Mutamycin 20mg Inj, 1 Vial

Mitomycin is an antitumor antibiotic that acts as an alkylating agent. It undergoes enzymatic reduction (primarily in the liver and tumor cells) to form an activated bifunctional or trifunctional alkylating metabolite. This metabolite then cross-links DNA, inhibiting DNA synthesis and, to a lesser extent, RNA and protein synthesis. It is cell cycle non-specific, but its effects are most pronounced in the late G1 and early S phases.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Feeling extremely tired or weak.
Pale skin.
Shortness of breath, sudden weight gain, or swelling in the arms or legs. Rarely, this medication can cause severe lung problems, which can be life-threatening. If you experience shortness of breath or a cough, contact your doctor immediately.

Additional Side Effects to Watch For

If you're receiving this medication through an IV infusion, watch for signs of skin infection, such as oozing, heat, swelling, redness, or pain. Tell your nurse if you experience any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the infusion site, as this medication can cause tissue damage if it leaks from the vein.

If you're using this medication in the bladder, be aware that bladder problems can occur, and in rare cases, may lead to the need for bladder removal. Contact your doctor immediately if you experience blood in your urine, painful urination, or a sudden urge to urinate.

Common Side Effects

Not everyone will experience side effects, and many people may only have mild symptoms. However, if you're bothered by any of the following side effects or if they persist, contact your doctor:

Upset stomach or vomiting.
Mouth irritation or mouth sores.
Hair loss.
Decreased appetite.
Bladder irritation (if using this medication in the bladder).
* Frequent urination (if using this medication in the bladder).

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

To ensure safe treatment, inform your doctor of the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced with these allergies.
Certain health conditions, including:
+ Bleeding problems or a low platelet count
+ Kidney disease
+ If you are breastfeeding, as you should not breastfeed while taking this medication

Additional Considerations for Bladder Use:

* If you have undergone a procedure for a bladder tumor within the past 3 weeks

It is essential to note that this list is not exhaustive, and you should discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While taking this drug, you may be at a higher risk of developing infections, some of which can be severe or even life-threatening. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or the flu.

You may also experience an increased tendency to bleed easily. To reduce the risk of injury, exercise caution in your daily activities and use a soft toothbrush and an electric razor for personal grooming.

If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or a decrease in appetite, consult your doctor, as they may be able to suggest ways to alleviate these symptoms.

Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Be sure to discuss any concerns or questions you have with your doctor.

Before receiving any vaccinations, consult your doctor, as certain vaccines may not be suitable for use with this medication, either due to an increased risk of infection or reduced vaccine efficacy.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to experiencing side effects.

This drug can cause harm to an unborn baby. If you are of childbearing potential, it is crucial to use effective birth control while taking this medication. If you become pregnant, notify your doctor immediately.

• Other myelosuppressive agents (e.g., other chemotherapy, radiation therapy): Increased risk of severe myelosuppression.
• Nephrotoxic agents (e.g., aminoglycosides, amphotericin B, cisplatin): Increased risk of renal toxicity, including hemolytic uremic syndrome (HUS).
• Pulmonary toxic agents (e.g., bleomycin, carmustine): Increased risk of pulmonary toxicity.
• Live vaccines: Risk of severe infection due to immunosuppression.

• Warfarin: Potential for increased anticoagulant effect (monitor INR).
• Phenytoin: Mitomycin may decrease phenytoin levels (monitor phenytoin levels).
• Immunosuppressants (e.g., cyclosporine, tacrolimus): Increased risk of severe immunosuppression and infection.

• Fever
• Chills
• Sore throat
• Unusual bleeding or bruising
• Fatigue
• Shortness of breath
• Cough
• Swelling of hands/feet
• Decreased urine output
• Dark urine
• Yellowing of skin/eyes (jaundice)
• Pain, redness, or swelling at injection site (extravasation)

Mitomycin is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. It is teratogenic and embryotoxic in animals. Women of childbearing potential should be advised to avoid becoming pregnant during therapy. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus.

It is not known whether mitomycin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from mitomycin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Breastfeeding is generally contraindicated.

Safety and effectiveness in pediatric patients have not been established. Use in pediatric populations is limited to specific oncology protocols where the potential benefits outweigh the significant risks. Dosing is highly individualized and requires specialized expertise.

Elderly patients may be more susceptible to the toxic effects of mitomycin, particularly myelosuppression and renal toxicity. Close monitoring of hematologic, renal, and pulmonary function is essential. Dose adjustments may be necessary based on individual tolerance and organ function.

• Mitomycin is a vesicant; ensure proper IV access and monitor for extravasation. If extravasation occurs, apply cold compresses and consider hyaluronidase.
• Myelosuppression is the dose-limiting toxicity and is often delayed (nadir 4-6 weeks post-dose) and cumulative. Careful monitoring of blood counts is crucial.
• Cumulative doses exceeding 50 mg/m² have been associated with an increased incidence of pulmonary toxicity and hemolytic uremic syndrome (HUS).
• Hemolytic Uremic Syndrome (HUS) is a rare but potentially fatal complication, characterized by microangiopathic hemolytic anemia, thrombocytopenia, and renal failure. Early recognition and discontinuation of the drug are critical.
• Intravesical administration for bladder cancer has a different toxicity profile, primarily local irritation and bladder spasms, with minimal systemic absorption.

• Fluorouracil (5-FU)
• Cisplatin
• Oxaliplatin
• Irinotecan
• Capecitabine
• Gemcitabine
• Doxorubicin
• Epirubicin

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it occurred.