Mycophenolate Mofetil (Page 9 of 10)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

17.1 Embryofetal Toxicity

Pregnancy loss and malformations

  • Inform females of reproductive potential and pregnant women that use of mycophenolate mofetil for oral suspension during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise that they must use an acceptable form of contraception [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
  • Encourage pregnant women to enroll in the Pregnancy Exposure Registry. This registry monitors pregnancy outcomes in women exposed to mycophenolate [see Use in Specific Populations (8.1)].

Contraception

  • Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential [see Use in Specific Populations (8.3)].
  • Females of reproductive potential must use an acceptable form of birth control during the entire mycophenolate mofetil for oral suspension therapy and for 6 weeks after stopping mycophenolate mofetil for oral suspension, unless the patient chooses abstinence. Mycophenolate mofetil for oral suspension may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended [see Use in Specific Populations (8.3)].
  • For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil for oral suspension should be discussed with the patient.
  • Advise sexually active male patients and/or their partners to use effective contraception during the treatment of the male patient and for at least 90 days after cessation of treatment. This recommendation is based on findings of animal studies [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

17.2 Development of Lymphoma and Other Malignancies

  • Inform patients that they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2)].
  • Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of broad-spectrum sunscreen with high protection factor.

17.3 Increased Risk of Serious Infections

Inform patients that they are at increased risk of developing a variety of infections due to immunosuppression. Instruct them to contact their physician if they develop any of the signs and symptoms of infection explained in the Medication Guide[see Warnings and Precautions (5.3)].

17.4 Blood Dyscrasias

Inform patients that they are at increased risk for developing blood adverse effects such as anemia or low white blood cells. Advise patients to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions (5.4)].

17.5 Gastrointestinal Tract Complications

Inform patients that mycophenolate mofetil for oral suspension can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding, or sudden onset or persistent abdominal pain [see Warnings and Precautions (5.5)].

17.6 Acute Inflammatory Syndrome

Inform patients that acute inflammatory reactions have been reported in some patients who received mycophenolate mofetil for oral suspension. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions (5.7)].

17.7 Immunizations

Inform patients that mycophenolate mofetil for oral suspension can interfere with the usual response to immunizations. Before seeking vaccines on their own, advise patients to discuss first with their physician [see Warnings and Precautions (5.8)].

17.8 Administration Instructions

  • Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil for oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water.
  • Advise patients to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case they should continue to take mycophenolate mofetil for oral suspension at the usual times.

17.9 Blood Donation

Advise patients not to donate blood during therapy and for at least 6 weeks following discontinuation of mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.11)].

17.10 Semen Donation

Advise males of childbearing potential not to donate semen during therapy and for 90 days following discontinuation of mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.12)].

17.11 Potential to Impair Driving and Use of Machinery

Advise patients that mycophenolate mofetil for oral suspension can affect the ability to drive or operate machines. Patients should avoid driving or operating machines if they experience somnolence, confusion, dizziness, tremor or hypotension during treatment with mycophenolate mofetil for oral suspension [see Warnings and Precautions (5.14)].

Brands listed are the trademarks of their respective owners.

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Iss. 11/2021

MEDICATION GUIDE

Mycophenolate Mofetil (mye” koe fen’ oh late moe’ fe til)

for Oral Suspension

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 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, including:

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 1 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 treatment 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 are a sexually active male whose female partner can become pregnant while you are taking mycophenolate mofetil for oral suspension , use effective contraception during treatment and for at least 90 days after stopping 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. You and your doctor may decide that other medicines to prevent rejection may be right for you. You and your doctor should report your pregnancy to the Mycophenolate Pregnancy Registry either:
    • By phone at 1-800-617-8191 or
    • By visiting the REMS website at: www.mycophenolateREMS.com

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

Increased risk of getting certain cancers. People who take mycophenolate mofetil for oral suspension 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
Increased risk of getting serious infections. Mycophenolate mofetil for oral suspension weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolate mofetil for oral suspension and can lead to hospitalizations and death. These serious 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 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.
    • COVID-19
  • A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, mycophenolate mofetil for oral suspension 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. Call 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 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 mycophenolate mofetil for oral suspension 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
See “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 is used with other medicines containing cyclosporine and corticosteroids.

