Ifosfamide Injection 1 G
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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 nurse.
• Ifyougetanyside effects, talk to your doctoror nurse. This includes any possible side effects not listed in this leaflet.
Throughout this leaflet, Ifosfamide Injection 1 g and 2 g will be called Ifosfamide.
Important things to know about Ifosfamide
Your doctor has prescribed Ifosfamidebecause you have cancerthat can be treated.
Ifosfamide is a medicine that kills cancercells but, as a
a number of side effects. Your doctor will notgiveyou Ifosfamide unless he or she thinks that your cancer is more of a risk to you thanany possible sideeffects. Your doctor will checkyou regularly and treat any side effects where possible.
• will reduce your blood cell count, which may make you feel tired and be more likely toget infections.
• can affect your kidneys and bladder. You may be given anothermedicinecalled Mesna to help prevent any damage. If you notice blood in your urine, tell your
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 notworkwellwith Ifosfamide:
• like most anti-cancer or chemotherapy medicines, you may loseyour hair (anything from thinning to total loss), although it should start to grow back onceyour
to help'
• Men or women should not have a child duringtreatment with Ifosfamide orforat least 6 monthsafter treatment. You should usean effective contraceptive. Ask your doctor foradvice.
Now read the rest of this leaflet. It includes other
What is in this leaflet:
1. What Ifosfamide is and what it is used for
2. Whatyou needto know before youare given Ifosfamide
3. How you will be given Ifosfamide
4. Possibleside effects
6. Contents of thepackand other information
1 What Ifosfamide is and what it is used for
Ifosfamide isacytotoxicdrug oranti-cancerdrug. It works by killing cancer cells, this is sometimes called‘chemotherapy’. It is usedto treat lots of different cancers. Ifosfamideis often used together with other anti-cancerdrugs or radiotherapy.
2 What you need to know before you are given Ifosfamide
You will not be given Ifosfamide if:
• you have ever had an allergic reaction to Ifosfamide. An allergic reaction can include shortness of breath, wheezing,
rash, itching or
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Tell your doctor if:
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• you have poorgeneral health orarefiail
• youare elderly.
The following medicines can increase the toxicity of Ifosfamide:
medicines that can increase the toxic effects on your blood cells and immunity:
• ACE inhibitors (used to treat high blood pressure)
• Carboplatin (usedto treat cancer)
• Cisplatin(usedtotreatcancer)
• Natalizumab (used to treat multiple sclerosis)
medicines that can increase the toxic effects on your
• anthracyclines such as bleomycin, doxorubicin, epirubicin, mitomycin (usedto treat cancer)
• radiation in the area of yourheart
medicines that can increase the toxic effects on your lungs:
• G-CSF.GM-CSF hormones (used to increase white blood cell numbers after chemotherapy)
medicines that can increase the toxic effects on your kidneys:
• Acyclovir (used to treat viruses)
• Aminoglycosides (used to treat bacterial infections)
• Amphotericin B (used to treatfungal infections)
• Carboplatin (usedto treat cancer)
• Cisplatin (used to treat cancer)
medicines that can increase the toxic effects on your bladder:
• Busulfan (usedto treat cancer)
• Irradiation of the bladder
medicines that can cause additive effects on you central nervous system when combined with ifosfamide
• Antiemetics (used tocontrol vomiting and nausea)
• Antihistamines (used to treat allergic reactions)
• Narcotics
• Sedatives
the following medicines can increase the toxicity of Ifosfamide:
• Carbamazepine, Phenytoin, Phenobarbital(usedto treat epilepsy)
• Corticosteroids (used to treat inflammation)
• Rifampin(usedtotreatbacterial infections)
• St. John’s (a herbal remedy for mild depression) the following medicines can reduce how effective Ifosfamide is:
• Ketoconazole, Fluconazole, ltraconazole(usedto treat bacterial or protozoal infections)
• Sorafenib(usedtotreatcancei)
• Aprepitant (usedto prevent beingsick)
other medicines that can affect or be affected by Ifosfamide include:
• Docetaxel (used to treat cancer)
• Coumarins such as warfarin (usedtothin the blood)
• Tamoxifen: (usedto treat breast cancer)
• Cisplatin: (used to treat cancer)
• lrinotecan:(usedtotreatcancer)
Using Ifosfamide with food and drink
Drinking alcohol can increase the nausea and vomiting caused by Ifosfamide.
