombocytopenic purpura)
• cancer of the adrenal medulla (part of the
adrenal gland)
• primitive neuro-ectodermal tumour, which
is a cancer of part of the nervous system
• Wilms' tumour, which is a type of kidney
cancer
• breast cancer that has spread to other
parts of the body
• multiple myeloma , which is a cancer of
cells of the immune system
• retinoblastoma , which is a type of cancer
of the eye.

Medicinal product group
Vincristine sulfate belongs to a group of
medicines called anti-mitotic cytostatics.
These medicines inhibit the growth of cancer
cells.

what it is used for

1 What Vincristine sulfate is and

1. What Vincristine sulfate is and what it is
used for
2. What you need to know before you use
Vincristine sulfate
3. How to use Vincristine sulfate
4. Possible side effects
5. How to store Vincristine sulfate
6. Contents of the pack and other
information

What is in this leaflet:

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 any further questions, please
ask your doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

Vincristine sulfate,
solution for injection 1 mg/ml
Vincristine sulfate

Other medicines and Vincristine
Attention:The following remarks can
apply to medicines you are currently
taking, or that you have used in the past
few weeks, or you may start to take in the
weeks following your treatment with
Vincristine sulfate .
The medicines mentioned in this section
may be known to you under a different
name, often the brand name. In this
section only the name of the active
ingredient or group of active ingredients
of the medicine is mentioned and not the
brand name. Check on the package or

You should avoid contact of vincristine
sulfate with the eyes. If vincristine does
get in the eye, you should immediately
flush the eyes with a lot of water and
consult your doctor if irritation persists.
Consult your doctor if one of the warnings
mentioned below is applicable to you, or
has been in the past:
• if you suffer from disorders of the
nervous system
• if your liver does not function very well,
see also section “Dosage and method of
use”
• if you are taking any medicines that can
be harmful to the nervous system; your
doctor will monitor you carefully during
treatment
• if you become constipated due to the
treatment; your doctor will take
measures to prevent constipation, such as
an adjusted diet or the use of products
that improve bowel movements
(laxatives, in particular lactulose)
• if you suffer from cardiac disorders such
as ischaemic heart disorders (heart and
blood circulation problems)
• if you have or develop an infection; tell
your doctor if this happens
• if you are sexually active; during the
treatment and for 6 months after the
discontinuation of the treatment both
you and your partner should take
precautions to prevent pregnancy.

Vincristine sulfate should only be
administered intravenously (via the vein)
and not by any other route. Other routes
of administration may be fatal.

Warnings and precautions
Vincristine sulfate should only be used
under strict supervision of doctors
experienced in the treatment with
cytostatics (medicines to treat cancer)

Do not use Vincristine sulfate if:
• you are allergic (hypersensitive) to
vincristine sulfate or any of the other
ingredients of this medicine (listed in
section 6),
• you suffer from a disorder of the nerves
and muscles called Charcot-Marie-Tooth
syndrome
• your liver function is severely impaired
• you are suffering from constipation or
are at risk of blockage of the intestines
(ileus), especially in children
• you are being treated with radiotherapy
on your liver.

you use Vincristine sulfate

2 What you need to know before

231-30-86622-M LEA VINCRISTINE 1mg/ml SOL FOR INJ TEVAH
PACKAGE LEAFLET: INFORMATION FOR THE USER

TEVA UK Ref:

