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Active substance(s): CYCLOPHOSPHAMIDE

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Endoxana® Injection 1g

 It is important to keep your gums healthy, as mouth ulcers and

Read all of this leaflet carefully before you are given 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, 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
 If you get any side effects, talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. See section

This medicine is available using the above name but will be referred to as
Endoxana throughout the leaflet.
Important things to know about Endoxana
Your doctor has prescribed Endoxana because you have cancer that can
be treated.

Endoxana is a medicine that kills cancer cells but, as a result, also
attacks normal cells. It can therefore have a number of side effects. Your
doctor will not give you Endoxana unless he or she thinks that your
cancer is more of a risk to you than any possible side effects. Your doctor
will check you regularly and treat any side effects where possible.

 will reduce your blood cell count, which may make you feel tired and be
more likely to get infections.
 can affect your kidneys and bladder. You may be given another
medicine called Mesna to help prevent any damage. If you notice blood
in your urine, tell your doctor immediately.
 like most anti-cancer or chemotherapy medicines, you may lose your
hair (anything from thinning to total loss), although it should start to
grow back once your treatment has finished. It may also make you feel
sick or be sick. Your doctor can give you advice or medicines to help.
 Men or women should not have a child during treatment with Endoxana
or for at least 6 months after treatment. You should use an effective
contraceptive. Ask your doctor for advice.
Now read the rest of this leaflet. It includes other important information
on the use of Endoxana that might be especially important for you.
In this leaflet:
1. What Endoxana is and what it is used for
2. What you need to know before you are given Endoxana
3. How Endoxana is given
4. Possible side effects
5. How to store Endoxana
6. Contents of the pack and other information
1. What Endoxana is and what it is used for
Endoxana is a cytotoxic drug or anti-cancer drug. It works by killing
cancer cells, this is sometimes called ‘chemotherapy’.
It is used to treat lots of different cancers. Endoxana is often used
together with other anti-cancer drugs or radiotherapy. Occasionally, some
doctors may prescribe Endoxana for other conditions not related to
cancer, your doctor will tell you if this applies to you.
2. What you need to know before you are given Endoxana
You will not be given Endoxana if:
 you have ever had an allergic reaction to cyclophosphamide. An
allergic reaction can include shortness of breath, wheezing, rash,
itching or swelling of the face and lips
 your bone marrow is not working properly (especially if you have
previously had chemotherapy or radiotherapy).
You will have blood tests to check how well your bone marrow is
 you have a urinary tract infection, which can be recognised as pain
when passing urine (cystitis)
 you currently have any infections
 you have ever had kidney or bladder problems as a result of previous
chemotherapy or radiotherapy
 you have a condition which decreases your ability to urinate (Urinary
outflow obstruction).
Tell your doctor if:
 you are already having, or have recently had, radiotherapy or
 you have diabetes
 you have liver or kidney problems. Your doctor will check how well your
liver and kidneys are working by doing a blood test
 you have had your adrenal glands removed
 you have heart problems or have had radiotherapy in the area of your
 you have poor general health or are frail
 you are elderly.
Take special care with Endoxana
 Endoxana can have effects on your blood and immune system.
 Blood cells are made in your bone marrow. Three different types of
blood cell are made:
 red blood cells, which carry oxygen around your body
 white blood cells, which fight infection, and
 platelets, which help your blood to clot.
 After taking Endoxana, your blood count of the three types of cells will
drop. This is an unavoidable side effect of Endoxana. Your blood count
will reach its lowest level about 5 to 10 days after you start taking
Endoxana and will stay low until a few days after you finish the course.
Most people recover to a normal blood count within 21 to 28 days. If
you have had a lot of chemotherapy in the past, it may take a little
longer to return to normal.
 You may be more likely to get infections when your blood count drops.
Try to avoid close contact with people who have coughs, colds and
other infections. Your doctor will treat you with appropriate medicine if
they think you have, or are at risk, of an infection.
 Your doctor will check that the number of red blood cells, white blood
cells and platelets is high enough before and during your treatment with
Endoxana. They may need to reduce the amount you are given or
delay your next dose.
 Endoxana can affect wound healing. Keep any cuts clean and dry, and
check they are healing normally.

