Jelmyto
Jelmyto (mitomycin) is used to treat adults with low-grade cancers of the kidney and bladder (upper tract urothelial cancer). It’s a gel that’s placed into the upper urinary tract through a nephrostomy tube or urinary catheter. This medication is given by a healthcare professional at a urology office or clinic, first once a week and then later once a month. Side effects can include side pain and blockage in the urinary tract. You also might notice that the color of your urine is blue or purple after your dose.
What is Jelmyto (mitomycin)?
What is Jelmyto (mitomycin) used for?
Low-grade upper tract bladder cancer in adults
How Jelmyto (mitomycin) works
Jelmyto (mitomycin) is an alkylating agent. It’s a type of chemotherapy that interferes with your cells’ ability to make DNA and RNA, the genetic material necessary for cell growth and division. By blocking your cells’ ability to make their genetic material, the medication prevents fast-growing cells (like cancer cells) from spreading.
Jelmyto is a gel form of mitomycin that’s given into the urinary tract so that it reaches your kidneys and bladder. The medication stays in the kidneys and bladder, where it works against the cancer cells, for 4 to 6 hours. Over time, the gel turns into liquid that your body gets rid of through your urine.
Drug Facts
What are the side effects of Jelmyto (mitomycin)?
Common Side Effects
- Blockages in the urinary tract (58%)
- Pain in the sides or lower back (flank pain; 41%)
- Lower blood cell counts (up to 38%)
- Kidney problems (e.g., signs of injury or stress to the kidney on lab tests, kidney failure; up to 38%)
- Blood in the urine (34%)
- Urinary tract infection (34%)
- Stomach pain (28%)
- Low albumin levels in the blood (28%)
- Feeling very tired (27%)
- Nausea (25%)
- Burning or pain with urination (23%)
- Vomiting (20%)
Other Side Effects
- Urinating more often
- Fever
- Chills
- Itchiness
- Lower appetite
- High blood pressure
- Abnormal electrolyte levels in the blood
Serious Side Effects
- Blockages in the urinary tract: pain in the sides and lower back (flank pain), fever, little to no urination
- Low blood cell counts: fever, chills, feeling very tired, unusual bleeding or bruising
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Trouble passing urine
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Jelmyto (mitomycin)
Pros
Given directly into the urinary tract to treat a certain type of bladder cancer
Treatments are once a week at the beginning, and then once a month
A possible treatment option that doesn’t involve surgery
Cons
Can make your urine blue or purple
Must follow specific instructions when you urinate after each dose
Can cause blockages in the urinary tract
Pharmacist tips for Jelmyto (mitomycin)
Your urologist will prescribe sodium bicarbonate tablets for you to help Jelmyto (mitomycin) work better. You’ll typically need to take sodium bicarbonate tablets by mouth the evening before, morning of, and sometimes 30 minutes before each Jelmyto (mitomycin) treatment. Talk with your urologist about how much sodium bicarbonate you should take and when to take it.
Let your urologist know if you take water pills (diuretics), such as furosemide (Lasix) or hydrochlorothiazide. Your urologist might ask you to skip your diuretic medication the day before your Jelmyto (mitomycin) treatment and have you restart it at least 4 hours after you get your cancer treatment.
You’ll get treated with Jelmyto (mitomycin) in a clinic or urologist’s office, where staff are trained in administering the cancer medication. A healthcare professional might give you other medications, including anesthesia, before your Jelmyto (mitomycin) dose to help you feel more comfortable.
After your Jelmyto (mitomycin) treatment, your urine might turn blue or violet. This is normal and it isn’t harmful.
You’ll need to take certain safety precautions when you urinate after each Jelmyto (mitomycin) treatment since you get rid of the medication from your body by urinating it out. Be sure to sit on the toilet when you urinate and flush several times. And wash your hands, inner thighs, and groin with soap and water after you urinate to remove any traces of the medication.
Avoid accidentally getting urine on yourself for at least 6 hours after your Jelmyto (mitomycin) dose. If urine gets on any clothes during this time, wash them right away, separated from other clothes.
Jelmyto (mitomycin) can lower your blood cell counts. This can put you at risk for infections and bleeding. Contact a healthcare professional if you have a fever or chills, feel very tired, or notice any unusual bleeding or bruising.
If you or your partner is able to become pregnant, use reliable birth control to prevent pregnancy while you’re getting treated with Jelmyto (mitomycin). Be sure to continue using birth control for at least 3 months (for males) and for at least 6 months (for females) after your last dose. This medication can cause harm to an unborn baby.