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1
15 March 2016

When medicines are used together, they
can sometimes influence each other’s
action and/or side effects; this is called an
interaction.
An interaction can occur when this
medicine is used together with:
• certain medicines that inhibit liver
enzymes, for example ritonavir (used to
treat HIV), nelfinavir (used to treat
HIV), ketoconazole (used to treat
fungal infections), itraconazole (used to
treat fungal infections), erythromycin
(used to treat infections) and
nefazodone (used to treat depression);
administration at the same time with
vincristine can lead to a premature
and/or increased severity of muscle
diseases
• certain medicines that inhibit a protein
called p-glycoprotein, for example
nifedipine (used to treat high blood
pressure): the amount of vincristine in
the blood may increase. This in turn,
may cause more side effects
• certain medicines to treat epilepsy, for
example, (fos)phenytoin; vincristine can
lower the amount of phenytoin in the
blood
• certain medicines to treat cancer and
other bone marrow inhibiting medicines
such as doxorubicin (especially in
combination with prednisone); the
effect, side effects and inhibiting effects
on the bone marrow can be increased
• certain medicines that may be harmful
to the nervous system such as isoniazid
(a medicine to treat tuberculosis),
L-asparaginase (a medicine to treat
blood cancer) and cyclosporin A (a
medicine that suppresses the immune
system); these products can possibly
increase the harmful effects of
vincristine on the nervous system
• vaccines (vaccinations); vincristine
suppresses the immune system of the
body and may have an effect on the
ability of the body to react to the
vaccine
• digoxin (a medicine to treat reduced
cardiac function and cardiac
arrhythmias); vincristine can reduce the
effect of digoxin
• mitomycin C (a medicine to treat
certain forms of cancer); administration
at the same time can cause problems
with your breathing
• radiotherapy (treatment of diseases
with the aid of radiation); radiotherapy
can increase the side effects of
vincristine on the nervous system
• ciclosporine, tacrolimus; when used at
the same time your immune system
may not be able to protect the body
from disease (immunosuppression) with
the risk of growth of certain cells (
lymphoproliferation)
• GM-CSF and G-CSF (medicines used to
stimulate the growth of blood cells after
chemotherapy): when used at the same
time this may cause a disease of the
nerves (neuropathy)
• dactinomycin; in patients with kidney
cancer (Wilm’s tumour) severe damage
to the liver has been reported

insert of all medicines you are using what
the name of the active ingredient is.

Version:

• Adults
The usual dose in adults is 1.4 mg per square
metre of body surface (the size of your body)
(maximum of 2 mg) once a week.
• Children
In children the usual dose is 1.5-2.0 mg per
square metre of body surface once a week.
For children who weigh 10 kg or less, the
starting dose is 0.05 mg per kg of body
weight once a week.
• Patients with a reduced liver function
If your liver is not working well, your doctor
will adjust your dose if necessary.

Vincristine should be given only into a vein
(intravenously)
The usual dose is

Follow the advice of your doctor carefully when
using Vincristine sulfate. Consult your doctor or
pharmacist if there is anything that you are not
sure about.
Consult your doctor if you have the feeling that
Vincristine sulfate is acting too strongly or not
strongly enough.

3 How to use Vincristine sulfate

Driving and using machines
• Treatment with Vincristine sulfate can
sometimes result in side effects of the nervous
system, such as reduced reflexes, muscle
weakness and visual problems (see “Possible
side effects”). If you experience any of these
side effects, DO NOT drive or use any
machines that require your attention.

Pregnancy, breast-feeding and fertility
Pregnancy
• Treatment with Vincristine is not
recommended during pregnancy.
• Contraceptive measures should be taken by
both men and women during the treatment
and for 6 months after you finish your
treatment.
• As soon as you suspect a pregnancy or if you
wish to have children, you should consult your
doctor.
• There are no adequate data about the use of
vincristine sulfate during human pregnancy to
determine the possible harmful affects. This
medicine has appeared harmful in animal
tests.
• Ask your doctor or pharmacist for advice
before you start using any medicine.
Breast-feeding
• DO NOT breast-feed while you are being
treated with Vincristine Sulfate.
• Ask your doctor or pharmacist for advice
before you start using any medicine.
Fertility
• Vincristine may have an anti-fertility effect,
which could be irreversible. Male patients are
therefore advised not to father a child either
during treatment, or for 6 months after
treatment, and to seek advice on storing of
sperm ("sperm banking") prior to treatment.

• bleomycin; this combination can cause a
condition that affects blood flow to the
extremities which include the fingers, toes,
nose and ears when exposed to temperature
changes or stress (Raynaud's syndrome).
Tell your doctor or pharmacist if you take,
have recently taken or might take any other
medicines, including medicines obtained
without a prescription.

Nervous system
• Common
Peripheral neuropathy, which involves damage
to the peripheral nervous system (PNS), the
nerves that carry electrical signals from the
brain and spinal cord to the rest of the body
and back again. It can affect movement,
sensation and bodily functions; you may
experience effects such as sensory
disturbances, observations of tickling, itching

Blood
• Common
Temporary increase in the number of platelets;
you may experience headache, dizziness,
tingling hands, fingers or feet, a blue coloured
nose, bruises or bleeding gums.
• Uncommon
Inhibition of bone marrow function, blood
deviations such as anaemia (you may
experience weakness, fatigue and/or general
malaise), shortage of white blood cells (which
is associated with an increased risk of
infections) and shortage of platelets (you may
experience bruising and bleeding tendencies).

Immune system
• Rare
Hypersensitivity reaction with a large drop in
blood pressure, paleness, restlessness, weak
rapid pulse, clammy skin and reduced
consciousness (anaphylaxis), rash and fluid
accumulation.