infections can occur. Ask your doctor about this if you are unsure.
Endoxana can damage the lining of your bladder, causing bleeding into
your urine and pain on urination. Your doctor knows this can happen
and, if necessary, he or she will give you a medicine called Mesna
which will protect your bladder.
Mesna can either be given to you as a short injection, or mixed into the
drip solution with your Endoxana, or as tablets.
More information on Mesna can be found in the Patient Information
Leaflet for Mesna Injection and Mesna tablets.
Most people having Endoxana with Mesna do not develop any
problems with their bladder, but your doctor may want to test your urine
for the presence of blood using a ‘dipstick’ or microscope.
If you notice that you have blood in the urine, you must tell your doctor
straight away as they may need to stop giving you Endoxana.
Cancer medicines and radiation therapy can increase the risk of you
developing other cancers; this can be a number of years after your
treatment has stopped. Endoxana has an increased risk of causing
cancer in the area of your bladder.
Endoxana can cause damage to your heart or affect the rhythm of it
beating. This increases with higher doses of Endoxana, if you are being
treated with radiation or other chemotherapy medicines or if you are
elderly. Your doctor will monitor your heart closely during treatment.
Endoxana can cause inflammation or scarring in your lungs. This can
occur more than six months after your treatment. If you start having
difficulty breathing tell your doctor straight away.
Endoxana can have life threatening effects on your liver.
If you have sudden weight gain, liver pain and jaundice tell your doctor
straight away.
Hair thinning or baldness can occur. Your hair should grow back
normally though it may be different in texture or colour.
Endoxana can make you feel sick or be sick. This can last for about 24
hours after taking Endoxana. You may need to be given medicines to
stop feeling or being sick. Ask your doctor about this.

Using other medicines and treatments
Tell your doctor or nurse if you are taking or have recently taken any
other medicines, including medicines you have bought yourself. In
particular, tell them about the following medicines or treatments as they
may not work well with Endoxana:
The following medicines can reduce how effective Endoxana is:
 aprepitant (used to prevent being sick)
 bupropion (an anti-depressant)
 busulfan, thiotepa (used to treat cancer)
 ciprofloxacin, chloramphenicol (used to treat bacterial infections)
 fluconazole, itraconazole (used to treat fungal infections)
 Prasugrel (used to thin the blood)
 Sulfonamides, such as sulfadiazine, sulfasalazine, sulfamethoxazole
(used to treat bacterial infections).
The following medicines can increase the toxicity of Endoxana:
 allopurinol (used to treat gout)
 azathioprine (used to reduce the activity of the immune system)
 chloral hydrate (used to treat insomnia)
 cimetidine (used to reduce stomach acid)
 disulfiram (used to treat alcoholism)
 glyceraldehyde (used to treat warts)
 protease inhibitors (used to treat viruses)
 ondansetron (used to prevent being sick)
 medicines that increase liver enzymes such as:
 rifampicin (used to treat bacterial infections)
 carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
 St. John’s wort (a herbal remedy for mild depression)
 Corticosteroids (used to treat inflammation)
 medicines that can increase the toxic effects on your blood cells and
 ACE inhibitors (used to treat high blood pressure).
 natalizumab (used to treat multiple sclerosis)
 paclitaxel (used to treat cancer)
 thiazide diuretics such as hydrochlorothiazide or chlortalidone (used
to treat high blood pressure or water retention)
 zidovudine (used to treat viruses)
 Clozapine (used to treat symptoms of some psychiatric disorders)
 medicines that can increase the toxic effects on your heart
 anthracyclines such as bleomycin, doxorubicin, epirubicin, mitomycin
(used to treat cancer)
 cytarabine, pentostatin, trastuzumab (used to treat cancer)
 radiation in the area of your heart
 medicines that can increase the toxic effects on your lungs
 amiodarone (used to treat irregular heart beat)
 G-CSF, GM-CSF hormones (used to increase white blood cell
numbers after chemotherapy)
 medicines that can increase the toxic effects on your kidneys
 amphotericin B (used to treat fungal infections)
 Indomethacin (used to treat pain and inflammation).
Other medicines that can affect or be affected by Endoxana include:
 etanercept (used to treat rheumatoid arthritis)
 metronidazole (used to treat bacterial or protozoal infections)
 tamoxifen (used to treat breast cancer)
 bupropion (used to help stop smoking)
 coumarins such as warfarin (used to thin the blood)
 cyclosporine (used to reduce the activity of the immune system)
 succinylcholine (used to relax muscles during medical procedures)
 digoxin, ß-acetyldigoxin (used to treat heart conditions)
 vaccines
 verapamil (used to treat high blood pressure, angina or irregular heart
Using Endoxana with food and drink
Drinking alcohol can increase the nausea and vomiting caused by

