post-title portfolio-title Ifosfamide for Injection IP with Mesna Injection 1000mg/10ml, 2000mg/20ml Taj Pharma 2020-03-06 06:50:45 no no

Ifosfamide for Injection IP with Mesna Injection 1000mg/10ml, 2000mg/20ml Taj Pharma

Overview

INTRODUCTION

Ifosfamide 2gm Injection is used in the treatment of different kinds of cancers. It is given alone or in combination with other chemotherapy medicines, radiotherapy and surgery to treat cancer of blood, breast, lung, ovaries, pancreas, testes, and lymph nodes.

Ifosfamide 2gm Injection is usually given as a slow infusion (drip) into a vein (intravenously) over several hours. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. It is advised that you drink extra fluids so that you pass more urine. This will help prevent bladder and kidney problems and keep your kidneys working well.

The most common side effects of this medicine include nausea, vomiting, anemia (low number of red blood cells), hair loss, decreased white blood cells count.? If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. It is very strong medicine and some people may develop serious side effects while taking it. This medicine may lower your ability to fight infections and lead to problems with your blood, liver or kidneys.

Before taking it, tell your doctor if you have liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. It may harm your baby. You and your partner should avoid becoming pregnant or fathering a child for several months after your treatment with it has stopped.

USES OF IFOSFAMIDE INJECTION

  • Pancreatic cancer
  • Ovarian cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Testicular cancer
  • Blood cancer

SIDE EFFECTS OF IFOSFAMIDE INJECTION

Common

  • Nausea
  • Vomiting
  • Anemia (low number of red blood cells)
  • Hair loss
  • Decreased white blood cell count
  • Infection
  • Blood in urine
  • CNS toxicity

HOW TO USE IFOSFAMIDE INJECTION

Your doctor or nurse will give you this medicine. Kindly do not self administer.

HOW IFOSFAMIDE INJECTION WORKS

Ifosfamide 2gm Injection is an anti-cancer medication. It works by damaging the genetic material (DNA and RNA) of the cancer cells. This stops their growth and multiplication.

SAFETY ADVICE

warningsAlcohol

UNSAFE

It is unsafe to consume alcohol with Ifosfamide 2gm Injection.

warningsPregnancy

CONSULT YOUR DOCTOR

Ifosfamide 2gm Injection is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

warningsBreastfeeding

UNSAFE

Ifosfamide 2gm Injection is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

warningsDriving

UNSAFE

Ifosfamide 2gm Injection may cause side effects which could affect your ability to drive.

warningsKidney

CAUTION

Ifosfamide 2gm Injection should be used with caution in patients with kidney disease. Dose adjustment of Ifosfamide 2gm Injection may be needed. Please consult your doctor.

warningsLiver

CAUTION

Ifosfamide 2gm Injection should be used with caution in patients with liver disease. Dose adjustment of Ifosfamide 2gm Injection may be needed. Please consult your doctor.

WHAT IF YOU FORGET TO TAKE IFOSFAMIDE INJECTION?

If you miss a dose of Ifosfamide 2gm Injection, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Ifosfamide for Injection IP with Mesna Injection 1000mg/10ml, 2000mg/20ml Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

a) Ifosfamide for Injection IP with Mesna Injection 1000mg/10ml Taj Pharma
b) Ifosfamide for Injection IP with Mesna Injection 2000mg/20ml Taj Pharma

2.QUALITATIVE AND QUANTITATIVE COMPOSITION??????????????????????????????

Clear, glass ampoules containing a clear, colourless, aqueous solution of mesna (sodium 2-mercapto-ethanesulphonate)
2000 mg in 20 ml and 1000 mg in 10 ml.

3.PHARMACEUTICAL FORM????

Ampoules of aqueous solution for intravenous and oral administration.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

For the prevention of urothelial toxicity including haemorrhagic cystitis, microhaematuria and macrohaematuria in patients treated with ifosfamide and cyclophosphamide, in doses considered to be urotoxic.

4.2 Posology and method of administration

Sufficient mesna must be given to adequately protect the patient from the urotoxic effects of the oxazaphosphorine.

The duration of mesna treatment should equal that of the oxazaphosphorine treatment plus the time taken for the urinary concentration of oxazaphosphorine metabolites to fall to non-toxic levels. This usually occurs within 8-12 hours after the end of oxazaphosphorine treatment but may vary depending on the scheduling of oxazaphosphorine. Urinary output should be maintained at 100 ml/hr (as required for oxazaphosphorine treatment) and the urine monitored for haematuria and proteinuria throughout the treatment period.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

Where ifosfamide or cyclophosphamide is used as an iv bolus:?
Mesna is given by intravenous injection over 15-30 minutes at 20% of the simultaneously administered oxazaphosphorine on a weight for weight basis (w/w). The same dose of mesna is repeated after 4 and 8 hours. The total dose of mesna is 60% (w/w) of the oxazaphosphorine dose. This is repeated on each occasion that the cytotoxic agents are used.

