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Uromitexan Multidose

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Uromitexan Multidose uses


1 INDICATIONS AND USAGE

Uromitexan Multidose is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Limitation of Use:

Uromitexan Multidose is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.

Uromitexan Multidose is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. (1)

Limitation of Use:

Uromitexan Multidose is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. (1)

2 DOSAGE AND ADMINISTRATION

Uromitexan Multidose may be given on a fractionated dosing schedule of three bolus intravenous injections or a single bolus injection followed by two oral administrations of Uromitexan Multidose Tablets as outlined below. The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is adjusted, the ratio of Uromitexan Multidose to ifosfamide should be maintained.


0 Hours

4 Hours

8 Hours

Ifosfamide

1.2 g/m2


--

--

Uromitexan Multidose Injection

240 mg/m2


240 mg/m2


240 mg/m2


0 Hours

2 Hours

6 Hours

Ifosfamide

1.2 g/m2


--

--

Uromitexan Multidose Injection

240 mg/m2


--

--

Uromitexan Multidose Tablets

--

480 mg/m2


480 mg/m2


Maintain sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. (2.3)

2.1 Intravenous Dosing

Uromitexan Multidose may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

Uromitexan Multidose injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of Uromitexan Multidose is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.

0 Hours


4 Hours


8 Hours


Ifosfamide


1.2 g/m2


–

–

Uromitexan Multidose Injection The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of Uromitexan Multidose to ifosfamide should be maintained.


240 mg/m2


240 mg/m2


240 mg/m2

2.2 Intravenous and Oral Dosing

Uromitexan Multidose may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of Uromitexan Multidose tablets as outlined below.

Uromitexan Multidose injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage at the time of ifosfamide administration. Uromitexan Multidose tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of Uromitexan Multidose is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.

0 Hours


2 Hours


6 Hours


Ifosfamide


1.2 g/m2


–

–

Uromitexan Multidose injection The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of Uromitexan Multidose to ifosfamide should be maintained.


240 mg/m2


–

–

Uromitexan Multidose tablets


–

480 mg/m2


480 mg/m2


The efficacy and safety of this ratio of intravenous and oral Uromitexan Multidose has not been established as being effective for daily doses of ifosfamide higher than 2 g/m2.

Patients who vomit within two hours of taking oral Uromitexan Multidose should repeat the dose or receive intravenous Uromitexan Multidose.

2.3 Monitoring for Hematuria

Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when Uromitexan Multidose is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.

2.4 Preparation for Intravenous Administration and Stability

Preparation

Determine the volume of Uromitexan Multidose injection for the intended dose.

Dilute the volume of Uromitexan Multidose injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:


Stability

The Uromitexan Multidose injection multidose vials may be stored and used for up to 8 days after initial puncture.

Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.

Do not mix Uromitexan Multidose injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.

The benzyl alcohol contained in Uromitexan Multidose injection vials can reduce the stability of ifosfamide. Ifosfamide and Uromitexan Multidose 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 Uromitexan Multidose 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.

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

Uromitexan Multidose is contraindicated in patients known to be hypersensitive to Uromitexan Multidose or to any of the excipients.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Uromitexan Multidose may cause systemic hypersensitivity reactions, including anaphylaxis. These reactions may include fever, cardiovascular symptoms (hypotension, tachycardia), acute renal impairment, hypoxia, respiratory distress, urticaria, angioedema, laboratory signs of disseminated intravascular coagulation, hematological abnormalities, increased liver enzymes, nausea, vomiting, arthralgia, and myalgia. These reactions may occur with the first exposure or after several months of exposure. Monitor for signs or symptoms. Discontinue Uromitexan Multidose and provide supportive care.

