post-title portfolio-title Mitomycin Dry Powder for Injection IP 10mg Taj Pharma 2020-02-14 08:44:04 no no

Mitomycin Dry Powder for Injection IP 10mg Taj Pharma

Overview

INTRODUCTION

Mitomycin 10mg Injection is used in the treatment of certain kinds of cancer of pancreas, breast, lung, and stomach. It can be used alone or in combination with some medicines as part of combination chemotherapy. It works by interfering with the growth of cancer cells, which are eventually destroyed.

Mitomycin 10mg Injection is given as an injection into vein under the supervision of a doctor and should not be self-administered. 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.

The most common side effects of this medicine include anemia (low number of red blood cells), decreased white blood cell count, increased bleeding tendency, loss of appetite, nausea, and vomiting.? If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them.

Before taking this medicine, inform your doctor if you have medical conditions involving blood, kidney, and liver or if you are suffering from any breathing disorder.? This medicine is known to reduce the number of blood cells in your blood thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with kidney, liver and heart function during treatment with this medicine. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.

USES OF MITOMYCIN INJECTION

  • Pancreatic cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Stomach cancer

SIDE EFFECTS OF MITOMYCIN INJECTION

Common

  • Anemia (low number of red blood cells)
  • Decreased white blood cell count
  • Increased bleeding tendency
  • Loss of appetite
  • Nausea
  • Vomiting
  • Feeling of discomfort
  • Low blood platelets
  • Weight loss
  • Rash

HOW TO USE MITOMYCIN INJECTION

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

HOW MITOMYCIN INJECTION WORKS

Mitomycin 10mg Injection is an anti-cancer medication. It works by damaging the genetic material (DNA) of the cancer cells and stops their growth and multiplication.

SAFETY ADVICE

warningsAlcohol

UNSAFE

Mitomycin 10mg Injection may cause excessive drowsiness with alcohol.

warningsPregnancy

UNSAFE

Mitomycin 10mg Injection is highly unsafe to use during pregnancy. Seek your doctor’s advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.

warningsBreastfeeding

CAUTION

Mitomycin 10mg Injection should be used with caution during breastfeeding. Breastfeeding should be held until the treatment of the mother is completed and the drug is eliminated from her body.

warningsDriving

UNSAFE

Mitomycin 10mg Injection may cause side effects which could affect your ability to drive.
Mitomycin 10mg Injection may cause nausea and vomiting and thereby reduce your reaction times to such an extent that the ability to drive a motor vehicle is impaired.

warningsKidney

CAUTION

Mitomycin 10mg Injection should be used with caution in patients with kidney disease. Dose adjustment of Mitomycin 10mg Injection may be needed. Please consult your doctor.
Use of Mitomycin 10mg Injection is not recommended in patients with end-stage kidney disease.

warningsLiver

CAUTION

Mitomycin 10mg Injection should be used with caution in patients with liver disease. Dose adjustment of Mitomycin 10mg Injection may be needed. Please consult your doctor.
Use of Mitomycin 10mg Injection may not be recommended in some patients with liver disease.

Mitomycin Dry Powder for Injection IP 10mg Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

a) Mitomycin dry powder for Injection IP 2mg Taj Pharma
b) Mitomycin dry powder for Injection IP 10mg Taj Pharma
c) Mitomycin dry powder for Injection IP 20mg Taj Pharma
d) Mitomycin dry powder for Injection IP 40mg Taj Pharma

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

a) Each vial contains:
Mitomycin IP? ? ?2mg
Excipients????? q.s

b) Each vial contains:
Mitomycin IP???? 10mg
Excipients????? q.s

c) Each vial contains:
Mitomycin IP????? 20mg
Excipients??????? q.s

d) Each vial contains:
Mitomycin IP????? 40mg
Excipients??????? q.s.

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM????

Powder for solution for injection/infusion or intravesical use

Blue-violet cake or powder.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

Mitomycin is used in palliative tumour therapy.