Pregnancy, breast-feeding and fertility
Do not become pregnant while taking Endoxana. This is because it can
cause miscarriage or damage your unborn baby. Tell your doctor if you
are pregnant, think you might be pregnant or are trying to become
 Men or women should not try to have a child during or for at least 6 to
12 months after treatment. You should use an effective contraceptive.
Ask your doctor for advice.
 Endoxana can affect your ability to have children in the future. Talk to
your doctor about freezing sperm samples or eggs before your
treatment starts.
Do not breast-feed while being treated with Endoxana. Ask your doctor
for advice.
Driving or using machines
Some of the side effects of treatment with Endoxana might affect your
ability to drive and use machines safely. Your doctor will decide if it is
safe for you to do so.
What to do if you see a different doctor, or have to go to hospital
If you see any other doctor or have to go to hospital for any reason, tell
them what medicines you are taking. Do not take any other medicines
unless your doctor knows you are taking Endoxana.
3. How Endoxana is given
Endoxana will be given to you by a doctor or nurse.
 It can be given as an injection or by mouth.
 When Endoxana is given as an injection, it will normally be added to a
large bag of fluid and will be slowly injected (infused) directly into your
vein. The vein can be in your arm, the back of your hand or a large vein
under your collar bone. Depending on your dose, it will usually take
between a few minutes to an hour to be given.
 When Endoxana is given by mouth, it will usually be made in to a
solution with some flavourings (called an ‘elixir’) which will make it taste
pleasant and easier to swallow.
 Endoxana is often given with other anti-cancer drugs or radiotherapy.
The usual dose
 Your doctor will decide how much of the medicine you need and when
you should be given it.
 The amount of Endoxana you will be given depends on:
 the type of illness you have
 how big you are (a combination of your height and weight)
 your general health
 whether you are being given other anti-cancer drugs or having
Endoxana is usually given as a series of courses of treatment. After each
course there is a break (a period when no Endoxana is given) before the
next course.
Your doctor may need to change the amount of medicine you are given
and monitor you more closely if you:
 have problems with your liver or kidneys
 you are elderly.
If you take too much Endoxana
In the event of an overdose, or if a child swallows any of your tablets, talk
to your doctor or local hospital emergency department immediately.
Hospital admission for special treatment may be needed.
4. Possible side effects
Like all medicines, Endoxana can cause side effects, although not
everybody gets them. Side effects can sometimes occur after ending the
treatment. The following side effects may happen with this medicine.
Tell your doctor straight away, if you notice any of the following
serious side effects:
 allergic reactions, signs of this would be shortness of breath, wheezing,
rash, itching or swelling of the face and lips
 getting bruises without knocking yourself, or bleeding from your gums.
This may be a sign that the platelet levels in your blood are getting too
 a lowering of your white blood cell count, your doctor will check this
during your treatment. It will not cause any signs, but you will be more
likely to get infections. If you think you have an infection (a high
temperature, feeling cold and shivery, or hot and sweaty, or any signs
of infection such as a cough, or stinging on passing water) you may
need antibiotics to fight infections because your blood count is lower
than usual
 very pale, lethargic and tired. This may be a sign of low red blood cells
(anaemia). Usually, no treatment is required, your body will eventually
replace the red blood cells. If you are very anaemic, you may need a
blood transfusion
 blood in your urine, pain while passing urine, or less urine being
Other possible side effects may be:
Immune system and Infections
 allergic reactions, signs of this would be shortness of breath, wheezing,
rash, itching or swelling of the face and lips (hypersensitivity). Severe
allergic reactions could lead to difficulty in breathing or shock, with a
possible fatal outcome (anaphylactic shock, anaphylactic/anaphylactoid
 reduction in the effectiveness of your immune system
 increased risk and severity of bacterial, fungal, viral, protozoal or
parasitic infections due to the effect of Endoxana on your immune
 reactivation of infections you have had before (latent infections)
 severe infection spreading through the blood which may lead to a
dangerous drop in blood pressure with a possible fatal outcome
(sepsis, shock).
 cancer of your blood (leukaemia)
 cancer of the bone marrow (myelodysplastic syndrome)
 cancer of the lymphatic system (Non-Hodgkin’s lymphoma)
 secondary tumours in various parts of the body, often in the area of the
 changes to your metabolism caused by the breakdown of the dying
cancer cells (Tumour lysis syndrome).

