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Mycophenolate Mofetil for Injection USP
How does this medication work? What will it do for me?
Mycophenolate mofetil belongs to the group of medications known as immunosuppressants. It is used in combination with other medications to prevent the rejection of organ transplants by suppressing the body’s natural defense, the immune system. It does this by preventing the formation of a certain type of white blood cell (called lymphocytes) that would normally attack the transplanted organ.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each vial of sterile, white-to-off-white lyophilized powder for I.V. infusion contains the equivalent of mycophenolate mofetil 500 mg as mycophenolate mofetil hydrochloride. Nonmedicinal ingredients: citric acid 5 mg, hydrochloric acid 45.625 mg, polysorbate 80 25 mg, and sodium hydroxide to adjust pH.
How should I use this medication?
Mycophenolate mofetil is usually started as soon as possible following the organ transplant. The dose varies according to circumstances. The dose for children following a kidney transplant is based on body surface area, which takes into account a person’s height and weight.
The medication is usually given twice daily. The 2 doses should be spaced as close to 12 hours apart as possible and at approximately the same time each day. The oral medication should be taken on an empty stomach (1 hour before or 2 hours after meals). If you vomit or have diarrhea after taking mycophenolate mofetil, always call your doctor for further direction. Do not stop taking the medication without first talking with your doctor.
You should leave the capsules and tablets in the blister packs until it is time for your dose. The capsules and tablets should be swallowed whole, and not crushed or chewed.
If using the suspension, be sure to shake the closed bottle well for about 5 seconds before each use. Do not mix the suspension with any liquid. Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Avoid skin contact with damaged capsules or caplets. If any powder from any of the forms of mycophenolate mofetil should get on your skin, quickly wash with soap and water. If the medication comes in contact with your eyes, rinse them thoroughly with water. Use a wet paper towel to wipe up spills.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist for instructions. Do not take a double dose to make up for a missed one.
Store mycophenolate mofetil tablets, capsules, and suspension at room temperature. Protect the tablets from light. Discard any unused portion of mycophenolate mofetil suspension 60 days after mixing.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to mycophenolate or any ingredients of the medication
- are pregnant
- are breast-feeding
- could have children and are not using highly effective birth control
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- difficulty sleeping
- joint pain or stiffness
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- back pain
- blood in the urine
- blood pressure changes
- fever or chills
- muscle cramps
- sore throat
- swelling of feet or lower legs
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- stomach pain
- symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
- white patches on mouth, tongue, or throat
Seek immediate medical attention if any of the following occur:
- chest pain
- difficulty breathing
- sudden, unusual tiredness or shortness of breath
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of bowel perforation (e.g., chills and fever, nausea, severe abdominal pain, vomiting)
- signs of sepsis (blood infection; e.g., fever, dizziness, chills, very high or very low body temperature, low blood pressure, pounding or rapid heartbeat, rapid, shallow breathing)
- symptoms of leukencephalopathy (e.g., seizures, vision loss, trouble thinking clearly, difficulty walking)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Blood donation: People taking mycophenolate should not donate blood during therapy and for at least 6 weeks after stopping this medication.
Bronchiectasis: When mycophenolate mofetil is used in combination with other immunosuppressants, there have been rare reports of bronchiectasis. Bronchiectasis is a condition where there is injury to the walls of the airways, resulting in a decreased ability to clear mucus and an increased risk of infection. If you develop symptoms such as coughing, shortness of breath, or recurrent respiratory infections, let your doctor know as soon as possible.
Drowsiness/reduced alertness: Mycophenolate may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.
Hepatitis reactivation: People who have hepatitis B or C infection that is dormant may experience the infection returning. If you have a history of hepatitis B or C infection, discuss with your doctor how this medication may affect your medical condition, and whether any special monitoring is needed.
Infection: This medication reduces the number of cells that fight infection in the body. Take extra measures to prevent infection, and avoid people with infections if at all possible. Report any signs of infection (e.g., fever, chills, sore throat, painful or difficult urination) to your doctor immediately.
Kidney function: If you have poor kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lymphoma and other malignancies: People taking immunosuppressant medications, such as mycophenolate mofetil, are at increased risk of developing a type of cancer known as lymphoma. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than one specific medication.
Possible warning signs of cancer include a change in bowel or bladder habits, sores that don’t heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough, or persistent and severe headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.
People with phenylketonuria: Mycophenolate mofetil oral suspension (liquid) contains aspartame (0.56 mg of phenylalanine per mL of suspension).
Pure red cell aplasia (PRCA): This medication may cause PRCA, a condition where the bone marrow does not make red blood cells. If you have symptoms of PRCA, such as sudden tiredness or shortness of breath, get immediate medical attention.
Stomach and intestinal problems: Since some people receiving this medication have experienced stomach bleeding, people with existing stomach and intestinal problems should be monitored closely by their doctor while taking this medication. If you notice symptoms of stomach bleeding (e.g., black, tarry stools; vomiting or spitting up blood or material that looks like coffee grounds; blood in the stools), seek immediate medical attention.
Pregnancy: Mycophenolate mofetil should not be used during pregnancy. Severe birth defects and pregnancy loss, including spontaneous abortion, have been reported when babies were exposed to this medication before birth. Women who may become pregnant should have a negative urine or blood pregnancy test within one week before starting this medication.
Two methods of effective birth control (unless abstinence is the chosen method) should be used before the start of treatment with mycophenolate mofetil, during treatment, and for 6 weeks after the medication has been stopped. Consult your doctor immediately if you become pregnant while taking this medication.
If you are a sexually active man whose partner could become pregnant, you should use condoms during and for 13 weeks after stopping treatment. Your partner should also use effective birth control during this time period.
Breast-feeding: It is not known if mycophenolate mofetil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may cause serious side effects for your baby. This medication is not recommended during breast-feeding.
Children: The safety and effectiveness of this medication for children with heart or liver transplants have not been established.
Seniors: Seniors may have a higher risk of side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between mycophenolate mofetil and any of the following:
- antacids containing magnesium and aluminum
- calcium carbonate
- magnesium supplements (magnesium citrate, magnesium sulfate)
- oral contraceptives (birth control pills)
- penicillins (e.g., penicillin, amoxicillin, ampicillin)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mycophenolate-Mofetil-for-Injection-USP