5.2 Dermatologic Toxicity

Drug rash with eosinophilia and systemic symptoms and bullous and ulcerative skin and mucosal reactions, consistent with Stevens-Johnson syndrome or toxic epidermal necrolysis have occurred. Uromitexan Multidose may cause skin and mucosal reactions characterized by urticaria, rash, erythema, pruritus, burning sensation, angioedema, periorbital edema, flushing and stomatitis. These reactions may occur with the first exposure or after several months of exposure. Discontinue Uromitexan Multidose and provide supportive care.

5.3 Benzyl Alcohol Toxicity

Benzyl alcohol, a preservative in Uromitexan Multidose, has been associated with serious adverse reactions and death in neonates, premature, and low-birth weight infants. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Consider the combined daily metabolic load of benzyl alcohol from all sources when prescribing Uromitexan Multidose (10.4 mg benzyl alcohol per mL). Neonates, premature, and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Monitor patients for signs or symptoms of toxicity. Avoid use in neonates, premature, and low-birth weight infants..

5.4 Laboratory Test Interferences

False-Positive Urine Tests for Ketone Bodies

A false positive test for urinary ketones may arise in patients treated with Uromitexan Multidose when using nitroprusside sodium-based urine tests (including dipstick tests). The addition of glacial acetic acid can be used to differentiate between a false positive result (cherry-red color that fades) and a true positive result (red-violet color that intensifies).

False-Negative Tests for Enzymatic CPK Activity

Uromitexan Multidose may interfere with enzymatic creatinine phosphokinase (CPK) activity tests that use a thiol compound (e.g., N-acetylcysteine) for CPK reactiviation. This may result in a falsely low CPK level.

False-Positive Tests for Ascorbic Acid

Uromitexan Multidose may cause false-positive reactions in Tillman’s reagent-based urine screening tests for ascorbic acid.

5.5 Use in Patients with a History of Adverse Reactions to Thiol Compounds

Uromitexan Multidose is a thiol compound, i.e., a sulfhydryl (SH) group-containing organic compound. Hypersensitivity reactions to Uromitexan Multidose and to amifostine, another thiol compound, have been reported. It is not clear whether patients who experienced an adverse reaction to a thiol compound are at increased risk for a hypersensitivity reaction to Uromitexan Multidose.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling.


The most common adverse reactions (> 10%) when Uromitexan Multidose is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Uromitexan Multidose adverse reaction data are available from four Phase 1 studies in which single intravenous doses of 600-1200 mg Uromitexan Multidose Injection without concurrent chemotherapy were administered to a total of 53 healthy volunteers and single oral doses of 600-2400 mg of Uromitexan Multidose Tablets were administered to a total of 82 healthy volunteers. The most frequently reported side effects (observed in two or more healthy volunteers) for healthy volunteers receiving single doses of Uromitexan Multidose Injection alone were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperesthesia, influenza-like symptoms, and coughing. In two Phase 1 multiple-dose studies where healthy volunteers received Uromitexan Multidose Tablets alone or intravenous Uromitexan Multidose followed by repeated doses of Uromitexan Multidose Tablets, flatulence and rhinitis were reported. In addition, constipation was reported by healthy volunteers who had received repeated doses of intravenous Uromitexan Multidose.

Additional adverse reactions in healthy volunteers receiving Uromitexan Multidose alone included injection site reactions, abdominal pain/colic, epigastric pain/burning, mucosal irritation, lightheadedness, back pain, arthralgia, myalgia, conjunctivitis, nasal congestion, rigors, paresthesia, photophobia, fatigue, lymphadenopathy, extremity pain, malaise, chest pain, dysuria, pleuritic pain, dry mouth, dyspnea, and hyperhidrosis. In healthy volunteers, Uromitexan Multidose was commonly associated with a rapid (within 24 hours) decrease in lymphocyte count, which was generally reversible within one week of administration.

Because Uromitexan Multidose is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to Uromitexan Multidose from those caused by the concomitantly administered cytotoxic agents.

Adverse reactions reasonably associated with Uromitexan Multidose administered intravenously and orally in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 3.