Avoid breastfeeding while you’re getting treatment with Jelmyto (mitomycin) and for at least 1 week after the last dose. There aren’t any studies about how safe the medication is for nursing mothers and their breastfed baby.
Frequently asked questions about Jelmyto (mitomycin)
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What are the risks and warnings for Jelmyto (mitomycin)?
Jelmyto (mitomycin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blockage in the urinary tract
Some people who got treatment with Jelmyto (mitomycin) developed blockages in the urinary tract. Some blockages involved narrowing of the urethra, or the tube that carries urine out of the body. This can lead to swelling in the kidney. In clinical studies, some blockages happened within the first 3 months of treatment, and most required procedures to open up the urinary tract (e.g., stenting).
Let a healthcare professional or your urologist know right away if you have pain in the sides and lower back (flank pain), fever, or little to no urination. These might be signs of a blockage in the urinary tract. If this happens, you’ll probably need to take a break from Jelmyto (mitomycin) treatment. You might need a procedure to open back up the urinary tract.
Low blood cell counts (bone marrow suppression)
Low blood cell counts can happen with Jelmyto (mitomycin) treatment. Having low platelet counts can put you at risk for bleeding, and having low white blood cells can put you at risk for infections.
Before each treatment, your urologist will check your blood cell counts from your blood tests to make sure Jelmyto (mitomycin) is safe for you to get. Your treatment will probably get delayed if your urologist notices that your blood counts are low. They also might make changes to your treatment plan.
Harm to unborn baby
Based on animal studies and on how the medication works, there’s a risk that Jelmyto (mitomycin) can harm an unborn baby. If you’re female and you’re able to become pregnant, use effective birth control during your treatment with Jelmyto (mitomycin) and for 6 months after your last dose. If you’re male and have a partner who could become pregnant, use effective birth control (e.g. condoms) during treatment and for 3 months after your last Jelmyto (mitomycin) dose.
Jelmyto (mitomycin) dosage forms
Typical dosing for Jelmyto (mitomycin)
The typical dose depends on the imaging test results of your urinary tract. Your urologist will use the imaging results to determine the amount of Jelmyto (mitomycin) to give.
In general, Jelmyto (mitomycin) is a 4 mg/mL gel that’s given once a week through a urinary catheter or nephrostomy tube for 6 weeks. The maximum dose is 15 mL (60 mg).
Your urologist will check to see whether the medication has worked well to treat your cancer 3 months after you started Jelmyto (mitomycin). Your urologist might decide to continue Jelmyto (mitomycin) once a month for up to 11 treatment sessions if the medication is working well for you.
Jelmyto (mitomycin) contraindications
Tear (perforation) in the urinary tract or bladder
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References
Best studies we foundAmerican Cancer Society. (2024). Neutropenia (low white blood cell counts).
American Cancer Society. (2024). Thrombocytopenia (low platelet count).
Au, J. L.-S., et al. (2001). Methods to improve efficacy of intravesical mitomycin C: Results of a randomized phase III trial. Journal of the National Cancer Institute.
Chandramohan, S., et al. (n.d.). Nephrostomy. British Society of Interventional Radiology.
Matin, S. F., et al. (2022). Durability of response to primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel: OLYMPUS trial final report. Journal of Urology.
MedlinePlus. (2022). Albumin blood test.
MedlinePlus. (2022). Stent.
MedlinePlus. (2022). Urethral stricture.
MedlinePlus. (2024). Hydronephrosis of one kidney.
National Cancer Institute. (n.d.). Intravenous pyelogram.
National Cancer Institute. (n.d.). Low grade.
National Cancer Institute. (n.d.). Myelosuppression.
Raman, J., et al. (2020). Management of low-grade upper tract urothelial carcinoma: An unmet need. Reviews in Urology.
UroGen Pharma, Inc. (2022). Jelmyto- mitomycin kit [package insert]. DailyMed.
UroGen Pharma, Inc. (2023). What to expect after treatment with Jelmyto.
UroGen Pharma, Inc. (2024). Jelmyto: A treatment plan that works for you.
UroGen Pharma, Inc. (2024). Managing side effects.
UroGen Pharma Ltd. (2020). UroGen Pharma receives U.S. FDA Expedited Approval for Jelmyto™, the first and only non-surgical treatment for patients with low-grade upper tract urothelial cancer. Business Wire.
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