Mitomycin 2 Injection 2mg

INTRODUCTION OF MITOMYCIN 2

MITOMYCIN 2 contains Mitomycin which belongs to a group of medicines called anti-neoplastic agent

WHAT MITOMYCIN 2 IS USED FOR?

• 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)
• It is also used for the prevention of a relapse in the case of superficial urinary bladder
• cancer after the ablation of tissue through the urethra (transurethral resection)

WARNINGS AND PRECAUTIONS

TALK TO DOCTOR

• Are allergic to any of the other ingredients of this medicine
• Are suffering from impaired lung, kidney or liver function
• Are undergoing radiation therapy
• Are being treated with other cytostatics (substances which inhibit cell growth/cell division)
• Have inflammation of the urinary bladder (in case of intravesical administration)
• Have been told that you have bone marrow depression
• Are immunized with live virus vaccine as this increase risk of infection

PREGNANCY & BREAST FEEDING

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine

CHILDREN & ADOLESCENTS

The use of MITOMYCIN 2 in children and adolescents is not recommended

DRIVING & USING MACHINES

It 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 conjunction with alcohol

INTERACTIONS

Tell your doctor if you are taking,

Anti-cancer drugs (used to treat cancer)
Vaccines

DIRECTIONS & FOR USE

• MITOMYCIN 2 must only be given by a doctor or nurse
• It is intended to be used for injection or infusion into a blood vessel (intravenous use) or for introduction into the urinary bladder (intravesical instillation)
• 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 miss your scheduled injection, contact your doctor or nurse
• Do not stop taking this medicine unless your doctor tells you to do so

SIDE EFFECTS OF MITOMYCIN 2

SERIOUS EFFECTS OF MITOMYCIN 2

• Shortness of breath
• Dry cough and crackles during breath-in (interstitial pneumonia)
• Severe renal dysfunction (nephrotoxicity)

COMMON EFFECTS OF MITOMYCIN 2

• 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
• Lung disorders presenting as shortness of breath, dry cough and inspiratory crackles (interstitial pneumonia)
• Dyspnea, 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)
• Inflammation of connective tissue (cellulitis) and death of tissue (tissue necrosis)
• following accidental injection into the surrounding tissue (extravasation)
• 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

UNCOMMON EFFECTS OF MITOMYCIN 2

• Inflammation of a mucous membrane (mucositis)
• Inflammation of the mucosa of the mouth (stomatitis)
• Diarrhoea, fever
• VHair loss (alopecia)
• Loss of appetite (anorexia)

RARE EFFECTS OF MITOMYCIN 2

• Life-threatening infection Blood poisoning (sepsis)
• Decrease in number of red blood cells sometimes together with acute renal dysfunction (hemolytic anemia, microangiopathic-hemolytic anemia), hemolytic uraemic syndrome
  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)
• Liver dysfunction
• Increased levels of liver enzymes (transaminases)
• Widespread skin rash

VERY RARE EFFECTS OF MITOMYCIN 2

• Faintness
• Skin rash or hives, itching
• Swelling of lips
• Face and airway with difficulty in breathing
• Loss of consciousness
• 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)

STORAGE

• Keep this medicine out of reach of children
• Store at a room temperature of 15-25°C