Uromitexan Multidose Regimen

Intravenous-Intravenous-IntravenousIntravenous dosing of ifosfamide and Uromitexan Multidose followed by either intravenous or oral doses of Uromitexan Multidose according to the applicable dosage schedule..


Intravenous-Oral-Oral


N exposed

119 (100.0%)

119 (100%)

Incidence of AEs

101 (84.9%)

106 (89.1%)

Nausea

65 (54.6)

64 (53.8)

Vomiting

35 (29.4)

45 (37.8)

Constipation

28 (23.5)

21 (17.6)

Leukopenia

25 (21.0)

21 (17.6)

Fatigue

24 (20.2)

24 (20.2)

Fever

24 (20.2)

18 (15.1)

Anorexia

21 (17.6)

19 (16.0)

Thrombocytopenia

21 (17.6)

16 (13.4)

Anemia

20 (16.8)

21 (17.6)

Granulocytopenia

16 (13.4)

15 (12.6)

Asthenia

15 (12.6)

21 (17.6)

Abdominal Pain

14 (11.8)

18 (15.1)

Alopecia


12 (10.1)

13 (10.9)

Dyspnea

11 (9.2)

11 (9.2)

Chest Pain

10 (8.4)

11 (9.2)

Hypokalemia

10 (8.4)

11 (9.2)

Diarrhea

9 (7.6)

17 (14.3)

Dizziness

9 (7.6)

5 (4.2)

Headache

9 (7.6)

13 (10.9)

Pain

9 (7.6)

10 (8.4)

Sweating Increased

9 (7.6)

2 (1.7)

Back Pain

8 (6.7)

6 (5.0)

Hematuria

8 (6.7)

7 (5.9)

Injection Site Reaction

8 (6.7)

10 (8.4)

Edema

8 (6.7)

9 (7.6)

Edema Peripheral

8 (6.7)

8 (6.7)

Somnolence

8 (6.7)

12 (10.1)

Anxiety

7 (5.9)

4 (3.4)

Confusion

7 (5.9)

6 (5.0)

Face Edema

6 (5.0)

5 (4.2)

Insomnia

6 (5.0)

11 (9.2)

Coughing

5 (4.2)

10 (8.4)

Dyspepsia

4 (3.4)

6 (5.0)

Hypotension

4 (3.4)

6 (5.0)

Pallor

4 (3.4)

6 (5.0)

Dehydration

3 (2.5)

7 (5.9)

Pneumonia

2 (1.7)

8 (6.7)

Tachycardia

1 (0.8)

7 (5.9)

Flushing

1 (0.8)

6 (5.0)

6.2 Postmarketing Experience

The following adverse reactions have been reported in the postmarketing experience of patients receiving Uromitexan Multidose in combination with ifosfamide or similar drugs, making it difficult to distinguish the adverse reactions which may be due to Uromitexan Multidose from those caused by the concomitantly administered cytotoxic agents. Because these reactions are reported from a population of unknown size, precise estimates of frequency cannot be made.

Cardiovascular: Hypertension

Gastrointestinal: Dysgeusia

Hepatobiliary: Hepatitis

Nervous System: Convulsion

Respiratory: Hemoptysis

7 DRUG INTERACTIONS

No clinical drug interaction studies have been conducted with Uromitexan Multidose.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B.

Risk Summary

There are no studies of Uromitexan Multidose in pregnant women. Reproduction studies performed in rats and rabbits at oral doses approximately 10 times the maximum recommended total daily intravenous-oral-oral human dose on a body surface area basis revealed no evidence of harm to the fetus due to Uromitexan Multidose. The incidence of malformations in human pregnancies has not been established for Uromitexan Multidose. All pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations and 15 to 20% for pregnancy loss. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Uromitexan Multidose or dimesna is excreted in human milk. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Uromitexan Multidose, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness of Uromitexan Multidose in pediatric patients have not been established. Uromitexan Multidose contains benzyl alcohol which has been associated with serious adverse reactions and death in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis and gasping respirations) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates, premature, and low-birth weight infants. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Neonates, premature, and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

8.5 Geriatric Use

Clinical studies of Uromitexan Multidose did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The ratio of ifosfamide to Uromitexan Multidose should remain unchanged.

