Note: This document contains side effect information about mitomycin. Some dosage forms listed on this page may not apply to the brand name Jelmyto.

Applies to mitomycin: injection gel/jelly. Other dosage forms:

• intravenous powder for solution

Serious side effects of Jelmyto

Along with its needed effects, mitomycin (the active ingredient contained in Jelmyto) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking mitomycin:

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

Other side effects of Jelmyto

Some side effects of mitomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may 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 or are bothersome or if you have any questions about them:

More common

• Skin itching

For Healthcare Professionals

Applies to mitomycin: compounding powder, intravenous powder for injection, intravesical solution, ureteral kit.

Hematologic

Very common (10% or more): Bone marrow toxicity (64%), thrombocytopenia, leucopenia, pancytopenia, neutropenia, granulocytopenia, erythropenia, microangiopathic hemolytic anemia, myelodysplastic syndrome, thrombotic thrombocytopenic purpura^[Ref]

Other

Very common (10% or more): Fever (14%)

Frequency not reported: Fatigue, edema, pain^[Ref]

Dermatologic

Common (1% to 10%): Allergic skin rash, contact dermatitis, palmar-plantar erythema, pruritus, exanthema, integument and mucous membrane toxicity

Uncommon (0.1% to 1%): Alopecia^[Ref]

Respiratory

Common (1% to 10%): Interstitial pneumonia, dyspnea, cough, shortness of breath

Rare (less than 0.1%): Pulmonary hypertension, pulmonary veno-occlusive disease (PVOD)^[Ref]

Renal

Common (1% to 10%): Renal dysfunction, increase in serum creatinine, glomerulopathy, nephrotoxicity

Rare (less than 0.1%): Hemolytic uremic syndrome (HUS) (commonly fatal), microangiopathic-hemolytic anemia (MAHA syndrome)^[Ref]

Cardiovascular

Rare (less than 0.1%): Heart failure (after previous therapy with anthracyclines)^[Ref]

Gastrointestinal

Very common (10% or more): Anorexia (14%), nausea (14%), vomiting (14%)

Uncommon (0.1% to 1%): Mucositis, stomatitis, diarrhea^[Ref]

Genitourinary

Common (1% to 10%): Cystitis (possibly hemorrhagic), dysuria, nocturia, pollakiuria, hematuria, local irritation of the bladder wall

Very rare (less than 0.01%): Necrotizing cystitis, allergic (eosinophilic) cystitis, stenosis of the efferent urinary tract, reduced bladder capacity, bladder wall calcification, bladder wall fibrosis, bladder perforation

Frequency not reported: Increased frequency of micturition, rash and pruritus on hands and genital area

Postmarketing reports: Bladder fibrosis/contraction rarely requiring cystectomy^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Severe allergic reaction^[Ref]

Immunologic

Rare (0.01% to 0.1%): Life-threatening infection (e.g., bacterial, viral, fungal), sepsis, hemolytic anemia

Frequency not reported: Septic shock^[Ref]

Local

Common (1% to 10%): Following extravasation: Cellulitis, tissue necrosis^[Ref]

Ocular

Frequency not reported: Blurred vision^[Ref]

Psychiatric

Frequency not reported: Confusion^[Ref]

Hepatic

Rare (less than 0.1%): Liver dysfunction, increased transaminases, jaundice, veno-occlusive disease (VOD)^[Ref]

Oncologic

Frequency not reported: Myelodysplastic syndrome, acute myeloid leukemia, acute leukemia^[Ref]

Nervous system

Frequency not reported: Headache, drowsiness, syncope^[Ref]