Pregnancy, breast-feeding and contraception
Do not become pregnant while taking Ifosfamide. This is because it can cause miscarriage or damage your unborn baby. Tell your doctor if you are pregnant, thinkyou might be pregnant or are trying to become pregnant.
• Men or women should nottry to have a child during or for at least 6 to 12 months after treatment. You should usean effective contraceptive. Askyourdoctor foradvice.
• Ifosfamide can affect your ability to have children in the future. Talk to your doctor about freezing sperm samples or eggs before yourtreatmentstarts.
Do not breast-feed while beingtreated with Ifosfamide. Ask your doctor foradvice.
Driving or operating machines
Some of the side effects of treatmentwith Ifosfamide might affect your ability to driveand use machines safely. Your doctor will decide if it issafeforyoutodoso.
If any of the above apply to youyourdoctormay need to do extra tests on your blood or urine and may decide to change your treatment.
Take special care with Ifosfamide:
• Ifosfamide can have effects on your blood and immune
• Blood cells are made in your bone marrow. Three different types of blood cell are made:
- red blood cells, whichcarry oxygenaround your body
- white bloodcells,whichflghtinfection, and
- platelets, which help yourbloodto dot.
• After taking Ifosfamide, your blood count of the three types of cells will drop. This is an unavoidable side effect of Ifosfamide. Your blood count will reach its lowest level about5to10daysafteryou start taking Ifosfamideand will stay low untilafewdaysafteryou finish the course. Mostpeople recover to a normal blood count within 21 to 28 days, tl you have hadalot of chemotherapy in the past, it maytakea little longer to return to normal.
• You may be morelikelytogetinfections whenyour blood countdrops. Try to avoid closecontadwith people who have coughs, colds and other infections.
• Yourdoctorwillcheckthatthe number of red blood cells, white blood cells and platelets is high enough before and during your treatment with Ifosfamide.
• Ifosfamide can affect wound healing. Keep any cuts clean and dry, and check they are healing normally.
• It is importantto keepyourgums healthy, as mouth ulcers and infections can occur. Askyour doctor about this if you are unsure.
• Ifosfamide can damage the lining of your bladder, causing bleeding intoyour urine. 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 youasashort injection, or mixed into the drip solution withyour Ifosfamide, or as tablets.
• More information on Mesna can be found in the Patient Information LeafletforMesna Injection and Mesnatablets.
• Most people having Ifosfamide with Mesna do not develop any problems with their bladder, but your doctormay want to testyour urine forthe presence of blood usinga ‘dipstick’ or microscope.
• If you noticethatyou have blood in the urine, you must tell your doctor straightaway.
• Ifosfamide can damage your kidneys so that they do not work properly.
• This is more likely to happen if you only have one kidney or if your kidneys are already damaged.
• This is often temporary and they return to normal once Ifosfamide therapy is stopped. Occasionally the damage is permanent and more severe.
• Your doctorwillcheckyour test results for signs of kidney
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 forany reason, tell them what medicinesyou are taking. Do nottake any other medicines unless yourdoctor knows you are taking Ifosfamide.
3 How you will be given Ifosfamide
Ifosfamide will be given to you by a doctor or nurse.
• Ifosfamide will normally be added toalaigebag of fluid and will be slowly injected (infused)directly in to your vein. Thevein can be in your arm, the backofyour hand ora large vein under yourcollarbone. Dependingon your dose, the Injection usually takes several hours but may be given over several days.
• Ifosfamide is oftengiven with other anti-cancerdrugs or radiotherapy.
The usual dose
• Your doctor will decide how much of the medidneyou need and when you should take it.