8.6 Use in Patients with Renal Impairment

No clinical studies were conducted to evaluate the effect of renal impairment on the pharmacokinetics of Uromitexan Multidose.

8.7 Use in Patients with Hepatic Impairment

No clinical studies were conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of Uromitexan Multidose.

10 OVERDOSAGE

There is no known antidote for Uromitexan Multidose.

In a clinical trial, 11 patients received intravenous Uromitexan Multidose 10 mg/kg to 66 mg/kg per day for 3 to 5 days. Patients also received ifosfamide or cyclophosphamide. Adverse reactions included nausea, vomiting, diarrhea and fever. An increased rate of these adverse reactions has also been found in oxazaphosphorine-treated patients receiving ≥80 mg Uromitexan Multidose per kg per day intravenously compared with patients receiving lower doses or hydration treatment only.

Postmarketing, administration of 4.5 g to 6.9 g of Uromitexan Multidose resulted in hypersensitivity reactions including mild hypotension, shortness of breath, asthma exacerbation, rash, and flushing.

11 DESCRIPTION

Uromitexan Multidose is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, Uromitexan Multidose, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows:

HS–CH2–CH2SO3–Na+

Uromitexan Multidose (mesna) injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. Uromitexan Multidose injection contains 100 mg/mL Uromitexan Multidose, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. Uromitexan Multidose Injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5.

Uromitexan Multidose (mesna) tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg Uromitexan Multidose. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Uromitexan Multidose reacts chemically with the urotoxic ifosfamide metabolites, acrolein and 4-hydroxy-ifosfamide, resulting in their detoxification. The first step in the detoxification process is the binding of Uromitexan Multidose to 4-hydroxy-ifosfamide forming a non-urotoxic 4-sulfoethylthioifosfamide. Uromitexan Multidose also binds to the double bonds of acrolein and to other urotoxic metabolites and inhibits their effects on the bladder.

12.3 Pharmacokinetics

Absorption

Following oral administration, peak plasma concentrations were reached within 1.5 to 4 hours and 3 to 7 hours for free Uromitexan Multidose and total Uromitexan Multidose (mesna plus dimesna and mixed disulfides), respectively. Oral bioavailability averaged 58% (range 45 to 71%) for free Uromitexan Multidose and 89% (range 74 to 104%) for total Uromitexan Multidose based on plasma AUC data from 8 healthy volunteers who received 1200 mg oral or intravenous doses.

Food does not affect the urinary availability of orally administered Uromitexan Multidose.

Distribution

Mean apparent volume of distribution (Vd) for Uromitexan Multidose is 0.652 ± 0.242 L/kg after intravenous administration which suggests distribution to total body water (plasma, extracellular fluid, and intracellular water).

Metabolism

Analogous to the physiological cysteine-cystine system, Uromitexan Multidose is rapidly oxidized to its major metabolite, Uromitexan Multidose disulfide (dimesna). Plasma concentrations of Uromitexan Multidose exceed those of dimesna after oral or intravenous administration.

Excretion

Following intravenous administration of a single 800 mg dose, approximately 32% and 33% of the administered dose was eliminated in the urine in 24 hours as Uromitexan Multidose and dimesna, respectively. Mean plasma elimination half-lives of Uromitexan Multidose and dimesna are 0.36 hours and 1.17 hours, respectively. Uromitexan Multidose has a plasma clearance of 1.23 L/h/kg.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Uromitexan Multidose.

Uromitexan Multidose was not genotoxic in the in vitro Ames bacterial mutagenicity assay, the in vitro mammalian lymphocyte chromosomal aberration assay or the in vivo mouse micronucleus assay.