The following side effects may occur at the
approximate frequencies shown:
Very common (may affect more than 1 in 10
people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 patients)
Not known (cannot be estimated from the
available data)

Like all medicines, Vincristine sulfate can cause
side effects, although not everybody gets them.

4 Possible side effects

If you have missed a dose of Vincristine sulfate
Your doctor will decide when you will receive this
medicine. If you think you have missed a dose,
please contact your doctor as soon as possible.

Consult your doctor or pharmacist should you
have any further questions regarding the use of
this medicine.

If you have received more Vincristine sulfate
than you should
If you are concerned that you have received too
much Vincristine sulfate, contact your doctor or
pharmacist immediately.
If you have received too much Vincristine
sulfate, the described side effects may be
experienced more strongly or with more serious
effects.
There is no effective treatment for a Vincristine
overdose. In case of an overdose your doctor will
take supportive measures and monitor you
carefully.

Method of use
Vincristine sulfate is injected by means of an
infusion or as a slow injection through the tube
of a running infusion into a vein (intravenous).
Vincristine should only be used under strict
supervision of doctors experienced in the
treatment with cytotoxic medicines.

Gastro-intestinal system
• Common
Constipation, abdominal pain, attack of
pain in the abdomen due to a cramping of
amongst others the intestines and biliary
system (organs and ducts (bile ducts,
gallbladder and associated structures) that
are involved in the production and
transportation of bile) (colic-like
abdominal pains), nausea, vomiting.
• Uncommon
Lack of appetite, weight loss, diarrhoea,
reduced effect of the intestine due to
paralysis (paralytic ileus, in which the
bowel ceases to function and there is no
peristalsis) especially in young children.
• Rare
Inflammation of the mucous membrane
of the mouth, dying off of tissue in the
small intestine and/or the occurrence of
damages in the wall of the intestine.

Respiratory system
• Common
Suddenly occurring shortness of breath
and breathlessness due to cramp of the
muscles of the airways (bronchospasm),
especially if the medicine is used at the
same time as mitomycin C.

Heart
• Uncommon
In some patients, who were treated
with vincristine in combination with
other products to treat cancer and who
were previously irradiated in the area
around the heart, disorders of the blood
vessels of the heart and heart attacks
have occurred.
• Rare
Increased blood pressure or reduced
blood pressure.

• Not Known
Disease occurring in the white matter of
the brain (leukoencephalopathy).
Symptoms include mental dysfunction
and convulsions

• Uncommon
Seizures/convulsions, often with
increased blood pressure. A few cases of
seizures followed by coma in children
have been reported. Altered
consciousness and mental changes such
as depression, agitation, sleeplessness,
confusion, severe mental illness in which
control over behaviour and actions is
disturbed (psychoses), observations of
things that are not there (hallucinations).

1

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

Kidneys and urinary tract
Elderly patients who also use medicines
that cause the lack of ability to urinate
(urinary retention) must stop using these
medicines soon after the vincristine
administration
• Uncommon
Problems with urinating (painful,
urinate often or not being able to
urinate well). Presence of high levels of
a certain breakdown product (uric acid)
in the blood, (hyperuricaemia).
• Rare
Inappropriate release of Antidiuretic
hormone (ADH), resulting in low blood
pressure, dehydration, abnormal levels
of nitrogen-containing compounds (you
may experience a dry mouth, confusion,
fatigue), fluid retention, which may
result in oedema and sodium shortage
(Syndrome of inappropriate antidiuretic
hormone secretion (SIADH)).
• Very Rare
Incontinence
Sexual organs
Irreversible infertility is more common in
males than in females.
• Common
Shortage of semen, nerve pain in the
testicles.
• Uncommon
Stopping of the menstruation.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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.

Other
Treatment related cancer. In some patients
who have been treated with vincristine in
combination with other products to treat
cancer, a different form of cancer occurred
after the treatment.
• Common
Irritation at the place of injection.
• Uncommon
Pain and inflammation of the veins and
the subcutaneous connective tissue during
injection into the vein, fever.
• Rare
Headache.

Do not use Vincristine sulfate if you notice
that the solution is not clear and colourless or
slightly yellow.

Ears and organs of balance
• Uncommon
Deafness.