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, including if you:

  • have any digestive problems, such as ulcers.
  • have Phenylketonuria (PKU). Mycophenolate mofetil for oral suspension contains aspartame (a source of phenylalanine).
  • have Lesch-Nyhan syndrome, Kelley-Seegmiller syndrome, or another rare inherited deficiency hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolate mofetil for oral suspension if you have one of these disorders.
  • plan to receive any vaccines. People taking mycophenolate mofetil for oral suspension should not receive live vaccines. Some vaccines may not work as well during treatment with mycophenolate mofetil for oral suspension.
  • are pregnant or plan 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 the medicines you take, including prescription and over-the-counter 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 at least 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 you are not sure when you took your last dose, take your prescribed dose of mycophenolate mofetil for oral suspension as soon as you remember. If your next dose is less than 2 hours away, 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, unless your doctor tells you otherwise.
  • If you are not able to swallow mycophenolate mofetil tablets or capsules, your doctor may prescribe mycophenolate mofetil for oral suspension. This is a liquid form of mycophenolate mofetil. Your pharmacist will mix the medicine before you pick it up from a pharmacy.
  • Do not mix mycophenolate mofetil for oral suspension with any other medicine. Mycophenolate mofetil for oral suspension should not be mixed with any type of liquids before taking the dose. See the Instructions for Use at the end of this Medication Guide for detailed instructions about how to take mycophenolate mofetil for oral suspension the right way.
  • Do not breathe in (inhale) or let mycophenolate mofetil for oral suspension powder or oral suspension come in contact with your skin or mucous membranes.
    • If you accidentally get the powder or oral suspension on the skin, wash the area well with soap and water.
    • If you accidentally get the powder or oral suspension in your eyes or other mucous membranes, flush with plain water.
  • 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 becoming pregnant. 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 for oral suspension 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 broad-spectrum sunscreen with a high protection factor. This is especially important if your skin is very fair or if you have a family history of skin cancer.
  • You should not donate blood while taking mycophenolate mofetil for oral suspension and for at least 6 weeks after stopping mycophenolate mofetil for oral suspension.
  • You should not donate sperm while taking mycophenolate mofetil for oral suspension and for 90 days after stopping mycophenolate mofetil for oral suspension.
  • Mycophenolate mofetil for oral suspension may influence your ability to drive and use machines (See “What are the possible side effects of mycophenolate mofetil for oral suspension? ”). If you experience drowsiness, confusion, dizziness, tremor, or low blood pressure during treatment with mycophenolate mofetil for oral suspension, you should be cautious about driving or using heavy machines.

What are the possible side effects of mycophenolate mofetil for oral suspension?

Mycophenolate mofetil for oral suspension can cause serious side effects, including:

  • 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 for oral suspension 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 1 month 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?”), including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.
  • Stomach problems. Stomach problems including intestinal bleeding, a tear in your intestinal wall (perforation) or stomach ulcers can happen in people who take mycophenolate mofetil for oral suspension. Bleeding can be severe and you may have to be hospitalized for treatment. Call your doctor right away if you have sudden or severe stomach-area pain or stomach-area pain that does not go away, or if you have diarrhea.
  • Inflammatory reactions. Some people taking mycophenolate mofetil for oral suspension may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization. This reaction could happen within weeks to months after your treatment with mycophenolate mofetil for oral suspension starts or if your dose is increased. Call your doctor right away if you experience these symptoms.
The most common side effects of mycophenolate mofetil for oral suspension include:
  • diarrhea
  • blood problems including low white and red blood cell counts
  • infections
  • blood pressure problems
  • fast heartbeat
  • swelling of the lower legs, ankles and feet
  • changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia)
  • stomach problems including diarrhea, constipation, nausea and vomiting
  • rash
  • nervous system problems such as headache, dizziness and tremor
Side effects that can happen more often in children than in adults taking mycophenolate mofetil for oral suspension include:
  • stomach area pain
  • fever
  • infection
  • pain
  • blood infection (sepsis)
  • diarrhea
  • vomiting
  • sore throat
  • colds (respiratory tract infections)
  • high blood pressure
  • low white blood cell count
  • low red blood cell count

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 FDA at 1-800-FDA-1088.

How should I store mycophenolate mofetil for oral suspension?

  • Store 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 between 36°F to 46°F (2°C to 8°C). Do not freeze.
Keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children.

General Information about the safe and effective use of 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.

What are the ingredients in mycophenolate mofetil for oral suspension?

Active Ingredient: mycophenolate mofetil

Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, corn syrup, maltodextrin, methylparaben, modified corn starch, natural flavor, sodium citrate anhydrous, sorbitol, soybean lecithin, and xanthan gum.

Brands listed are the trademarks of their respective owners.

Manufactured In Croatia By: Pliva Hrvatska d.o.o., Zagreb, CroatiaManufactured For: Teva Pharmaceuticals , Parsippany, NJ 07054

This Medication Guide has been approved by the U.S. Food and Drug Administration. Iss. 11/2021

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