Example dosage schedule:

 0 hrs4 hrs8 hrs
Cyclophosphamide/Ifosfamide1 g
Mesna200 mg200 mg200 mg

If necessary the dose of mesna can be increased to 40% of the oxazaphosphorine dose given four times at three hourly intervals (0, 3, 6 and 9 hours). (Total dose = 160% (w/w) of the oxazaphosphorine dose). This larger dose is recommended in children, in patients whose urothelium may be damaged from previous treatment with oxazaphosphorine or pelvic irradiation, or in patients who are not adequately protected by the standard dose of mesna.

Example dosage schedule:

 0 hrs3 hrs6 hrs9 hrs
Cyclophosphamide/Ifosfamide1 g
Mesna400 mg400 mg400 mg400 mg


Where cyclophosphamide is used orally:

The same dose regimen of mesna applies as though cyclophosphamide were used as an i.v. bolus.

Where ifosfamide is used as a 24-hour infusion:
Mesna can be used as a concurrent infusion. An initial 20% (w/w) of the total ifosfamide dose is given as an i.v. bolus, then an infusion of 100% (w/w) of the ifosfamide over 24 hours, followed by a further 12-hour infusion of 60% (w/w) of the ifosfamide dose. Total mesna dose = 180% of the ifosfamide dose.

Example dosage schedule:

 0 hrs0-24 hrs24 hrs28 hrs32 hrs36 hrs
Ifosfamide5 g/m2?infusion
Mesna1 g/m?2?iv5 g/m2?infusion?3g/m2?infusion
1 g/m2?iv1 g/m2?iv1 g/m2?iv


Where ifosfamide is used as a long-term infusion:

An initial 20% (w/w) of the first 24 hours ifosfamide dose is given as an i.v. bolus as the ifosfamide infusion starts. Then each 24 hour infusion of ifosfamide is given with a concurrent 24 hour infusion (100% w/w) of mesna. A 12 hour infusion of mesna (60% (w/w) of the final 24 hour dose of ifosfamide) should be commenced as the ifosfamide-mesna infusion finishes.
Example dosage schedule:

Day 1Day 2Day 3Day 4
0 hrs0-24 hrs0-24 hrs0-24 hrs24 hrs4 hrs8 hrs12 hrs
Ifosfamide2 g/m2infusion2 g/m2infusion2 g/m2infusion
Mesna0.4g/m2?iv2 g/m2infusion2 g/m2infusion2 g/m2infusion?1.2 g/m2?infusion
0.4 g/m2?iv0.4 g/m2?iv0.4 g/m2?iv

The final 12-hour infusion of mesna, after long-term or 24 hour infusion of ifosfamide, may be replaced by boluses at 28, 32 and 36 hours, each of 20% (w/w) of the ifosfamide dose, or by oral mesna.

Mesna can be mixed in the same infusion bag as the ifosfamide.

Oral use of mesna ampoules:
Mesna has been shown to be effective when taken orally. Compared with intravenous administration, overall availability of mesna in urine after oral administration is approximately 50%; the onset of urinary excretion is delayed by up to 2 hours and is more prolonged than following intravenous dosing.

With the exception of continuous long-term infusions of oxazaphosphorines with mesna, intravenously administered mesna may be replaced by oral administration of mesna. The dosage should be 40% w/w of the dosage of the oxazaphosphorines. The contents of the ampoule should be added to a flavoured soft drink (e.g. orange juice, cola). This mixture is stable when refrigerated in a sealed container for 24 hours.

For intermittent oxazaphosphorine therapy following an initial intravenous injection of mesna at a dose of 20% (w/w) of the oxazaphosphorine dose, oral mesna (40% w/w) should be administered at 2 hours and again at 6 hours after the initial intravenous dose.
Alternatively, three oral doses of mesna may be administered, replacing the i.v. dose with an oral dose (40% w/w) 2 hours prior to administration of oxazaphosphorines.

Example dosage schedule:

 – 2 hrs0 hrs2 hrs6 hrs
Cyclophosphamide/Ifosfamide1 g iv
Mesna200 mg po200 mg po200 mg po
100 mg iv200 mg po200 mg po

Where ifosfamide is used as a long-term continuous infusion with concomitant mesna, oral mesna may be taken as the infusion of ifosfamide and mesna finishes, then at 2 hours and 6 hours after the time at the finish of the infusion. All oral mesna doses should be 40% (w/w) of the?final 24 hour?ifosfamide dose.

