Mesna oral / injection

You should not use this medicine if you are allergic to mesna or similar medicines.

To make sure mesna is safe for you, tell your doctor if you have:

• an allergy to any medicine that contains sulfur;

• an autoimmune disorder such as lupus or rheumatoid arthritis; or

• if you are being treated with a cancer medicine called cyclophosphamide.

FDA pregnancy category B. Mesna is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether mesna passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

Call your doctor for instructions if you miss a dose of mesna.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Usual Adult Dose for Hemorrhagic Cystitis Prophylaxis:

Mesna may be given on a fractionated dosing schedule of either 3 bolus IV injections or a single injection followed by 2 oral doses. The IV formulation is administered at 20% of the ifosfamide dose while the oral formulation is administered at 40% of the ifosfamide dose.

IV: Mesna is given at 20% of the ifosfamide dose once at the time of ifosfamide administration and 20% of the ifosfamide dose 4 and 8 hours after each dose of ifosfamide (e.g., if ifosfamide were given at 1.2 g/m2, the dose of mesna would be 240 mg/m2 given at 0, 4, and 8 hours after ifosfamide)

ORAL (to be given after one dose of IV mesna): Mesna is given at 40% of the ifosfamide dose at 2 and 6 hours after each dose of ifosfamide (e.g., if ifosfamide were given at 1.2 g/m2, the IV dose of mesna would be 240 mg/m2 given at the time of ifosfamide administration and the oral dose of this drug would be 480 mg/m2 given at 2 and 6 hours after ifosfamide)

Comments:
-In order to maintain adequate protection, the recommended dosage regimen should be repeated on each day that ifosfamide is administered.
-When the dosage of ifosfamide is adjusted (either increased or decreased), the dose of mesna should also be modified accordingly.
-Adequate hydration and sufficient urinary output should be maintained, as required for ifosfamide treatment, and urine should be monitored for the presence of hematuria. If severe hematuria develops when mesna is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

Use: A prophylactic agent to reduce the incidence of ifosfamide-induced hemorrhagic cystitis

Data not available

Data not available

Stability:
-The multidose vials may be stored and used for up to 8 days after initial puncture.
-Store diluted solutions at 25°C (77°F) and use within 24 hours.

General:
-Do not mix mesna injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.
-The benzyl alcohol contained in mesna injection vials can reduce the stability of ifosfamide. Ifosfamide and mesna may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with mesna and may reduce the stability of ifosfamide.
-Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.


PATIENT COUNSELING INFORMATION
-Advise the patient to discontinue mesna and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction, including systemic anaphylactic reactions occur.
-Advise the patient to take mesna at the exact time and in the exact amount as prescribed.
-Advise the patient to contact their healthcare provider if they vomit within 2 hours of taking oral mesna, or if they miss a dose of oral mesna.
-Mesna does not prevent hemorrhagic cystitis in all patients nor does it prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide.
-Advise the patient to report to their healthcare provider if his/her urine has turned a pink or red color.
-Advise the patient to drink 1 to 2 liters of fluid each day during mesna therapy.
-Advise the patient that Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions have occurred. Advise the patient to report to their healthcare provider if signs and symptoms of these syndromes occur.

Reproduction studies in animals at oral doses approximately 10 times the maximum recommended total daily human dose on a body surface area basis revealed no evidence of harm to the fetus. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Benefit should outweigh risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B