Mitosol

Name: Mitosol

Pharmacology

Mechanism of Action

Inhibits synthesis of deoxyribonucleic acid (DNA); guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking

Cellular RNA and protein synthesis may also be suppressed

Absorption

Systemic exposure following ocular administration is unknown, but is expected to be multiple orders of magnitude lower than those achieved by IV administration

Metabolism

Cleared from ophthalmic tissue after intraoperative topical application and irrigation, as metabolism occurs in other affected tissues; systemic clearance is affected primarily by metabolism in the liver

Elimination

Excretion: Urine 10% (as unchanged)

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Overdose

No information provided.

Side Effects of Mitosol

Injectable:

Common side effects include the following:

  • fever
  • loss of appetite
  • nausea
  • vomiting

Topical:

Common side effects of mitomycin eye solution include serious eye inflammation, loss of sight, cataract.

Mitosol Interactions

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

Be sure to mention if you have every received doxorubicin (Adriamycin, Rubex). Your doctor may need to monitor you carefully for side effects.

Mitosol FDA Warning

Injectable:

Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin.

Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses ≥60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.

The incidence of the syndrome has not been defined.

What should I discuss with my healthcare provider before receiving mitomycin ophthalmic?

You should not be treated with this medicine if you are allergic to mitomycin.

You should not be treated with mitomycin ophthalmic if you are pregnant, or if you think you may be pregnant. Mitomycin could harm the unborn baby or cause birth defects.

Before you receive mitomycin ophthalmic, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

It is not known whether mitomycin ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed after being treated with this medicine. Follow your doctor's instructions about how long after treatment you should wait before you can breast-feed again.

Before Using Mitosol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mitomycin topical eye solution in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mitomycin topical eye solution in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Smallpox Vaccine
  • Tamoxifen
  • Typhoid Vaccine
  • Vinblastine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cataracts or
  • Hypotonia (decreased tension or pressure in the eye) or
  • Lens implant—Use with caution. May increase the likelihood of side effects.

How do I store and/or throw out Mitosol?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Adverse Reactions

Ophthalmic Adverse Reactions

The most frequent adverse reactions to Mitosol® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:

Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctivial necrosis, thin-walled bleb

Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism

Endophthalmitis

Hypotony: choroidal reactions (choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)

Inflammation: iritis, fibrin reaction

Lens: cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae

Retina: retinal pigment epithelial tear, retinal detachment (serous and rhegatogenous)

Scleritis: wound dehiscence

Vascular: hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage

Additional Reactions: macular edema, sclera thinning or ulceration, intraocular lens capture, disk swelling, malignant glaucoma, lacrimal drainage system obstruction, ciliary block, corneal vascularization, visual acuity decrease, cystic conjunctival degeneration, upper eyelid retraction, dislocated implants, severe loss of vision.

What happens if I overdose?

Since Mitosol is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What other drugs will affect Mitosol?

It is not likely that other drugs you take orally or inject will have an effect on mitomycin used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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