Mutamycin 40mg Inj, 1 Vial

Mitomycin is an antitumor antibiotic that acts as an alkylating agent. It undergoes enzymatic reduction within the cell to form bifunctional and trifunctional alkylating agents. These active metabolites cross-link DNA, inhibiting DNA synthesis and function. It also inhibits RNA and protein synthesis to a lesser extent. Mitomycin is cell cycle non-specific.

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:

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.
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.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Fatigue and Weakness: Feeling extremely tired or weak.
Anemia: Pale skin.
Respiratory Issues: 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.

IV Infusion-Specific Side Effects:

Skin Infection: Oozing, heat, swelling, redness, or pain at the infusion site.
Tissue Damage: If the medication leaks from the vein, it can cause tissue damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the infusion site.

Bladder-Specific Side Effects:

Bladder Problems: This medication can cause bladder issues, which may lead to bladder removal in severe cases. If you experience blood in your urine, painful urination, or a sudden urge to urinate, contact your doctor immediately.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Common Side Effects: Upset stomach, vomiting, mouth irritation, mouth sores, hair loss, or decreased appetite.
Bladder-Specific Side Effects: Bladder irritation or frequent urination.

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 to this medication, its components, or other substances, including foods and drugs. Describe the symptoms you experienced during any previous allergic reactions.
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
* If you are using this medication for bladder treatment, tell your doctor if you have had a procedure for a bladder tumor within the past 3 weeks

It is essential to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor and pharmacist 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 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 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.

• Live vaccines (due to immunosuppression)

• Other myelosuppressive agents (e.g., other chemotherapy, radiation therapy) - increased risk of severe bone marrow suppression
• Nephrotoxic agents (e.g., aminoglycosides, amphotericin B, cisplatin) - increased risk of renal toxicity, including hemolytic uremic syndrome (HUS)
• Hepatotoxic agents - increased risk of liver toxicity
• Pulmonary toxic agents (e.g., bleomycin) - increased risk of pulmonary toxicity

• Anticoagulants (e.g., warfarin) - potential for increased bleeding risk due to thrombocytopenia
• Immunosuppressants (e.g., cyclosporine, tacrolimus) - increased risk of infection and malignancy

• Not available

• Signs of infection (fever, chills, sore throat)
• Unusual bleeding or bruising (petechiae, ecchymosis, melena)
• Severe fatigue or weakness
• Shortness of breath, cough, or difficulty breathing
• Swelling in legs or ankles
• Changes in urination (decreased output, dark urine)
• Nausea, vomiting, diarrhea
• Mouth sores
• Hair loss
• Skin rash or discoloration

Mitomycin is contraindicated in pregnancy (Category D). It can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception.

It is not known whether mitomycin is excreted in human milk. However, due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during mitomycin therapy and for a period after the last dose (e.g., at least 1 week or as advised by physician).

Safety and effectiveness in pediatric patients have not been established. Use in children is generally not recommended unless in specific clinical trials or for very specific indications where benefits outweigh risks, with extreme caution and close monitoring.

Elderly patients may be at increased risk for toxicity, particularly myelosuppression and renal toxicity, due to age-related decline in organ function. Close monitoring of hematologic, renal, and hepatic parameters 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 delayed and cumulative, with nadir typically occurring 4-6 weeks after administration. Close and prolonged hematologic monitoring is crucial.
• Hemolytic Uremic Syndrome (HUS) is a rare but potentially fatal complication, often occurring after multiple doses. Monitor for signs of microangiopathic hemolytic anemia (e.g., schistocytes on blood smear), thrombocytopenia, and renal failure.
• Pulmonary toxicity (interstitial pneumonitis) is also a serious, though less common, adverse effect. Monitor for new or worsening dyspnea and cough.
• Mitomycin is light-sensitive; protect reconstituted solution from light.
• Intravesical administration for bladder cancer is a common use, but the product (Mutamycin 40mg Inj) is for systemic use. Ensure correct route of administration.

• Other alkylating agents (e.g., cyclophosphamide, cisplatin, carboplatin)
• Other antitumor antibiotics (e.g., doxorubicin, bleomycin)
• Other cytotoxic agents depending on the specific cancer type and stage.

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 to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper 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 amount, and the time it occurred, as this will aid in receiving appropriate treatment.