Mitomycin (Injection)

Mitomycin (Injection) is used to treat low-grade upper tract urothelial cancer (LG-UTUC). LG-UTUC is a type of cancer that affects the lining of the upper urinary tract (for example, the lining of the kidney).

Mitomycin works by stopping the growth of cancer cells, which are then eliminated by the body.

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to monitor you closely to ensure that this medicine is working correctly. Blood and urine tests may be needed to check for any unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment with this medicine and for at least 6 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after their last dose. If you think you have become pregnant while receiving this medicine, inform your doctor immediately.

This medicine may cause ureteric obstruction (swelling and narrowing of the tube that carries urine from the kidney to the bladder). Contact your doctor right away if you experience fever, lower back or side pain, or have trouble urinating.

Mitomycin can temporarily reduce the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are specific precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Speak with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

Mitomycin may change the color of your urine to violet or blue. It is advised to do the following after receiving this medicine:

• Avoid skin contact with urine for at least 6 hours.
• Both male and female patients should sit on the toilet when urinating and flush it several times after use.
• Wash your hands, inner thighs, and genital area thoroughly with soap and water after using the bathroom.
• Wash any clothing soiled with urine immediately and separately from other clothing.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how mitomycin injection affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of mitomycin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together with caution. If you are receiving this medicine, it is very important that your healthcare provider knows if you are taking any of the medicines listed below. The following interactions are significant, but this list may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change other medicines you are taking.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Hexaminolevulinate
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Tamoxifen
• Typhoid Vaccine, Live
• Vinblastine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems can affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Blood or bone marrow problems (e.g., neutropenia, thrombocytopenia)—Use with caution, as it may worsen these conditions.

• Kidney disease—Use with caution, as the effects may be stronger due to slower removal of the medicine from the body.

• Perforation (hole or tear) of the bladder or upper urinary tract—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Bladder pain
• Bloody or cloudy urine
• Chest pain
• Chills
• Cough or hoarseness
• Decrease in urine output or decrease in urine-concentrating ability
• Difficult, burning, or painful urination
• Fever
• Frequent urge to urinate
• Lower back or side pain
• Pale skin
• Severe nausea and vomiting
• Sores, ulcers, or white spots on lips or in mouth
• Swollen glands
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Fainting or loss of consciousness
• Fast or irregular breathing
• Lower abdominal or stomach pain
• Swelling of the eyes or eyelids
• Tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Skin itching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In Canada

• mitoMYcin
• Mutamycin

Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given to your kidney through a tube called a catheter (eg, ureteral catheter or nephrostomy tube).

Mitomycin is given once a week for 6 weeks. If this medicine is working properly after 3 months of treatment, you may receive it once a month for 11 months.

Your doctor will tell you to take sodium bicarbonate before each treatment with this medicine. Follow your doctor's instructions about how and when to take this.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.