Mitomycin is administered?intravenously?as monochemotherapy or in combined cytostatic chemotherapy in the case of:

  • advanced metastatic gastric carcinoma
  • advanced and/or metastatic breast cancer

Furthermore mitomycin is administered?intravenously?in combined chemotherapy in the case of:

  • non-small cell bronchial carcinoma
  • advanced pancreatic carcinoma

Intravesical?administration for relapse prevention in superficial urinary bladder carcinoma after transurethral resection.

4.2 Posology and method of administration

Posology

Mitomycin should only be used by doctors experienced in this therapy if there is a strict indication and with continual monitoring of the haematological parameters. It is essential that the injection is administered intravenous. If the medicinal product is injected perivasally, extensive necrosis occurs in the area concerned.

Unless otherwise prescribed, mitomycin is dosed as follows:

Intravenous administration

In cytostatic monochemotherapy mitomycin is usually administered intravenously as a bolus injection. The recommended dosage is 10 – 20 mg/m2?of body surface every 6 – 8 weeks, 8 – 12 mg/m2?of body surface every 3 – 4 weeks or 5-10 mg/m2?of body surface every 1-6 weeks, depending on the therapeutic scheme used.

A dose greater than 20 mg/m2?gives more toxic manifestations without therapeutic benefits. The maximum cumulative dose of mitomycin is 60 mg/m2.

In combination therapy the dosage is considerably lower. Because of the risk of additive myelotoxicity, proven treatment protocols may not be deviated from without a specific reason.

Intravesical administration

In intravesical therapy, 20 – 40 mg of mitomycin in 20 – 40 ml of phosphate buffer pH 7.4 or sodium chloride (0.9%) solution, is instilled weekly into the bladder. The treatment period is 8 to 12 weeks. In the case of intravesical administration the urine pH should be higher than pH 6.

Alternative dose recommendation in the prevention of recurrent superficial bladder tumours is 4-10 mg (0.06-0.15 mg/kg of body weight) instilled into the bladder though a urethral catheter 1 or 3 times per week. The solution should be retained in the bladder for 1-2 hours.

Special population

The dose must be reduced in patients who have undergone extensive previous cytostatic therapy, in case of myelosuppression or in elderly patients.

Older patients

Insufficient data from clinical studies are available concerning the use of mitomycin in patients ?65 years of age.

The product should not be used in patients with renal impairment (see section 4.3)

The product is not recommended in patients with hepatic impairment due to lack efficacy and safety data in this group of patients.

Paediatric population

The safety and efficacy of mitomycin in children aged from 0 to 17 years have not been established.

Method of administration

Mitomycin is intended for intravenous injection or infusion or for intravesical instillation after being dissolved. Partial use is applicable.

For preparation of reconstituted solution, see section 6.6.

Mitomycin 20 mg, powder for solution for injection/infusion or intravesical use may not be reconstituted in water, regardless the method of administration (i.e. intravenous or intravesical)

Notes

  • Mitomycin must not be used in mixed injections.
  • Other injection solutions or infusion solutions must be administered separately.
  • It is essential that the injection is administered intravenous.

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
  • Breastfeeding (see section 4.6)

Systemic therapy

Pancytopenia or isolated leucopoenia/thrombopenia, haemorrhagic diathesis and acute infections are absolute contraindications.

Restrictive or obstructive disturbances to pulmonary ventilation, renal function, liver function and/or a poor general state of health are relative contraindications. Temporal connection with radiotherapy or other cytostatic may be a further contraindication.

Intravesical therapy

Perforation of the bladder wall is an absolute contraindication.

Cystitis is a relative contraindication.

4.4 Special warnings and precautions for use

Due to the toxic effects on the bone marrow of mitomycin, other myelotoxic therapy modalities (in particular other cytostatics, radiation) must be administered with particular caution in order to minimise the risk of additive myelosuppression.

It is essential that the injection is administered intravenous. If the medicinal product is injected perivasally, extensive necrosis occurs in the area concerned. To avoid necrosis following recommendations apply:

  • Always inject into large veins in the arms.
  • Do not directly inject intravenously, but rather into the tube of a good and securely running infusion.
  • Before removing the cannula after central venous administration, flush it through for a few minutes using the infusion in order to release any residual mitomycin.