No studies on male or female fertility were conducted. No signs of male or female reproductive organ toxicity were seen in 6-month oral rat studies (≤ 2000 mg/kg/day) or 29-week oral dog studies (520 mg/kg/day) at doses approximately 10-fold higher than the maximum recommended human dose on a body surface area basis.

14 CLINICAL STUDIES

14.1 Intravenous Uromitexan Multidose

Hemorrhagic cystitis produced by ifosfamide is dose dependent. At a dose of 1.2 g/m2 ifosfamide administered daily for 5 days, 16 to 26% of the patients who received conventional uroprophylaxis (high fluid intake, alkalinization of the urine, and the administration of diuretics) developed hematuria (>50 RBC per hpf or macrohematuria) (Studies 1, 2, and 3). In contrast, none of the patients who received Uromitexan Multidose injection together with this dose of ifosfamide developed hematuria (Studies 3 and 4). In two randomized studies, (Studies 5 and 6), higher doses of ifosfamide, from 2 g/m2 to 4 g/m2 administered for 3 to 5 days, produced hematuria in 31 to 100% of the patients. When Uromitexan Multidose was administered together with these doses of ifosfamide, the incidence of hematuria was less than 7%.


Study


Conventional

Uroprophylaxis

(number of patients)


Standard Uromitexan Multidose

Intravenous Regimen

(number of patients)


Uncontrolled Studies Ifosfamide dose 1.2 g/m2 d x 5


Study 1

16% (7/44)

-

Study 2

26% (11/43)

-

Study 3

18% (7/38)

0% (0/21)

Study 4

-

0% (0/32)

Controlled Studies Ifosfamide dose 2 g/m2 to 4 g/m2 d x 3 to 5


Study 5

31% (14/46)

6% (3/46)

Study 6

100% (7/7)

0% (0/8)

14.2 Oral Uromitexan Multidose

Clinical studies comparing recommended intravenous and oral Uromitexan Multidose dosing regimens demonstrated incidences of grade 3 to 4 hematuria of <5%. Study 7 was an open label, randomized, two-way crossover study comparing three intravenous doses with an initial intravenous dose followed by two oral doses of Uromitexan Multidose in patients with cancer treated with ifosfamide at a dose of 1.2 g/m2 to 2.0 g/m2 for 3 to 5 days. Study 8 was a randomized, multicenter study in cancer patients receiving ifosfamide at 2.0 g/m2 for 5 days. In both studies, development of grade 3 or 4 hematuria was the primary efficacy endpoint. The percent of patients developing hematuria in each of these studies is presented in Table 5.


Uromitexan Multidose Dosing Regimen


Study


Standard Intravenous

Regimen

(number of patients)


Intravenous +

Oral Regimen

(number of patients)


Study 7

0% (0/30)

3.6% (1/28)

Study 8

3.7% (1/27)

4.3% (1/23)

16 HOW SUPPLIED/STORAGE AND HANDLING

Uromitexan Multidose (mesna) injection 100 mg/mL


Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)

Uromitexan Multidose (mesna) tablets


Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)

17 PATIENT COUNSELING INFORMATION


Baxter Logo

Uromitexan Multidose (mesna) injection manufactured by:

Uromitexan Multidose (mesna) tablets manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

For Product Inquiry 1800 ANA DRUG (1-800-262-3784)

Made in Germany

Baxter, Uromitexan Multidose, and IFEX are trademarks of Baxter International Inc.

Material No. HA-30-01-447

Patient Information

Uromitexan Multidose (MES-nex)

(mesna)

tablets

Uromitexan Multidose (MES-nex)

(mesna)

injection

What is the most important information I should know about Uromitexan Multidose?

Uromitexan Multidose can cause serious allergic reactions and skin reactions. These side effects can happen the first time you are treated with Uromitexan Multidose, or after several months of treatment with Uromitexan Multidose. Stop treatment with Uromitexan Multidose and call your doctor or go to the nearest hospital emergency room right away if you develop any of the symptoms listed below:


See “What are the possible side effects of Uromitexan Multidose?” for more information about side effects.