• The amount of Ifosfamideyouwill needto take depends
- the type of illness you have
- how bigyou are (a combination of your heightand weight)
- your general health
- whether youare being given otheranti-cancer drugs or having radiotherapy.
Ifosfamide is usually given as a series of courses of treatment. Afteracourse there is a break (a periodwhen no injections are given) before the next course.
If you are given too much Ifosfamide It is unlikely that you will be given more Ifosfamide than you should, because it will be given to you by a trained and qualified person. They would stop the injection straightaway if too much was given.
4 Possible side effects
Like all medicines, Ifosfamidecan cause side effects, although not everybodygets them.Thefollowingside effects may happen with this medicine.
Tell your doctor straight away, if you notice any of the following serious side effects:
• Cancer medicines and radiation therapy can increase the riskof you developing othercancers; this can be a number of years after yourtreatment hasstopped.
• Ifosfamide can causedamage to your heart oraffectthe rhythm of it beating. This increases with higher doses of Ifosfamide, 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.
• Ifosfamide can cause inflammation orscarringinyour lungs. This can occur more than six months after your treatment. If you start having difficulty breathing tell your doctor straight away.
• Ifosfamide can have lifethreatening effects onyourliver.
If you have sudden weightgain, liver pain and jaundicetell your doctor straightaway.
• Hair thinning or baldness can occur. Your hairshould grow back normally though it may be different in texture or
• Ifosfamide can makeyou feel sickor be sick. Thiscan last for about 24 hours after taking Ifosfamide. You may need to be given medicines to stop feeling or being sick. Askyour doctor about this.
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Turn over leaflet forfurther information. HA-30-01-360
• ulceration of the lining of thedigestivesystem(mucosal ulceration)
• increased saliva production
• life-threatening decreaseofyourlungs ability to transfer oxygen in toyourblood (respiratory failure)
• conditions causing inflammation of the lungs which can cause breathlessness, cough and raised temperature or scarring of the lungs (pneumonitis, acuterespiratory distress syndrome)
• scarring of the lungs which causes shortness of breath (interstitial lung disease, pulmonary fibrosis)
• 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 hypertension)
• shortness ofbreath(dyspnoea)
• decrease levels of oxygen in your body (hypoxia)
- motionless and unresponsive to stimuli(catatonia)
- panic attack
- inabilitytospeak(mutism)
- repeating words (echotalia)
- beingfixedonatask(perseveration).
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(anaphylacticshock, anaphylactic/anaphytactoid
• reduction in the effectiveness of your immune system (immunosuppression)
• increased risk and severity of bacterial, fungal, viral, protozoal or parasitic infections dueto theetfect of ifostamide on your immune system
• 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)
• swelling of theskinaroundtheface, inside of the mouth and throat (angioedema)
• a skin rash of red itchy swellings (urticaria).
• secondary tumours in various parts of the body, often in the area of the bladder
• progression of underlying cancers.
Blood and Lymphatic System
• decrease in the activity otyourbonemarrow (myelosuppression)
This can causeadecrease in thenumber of cells in your blood:
- white cells - which fight infection (leucopenia, agranulocytosis). This may be associated with fever (febrile bone marrow aplasia)
- platelets-whichhelpyourblooddot (thrombocytopenia)
- redceHs-whichcarryoxygenaroundthebody (anaemia, neonatal anaemia, haemolyticanaemia)
This may be associated with a decrease in theirability to carry oxygen(methaemoglobinaemia)
• formation of small blood clots in your blood vessels disrupting the normal blood how around your body (disseminated intravascular coagulation)
• haemolytic uremic syndrome - a condition causing abnormal breakdown of the red blood cells, decreased numbers of platelets in the blood and kidney failure.
Endocrine System
• increase in the release of antidiuretic hormone fromthe pituitary gland (SIADH). This affects the kidneys causing the low levels of sodium in your blood (hypematraemla) and water retention.