If extravasation occurs, it is recommended that the area is immediately infiltrated with sodium bicarbonate 8.4% solution, followed by an injection of 4 mg dexamethasone. A systemic injection of 200 mg of Vitamin B6 may be of some value in promoting the regrowth of tissues that have been damaged.

Long-term therapy may result in cumulative bone marrow toxicity. Bone marrow suppression may only manifest itself after a delay, being expressed most strongly after 4 – 6 weeks, accumulating after prolonged use and therefore often requiring an individual dose adjustment.

Elderly patients often have reduced physiological function, bone marrow depression, which may be protracted, so administer mitomycin with special caution in this population while closely monitoring patient’s condition.

Particular caution is required when possible occurrence or aggravation of infectious disease and bleeding tendency.

Mitomycin is a mutagenic and potentially carcinogenic substance in humans. Contact with the skin and mucous membranes is to be avoided.

In the case of pulmonary symptoms, which cannot be attributed to the underlying disease, therapy should be stopped immediately. Pulmonary toxicity can be well treated with steroids.

Therapy should be stopped immediately also if there are symptoms of haemolysis or indications of renal dysfunction (nephrotoxicity).

At doses of > 30 mg of mitomycin/m2?of body surface microangiopathic-haemolytic anaemia has been observed. Close monitoring of renal function is recommended.

New findings suggest a therapeutic trial may be appropriate for the removal of immune complexes that seem to play a significant role in the onset of symptoms by means of staphylococcal protein A.

Occurrence of acute leukaemia (in some cases following preleukaemic phase) and myelodysplastic syndrome has been reported in the patients treated concomitantly with other antineoplastic agents.

Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitomycin. Therefore, live virus vaccines should not be administered during therapy. It is advised to use live virus vaccines with caution after stopping chemotherapy, and vaccinate not sooner than 3 months after the last dose of chemotherapy (see section 4.5).

Recommended check-ups and safety measures in the case of intravenous administration:

Before the start of treatment

  • Complete blood count
  • Pulmonary function test if pre-existing lung dysfunction is suspected
  • Renal function test in order to exclude renal insufficiency
  • Liver function test in order to exclude liver insufficiency

During therapy

  • Regular checks of the blood count
  • Close monitoring of renal function

4.5 Interaction with other medicinal products and other forms of interaction

Myelotoxic interactions with other bone marrow-toxic treatment modalities (especially other cytotoxic medicinal products, radiation) are possible.

Combination with vinca alkaloids or bleomycin may reinforce pulmonary toxicity.

An increased risk of haemolytic-uremic syndrome has been reported in patients receiving a concomitant administration of mitomycin and fluorouracil or tamoxifen.

In animal experiments, pyridoxine hydrochloride (vitamin B6) resulted in the loss of effect of mitomycin.

No injections with live vaccines should be carried out in connection with mitomycin treatment (see section 4.4).

The cardiotoxicity of Adriamycin (doxorubicin) may be reinforced by mitomycin.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of mitomycin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Mitomycin has a mutagenic, teratogenic and carcinogenic effect and therefore may impair the development of an embryo. Mitomycin should not be used during pregnancy. In the case of a vital indication for the treatment of a pregnant patient a medical consultation should be carried out with respect to the risk of the harmful effects on the child, which are associated with the treatment.

Breastfeeding

It is suggested that mitomycin is excreted in breast milk. Due to its proven mutagenic, teratogenic and carcinogenic effects, mitomycin should not be administered during breastfeeding. Breastfeeding women must first discontinue breastfeeding before initiating treatment with mitomycin.

Fertility/ Contraception in males and females

Female patients of a sexually mature age should take contraceptive measures during and up to 6 months after the end of chemotherapy or refrain from sexual intercourse.

