Mutamycin 5mg Inj, 1 Vial

Mitomycin is an antitumor antibiotic that acts as an alkylating agent. It undergoes reductive activation within cells to form bifunctional and trifunctional alkylating metabolites. These metabolites cross-link DNA, primarily at guanine-cytosine rich sequences, inhibiting DNA synthesis and function. It also inhibits RNA and protein synthesis to a lesser extent. Mitomycin is cell cycle non-specific, meaning it is active in all phases of the cell cycle.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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 bruising that worsens, 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 may 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 IV infusion, be aware of the following:

Signs of skin infection: oozing, heat, swelling, redness, or pain at the infusion site.
Tissue damage: if the medication leaks from the vein, it can cause damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the infusion site.

If you're using this medication in the bladder, be aware of the following:

Bladder problems: this medication can cause bladder issues, which may lead to removal of the bladder. Contact your doctor immediately if you experience blood in your urine, painful urination, or a sudden urge to urinate.

Common Side Effects

Most people don't experience severe side effects, but some may occur. 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.

If you're using this medication in the bladder, you may also experience:

Bladder irritation.
Frequent urination.

Reporting Side Effects

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 must inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help determine if it is safe to take this medication with your other treatments. Never start, stop, or change 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, so it is crucial to be cautious and avoid injuries. To reduce the risk of bleeding, use a soft-bristled toothbrush and an electric razor for shaving.

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 essential to use effective birth control while taking this medication. If you become pregnant, notify your doctor immediately.

• Live vaccines (e.g., MMR, varicella, yellow fever): Increased risk of severe infection.
• 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 HUS.
• Pulmonary toxic agents (e.g., bleomycin, carmustine): Increased risk of pulmonary toxicity.

• Warfarin: Potential for increased anticoagulant effect due to bone marrow suppression and reduced platelet count.
• Phenytoin: Mitomycin may decrease phenytoin levels, requiring monitoring.
• Immunosuppressants (e.g., cyclosporine, tacrolimus): Increased risk of infection and myelosuppression.

• Fever, chills, sore throat (signs of infection/myelosuppression)
• Unusual bleeding or bruising (thrombocytopenia)
• Fatigue, pallor, shortness of breath (anemia)
• Nausea, vomiting, diarrhea, mucositis (GI toxicity)
• Skin rash, itching, redness at injection site (extravasation, hypersensitivity)
• Cough, dyspnea, wheezing (pulmonary toxicity)
• Swelling of hands/feet, decreased urine output, dark urine (renal toxicity, HUS)
• Headache, confusion, seizures (rare CNS effects)

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 and to use effective contraception. If the drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, 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 during mitomycin therapy.

Safety and effectiveness in pediatric patients have not been established. Use in children is generally limited to specific protocols for certain solid tumors and is considered off-label. Dosing is typically based on body surface area, but close monitoring for severe toxicities is crucial.

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

• Mitomycin is a potent vesicant; ensure proper IV access and monitor closely for extravasation. If extravasation occurs, discontinue infusion immediately, aspirate residual drug, and consider local injection of sodium thiosulfate.
• The nadir for myelosuppression (especially thrombocytopenia and leukopenia) typically occurs 4-6 weeks after a single dose, which is later than many other chemotherapies. This delayed and cumulative toxicity requires careful monitoring.
• Pulmonary toxicity (interstitial pneumonitis) can be severe and irreversible. Patients presenting with new or worsening cough, dyspnea, or infiltrates on chest X-ray should be evaluated promptly.
• Hemolytic Uremic Syndrome (HUS) is a rare but potentially fatal complication. Early recognition of microangiopathic hemolytic anemia, thrombocytopenia, and renal failure is critical.
• Mitomycin is often used in combination regimens, and its toxicities can be additive with other myelosuppressive or organ-toxic agents.
• Intravesical administration for bladder cancer is a common use, but this route has different systemic absorption and toxicity profiles compared to IV administration.

• Other alkylating agents (e.g., cyclophosphamide, cisplatin, oxaliplatin)
• Antimetabolites (e.g., 5-fluorouracil, capecitabine, gemcitabine)
• Topoisomerase inhibitors (e.g., irinotecan, etoposide)
• Taxanes (e.g., paclitaxel, docetaxel)
• Targeted therapies (e.g., trastuzumab, ramucirumab for gastric cancer)
• Immunotherapy (e.g., pembrolizumab, nivolumab)

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 someone else's medication. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.