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MYCOPHENOLATE MOFETIL capsule


  1. What Is The Most Important Information I Should Know About Mycophenolate Mofetil Capsules?
  2. Can Cause Serious Side Effects, Including:
  3. What Is Mycophenolate Mofetil Capsules?
  4. Who Should Not Take Mycophenolate Mofetil Capsules?
  5. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  6. What Should I Avoid While Taking Mycophenolate Mofetil Capsules?
  7. Inactive Ingredients:
  8. Manufactured By:
  9. Manufactured For:
  10. Mycophenolate Mofetil Capsules And Tablets Can Cause Serious Side Effects:
  11. Call Your Doctor Right Away If You Have Any Of The Following Signs And Symptoms Of Infection:
  12. Who Should Not Take Mycophenolate Mofetil Capsules And Tablets?
  13. Tell Your Doctor About All Of Your Medical Conditions, If You:
  14. How Should I Take Mycophenolate Mofetil Capsules And Tablets?
  15. What Should I Avoid While Taking Mycophenolate Mofetil Capsules And Tablets?
  16. Common Side Effects Include:
  17. Side Effects That Happen More Often In Children Than In Adults Taking Mycophenolate Mofetil Include:
  18. How Should I Store Mycophenolate Mofetil Capsules And Tablets?
  19. Active Ingredient:
  20. Mycophenolate Mofetil Capsules Usp, 250 Mg:
  21. Mycophenolate Mofetil Tablets Usp, 500 Mg:
  22. Patient Information

What Is The Most Important Information I Should Know About Mycophenolate Mofetil Capsules? ⮝

Mycophenolate mofetil capsules

Can Cause Serious Side Effects, Including: ⮝

Increasedriskoflossofa pregnancy (miscarriage) and higher risk of birth defects.Females who take Mycophenolate mofetil 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 capsules. You should have 1 pregnancy test immediately before starting Mycophenolate mofetil capsules 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 treatment and for 6 weeks after stopping Mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil 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 capsules, and you could become pregnant. If you take birth control pills while using Mycophenolate mofetil capsules 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 capsules.

  • If you are sexually active male whose female partner can become pregnant while you are taking Mycophenolate mofetil capsules,use effective contraception during treatment and for at least 90 days after stopping Mycophenolate mofetil capsules.
  • 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 capsules, do not stop taking Mycophenolate mofetil. 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 1-800-617-8191or
    • By visiting the REMS website atwww.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 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 change in the size and color of a mole
  • a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
  • a new skin lesion or bump
  • any other changes to your health

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 capsules 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 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. Call your doctor right away if you have any of the following symptoms:
    • Weakness on one side of the body
    • You are confused or have problems thinking
    • You do not care about things that you usually care about (apathy)
    • You cannot 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 (" for information about other serious side effects.

What Is Mycophenolate Mofetil Capsules? ⮝

  • Mycophenolate mofetil capsules 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 capsules is used with other medicines containing cyclosporine and corticosteroids.

Who Should Not Take Mycophenolate Mofetil Capsules? ⮝

Donottake Mycophenolate mofetil capsules if you are allergic to mycophenolate mofetil or any of the ingredients in Mycophenolate mofetil capsules.

Tell Your Doctor About All Of Your Medical Conditions, Including If You: ⮝

  • have any digestive problems, such as ulcers.
  • have Lesch-Nyhan or Kelley-

    • Take Mycophenolate mofetil capsules exactly as prescribed.
    • Do not stop taking Mycophenolate mofetil capsules or change the dose unless your doctor tells you to.
    • If you miss a dose of Mycophenolate mofetil capsules, or you are not sure when you took your last dose, take your prescribed dose of Mycophenolate mofetil capsules 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 capsules on an empty stomach, unless your doctor tells you otherwise.
    • Do notopen or crush Mycophenolate mofetil capsules.
    • If you are not able to swallow Mycophenolate mofetil capsules, your doctor may prescribe Mycophenolate mofetil 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 notbreathe in (inhale) or let Mycophenolate mofetil powder come in contact with your skin or mucous membranes.
      • If you accidentally get the powder on the skin, wash the area well with soap and water.
      • If you accidentally get the powder in your eyes or other mucous membranes, flush with plain water.
    • If you take too much Mycophenolate mofetil capsules, call your doctor or the poison control center right away.