Mitomycin has a genetically harmful effect. Men who are being treated with mitomycin are therefore advised not to father a child during treatment and up to 6 months thereafter and to seek advice on the preservation of sperm before the start of therapy due to the possibility of irreversible infertility caused by the therapy with mitomycin.

4.7 Effects on ability to drive and use machines

Even when used in accordance with instructions these medicinal products may cause nausea and vomiting and thereby reduce reaction times to such an extent that the ability to drive a motor vehicle or operate machinery is impaired. This applies even more in connection with alcohol.

4.8 Undesirable effects

Undesirable effects are listed below by system organ class and frequency. Frequencies below are defined as:

Very common (? 1/10), common (? 1/100 to < 1/10), uncommon (? 1/1,000 to < 1/100), rare (? 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data)

Possible side-effects under systemic therapy

The most common side effects of mitomycin administered systemically are gastrointestinal symptoms like nausea and vomiting and bone marrow suppression with leukopenia and mostly dominant thrombocytopenia. This bone marrow suppression occurs in up to 65% of patients.

In up to 10% of patients serious organ toxicity in the form of interstitial pneumonia or nephrotoxicity must be expected.

Mitomycin is potentially hepatotoxic.

Blood and the lymphatic system disordersVery common

Bone marrow suppression, leucopenia thrombocytopenia

Rare

Life-threatening infection, sepsis,

haemolytic anaemia

Immune system disordersVery rare

Severe allergic reaction

Cardiac disordersRare

Heart failure after previous therapy with anthracyclines

Respiratory, thoracic and mediastinal disordersCommon

Interstitial pneumonia, dyspnoe, cough, shortness of breath

Rare

Pulmonary hypertension, pulmonary veno-occlusive disease (PVOD)

Gastrointestinal disordersVery common

Nausea, vomiting,

Uncommon

Mucositis, stomatitis, diarrhoea, anorexia

Hepato-biliary disordersRare

Liver dysfunction, increased transaminases, jaundice, veno-occlusive disease (VOD) of the liver

Skin and subcutaneous tissue disordersCommon

Exanthema, allergic skin rash, contact dermatitis, palmar-plantar erythema

Uncommon

Alopecia

Rare

Generalised exanthema

Renal and urinary disordersCommon

Renal dysfunction, increase in serum creatinine, glomerulopathy, Nephrotoxicity

Rare

Haemolytic uraemic syndrome(HUS) (commonly fatal), microangiopathic-haemolytic anaemia (MAHA syndrome)

General disorders and administration site conditionsCommon

Following Extravasation:

Cellulitis, tissue necrosis

Uncommon

Fever

Possible side-effects under intravesical therapy

Skin and subcutaneous tissue disordersCommon

Pruritus, allergic skin rash, contact dermatitis, Palmar plantar erythrodysaesthesia (PPE)

Rare

Generalised exanthema

Renal and urinary disordersCommon

Cystitis (possibly haemorrhagic), dysuria, nocturia, pollakisuria, hematuria, local irritation of the bladder wall

Very rare

necrotizing cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduction in bladder capacity, bladder wall calcification, and bladder wall fibrosis.

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

In case of overdose severe myelotoxicity or even myelophthisis must be expected, with the full-blown clinical effect only appearing after approximately 2 weeks.

The period until which the number of leucocytes falls to the lowest value may be 4 weeks. Prolonged close haematological monitoring therefore also has to be carried out if an overdose is suspected.

As there are no effective antidotes available, the greatest level of caution is required during each application.

5.PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agent, Other cytotoxic antibiotics

The antibiotic mitomycin is a cytostatic medicinal product from the group of alkylating agents.