Blood and Lymphatic System
 decrease in the activity of your bone marrow (myelosuppression). This
can cause a decrease in the number of cells in your blood:
 white cells – which fight infection (leucopenia, agranulocytosis,
granulocytopenia, lymphopenia, neutropenia). This may be
associated with fever (febrile neutropenia)
 platelets – which help your blood clot (thrombocytopenia)
 red cells – which carry oxygen around the body (anaemia). This may
be associated with a decrease in their ability to carry oxygen
(decreased haemoglobin)
 red cells, white cells and platelets at the same time (pancytopenia)
 formation of small blood clots in your blood vessels disrupting the
normal blood flow around your body (disseminated intravascular
 haemolytic uremic syndrome – a condition causing abnormal break
down of the red blood cells, decreased numbers of platelets in the
blood and kidney failure.
Endocrine System
 swelling of the brain due to too much water in your blood (water
intoxication). Signs of this can be headache, changes in personality or
behaviour, confusion, drowsiness
 increase in the release of antidiuretic hormone from the pituitary gland.
This affects the kidneys causing the low levels of sodium in your blood
(hypernatremia) and water retention.
Metabolism and Nutrition
 low blood levels of sodium which can cause tiredness and confusion,
muscle twitching, fits and coma (hyponatremia)
 accumulation of fluid in the body (water retention), which may been
seen as fluid beneath the skin or swelling in you limbs
 high blood sugar levels which can cause thirst, tiredness and irritability
 low blood sugar levels which can cause confusion and sweating
 loss of appetite (anorexia)
 dehydration.
Digestive system
 feeling sick and being sick (nausea, vomiting).
 inflammation of your intestines or bowel which may resulting in bleeding
(enteritis, cecitis, hemorrhagic enterocolitis)
 bleeding in your stomach or intestines (gastrointestinal haemorrhage)
 tummy discomfort or severe tummy and back pain, this may be caused
by inflammation of the pancreas (acute pancreatitis)
 Inflammation which causes abdominal pain or diarrhoea (colitis)
 constipation or diarrhoea
 ulcers in the lining of your digestive system (mucosal ulceration)
 inflammation of the lining of your mouth including ulcers (stomatitis)
 swelling of the glands in your neck (parotid gland inflammation).
Psychiatric Disorders
 Confusion
Nervous System
 effects on the brain (encephalopathy), signs of this can be problems in
thinking or concentrating, reduced alertness, changes in personality,
tiredness, fits, muscle twitching, and shaking
 fits (convulsions)
 dizziness
 a syndrome called Reversible posterior leukoencephalopathy
syndrome, which can cause swelling of the brain, headache, confusion,
fits and loss of sight
 effects on the spinal cord (Myelopathy), which can cause numbness,
weakness and tingling in the hands, loss of motor skills
 a disorder of the nerves which can cause weakness, tingling or
numbness (peripheral neuropathy). This could be in more than one set
of nerves (polyneuropathy)
 pain from your nerves, which can also feel like an aching or burning
sensation (neuralgia)
 tingling or numbness, often in the hands or feet (paresthesia)
 shaking (tremor)
 changes in your sense of touch (dysesthesia) or loss of sensation
 changes in your sense of taste (dysgeusia) or loss of taste
 changes in your sense of smell (parosmia).
Eyes and Ears
 blurring, reduction or loss of sight
 inflammation of the eye (conjunctivitis)
 increased tear formation (lacrimation).
 deafness or hearing impairment
 ringing in the ears (tinnitus).
Heart and Circulation
 heart attack (myocardial infarction)
 changes in your heart rhythm (arrhythmia) which may be noticeable
 irregular heart beat (fibrillation)
 faster heart beat (tachycardia), which may be life threatening
(ventricular tachycardia)
 slower heart beat (bradycardia)
 decrease in your hearts ability to pump enough blood around your body
which may be life threatening (cardiogenic shock, heart failure or
cardiac arrest)
 disease of the heart muscle (cardiomyopathy)
 inflammation of the tissues in or around your heart (myocarditis,
 build up of fluid in the sac around your heart (pericardial effusion).
Increased pressure from this fluid can stop the heart filling properly
(cardiac tamponade)
 abnormal ECG heart tracing (Electrocardiogram QT prolonged).
 blood clot in the lungs which causes chest pain and breathlessness
(pulmonary embolism)
 blood clot, usually in a leg, which causes pain swelling or redness
(venous thrombosis)
 inflammation of the blood vessels (vasculitis)

