Mitosol

Dosage Forms & Strengths

ophthalmic solution

• 0.2mg/vial (contained within entire kit)

Glaucoma Surgery

Indicated for as adjunct to ab externo glaucoma surgery

Sponges provided within the kit should be fully saturated with the entire reconstituted contents (see Administration)

A treatment area approximating 10mm x 6mm +/- 2mm should be treated with mitomycin ophthalmic

Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps

Keep the sponges on the treatment area for 2 minutes, and then remove and copious irrigate surgical site

Administration

Intended for topical application to the surgical site of glaucoma filtration surgery

Not for intraocular administration; if intraocular administration occurs, cell death may lead to corneal infarction, retinal infarction, and ciliary body atrophy

Reconstitution

• Each vial contains a lyophilized mixture of mitomycin 0.2 mg and mannitol 0.4 mg
• To reconstitute, add 1 mL of sterile water for injection, then shake to dissolve
• If product does not dissolve immediately, allow to stand at room temperature until the product dissolves into solution
• Following reconstitution, resulting solution has a pH of 5.0-8.0
• Preparing sponges: See full prescribing information

Stability

• Unreconstituted vials: Store at controlled room temperature (ie, 20-25°C [68-77°F]); avoid excessive heat and protect form light
• Reconstituted vials: When reconstituted to concentration of 0.2 mg/mL, stable for 1 hr at room temperature

Handling & disposal

• Procedures for proper handling and disposal of anticancer drugs should be followed
• Appropriate containment and disposal devices are included in each kit

Pterygium (Orphan)

Prevention of recurrence of pterygium after its surgical excision

Orphan designation sponsor

• Mobius Therapeutics, Inc; 1141 South 7th Street; St. Louis, MO 63104

Corneal Subepithelial Haze (Orphan)

Prevention of corneal subepithelial haze formation following surface ablation laser keratectomy

Orphan designation sponsor

• Mobius Therapeutics, Inc; 1141 South 7th Street; St. Louis, MO 63104

Safety and efficacy not established

Dosage Forms and Strengths

Mitosol® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0. 4.

Mitosol® (mitomycin for solution) is available in a kit containing:

One   Vial containing 0.2 mg mitomycin
One   1 mL syringe (Sterile Water For Injection) with Connector
One   Plunger Rod
One   Vial Adapter with Spike
One   1 mL TB Syringe, Luer Lock
One   Sponge Container
Six   3 mm Absorbent Sponges
Six   6 mm Absorbent Sponges
Six   Half Moon Sponges
One   Instrument Wedge Sponge
One   Alcohol Prep Pad, Sterile
One   Chemotherapy Waste Bag

Three kits are supplied in each carton (NDC 49771-002-03).

Storage and Handling

Store kits at 20° - 25° C (68° - 77° F). Protect from light.

Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed. Appropriate containment and disposal devices are included within the Mitosol® (mitomycin for solution) Kit for Ophthalmic Use.

Manufactured for: Mobius Therapeutics, LLC 4041 Forest Park Avenue St. Louis, MO 63108. Revised 01/2012

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.

Injectable:

• Mitomycin can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising.
• Mitomycin may cause hemolytic uremic syndrome (a potentially life-threatening condition that involves injury to red blood cells, causing anemia and kidney problems). If you experience any of the following symptoms, tell your doctor immediately: red or bloody stools or diarrhea; decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive mitomycin and to check your body's response to mitomycin.

Do not use mitomycin injection if you

• are allergic to it or to any inactive ingredients
• are pregnant

Topical:

Serious side effects with mitomycin include the following:

• Cell Death. Use of mitomycin in high concentrations or use for longer than intended may lead to unintended eye damage including thinning or perforation.
• Hypotony (low eye pressure). The use of mitomycin has been associated with an increased instance of post-operative hypotony.
• Cataract development

Do not use mitomycin eye solution if you

• allergic to it or to any inactive ingredients
• are pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of mitomycin, there are no specific foods that you must exclude from your diet.

The FDA categorizes medications based on safety for use during pregnancy.

Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mitomycin falls into category X. It has been shown that women taking mitomycin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

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

Mitomycin topical eye solution is used to help in glaucoma surgery. This medicine belongs to the group of medicines called antimetabolites.

This medicine is to be applied only by or under the immediate supervision of your doctor.

• If you have an allergy to mitomycin or any other part of Mitosol (mitoMYcin (ophthalmic)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not use this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Mitosol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

In placebo-controlled studies reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 3 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.

In studies with a historical control reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 5 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.

Manufactured for:
Mobius Therapeutics, LLC
1000 Executive Parkway
Suite 224
St. Louis, MO 63141

Vial Label

NDC 49771-002-02

Mitosol®
(mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin for
reconstitution
Protect from light.
Single Use Vial
Dose: See Package Insert.

Rx Only

Store at 20°-25°C (68°-77°F).

Manufactured for:
Mobius Therapeutics, LLC
1000 Executive Parkway
Suite 224
St. Louis, MO 63141

Manufactured by:
Intas Pharmaceuticals Ltd.
Ahmedabad-382 210, INDIA.

Mfg. Lic. No.: G/1026

10 9750 2 658376 INL5021

A healthcare provider will apply Mitosol to your eye(s) during glaucoma surgery.

Glaucoma surgery is usually performed while you are awake. You will be given medicine to numb your eyes and reduce pain or discomfort during your surgery.

If general anesthesia is used for your surgery, you will not be awake during the operation.

Mitosol is a liquid medicine that is applied first to a tray of tiny sponges. The sponges will soak in the mitomycin for at least 60 minutes.

Once the sponges are saturated with mitomycin, your surgeon will place the sponges directly onto your eye.

The sponges will be left in place for 2 minutes and then removed.

After the sponges are removed, your eye will be rinsed thoroughly.

Your doctor may prescribe other eye medications for you to use after surgery. Use all medications as directed. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.