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Drug overview for ZUSDURI (mitomycin):
Generic name: MITOMYCIN (MYE-toe-MYE-sin)
Drug class:
Therapeutic class: Antineoplastics
Mitomycin is an antineoplastic antibiotic produced by Streptomyces caespitosus.
No enhanced Uses information available for this drug.
Generic name: MITOMYCIN (MYE-toe-MYE-sin)
Drug class:
Therapeutic class: Antineoplastics
Mitomycin is an antineoplastic antibiotic produced by Streptomyces caespitosus.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ZUSDURI (mitomycin) have been approved by the FDA:
Indications:
Non-muscle invasive bladder cancer
Professional Synonyms:
Superficial carcinoma of urinary bladder
Indications:
Non-muscle invasive bladder cancer
Professional Synonyms:
Superficial carcinoma of urinary bladder
The following dosing information is available for ZUSDURI (mitomycin):
Dosage of mitomycin must be based on the clinical and hematologic response and tolerance of the patient and whether other myelosuppressive therapy is also being used to obtain optimum therapeutic results with minimum adverse effects. Clinicians should consult published protocols for the dosage of mitomycin and other chemotherapeutic agents and the method and sequence of administration.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZUSDURI 40 MG VIAL | Maintenance | Adults instill 75 mg by intravesical route once weekly for 6 weeks |
| ZUSDURI SINGLE-DOSE KT(40MGX2) | Maintenance | Adults instill 75 mg by intravesical route once weekly for 6 weeks |
No generic dosing information available.
The following drug interaction information is available for ZUSDURI (mitomycin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ZUSDURI (mitomycin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Lactation |
| Rupture of bladder |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Increased risk of bleeding due to coagulation disorder |
| Pregnancy |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
The following adverse reaction information is available for ZUSDURI (mitomycin):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Urethral stricture Urinary retention |
There are 21 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Anemia Dysuria Eosinophilia Hematuria Hyperkalemia Kidney disease with reduction in glomerular filtration rate (GFr) Lymphopenia Neutropenic disorder Urinary tract infection |
Balanitis Edema of male genital organs Fatigue Genital organ pruritus Increased urinary frequency Pain in penis Swelling of vagina Urethritis Urinary incontinence Urinary urgency Vulvovaginal pain |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ZUSDURI (mitomycin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Mitomycin has produced teratogenic effects in animals. Safe use of mitomycin in pregnant women has not been established.
It is not known whether mitomycin is distributed in milk. Because of the potential for serious adverse reactions to mitomycin in nursing infants, nursing should be discontinued during mitomycin therapy.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ZUSDURI (mitomycin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZUSDURI (mitomycin)'s list of indications:
| Non-muscle invasive bladder cancer | |
| C67.9 | Malignant neoplasm of bladder, unspecified |
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