MYCOPHENOLATE MOFETIL - mycophenolate mofetil powder, for suspension 
Ascend Laboratories, LLC

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SPL MEDGUIDE


Mycophenolate Mofetil for oral suspension USP 200 mg/ml
(mye" koe fen' oh late moe' fe til)

Read the Medication Guide that comes with mycophenolate mofetil for oral suspension before you start taking it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about mycophenolate mofetil for oral suspension?
Mycophenolate mofetil for oral suspension can cause serious side effects:

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolate mofetil for oral suspension during pregnancy have a higher risk of 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 who can become pregnant:

your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking mycophenolate mofetil for oral suspension.

you should have one pregnancy test immediately before starting mycophenolate mofetil for oral suspension and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.

you must use acceptable birth control during your entire mycophenolate mofetil for oral suspension therapy and for 6 weeks after stopping mycophenolate mofetil for oral suspension, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely.


Mycophenolate mofetil for oral suspension 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 mycophenolate mofetil for oral suspension, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil for oral suspension you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil for oral suspension.
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.

If you become pregnant while taking mycophenolate mofetil for oral suspension, do not stop taking mycophenolate mofetil for oral suspension. Call your doctor right away. In certain situations, you and your doctor may decide that taking mycophenolate mofetil for oral suspension is more important to your health than the possible risks to your unborn baby.

•  You and your doctor should report your pregnancy to

•  Mycophenolate Pregnancy Registry (1-800-617-8191)


The purpose of this registry is to gather information about the health of you and your baby.

Increased risk of getting serious infections. Mycophenolate mofetil weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil and can lead to death. These serious infections can include:

Viral infections. Certain viruses can live in your body and cause active infection when your immune system is weak. Viral infections that can happen with mycophenolate mofetil for oral suspension 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.

Hepatitis B and C viruses.  Hepatitis viruses can affect how your liver works. Talk to your doctor about how hepatitis viruses may affect you.

A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil 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 right away if you have any of the following symptoms.

Weakness on one side of the body

You do not care about things that you usually care about (apathy)

You are confused or have problems thinking

You can not control your muscles

Fungal infections. Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections (see “What are the possible side effects of mycophenolate mofetil for oral suspension?”)



Call your doctor right away 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 mycophenolate mofetil have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:

unexplained fever, prolonged tiredness, weight loss or lymph node swelling

a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other

a change in the size and color of a mole

a new skin lesion or bump

any other changes to your health


See the section “What are the possible side effects of mycophenolate mofetil for oral suspension?” for information about other serious side effects.
What is mycophenolate mofetil for oral suspension?
Mycophenolate mofetil for oral suspension is a prescription medicine to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant. Rejection is when the body’s immune system perceives the new organ as a “foreign” threat and attacks it.
Mycophenolate mofetil for oral suspension are used with other medicines called cyclosporines (Sandimmune®, Gengraf®, Neoral®) and corticosteroids.
Mycophenolate mofetil for oral suspension has been used safely and works in children who received a kidney transplant as it does in adults. It is not known if Mycophenolate mofetil for oral suspension is safe and works in children who receive a heart or liver transplant.

Who should not take mycophenolate mofetil for oral suspension?
Do not take mycophenolate mofetil for oral suspension if you are allergic to mycophenolate mofetil or any of the ingredients in mycophenolate mofetil for oral suspension. See the end of this Medication Guide for a complete list of ingredients in mycophenolate mofetil for oral suspension.

What should I tell my doctor before taking mycophenolate mofetil for oral suspension?
Tell your doctor about all of your medical conditions, if you:

have any digestive problems,such as ulcers

have Phenylketonuria (PKU). Mycophenolate mofetil oral suspension contains aspartame (a source of phenylalanine)

have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil if you have one of these disorders

plan to receive any vaccines. People taking mycophenolate mofetil for oral suspension should not take live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil for oral suspension.

are pregnant or are planning to become pregnant. See “What is the most important information I should know about mycophenolate mofetil for oral suspension?”

are breastfeeding or plan to breastfeed. It is not known if mycophenolate mofetil passes into breast milk. You and your doctor will decide if you will take mycophenolate mofetil for oral suspension or breastfeed.