Example dosage schedule:

 0 hrs0-24 hrs24 hrs26 hrs30 hrs
Ifosfamide5 g/m2?infusion
Mesna1 g/m2?iv5 g/m2?infusion2 g/m2?po2 g/m2?po2 g/m2?po

Mesna is also available for oral administration as Mesna Tablets. For further information see the Summary of Product Characteristics for Mesna Tablets or contact Baxter Healthcare Limited.

Children

Children generally micturate more frequently than adults and therefore it may be necessary to shorten the interval between doses and/or to increase the number of individual doses.

Elderly

No specific information is available. Clinical trials have included patients over 65 and no adverse reactions specific to this age group have been reported.

4.3 Contraindications

Known hypersensitivity to mesna or any of the excipientsother Low Molecular Weight Heparins.

4.4 Special warnings and precautions for use

WARNINGS

Hypersensitivity

Hypersensitivity reactions to mesna have been reported following administration of mesna as an uroprotectant. These include various skin and subcutaneous tissue symptoms (see Section 4.8).

In addition, cases of severe bullous and ulcerative skin and mucosal reactions were reported.

In some cases, skin reactions were accompanied by one or more other symptoms, such as fever, cardiovascular symptoms, pulmonary symptoms, haematological abnormalities, nausea, vomiting, pain in the extremities, arthralgia, myalgia, malaise, and conjunctivitis (see Section 4.8).

Some reactions have presented as anaphylaxis.

Fever accompanied by, e.g., hypotension but no skin manifestations has also been reported.

Some patients with a history of a reaction have shown positive delayed-type skin test results. However, a negative delayed reaction does not exclude hypersensitivity to mesna. Positive immediate-type skin test reactions have occurred in patients regardless of previous mesna exposure or history of hypersensitivity reactions, and may be related to the concentration of the mesna solution used for testing.

Prescribers should be aware that:

– severe as well as minor reactions were reported with the use of mesna in regimens to treat both severe systemic autoimmune disease and malignancy and that mesna should be suspected in any hypersensitivity reaction,

– these reactions may occur with first exposure or after several months of exposure and in some cases can be life threatening,

– the occurrence and severity of reactions appeared to vary with the dose administered with a tendency to shorter intervals following subsequent exposures,

– hypersensitivity reactions to mesna were interpreted to resemble the clinical picture of sepsis and, in patients with autoimmune disorders, resemble an exacerbation of the underlying disease.

Thiol Compounds:

Mesna is a thiol compound, i.e., a sulfhydryl (SH) group-containing organic compound. Thiol compounds show some similarities in their adverse reaction profile, including a potential to elicit severe skin reactions. Examples of drugs that are thiol compounds include amifostine, penicillamine, and captopril.

It is not clear whether patients who experienced an adverse reaction to such a drug are at increased risk for any reactions, or similar reactions, to another thiol compound. However, when considering subsequent use of another thiol compound in such patients, the possibility of an increased risk should be taken into account.

PRECAUTIONS

Mesna does not prevent hemorrhagic cystitis in all patients. Patients should be monitored accordingly.

Sufficient urinary output should be maintained, as required for oxazaphosphorine treatment.

Sodium content

Mesna solution for injection contains approximately 59 mg of sodium per 400 mg mesna.

Lab test interferences

Mesna treatment may cause false positive reactions in nitroprusside sodium-based urine tests (including dipstick tests) for ketone bodies. The addition of glacial acetic acid can be used to differentiate between a false positive result (cherry-red color that fades) and a true positive result (red-violet color that intensifies).

Mesna treatment may cause false positive reactions in Tillman’s reagent-based urine screening tests for ascorbic acid.

In pharmacokinetics studies in healthy volunteers, serum creatine phosphokinase (CPK) values were lower in samples taken 24 hours after mesna dosing than in pre- dosing samples. While available data are insufficient to determine the cause of this phenomenon, it might be considered to represent a significant interference with thiol (e.g., N-acetylcysteine) dependent enzymatic CPK tests.

See also Section 4.8 for information on laboratory test abnormalities observed in pharmacokinetic studies.

4.5 Interaction with other medicinal products and other forms of interaction

The systemic effects of oxazaphosphorines are not affected by mesna. In clinical trials it was shown that overdoses of mesna did not diminish the acute toxicity, subacute toxicity, leucocytic activity, and immunosuppressive efficacy of oxazaphosphorines. Animal studies with ifosfamide and cyclophosphamide on a variety of tumours have also demonstrated that mesna does not interfere with their antineoplastic activity.