Mitomycin is an antibiotic isolated from Streptomyces caespitosus with anti-neoplastic effect. It is present in an inactive form. Activation to a trifunctional alkylating agent is rapid, either at physiological pH in the presence of NADPH in serum or intracellularly in virtually all cells of the body with the exception of the cerebrum, as the blood-brain barrier is not overcome by mitomycin. The 3 alkylating radicals all stem from a quinone, an aziridine and a urethane group. The mechanism of action is based predominantly on the alkylation of DNA (RNA to a lesser extent) with the corresponding inhibition of DNA synthesis. The degree of DNA damage correlates with the clinical effect and is lower in resistant cells than in sensitive ones. As with other alkylating agents, proliferating cells are damaged to a greater extent than those that are in the resting phase (GO) of the cell cycle. Additionally, free peroxide radicals are released, particularly in the case of higher doses, which result in DNA breaks. The release of peroxide radicals is associated with the organ-specific pattern of side-effects.

5.2 Pharmacokinetic properties

After the intravenous administration of 10 – 20 mg/m2?of mitomycin, maximum plasma levels of 0.4 – 3.2 ?g/ml have been measured. The biological half-life is short and is between 40 and 50 minutes. The serum level falls biexponentially, steeply at first within the first 45 minutes, and then more slowly.

After approximately 3 hours the serum levels are usually below the detection limit. The main location for metabolism and elimination is the liver. Accordingly, high concentrations of mitomycin have been found in the gall bladder. Renal excretion plays only a minor role with respect to the elimination.

During intravesical therapy mitomycin is only absorbed in insignificant doses. Nevertheless, a systemic effect cannot be excluded completely.

5.3 Preclinical safety data

In animals, mitomycin is toxic to all proliferating tissues, particularly the cells of the bone marrow and the mucous membrane of the gastrointestinal tract, resulting in the inhibition of spermiogenesis.

Mitomycin has mutagenic, carcinogenic and teratogenic effects which can be demonstrated in corresponding experimental systems.

Local tolerance

Mitomycin causes severe necrosis in the case of paravenous injection or leakage from the blood vessel into surrounding tissue.

6.PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6

6.3 Shelf life

Unopened vial: 2 years

The reconstituted product should be used immediately.

The contents of the vials are intended for single use only. Unused solutions must be discarded.

6.4 Special precautions for storage

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Mitomycin is contained within a amber colored, type I glass vial with a bromo butyl rubber stopper and an aluminium seal.

The 20 mg vials are packaged into cartons containing 1 or 5 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Intravenous use:

Mitomycin 20 mg, powder for solution for injection/infusion or intravesical use may not be reconstituted in water.

The contents of the vial should be reconstituted with saline or 20% glucose solution in a ration of:

20 ml for the 20 mg of mitomycin.

Reconstitution/ Dilution FluidConcentrationpH rangeOsmolality
Saline1.0mg/mL, (Reconstitution)

0.1 mg/mL (Dilution)

4.5 ? 7.5Approx. 290 mOsm/Kg
20% glucose solution1.0mg/mL, (Reconstitution)

0.1 mg/mL (Dilution)

3.5 ? 7.0Approx. 1100 mOsm/Kg

Intravesical use:

Mitomycin 20 mg, powder for solution for injection/infusion or intravesical use may not be reconstituted in water.

The contents of the vial should be reconstituted with saline or phosphate buffer 7.4 in a ration of:

20 ml for the 20 mg of mitomycin.

Reconstitution FluidConcentrationpH rangeOsmolality
Saline1.0 mg/mL4.5 ? 7.5Approx. 290 mOsm/Kg
Phosphate Buffer pH 7.41.0 mg/mL6.0 ? 8.5Approx. 185 mOsm/Kg

Pregnant healthcare personnel should not handle and/or administer drug product. Mitomycin should not be allowed to come into contact with the skin. If it does, it should be washed several times with 8.4% sodium bicarbonate solution, followed by soap and water. Hand creams and emollients should not be used as they may assist the penetration of the drug into the epidermal tissue.

In the event of contact with the eye, it should be rinsed several times with saline solution. It should then be observed for several days for evidence of corneal damage. If necessary, appropriate treatment should be instituted.

The reconstituted solution is clear blue-violet colour free from visible particulate matter.

Any unused product or waste material should be disposed of in accordance with local requirements.

