Mitomycin Pyelocalyceal

What is Mitomycin Pyelocalyceal?

• Mitomycin Pyelocalyceal (Jelmyto) is an alkylating drug used for the treatment of adult patients with low-grade UpperTract Urothelial Cancer (LG-UTUC).

Mitomycin

Mitomycin molecule ball

What are the uses of this medicine?

• Mitomycin Pyelocalyceal (Jelmyto) is used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

How does this medicine work?

Mitomycin mechanism2

• Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA).
• The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking.
• At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have a hole or tear (perforation) of your bladder or upper urinary tract.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• diuretics ('water pills')

Is this medicine FDA approved?

• In April 2020, mitomycin gel, sold under the brand name Jelmyto, was approved in the United States for the treatment of low-grade upper tract urothelial cancer (UTUC).
• Urothelial cancer is a cancer of the lining of the urinary system.

How should this medicine be used?

• Administer 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to instillation procedure (total of 3.9 g).

Recommended dosage:

• The dose of JELMYTO to be instilled is 4 mg per mL via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).
• Instill JELMYTO once weekly for six weeks.
• For patients with a complete response 3 months after JELMYTO initiation, JELMYTO instillations may be administered once a month for a maximum of 11 additional instillations.

Administration:

• JELMYTO is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration.
• JELMYTO will be given to you by your healthcare provider.
• You will receive JELMYTO 1 time a week for 6 weeks.
• It is important that you receive all 6 doses of JELMYTO according to your healthcare provider's instructions.
• Your healthcare provider may recommend up to an additional 11 monthly doses.
• JELMYTO is given to your kidney through a tube called a catheter.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As pyelocalyceal solution

This medicine is available in fallowing brand namesː

• JELMYTO

What side effects can this medication cause?

The most common side effects of this medicine include:

• urinary tract infection
• blood in your urine
• side pain
• nausea
• trouble with urination
• kidney problems
• vomiting
• tiredness

JELMYTO may cause serious side effects, including:

• ureteric obstruction
• Bone marrow problems

What special precautions should I follow?

• Ureteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving JELMYTO. Monitor patients for signs and symptoms of ureteric obstruction. Transient or long-term ureteral stents or alternative procedures may be required. Withhold or permanently discontinue JELMYTO based on the severity of the ureteric obstruction.
• The use of JELMYTO can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. Thrombocytopenia and neutropenia may occur. Monitor blood counts. Withhold or permanently discontinue JELMYTO based on the severity.
• Based on findings in animals and mechanism of action, JELMYTO can cause fetal harm when administered to a pregnant woman. Advise of potential risk to a fetus and to use effective contraception.
• Advise women not to breastfeed during treatment with JELMYTO and for 1 week following the last dose
• Advise patients that JELMYTO contains mitomycin which is a violet to blue color and may discolor urine following the instillation procedure.
• Advise patients to avoid contact with urine for at least six hours post-instillation.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• Safety and efficacy in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mitomycin
• Inactive ingredients: hydroxypropyl methylcellulose, mannitol, poloxamer, polyethylene glycol, and water for injection

Who manufactures and distributes this medicine?

Distributed by:

• UroGen Pharma, Inc.
• Princeton, NJ

• JELMYTO® and UroGen® are registered trademarks of UroGen Pharma, Ltd.

What should I know about storage and disposal of this medication?

• Store the JELMYTO carton at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Avoid excessive heat over 40°C (104°F).
• JELMYTO is a cytotoxic drug.
• Follow applicable special handling and disposal procedures

• Dailymed label info on Mitomycin Pyelocalyceal
• FDA Mitomycin Pyelocalyceal