Mesna also does not affect the antineoplastic efficacy of other cytostatics (e.g. adriamycin, BCNU, methotrexate, vincristine), nor the therapeutic effect of other drugs such as digitalis glucosides.

Food does not influence the absorption and urinary elimination of mesna.

4.6 Fertility, pregnancy and lactation

There are no adequate data from the use of mesna in pregnant or lactating women. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing mesna.

Pregnancy and lactation are contraindications for cytostatic treatment, and consequently Mesna is not likely to be used under these circumstances.

Should an individual patient be undergoing oxazaphosphorine therapy during pregnancy then Mesna should be administered to this patient.

Mothers should not breast-feed whilst being treated with these drugs.

Animal studies have shown no evidence of embryotoxic or teratogenic effects of mesna.

4.7 Effects on ability to drive and use machines

Patients undergoing treatment with mesna may experience undesirable effects (including, e.g., syncope, light-headedness, lethargy/drowsiness, dizziness, and blurred vision) which could affect the ability to drive or use machines. The decision to drive or operate machinery should be made on an individual basis.

4.8 Undesirable effects

The most frequently occurring adverse reactions (> 10%) associated with use of mesna are: headache, infusion site reactions, abdominal pain/colic, lightheadedness, lethargy/drowsiness, pyrexia, rash, diarrhoea, nausea, flushing, and influenza-like illness.

The most severe adverse reactions associated with use of mesna are: bullous skin reactions, anaphylaxis, and drug rash with eosinophilia and systemic symptoms (DRESS).

Because mesna is used in combination with oxazaphosphorines or oxazaphosphorine- containing combination chemotherapy, it is often difficult to distinguish adverse reactions that may be due to mesna from those caused by concomitantly administered cytotoxic agents.

ADR frequency is based upon the following scale: Very common (?1/10); Common (?1/100 – <1/10), Uncommon (?1/1,000 – <1/100), Rare (?1/10,000 – <1/1,000), Very rare (<1/10,000), Unknown (adverse reactions reported in the post-marketing experience)

System Organ Class (SOC)Adverse ReactionFrequency
BLOOD AND LYMPHATIC SYSTEM DISORDERSLymphadenopathyCommon
IMMUNE SYSTEM DISORDERSAnaphylaxis

Hypersensitivity

Unknown

Unknown

METABOLISM AND NUTRITION DISORDERSDecreased appetite

Feeling of dehydration

Common

Common

PSYCHIATRIC DISORDERSInsomnia

Nightmare

Common

Common

NERVOUS SYSTEM DISORDERSHeadache

Light-headedness

Lethargy/Drowsiness

Dizziness

Paresthesia

Hyperesthesia

Syncope

Hypoesthesia

Disturbance in attention

Very common

Very common

Very common

Common

Common

Common

Common

Common

Common

EYE DISORDERSConjunctivitis

Photophobia

Vision blurred

Common

Common

Common

CARDIAC DISORDERSPalpitations

Tachycardia

Common

Unknown

VASCULAR DISORDERSFlushing

Hypotension

Very common

Unknown

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERSNasal congestion

Cough

Pleuritic pain

Dry mouth

Bronchospasm

Dyspnea

Laryngeal discomfort

Epistaxis

Respiratory distress

Hypoxia

Common

Common

Common

Common

Common

Common

Common

Common

Unknown

Unknown

GASTROINTESTINAL DISORDERSAbdominal pain/colic

Nausea

Diarrhoea

Mucosal irritation1

Flatulence

Vomiting

Burning pain (substernal / epigastric)

Constipation

Gingival bleeding

Very common

Very common

Very common

Common

Common

Common

Common

Common

Common

HEPATOBILIARY DISORDERSTransaminases increasedCommon
SKIN AND SUBCUTANEOUS TISSUE DISORDERSRash2

Pruritus

Hyperhidrosis

Erythema multiforme

Drug rash?3

Ulcerations and/or bullae/blistering?4

Angioedema

Urticaria

Burning sensation

Erythema

Very common

Common

Common

Unknown

Unknown

Unknown

Unknown

Unknown

Unknown

Unknown

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERSArthralgia

Back pain

Myalgia

Pain in extremity

Pain in jaw

Common

Common

Common

Common

Common

RENAL AND URINARY DISORDERSDysuria

Acute renal failure

Common

Unknown

GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONSInfusion site reactions

– Infusion site pruritus

– Infusion site rash

– Infusion site pain

– Infusion site erythema

– Infusion site urticaria

– Infusion site swelling

Pyrexia

Influenza-like illness

Rigors

Fatigue

Chest pain

Malaise

Face oedema

Oedema peripheral

Asthenia

Very common

Very common

Very common

Common

Common

Common

Common

Very common

Very common

Common

Common

Common

Common

Unknown

Unknown

Unknown

INVESTIGATIONSActivated partial thromboplastin time prolongedUnknown

1Oral, rectal

2Including nonpruritic, pruritic, erythema/erythematous, eczematous, papular, and/or macular rashes.

