Mitomycin (patient information)

Mitomycin (patient information)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

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Overview

Mitomycin (patient information) is an antineoplastic agent that is FDA approved for the treatment of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed.. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Mitomycin (patient information) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mitomycin (patient information) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mitomycin (patient information) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Mitomycin (patient information) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Mitomycin (patient information) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Mitomycin (patient information) in pediatric patients.

Contraindications

There is limited information regarding Mitomycin (patient information) Contraindications in the drug label.

Warnings

There is limited information regarding Mitomycin (patient information) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Mitomycin (patient information) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Mitomycin (patient information) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Mitomycin (patient information) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Mitomycin (patient information) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mitomycin (patient information) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mitomycin (patient information) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mitomycin (patient information) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Mitomycin (patient information) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Mitomycin (patient information) in geriatric settings.

Gender

There is no FDA guidance on the use of Mitomycin (patient information) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mitomycin (patient information) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mitomycin (patient information) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mitomycin (patient information) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mitomycin (patient information) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mitomycin (patient information) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Mitomycin (patient information) Administration in the drug label.

Monitoring

There is limited information regarding Mitomycin (patient information) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mitomycin (patient information) and IV administrations.

Overdosage

There is limited information regarding Mitomycin (patient information) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mitomycin (patient information)
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Mechanism of Action

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. T

Structure

Mitomycin is a blue-violet crystalline powder with the molecular formula of C 15H 18N 4O 5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;

The compound is heat stable, has a high melting point, and is freely soluble in organic solvents.

Pharmacodynamics

There is limited information regarding Mitomycin (patient information) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Mitomycin (patient information) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Mitomycin (patient information) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Mitomycin (patient information) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Mitomycin (patient information) How Supplied in the drug label.

Storage

There is limited information regarding Mitomycin (patient information) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Mitomycin (patient information) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Mitomycin (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Mutamycin

Look-Alike Drug Names

There is limited information regarding Mitomycin (patient information) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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IMPORTANT WARNING:

Mitomycin can cause a decrease in the number of blood cells in your bone marrow. Mitomycin also can cause kidney damage. Your doctor will order certain lab tests to check your response to mitomycin.

About your treatment

Your doctor has ordered the drug mitomycin to help treat your illness. The drug is given by injection into a vein.

This medication is used to treat:

• adenocarcinoma of the stomach and pancreas

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.

Other uses for this medicine

Mitomycin is also used to treat adenocarcinoma of the colon and rectum; squamous cell carcinoma of the head and neck, lungs, and cervix; adenocarcinoma and duct cell carcinoma of the breast; and bladder cancer. Talk to your doctor about the possible risks of using this drug for your condition.

Precautions

Before taking mitomycin

• tell your doctor and pharmacist if you are allergic to mitomycin or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially aspirin and vitamins.
• tell your doctor if you have or have ever had kidney disease.

you should know that mitomycin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin taking this drug. You should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for further details.) Use a reliable method of birth control to prevent pregnancy. Mitomycin may harm the fetus.

• do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.

Side effects

Mild side effects

Side effects from mitomycin are common and include:

• nausea and vomiting
• loss of appetite
• thinned or brittle hair

Severe side effects

Tell your doctor if either of these symptoms is severe or lasts for several hours:

• fatigue or weakness
• mouth blistering

If you experience any of the following symptoms, call your doctor immediately:

• unusual bruising or bleeding
• pain, redness, or swelling at the injection site
• fever
• chills
• sore throat
• cough
• rash
• itching
• difficulty urinating
• swelling of the ankles or feet
• dizziness
• shortness of breath or difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Brand names

• Mutamycin®

Other names

• Mitomycin-C