Waste material should be destroyed according to hospital standard procedures applicable to cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA)

Mitomycin Dry Powder for Injection IP 10mg Taj Pharma

Package leaflet: Information for the patient

Mitomycin

?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 Mitomycin is and what it is used for
  2. What you need to know before you take Mitomycin
  3. How to take Mitomycin
  4. Possible sideeffects
  5. How to store Mitomycin
  6. Contents of the pack and other information
1 WHAT MITOMYCIN IS AND WHAT IT IS USED FOR

Mitomycin is a medicine for the treatment of cancer, i.e. a medicine which prevents or considerably delays the division of active cells by influencing their metabolism in various ways.
The therapeutic application of medicinal products for the treatment of cancer is based on the fact that one way in which cancer cells differ from normal cells in the body is that the rate of cell division is increased due to a lack of control of their growth.

Therapeutic Indications
Mitomycin is used in cancer therapy for the relief of symptoms (palliative cancer therapy).

Intravenous application
When administered intravenously it is used in monochemotherapy, i.e. treatment with only one active substance, or in combined cytostatic chemotherapy, i.e. treatment with several active substances. Mitomycin is effective in the case of the following tumours:
? advanced metastatic stomach cancer (stomach carcinoma)
? advanced and/or metastatic breast cancer (breast carcinoma)
? cancer of the respiratory tract (non-small cell bronchial carcinoma)
? advanced cancer of the pancreas (pancreatic carcinoma)

Intravesical application
Application in the urinary bladder (intravesical application) for the prevention of a relapse in the case of superficial urinary bladder cancer after the ablation of tissue through the urethra (transurethral resection).

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE MITOMYCIN

Do not use Mitomycin if you:
? are allergic to mitomycin or any of the other ingredients of this medicine (listed in section 6).
? during breastfeeding
? in the case of systemic administration if you suffer from a major reduction in the number of all types of blood cells (including red and white blood cells as well as platelets [pancytopenia]), or an isolated reduction of white blood cells (leucopenia) or blood platelets (thrombocytopenia), a tendency to bleeding (haemorrhagic diathesis) or acute infections (disease caused by pathogens).
? in the case of intravesical administration (application in the urinary bladder) if you have perforation of the bladder wall

Warnings and precautions

Talk to your doctor or pharmacist before using Mitomycin.
– if you are suffering from impaired lung, kidney or liver function.
– if your general state of health is not good.
– if you are undergoing radiation therapy.
– if you are being treated with other cytostatics (substances which inhibit cell growth/cell division).
– if you have inflammation of the urinary bladder (in case of intravesical administration).
– if you have been told that you have bone marrow depression (your bone marrow is not able to make the blood cells that you need); it may be worse (especially in elderly and during long term treatment with mitomycin); infection may be aggravated due to bone marrow depression and may lead to fatal conditions
– if you are capable to have a baby as mitomycin may affect your ability to have children in the future.
– if you have bleeding tendency and occurrence of infectious disease.
– if you are immunized with live virus vaccine as this increase risk of infection. You will be given the treatment under the supervision of a healthcare professional who is experienced in this particular branch of medicine to minimise any unwanted side effects in the injection site.

Children and adolescents
The use of mitomycin in children and adolescents is not recommended.

Other medicines and Mitomycin
Tell your doctor if you are taking or have recently taken any other medicines or might take any other medicines. Through the additional use of other types of therapy (in particular other anti-cancer medicines, radiation) which also have harmful effects on you, it is possible that the adverse effects of mitomycin will be reinforced.

There are reports from animal experiments that the effect of mitomycin lost, if administered together with Vitamin B6.

You should not get vaccinated, especially with live vaccines during mitomycin treatment. Please note that the above also applies to medications used in the recent past.

Pregnancy, breast-feeding and fertility
Mitomycin should not be used during pregnancy. Your doctor has to evaluate the benefit against the risk of harmful effects on your child, if mitomycin treatment during pregnancy is necessary. Women of child-bearing age should avoid becoming pregnant.

Contraceptive measures must be taken by both male and female patients during and for at least six months after cessation of therapy. Still, if you become pregnant during this period you must immediately inform your doctor.

