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Renodapt (Mycophenolate Mofetil)
Product Highlights
Renodapt (mycophenolate mofetil) belongs to a group of medicines known as immunosuppressants. It is used to lower the body's natural immunity in patients who receive organ transplants (for example, kidney, liver and heart). When a patient receives an organ transplant the body's defense cells will try to reject the transplanted organ. Renodapt works by preventing the defense cells from getting rid of the transplanted organ.
Indication
Renodapt is used as a prophylaxis to prevent transplant rejection in organ transplantation and as a rescue therapy in patients with rejection episodes.
Composition
250mg capsules, 500mg and 750mg tablets
Dosage
This medicine should be taken on an empty stomach.
The medicine is to be taken only as directed by your doctor. The dosage of this medicine is different for different patients. Follow your doctor's advice. Do not take more or less than the dosage prescribed by your doctor. Taking too much may increase the chance of side effects while taking too little may lead to rejection of your transplanted organ.
To remember to take your medicine, try to get into the habit of taking it at the same time each day. The amount of medicine that you take will depend on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses and the duration of the recommended dosage depends on the medical problem for which you are using the medicine.
Do not stop taking this medicine without first checking with your doctor. Your physician will use the results of tests and your physical examination to decide how long you should take this medicine.
The capsules or tablets of mycophenolate should be swallowed whole. The tablets should not be crushed and the capsules should not be opened. It is important that other people should not be exposed to the mycophenolate powder.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosage schedule. Do not take double doses.
Drug Interactions
Your doctor may already be aware of possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with your doctor. This drug should not be used with the following medications because very serious interactions may occur: azathioprine, cholestyramine, colestipol, live vaccines, and natalizumab.
Before using prescription and nonprescription/ herbal products like: antacids containing aluminum and/or magnesium, antivirals (e.g., acyclovir, ganciclovir, valganciclovir), calcium-free phosphate binders (e.g., aluminum products, lanthanum, sevelamer), or rifampin consult your doctor.
Mycophenolate mofetil may decrease the effectiveness of combination-type birth control pills by decreasing the amount of certain hormones in your system. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor for details.
This document does not contain all possible interactions. Therefore, before using this product tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share the list with your doctor.
Side Effects and Precautions
During mycophenolate mofetil treatment you may experience any of the following side effects: infection, constipation, nausea, headache, dizziness, diarrhea, vomiting, stomach upset, loss of appetite, gas, tremor, or trouble in sleeping. If any of these effects persist or worsen, notify your doctor promptly.
Also, contact your doctor immediately in case any of these unlikely but serious side effects occur: unusual tiredness, irregular heartbeat, muscle weakness, easy bleeding/ bruising, swelling of the feet or ankles, mental/ mood changes, weakness on one side of the body. Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/ abdominal pain, black/ tarry stools, vomit that looks like coffee grounds, shortness of breath, decrease in urination.
A very serious allergic reaction to this drug is unlikely. However, seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, and trouble breathing. Mycophenolate decreases the body's ability to protect against illness and infection and may also increase your risk of developing lymph node tumors (lymphoma) and other types of tumors. Therefore, this medication must only be given under close medical supervision.
Note: If there are any signs of organ rejection like decreased urination, retention of fluid in the body, increased blood level of creatinine or blood urea, please contact your doctor immediately.
Caution in women of child-bearing age
Women who take MMF during pregnancy have a higher risk of losing a pregnancy (miscarriage) during the first 3 months (first trimester) and a higher risk that their baby will be born with birth defects. If you are a female and are able to become pregnant:
- Your doctor will discuss with you about effective birth control methods (contraceptive counseling)
- You should have a negative pregnancy test within 1 week before you start to take MMF
- You must use two different types of effective birth control at the same time for 4 weeks before you start taking MMF, during your entire MMF therapy and for 6 weeks after stopping MMF unless you choose to avoid sexual intercourse completely (abstinence).
MMF decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take MMF and you could become pregnant. If you plan to become pregnant, talk with your doctor.
Your doctor will decide if other medicines to prevent rejection may be right for you. In certain situations you and your doctor provider may decide that taking MMF is more important to your health than the possible risks to your unborn baby.
If you get pregnant while taking MMF, inform your doctor immediately.
Increased risk of getting serious infections
MMF weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with MMF and can lead to death. Types of infections can include:
Viral infections: Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with MMF include: Shingles, other herpes infections and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections.
BK virus: BK virus can affect how your kidney works and cause your transplanted kidney to fail.
A brain infection called Progressive Multifocal Leukoencephalopathy (PML): In some patients MMF may cause an infection of the brain that may cause death. You are at risk for this brain infection because you have a weakened immune system. You should tell your doctor if you have any of the following symptoms:
- Weakness on one side of the body
- Disinterest about things that you usually care about (apathy)
- You are confused or have problems thinking
- You cannot control your muscles
Fungal infections: Yeasts and other types of fungal infections can happen with MMF and can cause serious tissue and blood infections
Inform your doctor immediately if you have any of the following signs and symptoms of infection
- Temperature of 100.5°F or greater
- Cold symptoms, such as a runny nose or sore throat
- Flu symptoms such as an upset stomach, stomach pain, vomiting or diarrhea
- Earache or headache
- Pain during urination
- White patches in the mouth or throat
- Unexpected bruising or bleeding
- Cuts, scrapes or incisions that are red, warm and oozing pus
Increased risk of getting certain cancers: People who take MMF have a higher risk of getting lymphoma and other cancers especially skin cancer. Inform your doctor if you have:
- Unexplained fever, prolonged tiredness, weight loss or lymph node swelling
- Brown or black skin lesion with uneven borders
- Change in the size and color of a mole
- New skin lesion or bump
- Any other changes to your health
This is not a complete list of possible side effects. If you notice any other effects other than those listed above, contact your doctor immediately.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Prevent freezing and keep out of reach of children. Do not keep outdated medicine or medicine no longer required.
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