What Should I Avoid While Taking Mycophenolate Mofetil Capsules? ⮝

  • Avoid becoming pregnant.

    Mycophenolate mofetil capsules

Inactive Ingredients: ⮝

microcrystalline cellulose, hydroxypropyl cellulose, povidone (K-90), croscarmellose sodium, talc and magnesium stearate.

The capsule shells contain FD&C blue #2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, iron oxide black and potassium hydroxide.

Manufactured By: ⮝

Concord Biotech Limited,

297-298/2P, At Valthera Ta. Dholka,

Ahmedabad 382225, Gujarat, India.

Manufactured For: ⮝

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Any trademarks in this document are property of their respective owner.

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

Revised: May 2019

Mycophenolate Mofetil Capsules And Tablets Can Cause Serious Side Effects: ⮝

Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects.Females who take mycophenolate mofetil during pregnancy have a higher risk ofmiscarriageduring 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.
you should have one pregnancy test immediately before starting mycophenolate mofetil 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 therapy and for 6 weeks after stopping mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely.

Mycophenolate mofetil 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, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil 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.

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,do notstop taking mycophenolate mofetil. Call your doctor right away.In certain situations, you and your doctor may decide that taking mycophenolate mofetil is more important to your health than the possible risks to your unborn baby.

You and your doctor should report your pregnancy to
o
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:
o
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 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.
o
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
o
Fungal infections.Yeasts and other types of fungal infections can happen with mycophenolate mofetil and can cause serious tissue and blood infections ().

Call Your Doctor Right Away If You Have Any Of The Following Signs And Symptoms Of Infection: ⮝

o
Temperature of 100.5 F or greater
o
Cold symptoms, such as a runny nose or sore throat
o
Flu symptoms, such as an upset stomach, stomach pain, vomiting or diarrhea
o
Earache or headache
o
Pain during urination
o
White patches in the mouth or throat
o
Unexpected bruising or bleeding
o
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:
o
unexplained fever, prolonged tiredness, weight loss or lymph node swelling
o
a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
o
a change in the size and color of a mole
o
a new skin lesion or bump
o
any other changes to your health

Mycophenolate Mofetil Capsules and Tablets 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 Capsules and Tablets is used with other medicines called cyclosporines (Sandimmune, Gengraf, Neoral) and corticosteroids.

Mycophenolate mofetil 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 is safe and works in children who receive a heart or liver transplant.

Who Should Not Take Mycophenolate Mofetil Capsules And Tablets? ⮝

Do not take mycophenolate mofetil if you are allergic to mycophenolate mofetil or any of the ingredients in Mycophenolate Mofetil Capsules and Tablets.

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-
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 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 works, and mycophenolate mofetil may affect how some medicines work. Especially tell your doctor if you take:

birth control pills (oral contraceptives).
sevelamer (Renagel, Renvela). These products should be taken 2 hours after taking mycophenolate mofetil
acyclovir (Zovirax), valacyclovir (Valtrex), ganciclovir (Cytovene-IV, Vitrasert), valganciclovir (Valcyte)
rifampin (Rifater, Rifamate, Rimactane, Rifadin)
antacids that contain magnesium and aluminum (mycophenolate mofetil 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, FlagylER, FlagylIV, Metro IV, Helidac, Pylera )
ciprofloxacin (Cipro, CiproXR, Ciloxan, ProquinXR) 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 Capsules And Tablets? ⮝

Take mycophenolate mofetil exactly as prescribed.
Do not stop taking mycophenolate mofetil or change the dose unless your doctor tells you to.
If you miss a dose of mycophenolate mofetil, or are not sure when you took your last dose, take the regular amount of mycophenolate mofetil 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 capsules, tablets and 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 can be taken with food if necessary.
Most people take mycophenolate mofetil by mouth either as caramel opaque/blue opaque capsules or white tablets. Some people may get mycophenolate mofetil soon after their transplant surgery as an infusion into a vein.
Do not crush mycophenolate mofetil tablets. Do not open or crush mycophenolate mofetil capsules.
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 oral suspension with any other medicine.
If you take too much mycophenolate mofetil, call your doctor or the poison control center right away.

