Mesnex (Oral)

Mesna is used to reduce the risk of inflammation and bleeding of the bladder (hemorrhagic cystitis) in patients who are treated with ifosfamide (cancer medicine).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine is used together with ifosfamide. Ifosfamide can harm your unborn baby while you are pregnant. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use an effective form of birth control during treatment with this medicine in combination with ifosfamide and for 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include: changes in facial skin color, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. It may affect the results of certain medical tests.

In deciding to use a medicine, you and your doctor need to consider the risks against the benefits. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to find out how mesna affects children. Safety and effectiveness in children have not been established.

Geriatric

Research has not shown any specific problems in older adults that would limit the effectiveness of mesna. However, older patients are more likely to have age-related liver, kidney, and heart issues, which may require caution and a dose adjustment for those taking mesna.

Breast Feeding

Studies indicate that this medication may change milk production or its composition. If you do not receive a different medication, you should watch the infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be taken together at all, while others can be used together even if there may be an interaction. In such cases, your doctor might want to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while on this medicine. The following interactions are important and are not necessarily a complete list.

Using this medicine with any of the following medications may increase the risk of certain side effects, but it may be necessary to use both. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to tell your doctor about any other medical problems you have, especially:

• Allergy to thiol compounds (e.g., amifostine), history of—Use with caution. May increase the risk of an allergic reaction happening again.

Along with its necessary effects, Mesnex (Oral) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine
• Chest pain
• Chills
• Cough
• Decreased urination
• Dizziness
• Dry mouth
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Increased thirst
• Lightheadedness
• Loss of appetite
• Mood changes
• Muscle pain or cramps
• Nausea
• Numbness or tingling in the hands, feet, or lips
• Painful or difficult urination
• Pinpoint red spots on the skin
• Rapid breathing
• Rapid weight gain
• Seizures
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Sunken eyes
• Swelling
• Swollen glands
• Tightness in the chest
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting
• Wrinkled skin

Less common

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up quickly from a lying or sitting position
• Sweating

Incidence not known

• Coughing or spitting up blood
• Dark urine
• General tiredness and weakness
• Headache
• Light-colored stools
• Nervousness
• Pounding in the ears
• Slow or fast heartbeat
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Mesnex (Oral). Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• Difficulty having a bowel movement
• Hair loss
• Lack or loss of strength
• Sleepiness or unusual drowsiness
• Stomach pain
• Weight loss

Less common

• Back pain
• Belching
• Feeling of warmth
• Heartburn
• Increased sweating
• Indigestion
• Redness of the face, neck, arms, and occasionally, upper chest
• Stomach discomfort or upset
• Trouble sleeping

Incidence not known

• Change or loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Mesnex

Available Dosage Forms:

• Tablet

Therapeutic Class: Hemorrhagic Cystitis Inhibitor

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Drink extra fluids (1 to 2 liters per day) so you will pass more urine while you are using this medicine. This may help prevent bladder and kidney problems.

If you vomit within 2 hours after you take this medicine, call your doctor right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For prevention of hemorrhagic cystitis: Adults—Dose must be determined by your doctor. Your dose will usually be taken 2 hours and 6 hours after each dose of ifosfamide. Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.