3with eosinophilia and systemic symptoms

4mucocutaneous, mucosal, oral, vulvovaginal, anorectal

  • Time to onset and experience with re-exposure

In these studies, some subjects experienced their events on first exposure to mesna and others after the second or third exposure. In general, the complete spectrum of symptoms experienced by a subject developed over a period of several hours.

Some subjects experienced no further reactions after their initial event while others experienced an exacerbation of events upon repeated dosing.

  • Infusion site reactions

In some subjects experiencing local cutaneous infusion site reactions, subsequent exposure to mesna resulted in a cutaneous event in other areas.

  • Cutaneous/mucosal reactions

Cutaneous and mucosal reactions were reported to occur after both intravenous and oral mesna. These reactions included rashes, pruritus, flushing, mucosal irritation, pleuritic pain, and conjunctivitis. Approximately one-quarter of subjects with any event experienced cutaneous/mucosal reactions in conjunction with other adverse symptoms, which included, dyspnea, fever, headache, gastrointestinal symptoms, drowsiness, malaise, myalgia, and influenza-like symptoms.

  • Gastrointestinal reactions

Gastrointestinal reactions reported in healthy subjects included nausea, vomiting, diarrhea, abdominal pain/colic, epigastric pain/burning, constipation, and flatulence and were reported to occur after intravenous and oral mesna administration.

  • In-vivo effect on lymphocyte counts

In pharmacokinetics studies in healthy volunteers, administration of single doses of mesna was commonly associated with a rapid (within 24 hours) and in some cases marked decrease in lymphocyte count, which was generally reversible within 1 week of administration. Data from studies with repeated dosing over several days are insufficient to characterize the time course of lymphocyte count changes under such conditions.

  • In-vivo effect on serum phosphorus levels

In pharmacokinetics studies in healthy volunteers, administration of mesna on single or multiple days was in some cases associated with moderate transient increases in serum phosphorus concentration.

These phenomena should be considered when interpreting laboratory results.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Reports of inadvertent overdose and observations from a high-dose tolerability study in healthy volunteers showed that, in adults, single doses in the range of approximately 4g to 7g of mesna can cause symptoms such as nausea, vomiting, abdominal pain/colic, diarrhoea, headache, fatigue, limb and joint pains, rash, flushing, hypotension, bradycardia, tachycardia, paresthesia, fever, and bronchospasm.

A markedly increased rate of nausea, vomiting and diarrhoea has also been found in oxazaphosphorine-treated patients receiving ? 80 mg mesna per kg per day intravenously compared with patients receiving lower doses or hydration treatment only.

A specific antidote to mesna is not known.

5.PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

is an antidote, and offers the possibility of reliably preventing urotoxic side- effects associated with aggressive cancer chemotherapy using oxazaphosphorine cytostatics. Extensive and wide-ranging pharmacological and toxicological investigations have shown that mesna has no intrinsic pharmacodynamics and low toxicity. The pharmacological and toxicological inertness of mesna administered systemically and its excellent detoxifying effect in the efferent urinary tract and bladder, are due to the nature of its pharmacokinetics.tidote, and offers the possibility of reliably preventing urotoxic side- effects associated with aggressive cancer chemotherapy using oxazaphosphorine cytostatics. Extensive and wide-ranging pharmacological and toxicological investigations have shown that mesna has no intrinsic pharmacodynamics and low toxicity. The pharmacological and toxicological inertness of mesna administered systemically and its excellent detoxifying effect in the efferent urinary tract and bladder, are due to the nature of its pharmacokinetics.

5.2 Pharmacokinetic properties

Mesna, a free thiol, is easily and rapidly transformed by auto-oxidation into its only metabolite mesna-disulphide (dimesna). Dimesna remains in the intravascular compartment and is quickly transported to the kidneys.

In the epithelium of renal tubuli, dimesna is again reduced to the free thiol compound, which is then able to react chemically in the urine with toxic oxazaphosphorine metabolites.