Tell your healthcare provider about all of the medicines you are taking including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect the way mycophenolate mofetil for oral suspension works, and mycophenolate mofetil for oral suspension may affect how some medicines work. Especially tell your doctor if you take:


birth control pills (oral contraceptives). See “What is the most important information I should know about mycophenolate mofetil for oral suspension?”

sevelamer (Renagel®, Renvela™). These products should be taken 2 hours after taking mycophenolate mofetil for oral suspension

Acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (Cytovene®-IV, Vitrasert®), valganciclovir (Valcyte®)

rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)

antacids that contain magnesium and aluminum (mycophenolate mofetil for oral suspension and the antacid should not be taken at the same time)

proton pump inhibitors (PPIs) (Prevacid®, Protonix®)

sulfamethoxazole/trimethoprim (BACTRIM™, BACTRIM DS™)

norfloxacin (Noroxin®) and metronidazole (Flagyl®, Flagyl® ER, Flagyl® IV, Metro IV, Helidac®, Pylera™)

ciprofloxacin (Cipro®, Cipro® XR, Ciloxan®, Proquin® XR) and amoxicillin plus clavulanic acid (Augmentin®, Augmentin XR™)

azathioprine (Azasan®, Imuran®)

cholestyramine (Questran Light®, Questran®, Locholest Light, Locholest, Prevalite®)


Know the medicines you take. Keep a list of them to show to your doctor or nurse and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

How should I take mycophenolate mofetil for oral suspension?

Take mycophenolate mofetil for oral suspension exactly as prescribed

Do not stop taking mycophenolate mofetil for oral suspension or change the dose unless your doctor tells you to

If you miss a dose of mycophenolate mofetil for oral suspension, or are not sure when you took your last dose, take the regular amount of mycophenolate mofetil for oral suspension prescribed as soon as you remember. If it is time for your next dose, skip the missed dose and take your next dose at your normal scheduled time. Do not take 2 doses at the same time. Call your doctor if you are not sure what to do

Take mycophenolate mofetil for oral suspension on an empty stomach, either 1 hour before or 2 hours after a meal, unless your healthcare provider tells you otherwise. With the approval of your healthcare provider, in stable kidney transplant patients, mycophenolate mofetil for oral suspension can be taken with food if necessary

Most people take mycophenolate mofetil by mouth. Some people may get mycophenolate mofetil for oral suspension soon after their transplant surgery as an infusion into a vein.

If you are not able to swallow mycophenolate mofetil tablets or capsules, your doctor may prescribe mycophenolate mofetil oral suspension. This is a liquid form of mycophenolate mofetil. Your pharmacist will mix the medicine before giving it to you.

Do not mix mycophenolate mofetil for oral suspension with any other medicine.

If you take too much mycophenolate mofetil for oral suspension, call your doctor or the poison control center right away


What should I avoid while taking mycophenolate mofetil for oral suspension?

Avoid pregnancy. See “What is the most important information I should know about mycophenolate mofetil for oral suspension?”

Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take mycophenolate mofetil have a higher risk of getting skin cancer. (See What is the most important information I should know about mycophenolate mofetil for oral suspension?”) Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if your skin is very fair or if you have a family history of skin cancer


What are the possible side effects of mycophenolate mofetil for oral suspension?
Mycophenolate mofetil for oral suspension can cause serious side effects:

See  ''What is the most important information I should know about mycophenolate mofetil for oral suspension?''

Low blood cell counts . People taking high doses of mycophenolate mofetil each day may have a decrease in blood counts, including

white blood cells, especially neutrophils .Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 3 months to 6 months after your transplant

red blood cells . Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low

platelets . Platelets help with blood clotting


Your doctor will do blood tests before you start taking mycophenolate mofetil for oral suspension and during treatment with mycophenolate mofetil for oral suspension to check your blood cell counts.
Tell your doctor right away if you have any signs of infection (see ''What is the most important information I should know about mycophenolate mofetil for oral suspension?'').or any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.