 reduced blood supply to your hands and feet (peripheral ischemia).

This may cause pain, weakness, numbness, ulcers, changes in skin
colour or temperature
low or high blood pressure (hypotension, hypertension)
reddening of the skin (flushing) which may be accompanied by feeling
hot or sweating (hot flushing).

 life-threatening decrease of your lungs ability to transfer oxygen in to
your blood (respiratory failure)
 blood clot in the lungs which causes chest pain and breathlessness
(pulmonary veno-occlusive disease)
 scarring of the lungs which causes shortness of breath (pulmonary
 conditions causing inflammation of the lungs which can cause
breathlessness, cough and raised temperature or scarring of the lungs
(pneumonitis, acute respiratory distress syndrome, obliterative
bronchiolitis, organizing pneumonia, alveolitis allergic)
 fluid in or around the lungs (pulmonary oedema, pleural effusion)
 increased blood pressure in the lungs which can cause shortness of
breath, fatigue, cough, angina, fainting, peripheral oedema (pulmonary
 difficulty in breathing or wheezing (bronchospasm)
 shortness of breath (dyspnea)
 decrease levels of oxygen in your body (hypoxia)
 cough
 blocked or runny nose
 pain at the back of your throat.
 increased liver size (hepatomegaly)
 yellowing of the skin or whites of the eyes (jaundice)
 blockage of the small veins in your liver (veno-occlusive liver disease)
which can cause weight gain, increased liver size, pain and jaundice
 conditions causing inflammation of the liver which can cause jaundice,
weight loss and malaise (hepatitis),
 disruption of the formation of bile by the liver which can cause itchiness,
jaundice, pale coloured stools, dark urine (cholestasis)
 a build up of toxins in the body due to liver failure (hepatotoxicity). This
may affect the brain causing confusion, reduced consciousness or
coma (hepatic encephalopathy)
 a build up of fluid in the abdomen causing swelling of the tummy and
shortness of breath (ascites)
 increased levels of certain proteins produced by your liver called
enzymes. Your doctor will do blood tests to test for these.
Skin and Subcutaneous Tissue
 life threatening conditions which cause rash, ulcers, sore throat, fever,
conjunctivitis, separation of skin layers (toxic epidermal necrolysis,
Stevens-Johnson syndrome)
 swelling, numbness, red lumps and peeling of skin on the hands and
feet (Palmar-plantar erythrodysesthesia syndrome)
 dark red raised itchy rash (urticaria)
 inflammation of this skin which may cause rash, blisters, itching, sores,
oozing and scarring (dermatitis)
 redness and blistering of the skin appearing months or years after
treatment (Radiation recall dermatitis)
 itchy, red rash which can develop in to sores (erythema multiforme)
 changes in colour of your fingernails and skin.
 separation of the nail bed which can cause nails to fall off
 dehydration
 excessive sweating (hyperhidrosis)
 swelling of the face
 hair loss (alopecia).
Musculoskeletal and Connective Tissue
 abnormal muscle breakdown which can lead to kidney problems
 serious illness which causes thickening of the skin and the connective
tissue in your internal organs (scleroderma)
 muscle spasms
 muscle pain (myalgia) or joint pain (arthralgia).
Renal and Urinary
 life threatening decrease in the abilities of your kidney to adequately
remove toxins and waste products from the blood (kidney failure)
 changes to the tissues within your kidneys which prevent them from
working correctly (renal tubular necrosis, renal tubular disorder)
 damage to the kidneys by toxins in the blood (toxic nephropathy)
 pain and difficultly passing urine (cystitis)
 blood in the urine (haematuria)
 glucose in the urine (nephrogenic diabetes insipidus)
 inflammation of the bladder lining which causes pain, bleeding, blood in
the urine, reduced urine flow (haemorrhagic cystitis)
 inflammation of the urethra which causes pain and bleeding.
(haemorrhagic ureteritis)
 death of the cells and tissues (necrosis), ulceration or scaring (fibrosis)
of the bladder
 decrease in the size of the bladder (bladder contracture)
 changes to the cells in the lining of your bladder
 increase in the levels of creatinine or urea nitrogen in your blood. Your
doctor will do blood tests to test for these.
Pregnancy and Fertility
 premature labour.
 infertility. Sperm production in men and egg production in women may
be reduced or stop. In some cases this can be permanent
 absence of menstrual periods (amenorrhea) or reduced frequency
 decrease in testicle size (testicular atrophy)
 decrease in the hormone oestrogen in the blood
 increase in the hormone gonadotrophin in the blood.
 use in young patients may result in some impairments of future fertility.