Elimination (being almost exclusively renal) starts immediately after administration. Excretion is as the free thiol (mesna) in the first 4 hours after a single dose, and almost exclusively as the disulphide (dimesna) thereafter. Renal elimination is almost complete after approximately 8 hours.

Approximately 30% of an intravenous dose is bioavailable as free thiol (mesna) in the urine.

5.3 Preclinical safety data

Nothing relevant.

6.PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate, Sodium Hydroxide, Water for Injections

?6.2 Incompatibilities

Mesna is incompatible with platinum derivatives (e.g. Cisplatin, carboplatin and nitrogen mustard) and must not be mixed in the same infusion solution.

Mixing mesna and epirubicin leads to inactivation of epirubicin and should be avoided.

6.3 Shelf life

5 years.

6.4 Special precautions for storage

Store protected from light, below 30?C.

6.5 Nature and contents of container

15 clear glass ampoules containing a clear colourless sterile aqueous solution of mesna in a folded cardboard box. Ampoules contain 4 ml or 10 ml of solution.

6.6 Special precautions for disposal and other handling

No special instructions necessary.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
Survey No.188/1 to 189/1,190/1 to 4,
Athiyawad, Dabhel,
Daman- 396210 (INDIA)

Ifosfamide for Injection IP with Mesna Injection 1000mg/10ml, 2000mg/20ml Taj Pharma
Package leaflet: Information for the patient

Ifosfamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read itagain.
  • If you have any further questions, ask your doctor orpharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harmthem, even if their signs of illness are the same asyours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

 

What is in this leaflet:

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

Important things to know about Ifosfamide Your doctor has prescribed Ifosfamide because you have cancer that can be treated.
Ifosfamide 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 Ifosfamide 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.
Ifosfamide:
? 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.
? can cause mental problems, such as confusion, feeling unusually sleepy and more seriously, fits and loss of consciousness.
? 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 Ifosfamide 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 Ifosfamide that might be especially important for you.

1 WHAT IFOSFAMIDE IS AND WHAT IT IS USED FOR

Ifosfamide 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. Ifosfamide is often used together with other anti-cancer drugs or radiotherapy.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 swelling of the face and lips
? you have a condition which decreases your ability to urinate (Urinary outflow obstruction)
? 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 working
? you have a urinary tract infection, which can be recognised as pain when passing urine (cystitis)
? your liver and kidneys are not working properly. You will have blood tests to check this
? you currently have any infections
? you have ever had kidney or bladder problems as a result of previous chemotherapy or radiotherapy.

Tell your doctor if:
? you are already having, or have recently had, radiotherapy or chemotherapy
? you have liver or kidney problems
? you have been treated with cisplatin
? you have poor general health or are frail
? you are elderly.
If any of the above apply to you your doctor may 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 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 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 about 5 to 10 days after you start taking Ifosfamide 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 check that the 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 important to keep your gums healthy, as mouth ulcers and infections can occur. Ask your doctor about this if you are unsure.
? Ifosfamide can damage the lining of your bladder, causing bleeding into your 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 you as a short injection, or mixed into the drip solution with your Ifosfamide, or as tablets.
? More information on Mesna can be found in the Patient Information Leaflet for Mesna Injection and Mesna tablets.
? Most people having Ifosfamide 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.
? 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 doctor will check your test results for signs of kidney damage.
? 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.
? Ifosfamide can cause damage to your heart or affect the 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 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.
? Ifosfamide 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.
? Ifosfamide can make you feel sick or be sick. This can last for about 24 hours after taking Ifosfamide. 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 Ifosfamide:

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 (used to treat cancer)
? Cisplatin (used to treat cancer)
? Natalizumab (used to treat multiple sclerosis)
medicines that can increase the toxic effects on your heart:
? anthracyclines such as bleomycin, doxorubicin, epirubicin, mitomycin (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:
? Acyclovir (used to treat viruses)
? Aminoglycosides (used to treat bacterial infections)
? Amphotericin B (used to treat fungal infections)
? Carboplatin (used to treat cancer)
? Cisplatin (used to treat cancer)
medicines that can increase the toxic effects on your bladder:
? Busulfan (used to treat cancer)
? Irradiation of the bladder
medicines that can cause additive effects on you central nervous system when combined with ifosfamide
? Antiemetics (used to control vomiting and nausea)
? Antihistamines (used to treat allergic reactions)
? Narcotics
? Sedatives the following
medicines can increase the toxicity of Ifosfamide:
? Carbamazepine, Phenytoin, Phenobarbital (used to treat epilepsy)
? Corticosteroids (used to treat inflammation)
? Rifampin (used to treat bacterial infections)
? St. John?s (a herbal remedy for mild depression)
the following medicines can reduce how effective Ifosfamide is:
? Ketoconazole, Fluconazole, Itraconazole (used to treat bacterial or protozoal infections)
? Sorafenib (used to treat cancer)
? Aprepitant (used to prevent being sick)
other medicines that can affect or be affected by Ifosfamide include:
? Docetaxel (used to treat cancer)
? Coumarins such as warfarin (used to thin the blood)
? Vaccines
? Tamoxifen: (used to treat breast cancer)
? Cisplatin: (used to treat cancer)
? Irinotecan: (used to treat cancer)