Breast-feeding must be discontinued before you start to use mitomycin.

Driving and using machines
Even when used in accordance with instructions this medicine may cause nausea and vomiting and thereby reduce your reaction times to such an extent that the ability to drive a motor vehicle or operate machinery is impaired.
This applies in particular in conjunction with alcohol.

3 HOW TO TAKE MITOMYCIN

Mitomycin should only be administered by healthcare professionals experienced in this kind of therapy.

Mitomycin is intended to be used for injection or infusion into a blood vessel (intravenous use) or for introduction into the urinary bladder (intravesical instillation) after being dissolved.

Your doctor will prescribe a dose and treatment regimen that is right for you.

Before you receive mitomycin as injection or infusion into a vein a blood test, check of lung, kidney and liver function is recommended to exclude any diseases, which could worsen during mitomycin therapy.

The needle must remain in the vein while mitomycin is being given. If the needle comes out or becomes loose, or the medicinal product is going into the tissue outside the vein (you may feel discomfort or pain)
– tell the doctor or nurse immediately.

If you are given more Mitomycin than you should
If you have been accidentally given a higher dose you may experience symptoms such as fever, nausea, vomiting and blood disorders. Your doctor may give you supportive treatment for any symptoms that may occur.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects following administration into a vein
Severe allergic reaction (symptoms may include faintness, skin rash or hives, itching, swelling of lips, face and airway with difficulty in breathing, loss of consciousness

?very rare (may affect up to 1 in 10,000 people)
Severe lung disease presenting as shortness of breath, dry cough and crackles during breath-in (interstitial pneumonia) as well as severe renal dysfunction (nephrotoxicity) may occur.
If you notice any of the above reactions please inform your doctor immediately because mitomycin therapy must be stopped.

Very common (may affect more than 1 in 10 people)
? Blood disorders: Inhibition of blood cell production in the bone marrow; decreased number of white blood cells (leucopenia) increasing the risk of infections; decreased number of platelets (thrombocytopenia) causing bruises and bleedings
? Nausea, vomiting

Common (may affect up to 1 in 10 people)
? Lung disorders presenting as shortness of breath, dry cough and inspiratory crackles (interstitial pneumonia)
? Dyspnoea, cough, shortness of breath
? Skin rashes and irritation of the skin
? Numbness, swelling and painful redness on palms and soles (palmar-plantar erythema)
? Kidney disorders (renal dysfunction, nephrotoxicity, glomerulopathy, increased levels of creatinine in the blood) – the kidneys may not be able to work
? Inflammation of connective tissue (cellulitis) and death of tissue (tissue necrosis) following accidental injection into the surrounding tissue (extravasation)

Uncommon (may affect up to 1 in 100 people)
? Inflammation of a mucous membrane (mucositis)
? Inflammation of the mucosa of the mouth (stomatitis)
? Diarrhoea
? Hair loss (alopecia)
? Fever
? Loss of appetite (anorexia)

Rare (may affect up to 1 in 1,000 people)
? Life-threatening infection
? Blood poisoning (sepsis)
? Decrease in number of red blood cells sometimes together with a acute renal dysfunction (haemolytic anaemia, microangiopathic-haemolytic anaemia (MAHA syndrome), Haemolytic uraemic syndrome (HUS)
? Loss of cardiac function (heart failure) after previous therapy with other anti-cancer medicines (anthracyclines)
? Increase in blood pressure in the vasculature of the lungs, e,g, leading to shortness of breath, dizziness and fainting (pulmonary hypertension)
? Obstructive disease of the pulmonary veins (pulmonary veno-occlusive disease [PVOD]
? Liver disease (liver dysfunction)
? Increased levels of liver enzymes (transaminases)
? Yellowing of the skin and whites of the eyes (icterus)
? Blockage of the small veins in the liver (veno-occlusive disease [VOD] of the liver) leading to fluid retention, increased liver size and raised levels of bilirubin in the blood
? Widespread skin rash

