Mitocyte ® Mitomycin for Injection USP (Mitomycin C Kyowa powder) 2,10 & 40mg

Mitomycin for Injection

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Mitocyte ® Mitomycin for Injection USP (Mitomycin C Kyowa powder) 2,10 & 40mg

MITOMYCIN IS A CHEMOTHERAPY DRUG USED TO TREAT DIFFERENT CANCERS INCLUDING BREAST, BLADDER, GULLET (OESOPHAGUS), STOMACH, PANCREAS, LUNG AND LIVER CANCERS.

POWDER FOR SOLUTION FOR INJECTION/INFUSION OR INTRAVESICAL USE
BLUE-VIOLET CAKE OR POWDER.

Generic Content- Mitomycin-C, Manufactured By: Taj Pharmaceuticals Ltd., India.
Available as: Mitocyte-C 40 mg, Mitocyte-C 10 mg & Mitocyte-C 2 mg.

What mitomycin C is

Mitomycin C is a chemotherapy drug. It is also called Mitomycin-C Kyowa. It is used on its own or in combination with other treatments for some types of cancer, including
• Bladder cancer
• Breast cancers that have spread
• Cancer of the neck of the womb (cervix)
• Stomach cancer
• Pancreatic cancer
• Lung cancer
• Liver cancer
• Cancer of the food pipe (oesophageal cancer)
It is sometimes used to treat bowel cancer, head and neck cancers, skin cancer and prostate cancer.
You may have it for other types of cancer as part of clinical trials.
How mitomycin C works
Mitomycin C works by sticking the cancer cell’s DNA (the cell’s genetic code) together so that it can't come apart again. The cell can't divide so the cancer cannot grow.
How you have mitomycin C
Mitomycin C is a purple liquid. You have it into your bloodstream (intravenously). You can have it through a thin, short tube (a cannula) put into a vein in your arm each time you have treatment. Or you may have it through a central line, a portacath or a PICC line. These are long, plastic tubes that give the drugs directly into a large vein in your chest. The tube can stay in place throughout the whole course of treatment.
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.

DOSAGE AND DIRECTIONS FOR USE:

There is limited but increasing evidence and concern that personnel involved in preparation and administration of parenteral antineoplastics may be at some risk because of the potential mutagenicity, teratogenicity, and/or carcinogenicity of these agents although the actual risk is unknown. Cautious handling both in the preparation and disposal of antineoplastic agents is recommended. Precautions include:
*	use of a biological containment cabinet during reconstitution and dilution of parenteral medications and wearing of disposable surgical gloves and masks
*	use of proper technique to prevent contamination of the medication, word area, and operator during transfer between containers (including proper training of personnel in this technique)
*	cautious and proper disposal of needles, syringes, vials, ampoules, and unused medication

The safety and efficacy of Mitomycin C in children has not been established. No data are available.
WARNINGS
Mitomycin should be administered under the supervision of a qualifi ed physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate
diagnostic and treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections
in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see “WARNINGS”
and “ADVERSE REACTIONS” Sections).
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic
hemolytic anemia, thrombocytopenia, and irreversible renal failure, has been reported in patients receiving systemic
mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in
combination with other cytotoxic drugs; however, most cases occur at doses ≥ 60 mg of mitomycin. Blood product
transfusion may exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defi ned
Intravenous administration
Intravenously, the dose should be given as slowly as possible and with great care in order to avoid extravasation.
The usual dose is in the range of 4-10 mg (0.06-0.15 mg/kg) given at 1-6 weekly intervals depending on whether other drugs are given in combination and on bone marrow recovery.
In a number of combination schedules, the dose is 10 mg/m2 of body surface area, the course being repeated at intervals for as long as required. A course ranging from 40-80 mg (0.58-1.2 mg/kg) is often required for a satisfactory response when used alone or in combination. A higher dosage course may be given when used alone or as part of a particular combination schedule and total cumulative doses exceeding 2 mg/kg have been given.
Intra-arterial administration
For administration into specific tissues, Mitomycin-C Kyowa can be given by the intra-arterial route directly into the tumours.
Dose reductions
Because of cumulative myelosuppression, patients should be fully re-evaluated after each course and the dose reduced if the patient has experienced any toxic effects. Doses greater than 0.6 mg/kg have not been shown to be more effective and are more toxic than lower doses.

Disease progression
If disease progression continues after two courses of treatment, the drug should be stopped since the chances of response are minimal.
Shelf life
Mitomycin-C 2 mg: 4 years
Mitomycin-C 10 mg: 4 years
Mitomycin-C 20 mg: 3 years
Mitomycin-C 40 mg: 2 years
After reconstitution, the solution is chemically and physically stable for 24 hours when protected from light and stored in a cool place. Do not refrigerate.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Special precautions for storage
Store in the original package.
The reconstituted solution should be protected from light and stored in a cool place

Mitomycin-C Kyowa is contained within a colourless, type I or III glass vial with a rubber stopper and an aluminium seal.
The 10, 20 and 40 mg vials are packaged into cardboard cartons containing 1 or 5 vials. The 2 mg vials are packaged into cardboard trays with an overwrap containing 10 vials.

Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals Mitomycin for Injection

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

Treat various types of cancer (such as stomach/pancreas cancer). It works by slowing or stopping the growth of cancer cells.

Mitomycin for Injection USP

Prescription Products (Rx)

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