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, think you might be pregnant or are trying to become pregnant.
? 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.
? Ifosfamide 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 Ifosfamide. Ask your doctor for advice.

Driving or operating machines
Some of the side effects of treatment with Ifosfamide 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 Ifosfamide.

3 HOW TO TAKE IFOSFAMIDE

Ifosfamide will be given to you by a doctor or nurse.
? Ifosfamide will normally be added to a large bag of fluid and will be slowly injected (infused) directly in to 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, the Injection usually takes several hours but may be given over several days.
? Ifosfamide 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 take it.
? The amount of Ifosfamide you will need to take 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 radiotherapy. Ifosfamide is usually given as a series of courses of treatment. After a course there is a break (a period when 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, Ifosfamide can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Tell your doctor straight away, if you notice any of the following serious side effects:
? getting bruises without knocking yourself, being slow to stop bleeding or bleeding from your nose or gums. This may be a sign that the platelet levels in your blood are getting too low
? 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, or less being passed
? mental state changes. In some people Ifosfamide can affect the brain. Sometimes people on Ifosfamide do not realise that they have been affected but friends and relatives may notice a change in them.

If any of the following side effects are seen your doctor will stop your treatment with Ifosfamide
? mania
? paranoia
? delusion
? delirium
? amnesia
? motionless and unresponsive to stimuli (catatonia)
? panic attack
? inability to speak (mutism)
? repeating words (echolalia)
? being fixed on a task (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 (anaphylactic shock, anaphylactic/anaphylactoid reaction)
? reduction in the effectiveness of your immune system (immunosuppression)
? increased risk and severity of bacterial, fungal, viral, protozoal or parasitic infections due to the effect of ifosfamide 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 the skin around the face, inside of the mouth and throat (angioedema)
? a skin rash of red itchy swellings (urticaria). Cancers
? 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 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). This may be associated with fever (febrile bone marrow aplasia)
? platelets ? which help your blood clot (thrombocytopenia)
? red cells ? which carry oxygen around the body (anaemia, neonatal anaemia, haemolytic anaemia) This may be associated with a decrease in their ability to carry oxygen (methaemoglobinaemia)
? formation of small blood clots in your blood vessels disrupting the normal blood flow around your body (disseminated intravascular coagulation)
? 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
? increase in the release of antidiuretic hormone from the pituitary gland (SIADH). This affects the kidneys causing the low levels of sodium in your blood (hypernatraemia) and water retention.

Metabolism and Nutrition
? loss or decrease of appetite
? changes to your metabolism caused 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, muscle weakness or spasms, depression, psychosis, delirium, confusion, or hallucinations (hypokalaemia)
? low blood levels of calcium which can cause muscle cramps and twitching, irregular heartbeat, overactive reflexes, and burning or tingling sensations in the hands and feet (hypocalcaemia)
? low blood levels of phosphate which can cause bone pain, confusion and muscle weakness (hypophosphataemia)
? high blood sugar levels which can cause thirst, tiredness and irritability (hyperglycaemia)
? excessive thirst that is also accompanied by excessive fluid intake (polydipsia).

Digestive system
? feeling sick and being (nausea, vomiting)
? diarrhoea
? inflammation of the lining of your mouth, including ulcers (stomatitis)
? inflammation of your intestines or bowel (enterocolitis)
? severe tummy and back pain which may be from inflammation of the pancreas (pancreatitis)
? decrease bowel activity which may lead to bowel obstruction (ileus)
? bleeding in your stomach or intestines (gastrointestinal haemorrhage)
? ulceration of the lining of the digestive system (mucosal ulceration)
? constipation
? increased saliva production Nervous System
? a disorder of the nerves which can cause weakness, 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 than 5 minutes, or recurrent seizures without regaining consciousness between seizures for greater than 5 minutes
? 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
? movement disorders and gait disturbances (movement disorder, extrapyramidal disorder, gait disorder)
? effects on the spinal cord (myelopathy), which can cause numbness, weakness and tingling in the hands, loss of motor skills
? pain from your nerves, which can also feel like an aching or burning sensation (neuralgia)
? flapping tremor of the hand (asterixis)
? tingling or numbness, often in the hands or feet (paresthesia)
? loss of sense of touch or sensation (hypoesthesia)
? inability to control bowel movements (faecal incontinence).