Metabolism and Nutrition
• loss ordecreaseof appetite
• changes to your metabolismcaused by the breakdown of the dying cancer cells (Tumour lysis syndrome)
• increase of acidity of body fluids (metabolic acidosis)
• low blood levels of potassium which can cause abnormal heart rhythms, constipation, fatigue, muscleweakness or spasms, depression, psychosis, delirium, contusion, or hallucinations (hypokalaemia)
• low blood levels of calciumwhichcancause muscle ciamps and twitching, irregular heartbeat, oveiactive rehexes, and burning or tingling sensations in the hands and feet (hypocalcaemia)
• low blood levels of phosphatewhich can cause bone pain, contusion and muscle weakness (hypophosphataemia)
• high bloodsugar levelswhichcancausethirst, tiredness and irritability (hyperglycaemla)
• excessive thirst that is also accompanied by excessive fluid intake (polydipsia).
Digestive system
• feeling sickandbeing(nausea, vomiting)
• inflammation of the lining of your mouth, including ulcers (stomatitis)
• inflammation of your intestines or bowel (enterocolitis)
• severetummy andbackpainwhich maybefrom inflammation of the pancreas (pancreatitis)
• decrease bowel activity which may lead to bowel
Nervous System
• adisoiderof the nerveswhichcancauseweakness, tingling or numbness (peripheral neuropathy)
• having difficulties in controlling or coordinating the muscles you use when you speak, or weakness of those muscles (Dysarthria)
• a syndrome called Status epilepticus (convulsive and nonconvulsive) defined as one continuous, unremitting seizure lasting longer than5 minutes, or recurrent seizures without regaining consciousness betweenseizuresfor greater than 5 minutes
• effects on thebiain (encephalopathy), signs of this can be problems in thinking or concentrating, reduced alertness, changes in personality, tiredness, fits, muscle twitching, and shaking
• movement disorders and gait disturbances (movement disorder, extiapyramidal disorder, gait disorder)
• effects on thespinalcoid (myelopathy), whichcan cause numbness, weakness and tingling in the hands, loss of
• pain from your nerves, whichcan alsofeel like an aching or burning sensation (neuralgia)
• happing tremor of thehand(asterixis)
• tingling or numbness, often in the hands or feet (paresthesia)
• loss of sense oftouchor sensation(hypoesthesla)
• inability to control bowel movements (faecal incontinence).
Eyes and Ears
• blurring, reduction or loss ofsight
• inflammation of the eye (conjunctivitis)
• irritation of the eyes
• deafness or hearing impairment
• dizziness or feeling of spinning (vertigo)
• ringing in the ears (tinnitus)
Heart and Circulation
• damagetotheheartmuscle(caidiotoxicity)
• changes in your heartrhythm (arrhythmia)
• irregular heart beat (atrial fibrillation)
• early heartbeat (premature atrial contractions)
• slower heartbeat(biadycaidia)
• heart attack(myocardial infarction)
• decrease in your hearts ability to pump enough blood around your bodywhich may be life threatening (cardiac failure orcaidiacarrest)
• bleeding in to the muscles of the heart (myocardial haemorrhage)
• chest pain from reduced blood supply to the heart (angina
• disease of theheart muscle(cardiomyopathy, congestive caidiomyopathy)
• abnormal ECGhearttiacing
• blood dot in the lungs which causes chest pain and breathlessness (pulmonary embolism)
• blood dot, usually inaleg.whichcauses pain swelling or redness (deep vein thrombosis)
• leaking of fluid from the circulation into surrounding tissues (capillary leaksyndrome)
• inflammation of the blood vessels (vasculitis)
• low or high blood pressure (hypotension, hypertension)
• reddening of theskin(tlushing).
• a build up of toxins in the bodydueto liver failure (hepatotoxicity)
• blockage of thesmallveins in your liver (veno-occlusive liver disease) which can cause weight rain, increased liver size, pain and jaundice
• reduction of blood supply or blockage of the portal vein of the liver (portal vein thrombosis)
• inflammation of the liver whichcan causejaundice, weight lossand malaise (cytolytic hepatitis).