What is Uromitexan Multidose?

Uromitexan Multidose is a prescription medicine used to reduce the risk of inflammation and bleeding of the bladder (hemorrhagic cystitis) in people who receive ifosfamide (a medicine used to treat cancer).

Uromitexan Multidose is not for use to reduce the risk of blood in the urine (hematuria) due to other medical conditions.

It is not known if Uromitexan Multidose is safe and effective in children.

Who should not receive Uromitexan Multidose?

Do not take Uromitexan Multidose if you are allergic to Uromitexan Multidose or any of the ingredients in Uromitexan Multidose. See the end of this leaflet for a complete list of ingredients in Uromitexan Multidose.

What should I tell my doctor before receiving Uromitexan Multidose?

Before you receive Uromitexan Multidose, tell your doctor if you:


Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Uromitexan Multidose?


What are the possible side effects of Uromitexan Multidose?

Uromitexan Multidose may cause serious side effects, including:

See “What is the most important information I should know about Uromitexan Multidose?”


The most common side effects of Uromitexan Multidose when given with ifosfamide include:


Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Uromitexan Multidose. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Uromitexan Multidose tablets?


Keep Uromitexan Multidose and all medicines out of the reach of children.

General information about the safe and effective use of Uromitexan Multidose

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Uromitexan Multidose for a condition for which it was not prescribed. Do not give Uromitexan Multidose to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Uromitexan Multidose that is written for health professionals.

For more information, call 1-800-262-3784.

What are the ingredients in Uromitexan Multidose?

Active ingredient: Uromitexan Multidose

Inactive ingredients:

Uromitexan Multidose injection: edetate disodium, sodium hydroxide, and benzyl alcohol as a preservative.

Uromitexan Multidose tablets: calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Baxter and Uromitexan Multidose are trademarks of Baxter International Inc.

Revised: January 2015

Container Label 400 mg Tablets

List 3565-9

Rx only

400 mg

Mesnex®

(mesna) Tablets

Baxter Healthcare

Corporation

460-656-00

Lot-number/Expires:

JMXXX MM.JJJJ

Carton Label 400 mg Tablets

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Uromitexan Multidose

(mesna) Tablets

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Uromitexan Multidose

(mesna) Tablets

Rx only

Each tablet contains 400 mg Uromitexan Multidose.

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)

.

For ORAL ADMINISTRATION

Dosage: See package insert for directions for use. Should not be prescribed without thorough

knowledge of dose, indications, and toxicology as contained in accompanying literature.

Manufactured for:

Baxter Logo

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Uromitexan Multidose

(mesna) Tablets

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Uromitexan Multidose

(mesna) Tablets

Rx only

Each tablet contains 400 mg Uromitexan Multidose.

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)

.

For ORAL ADMINISTRATION

Dosage: See package insert for directions for use. Should not be prescribed without thorough

knowledge of dose, indications, and toxicology as contained in accompanying literature.

Manufactured for:

Baxter Logo

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

460-657-00

Bar Code

N3 6710835659 1

70010157-

1714/943

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Uromitexan Multidose

(mesna) Tablets

C

943

HA-80-01-785

USA

Lot Number/Expires:

2640B4050

JMXXXA MM.JJJJ

Bar Code

Uromitexan Multidose pharmaceutical active ingredients containing related brand and generic drugs:


Uromitexan Multidose available forms, composition, doses:


Uromitexan Multidose destination | category:


Uromitexan Multidose Anatomical Therapeutic Chemical codes:


Uromitexan Multidose pharmaceutical companies:


References

  1. Dailymed."MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Uromitexan Multidose?

Depending on the reaction of the Uromitexan Multidose after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Uromitexan Multidose not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Uromitexan Multidose addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Uromitexan Multidose, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Uromitexan Multidose consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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