Eyes and Ears
? blurring, reduction or loss of sight
? 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
? damage to the heart muscle (cardiotoxicity)
? changes in your heart rhythm (arrhythmia)
? irregular heart beat (atrial fibrillation)
? early heartbeat (premature atrial contractions)
? slower heart beat (bradycardia)
? heart attack (myocardial infarction)
? decrease in your hearts ability to pump enough blood around your body which may be life threatening (cardiac failure or cardiac arrest)
? bleeding in to the muscles of the heart (myocardial haemorrhage)
? chest pain from reduced blood supply to the heart (angina pectoris)
? disease of the heart muscle (cardiomyopathy, congestive cardiomyopathy)
? abnormal ECG heart tracing
? 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 (deep vein thrombosis)
? leaking of fluid from the circulation into surrounding tissues (capillary leak syndrome)
? inflammation of the blood vessels (vasculitis)
? low or high blood pressure (hypotension, hypertension)
? reddening of the skin (flushing).

Lungs
? life-threatening decrease of your lungs ability to transfer oxygen in to your blood (respiratory failure)
? conditions causing inflammation of the lungs which can cause breathlessness, cough and raised temperature or scarring of the lungs (pneumonitis, acute respiratory 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 of breath (dyspnoea)
? decrease levels of oxygen in your body (hypoxia)
? cough

Liver
? a build up of toxins in the body due to liver failure (hepatotoxicity)
? liver failure
? blockage of the small veins in your liver (veno-occlusive liver disease) which can cause weight gain, 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 which can cause jaundice, weight loss and malaise (cytolytic hepatitis).

Skin and Subcutaneous Tissue
? hair loss (alopecia)
? inflammation of this skin which may cause rash, blisters, itching, sores, oozing and scarring (dermatitis)
? skin eruption or reaction consisting of small, round, raised bumps that have clear borders (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 erythrodysesthesia syndrome)
? redness and blistering of the skin appearing months or years after treatment (Radiation recall dermatitis)
? swelling of the face
? 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 bed which can cause nails to fall off
? excessive sweating (hyperhidrosis).

Musculoskeletal and Connective Tissue
? abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
? softening of the bones that could cause severe bone pain, pain caused by slight crack in the bone back pain, partial or complete fractures and muscle weaknesses (osteomalacia, rickets)
? growth retardation
? muscle pain (myalgia) or joint pain (arthralgia)
? muscle twitching.

Renal and Urinary
? inflammation of the bladder lining which causes pain, bleeding, blood in the urine, reduced urine flow (haemorrhagic cystitis)
? blood in the urine (haematuria)
? life threatening decrease in the abilities of your kidney to 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 doctor will do urine tests to test for these
? kidney malfunction causing urine to appear cloudy or murky colour (phosphaturia)
? kidney malfunction leads to excessive urine production and excessive thirst, resulting in deficits of water, calcium, potassium, magnesium, and other substances in the body (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 usually defined 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 some cases this 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 ejaculate of the male (oligospermia).

Congenital, Familial and Genetic Disorders
? reduction in growth, deformity or death of a foetus while in the womb.

General Disorders and Administrative Site Conditions
? inflammation of a vein, usually in the legs (phlebitis)
? fatigue
? feeling of general discomfort or uneasiness (malaise)
? life threatening failure of multiple organs
? general physical deterioration
? appearance of skin changes and irritation at the site of injection or infusion
? swelling
? pain
? fever
? chills.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORE IFOSFAMIDE

Because Ifosfamide 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 this medicine out of the sight and reach of children.
? Do not use Ifosfamide 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 25?C.
Store in the original container.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Ifosfamide contains

The active substance is Ifosfamide.

a) Each lyophilized vial (10ml) contains:
Ifosfamide IP 1000mg
Excipients? ? ? ? q.s.

b) Each lyophilized vial (20ml) contains:
Ifosfamide IP 2000mg
Excipients? ? ? ? q.s.

There are no other ingredients

Contents of the pack

Ifosfamide is a dry white powder supplied in clear glass vials. Each carton contains 1 vial.
The contents of each vial has to be mixed with sterile water (called ?water for injections?) before use.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
at SURVEY NO. 188/1, 190/1TO 4, ATHIYAWAD , DABHEL,
DAMAN- 396210 (INDIA)

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