•  Stomach problems. Stomach and intestinal bleeding can happen in people who take high doses of mycophenolate mofetil for oral suspension. Bleeding can be severe and you may have to be hospitalized for treatment


Common side effects include:


diarrhea. Call your doctor right away if you have diarrhea. Do not stop taking mycophenolate mofetil for oral suspension without first talking with your doctor

vomiting

pain

stomach area pain

swelling of the lower legs, ankles and feet

high blood pressure


Side effects that happen more often in children than in adults taking mycophenolate mofetil for oral suspension include:



stomach area pain

 • sore throat

fever

 • colds (respiratory tract infections)

infection

 • high blood pressure

pain

• low white blood cell count

 blood infection (sepsis)

• low red blood cell count

diarrhea

 

vomiting

 


These are not all of the possible side effects of mycophenolate mofetil for oral suspension. Tell your doctor about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1800-FDA-1088.

How should I store mycophenolate mofetil for oral suspension?

Store the prepared mycophenolate mofetil for oral suspension at room temperature, between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store mycophenolate mofetil for oral Suspension in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze mycophenolate mofetil for oral suspension.

•  Keep mycophenolate mofetil for oral suspension and all medicines  out of the reach  of  children.


General information about mycophenolate mofetil for oral suspension
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for oral suspension for a condition for which it was not prescribed. Do not give mycophenolate mofetil for oral suspension to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about mycophenolate mofetil for oral suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolate mofetil that is written for healthcare professionals.

What are the ingredients in mycophenolate mofetil for oral suspension?
Active Ingredient: Mycophenolate mofetil USP
Inactive Ingredients:
Mycophenolate mofetil for oral suspension 200mg/ml: Sorbitol, sodium citrate dehydrate, citric acid anhydrous, methylparaben, xanthum gum, aspartame, soybeanlecithin and N & A gum fruit flavour.

This Medication Guide has been approved by the US Food and Drug Administration.

CYTOVENE-IV, and VALCYTE are registered trademarks of Hoffmann-La Roche Inc.
BACTRIM and BACTRIM DS are trademarks of Hoffmann-La Roche Inc.

Any other trademarks in this document are the property of their respective owners.

DOSING INSTRUCTIONS FOR PATIENTS:

 
Mycophenolate Mofetil
For Oral Suspension USP
 
Please follow instructions carefully to ensure
proper dosing of the oral suspension.

mycophenolate-fig1


Mycophenolate Mofetil
For Oral Suspension USP
· 
Shake closed bottle well for about 5 seconds before each use.
·  Remove child-resistant cap.
·  Before inserting the tip of the oral dispenser into bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Insert tip firmly into opening of the bottle adapter.
·  Turn the entire unit (bottle and oral dispenser) upside down.
·  Pull the plunger out slowly until the desired amount of medication is withdrawn into the oral dispenser (see figure).




mycophenolate-fig2

· Turn the entire unit right side up and remove the oral dispenser slowly from the bottle.
· Dispense directly into mouth.
  Do not mix with any liquid prior to dispensing.
· Close bottle with child-resistant cap after each use.
· Disassemble oral dispenser, rinse under running tap water and air dry prior to next use.
  Care should be taken to avoid contact of the skin with the suspension.
  If such contact occurs, wash thoroughly with soap and water.
· Should a spill occur, wipe up using paper towels wetted with water.
  Recap the bottle and wet wipe its outside surfaces.


Manufactured in India by:
Alkem Laboratories Limited
H.O.: ALKEM HOUSE,
Senapati Bapat Marg, Lower Parel,
Mumbai – 400 013, INDIA

Distributed by: Ascend Laboratories, LLC
Parsippany, NJ07054

PT2156-03

Revised: February ,2018

Revised: 4/2018
Ascend Laboratories, LLC