Very rare (may affect up to 1 in 10,000 people)
? Severe allergic reaction (symptoms may include faintness, skin rash or hives, itching, swelling of lips, face and airway with difficulty in breathing, loss of consciousness

Possible side effects following installation in the bladder

Common (may affect up to 1 in 10 people)
? Skin rashes (exanthema, allergic skin rash, contact dermatitis)
? Numbness, swelling and painful redness on palms and soles (palmar-plantar erythrodysaesthesia (PPE)/hand-foot syndrome)
? Bladder inflammation (cystitis) – which may be accompanied with blood in the bladder/urine ? Painful urination, excessive frequent urination sometimes over the night (dysuria, pollakisuria, nocturia)
? Blood in urine (hematuria)
? Local irritation of the bladder wall

Rare (may affect up to 1 in 1,000 people)
?Widespread skin rash

Very rare (may affect up to 1 in 10,000 people)
? Severe inflammation of the bladder where portions of the bladder wall may undergo tissue death (allergic cystitis, necrotizing cystitis)
? Stenosis of the efferent urinary tract
? Reduction in bladder capacity
? Hardening of bladder wall (bladder wall calcification, bladder wall fibrosis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5 HOW TO STORE MITOMYCIN

Keep out of the sight and reach of children.
Mitomycin does not require any special storage condition. Use immediately after reconstitution.
Do not use Mitomycin after the expiry date which is stated on the label after ?Exp Date?. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

?6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Mitomycin contains
– The active substance is mitomycin

a) Each vial contains:
Mitomycin IP? ? ?2mg
Excipients????? q.s

b) Each vial contains:
Mitomycin IP???? 10mg
Excipients????? q.s

c) Each vial contains:
Mitomycin IP????? 20mg
Excipients??????? q.s

d) Each vial contains:
Mitomycin IP????? 40mg
Excipients??????? q.s.

– The other ingredient is mannitol

The 10 and 20 mg vials are packaged into cartons containing 1 or 5 vials. The other vials are packaged into cartons containing 1, 5 or 10 vials.

Contents of the pack

Mitomycin Powder for Solution for Injection is a powder which is mixed before injection. It is packaged in glass vials with a rubber stopper and aluminium seal.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA)

 

What people say about our doctor?

Loading…

More from Portfolio

Loading…
  • Megestrol Acetate Tablets IP 40mg Taj Pharma

    Megestrol Acetate Tablets IP 40mg Taj Pharma Overview INTRODUCTION Megestrol Acetate 40 Tablet is used to treat breast cancer and endometrial cancer. It specifically helps treat breast and endometrial cancer that are hormone dependent. It may also be used for treating low appetite and weight loss in patients with advanced cancer or HIV. Megestrol Acetate […]

  • Lenalidamide Hard Capsules IP 20mg Taj Pharma

    Lenalidamide Hard Capsules IP 20mg Taj Pharma Overview INTRODUCTION Lenalidamide 20 Capsule is used in the treatment of multiple myeloma and lepra reaction. This medicine belongs to a group of medicines which affect how your immune system works. Lenalidamide 20 Capsule can be taken with or without food, but try to have it at the […]

  • Imiquimod Cream IP 5% Taj Pharma

    Imiquimod Cream IP 5% Taj Pharma Overview INTRODUCTION Imiquimod Cream IP 5% Taj Pharma is used in the treatment of genital warts, rough and scaly patches that appear due to exposure to the sun and a certain type of skin cancer. It works by triggering the immune system to fight against the virus responsible for […]

  • Everolimus Tablets IP 2.5mg, 5mg, 10mg Taj Pharma

    Everolimus Tablets IP 2.5mg, 5mg, 10mg Taj Pharma Overview INTRODUCTION Everolimus 10mg Tablet is used for the prevention of organ rejection in transplant patients. It regulates the body?s immune response, so the body can accept the new organ. It is also used in combination with other medicines to treat cancers of breast, pancreas, lungs and […]

Latest News on Your Doctor's Blog