PL 00289/1060

86622-M
93.134.016-D

This leaflet was last revised in March 2016

Teva UK Limited
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG, United Kingdom

Marketing Authorisation Holder

Pharmachemie B.V.
Swensweg 5, P.O. Box 552
2003 RN Haarlem, the Netherlands

Manufacturer

Marketing Authorisation Holder and
Manufacturer

Pack sizes :
1 vial of 1 ml containing 1 mg vincristine
sulfate
1 vial of 2 ml containing 2 mg vincristine
sulfat.
1 vial of 5 ml containing 5 mg vincristine
sulfate
Not all pack sizes may be marketed.

Solution for injection.
Vincristine sulfate is a clear, colourless or
slightly yellow solution, free of particles other
than gas bubbles.

What Vincristine sulfate looks like and
contents of the pack:

What Vincristine sulfate contains:
The active substance is vincristine sulfate,
1 mg per ml injection fluid.
The other ingredients are mannitol , sulfuric
acid and/or sodium hydroxide and water for
injections.

of the pack and other
6 Contents
information

Do not use Vincristine sulfate after the expiry
date which is stated on the container after
“EXP” The expiry date refers to the last day
of that month.

Store in a refrigerator (2–8 °C).
Keep container in the outer carton in order to
protect from light.

Keep this medicine out of the sight and
reach of children.

5 How to store Vincristine sulfate

Version:

Skin
• Very common
Hair loss (reversible after treatment is
stopped).

Liver or bile
• Rare
Liver disorder as a result of vein closures
in the liver, particularly in children.

• Very rare
Inflammation of the pancreas
(pancreatitis).

231-30-86622-M LEA VINCRISTINE 1mg/ml SOL FOR INJ TEVAH
or tingling without cause, nerve pain
(amongst others in the jaw or testicles),
problems with moving, loss of certain
reflexes (deep tendon reflexes),
paralysis or weakness of muscles of the
foot (foot drop), muscle weakness,
coordination problems (for instance,
walking as if drunk) and paralysis. The
cranial nerve (brain nerve) may be
affected, which may lead to paralysis of
certain muscles, muscle weakness of the
larynx, hoarseness, paralysis of the vocal
cord, muscle weakness of the outer eye
muscles, drooping of the eyelids
(ptosis), double vision, disorders of the
ocular nerves, disorders of the nerves
outside the eye, (transient) blindness.

TEVA UK Ref:

Excreta and vomitus should be handled with
caution.

Extravasation should be avoided. Should
extravasation occur, the injection should be
stopped immediately and any remaining
dose should be injected in a different vein.
Local injection of hyaluronidase 250 IU/mL
(1 mL subcutaneous around the lesion and
moderate heat application at the site where
the extravasation occurred, can help disperse
the product and limit the discomfort and
possible cellulitis to a minimum. In the unit
where vincristine sulfate is administered, the
hospital’s cytostatics extravasation set of the
hospital should be available.

If the solution does get in contact with the
skin, mucous membranes or eyes, immediate
excessive flushing with water should occur.

Any contact with the liquid should be
avoided. The solutions should be prepared in
a special area in which smoking, eating and
drinking are prohibited. During the
preparation a strictly aseptical work
technique must be applied; as protective
measures the use of gloves, mouth mask,
safety goggles and protective clothing are
needed. The use of a LAF-cabinet with
vertical flow direction is recommended.
During administration gloves should be
worn. With waste processing, the nature of
this product should be taken into account.

Handling and disposal
Injectable solutions of cytotoxic drugs should
be prepared by specialized trained personnel
who are familiar with the drugs used, under
conditions that guarantee environmental
protection and especially protection of
personnel handling the drugs. Vincristine
should not be handled by pregnant staff.

Inspection prior to use
Only clear solutions without particles should
be used. The product should not be used in
case of a defective container.

10. Special precautions for disposal other handling>

Not all pack sizes may be marketed

Pack sizes:
One vial containing 1 ml of solution.
One vial containing 2 ml of solution.
One vial containing 5 ml of solution.

Colourless Type I glass vial with bromobutyl
rubber stopper, aluminium seal and
polypropylene snap-cap containing 1 ml,
2 ml or 5 ml of solution.

9. Nature and contents of container

Store and transport refrigerated (2-8°C).
Keep vial in the outer carton in order to
protect from light.

8. Special precautions for storage

and conditions prior to use are the
responsibility of the user and would normally
not be longer than 24 hours at 2 to 8 °C,
unless dilution has taken place in controlled
and validated aseptic conditions.

15 March 2016

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86622-M

Broken containers should be handled with
the same precautions and treated as
contaminated waste. Contaminated waste
should be disposed of by incineration in
rigid, appropriately labelled containers.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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