What Should I Avoid While Taking Mycophenolate Mofetil Capsules And Tablets? ⮝

Avoid pregnancy.
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. () 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.

Common Side Effects Include: ⮝

diarrhea. Call your doctor right away if you have diarrhea. Do not stop taking mycophenolate mofetil 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 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. 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 1-800-FDA-1088 or to Roxane Laboratories, Inc., at 1-800-962-8364.

How Should I Store Mycophenolate Mofetil Capsules And Tablets? ⮝

Store Mycophenolate Mofetil Capsules and Tablets at room temperature, between 59 F to 86 F (15 C to 30 C). Keep the container closed tightly.
Store the prepared mycophenolate mofetil 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 oral suspension in the refrigerator at 36 F to 46 F (2 C to 8 C).Do not freeze mycophenolate mofetil oral suspension.
Keep Mycophenolate Mofetil Capsules and Tablets and all medicines out of the reach of children.

General Information about Mycophenolate Mofetil Capsules and Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolate mofetil for a condition for which it was not prescribed. Do not give mycophenolate mofetil 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. 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. For more information, call 1-800-962-8364 or visit www.Roxane.com.

Active Ingredient: ⮝

mycophenolate mofetil USP

Mycophenolate Mofetil Capsules Usp, 250 Mg: ⮝

croscarmellose sodium, magnesium stearate, povidone, and pregelatinized starch. The capsule shells contain FD&C blue #1, FD&C red #3, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Mycophenolate Mofetil Tablets Usp, 500 Mg: ⮝

croscarmellose sodium, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, polydextrose, povidone, pregelatinized starch, titanium dioxide, and triacetin.

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

CellCept, 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.

For additional copies of this Medication Guide, please call 1-800-962-8364 or visit www.Roxane.com.

Roxane Laboratories, Inc.
Columbus, Ohio 43216

10004763/07

Revised December 2013
RLI, 2013

Patient Information ⮝

Information for Patients

See FDA-approved patient labeling (Medication Guide).

17.1 Embryofetal Toxicity

Pregnancy loss and malformations

  • Inform females of reproductive potential and pregnant women that use of Mycophenolate mofetil capsules 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[seeWarnings 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[seeUse in Specific Populations (8.1)].

Contraception

  • Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential[seeUse in Specific Populations (8.3)].
  • Females of reproductive potential must use an acceptable form of birth control during the entire Mycophenolate mofetil capsules therapy and for 6 weeks after stopping Mycophenolate mofetil capsules, unless the patient chooses abstinence. Mycophenolate mofetil capsules may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended[seeUse 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 capsules 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[seeUse 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[seeWarnings and Precautions (5.2)].
  • Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of 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.

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[seeWarnings and Precautions (5.4)].

17.5 Gastrointestinal Tract Complications

Inform patients that Mycophenolate mofetil capsules 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[seeWarnings and Precautions (5.5)].

17.6 Immunizations

Inform patients that Mycophenolate mofetil capsules can interfere with the usual response to immunizations. Before seeking vaccines on their own, advise patients to discuss first with their physician.[seeWarnings and Precautions (5.7)].

17.7 Administration Instructions

  • Advise patients not to open Mycophenolate mofetil capsules.
  • Advise patients to avoid inhalation or contact of the skin or mucous membranes with the powder contained in Mycophenolate mofetil capsules. 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 capsules at the usual times.

17.8 Blood Donation

Advise patients not to donate blood during therapy and for at least 6 weeks following discontinuation of Mycophenolate mofetil capsules.

17.9 Semen Donation

Advise males of childbearing potential not to donate semen during therapy and for 90 days following discontinuation of Mycophenolate mofetil capsules.

17.10 Potential to Impair Driving and Use of Machinery

Advise patients that Mycophenolate Mofetil 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.


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