Congenital, Familial and Genetic Disorders
 reduction in growth, deformity or death of a foetus while in the womb
 toxic effects on the foetus such as myelosuppression and
General Disorders and Administrative Site Conditions
 life threatening failure of multiple organs
 general physical deterioration
 flu-like symptoms such as headache, fever, chills, joint and muscle
pain, weakness, tiredness
 chest pain
 swelling
 Injection/infusion site reactions such as swelling, redness, pain,
inflammation, tissue damage, tissue death, clot formation
 inflammation of the linings of your body cavities (mucosal
Reporting of side effects
If you get any side effects, talk to your doctor, nurse 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:
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Endoxana
Because Endoxana is usually given in hospital it will be stored safely and
correctly by the hospital staff. If you do need the storage conditions they
are given below:
 Keep out of the sight and reach of children.
 Do not use Endoxana after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
 Do not store above 25ºC. Store in the original container.
After reconstitution, store at (2-8°C) and protect from light.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of is the drug, when you no longer
need it. These measures will help to protect the environment.
6. Contents of the pack and other information
What Endoxana contains
The active substance is cyclophosphamide and each vial contains 1 g.
Each vial contains cyclophosphamide monohydrate equivalent to
1000 mg anhydrous cyclophosphamide.
There are no other ingredients.
How Endoxana looks like and contents of the pack
Endoxana is a powder for solution for injection.
Endoxana is a dry, white powder supplied in clear glass vials. Each
carton contains one vial.
Nature and contents of container
Vials are packed with or without a protective plastic overwrap. Protective
plastic overwrap does not come into contact with the medicinal product
and provides additional transport protection, which increases the safety
for the medical and pharmaceutical personnel.
Manufacturer and Product Licence holder
Manufactured by Baxter Oncology GmbH, Kantstrasse 2, DE-33790
Halle, Germany.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.

PL 20636/2742

Leaflet revision and issue date (Ref) 24.01.17[4]
Endoxana is a trademark of Baxter Healthcare SA.

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