Mitomycin

What is Mitomycin?

• Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity.

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What are the uses of this medicine?

• Mitomycin is used in combination with other medications to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy.
• Mitomycin for Injection is not recommended as single-agent, primary therapy.

How does this medicine work?

• Mitomycin is an antibiotic that is isolated from the broth of Streptomyces caespitosus.
• Mitomycin belongs to a group of alkylating agents that work by cross-linking the complementary strands found in DNA with absolute specificity and high efficiency for the CpG sequence.
• Once activated by a reduction cascade, a series of spontaneous transformations cause mitomycin to attack DNA twice, resulting in cross-linking of strands of DNA double helix, thereby inhibiting DNA synthesis.
• Mitomycin is non-specific for a particular cell cycle phase but can exert its maximum effect in both the late G as well as the early S-phases.

• It also suppresses RNA and protein synthesis at higher concentrations, hence being useful against some bacteria, spirochetes, and viruses. Lending to its toxic profile, mitomycin has a limited role as an antibiotic.
• Mitomycin also causes chromosomal breaks, thus leading to shortened strands of DNA, which eventually leads to chromosomal damage; this property renders mitomycin a potent carcinogen and teratogen.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have demonstrated a hypersensitive or idiosyncratic reaction to it in the past.
• with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Mitomycin.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• After full hematological recovery from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals:
• 20 mg/m 2 intravenously as a single dose via a functioning intravenous catheter.

Administration:

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
• Mitomycin should be given intravenously only, using care to avoid extravasation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result.
• Each vial contains either mitomycin 5 mg and mannitol 10 mg, mitomycin, 20 mg and mannitol 40 mg or mitomycin 40 mg and mannitol 80 mg. To administer, add Sterile Water for Injection, 10 mL, 40 mL or 80 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As MITOMYCIN injection, powder, lyophilized, for solution

This medicine is available in fallowing brand namesː

• Mitosol
• Mutamycin

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• loss of appetite or weight
• sores in the mouth and throat
• headache
• fainting
• blurred vision
• hair loss
• loss of strength and energy
• rash

This medicine may cause some serious side effects which may include:

• pain, itching, redness, swelling, blisters, or sores on the skin especially near the injection site
• shortness of breath
• difficulty breathing
• fast, irregular, or pounding heartbeat

What special precautions should I follow?

• Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids in patients who had previously or simultaneously received mitomycin. Bronchodilators, steroids and/or oxygen have produced symptomatic relief.
• A few cases of adult respiratory distress syndrome have been reported in patients receiving mitomycin in combination with other chemotherapy and maintained at FlO 2 concentrations greater than 50% perioperatively. Careful attention should be paid to fluid balance and overhydration should be avoided.
• Bladder fibrosis/contraction has been reported with intravesical administration (not an approved route of administration), which in rare cases has required cystectomy.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Safe use of mitomycin in pregnant women has not been established.
• Teratological changes have been noted in animal studies.
• The effect of mitomycin on fertility is unknown.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: MITOMYCIN
• Inactive ingredients: MANNITOL

Who manufactures and distributes this medicine?

• Packager: Accord Healthcare Inc

What should I know about storage and disposal of this medication?

• Store dry powder at 25°C, excursion permitted between 15°C and 30°C, protected from light.
• Avoid excessive heat, over 40 °C (104° F). Protect reconstituted solution from light.
• Store solution under refrigeration 2° to 8 °C (36° to 46°F), discard after 14 days.
• If unrefrigerated, discard after 7 days.

• Dailymed label info on Mitomycin
• FDA Mitomycin

Mitomycin Resources
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