Skin andSubcutaneous Tissue
• hair loss (alopecia)
• inflammation of this skin which may cause lash, blisters, itching, sores, oozing and scarring (dermatitis)
• skin eruption or reaction consisting of small, round, raised bumps that have clear boiders (popular rash)
• 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 erythrodysesthesla syndrome)
• redness and blistering of theskinappearing months or years after treatment (Radiation recall dermatitis)
• swelling of theface
• rash
• itching (pruritus)
• itchy, red rash which can develop in to sores (erythema)
• changes in colour of your fingernails and skin
• separation of the nail bedwhich can causenails to fall off
• excessive sweating(hyperhidrosis).
Musculoskeletal and Connective Tissue
• abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
• softening of the bones thatcouldcausesevere bone pain, pain caused by slightcrackinthe bone backpain, partial or complete fractures and musdeweaknesses (osteomalacia, rickets)
• growth retaidation
• muscle pain (myalgia) or joint pain (arthralgia)
• muscle twitching.
Renal and Urinary
• inflammation of thebladderliningwhichcauses pain, bleeding, I oodintheurine, reduced urineflow (haemorrhagic cystitis)
• blood in theurine(haematuria)
• life threatening decrease in theabilities of your kidneyto adequately remove toxins and waste products from the blood (renal dysfunction, renal failure)
• kidney malfunction causing increased of total urine amino acids into urine (aminoaciduria). Your doctorwilldo urine tests totestforthese
• kidney malfunctioncausing urine to appear cloudy or murkycolour (phosphaturla)
• kidney malfunction leads to excessive urine production and excessive thirst, resulting in deficits of water, calcium, potassium, magnesium, and othersubstances in thebody (fanconi syndrome)
• inflammation of the kidneys (tubulointerstitial nephritis)
• changes to the structure of your kidneys which prevent them from working correctly (renal structural damage)
• glucose in the urine (nephrogenic diabetes insipidus)
• condition usuallydefined as excessive or abnormally large production or passage of urine (polyuria)
• repeated inability to control urination (enuresis)
• feeling of residual urine.
Pregnancy and Fertility
• infertility. Sperm production in men and egg production in women may be reduced or stop. In somecasesthis can be permanent
• loss of ovarian function before age 40 (ovarian failure, premature menopause)
• absence of menstrual periods (amenorrhea) or absence of ovulation (ovulation disorder)
• absence of measurable level of sperm in male semen (azoospermia)or less number of sperm in the ejaculateof themale (oligospermia).
Congenital, Familial and Genetic Disorders
• reduction in growth, deformity or death of afoetuswhile in thewomb.
GeneialDisordersandAdministrativeSiteConditions
• inflammation of a vein, usually in the legs (phlebitis)
• feeling of general discomfort or uneasiness (malaise)
• life threatening failure of multiple organs
• general physical deterioration
• appearance of skinchangesandirritationat thesite of injection or infusion
• swelling • chills.
Reporting of side effects
Ifyou getanyside effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme www.mhra.gov.uk/yellowcaid
5 How Ifosfamide is stored
Becauselfostamide is usually given in hospital itwill be stored safely and correctly by the hospital staff. If you do need
• Keep this medicine out of the^ight and reach of children.
on the label after EXP. The expiry date refers to the tastday • Donot storeabove25°C.Storeinthe originalcontainer.
6 Contents of the pack and other information
What Ifosfamide contains
Theactivesubstance is Ifostamide and each vial contains 1gor2g.
There are no other ingredients.
What Ifosfamide looks like and contents of the pack
Ifostamide is adrywhitepowder supplied indearglassvials. Each carton contains 1 vial.
The contents of each vial has to be mixed with sterile water (called ‘water for injections’) before use.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
CaxtonWay Thetfoid Norfolk IP24 3SE United Kingdom
Send all enquiries to this address.
Ifostamide is manufactured by:
Baxter Oncology GmbH
33790 Halle/Westfalen Germany
This leaflet was last revised in 01/2014.
For information about Ifosfamide or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:
Tel: 01635 206345.
Baxter isatiademarkof Baxter International Inc
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Ut: C 443