Mycophenolic Acid (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

360 mg tablet: Pink to light pink colored, enteric coated, ovaloid biconvex tablet, debossed with “C2″ on one side and plain on other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.

Bottles of 120 with child resistance closure, NDC 70748-218-16

180 mg tablet: Lime green colored, enteric coated, round biconvex tablet, debossed with “C1″ on one side and plain on other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.

Bottles of 120 with child resistance closure, NDC 70748-217-16

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP).

Handling

Keep out of reach and sight of children. Mycophenolic acid delayed-release tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [see Dosage and Administration (2.3) ].

Teratogenic effects have been observed with mycophenolate sodium [see Warnings and Precautions (5.1) ]. If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryofetal Toxicity

Pregnancy loss and malformations

  • Inform pregnant women and females of reproductive potential that use of mycophenolic acid delayed-release tablets in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise patients 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 Mycophenolate Pregnancy Registry (1-800-617-8191). 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 acceptable form of birth control during the entire mycophenolic acid delayed-release tablets therapy and for 6 weeks after stopping mycophenolic acid delayed-release tablets, unless the patient chooses to avoid heterosexual sexual intercourse completely (abstinence). mycophenolic acid delayed-release tablets 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 embryo-fetal toxicity. Risks and benefits of mycophenolic acid delayed-release tablets should be discussed with the patient [see Use in Specific Populations (8.3) ].
  • 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 after cessation of treatment. This recommendation is based on findings of animal studies.

Development of Lymphoma and Other Malignancies

  • Inform patients they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.3) ].
  • Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a broad- spectrum sunscreen with a high protection factor [see Warnings and Precautions (5.3) ].

Increased Risk of Infection

Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection as explained in the Medication Guide [see Warnings and Precautions (5.4, 5.5)].

Blood Dyscrasias

Inform patients they are at increased risk for developing blood dyscrasias (e.g., neutropenia or anemia) and to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions (5.6) ].

Gastrointestinal Tract Complications

Inform patients that mycophenolic acid delayed-release tablets 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 (5.7) ].

Immunizations

Inform patients that mycophenolic acid delayed-release tablets can interfere with the usual response to immunizations and that they should avoid live vaccines. Before seeking vaccines on their own, advise patients to discuss first with their physician [see Warnings and Precautions (5.8) ].

Administration Instructions

Advise patients to swallow mycophenolic acid delayed-release tablets whole, and not to crush, chew, or cut the tablets. Inform patients to take mycophenolic acid delayed-release tablets on an empty stomach, 1 hour before or 2 hours after food intake.

Blood Donation

Advise patients not to donate blood during therapy and for at least 6 weeks following discontinuation of mycophenolic acid delayed-release tablets [see Warnings and Precautions (5.10)].

Semen Donation

Advise males of childbearing potential not to donate semen during therapy and for 90 days following discontinuation of mycophenolic acid delayed-release tablets [see Warnings and Precautions (5.11)].

Drug Interactions

Patients should be advised to report to their doctor the use of any other medications while taking mycophenolic acid delayed-release tablets. The simultaneous administration of any of the following drugs with mycophenolic acid delayed-release tablets may result in clinically significant adverse reactions:

  • Antacids with magnesium and aluminum hydroxides [see Drug Interactions (7.1)], Clinical Pharmacology (12.3)]
  • Azathioprine [see Drug Interactions (7.2)]
  • Cholestyramine [see Drug Interactions (7.3)], Clinical Pharmacology (12.3)]
  • Hormonal Contraceptives (e.g., birth control pill, transdermal patch, vaginal ring, injection, and implant) [see Warnings and Precautions (5.2), Drug Interactions (7.8)]

Manufactured by:

Concord Biotech Limited

Valthera, Ahmedabad-382225

Gujarat, India.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

June — 2020

MEDICATION GUIDE

Mycophenolic Acid Delayed-Release Tablets

(mye” koe fe nol′ ik as′ id)

Read the Medication Guide that comes with mycophenolic acid delayed-release tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have any questions about mycophenolic acid delayed-release tablets, ask your doctor.

What is the most important information I should know about Mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets can cause serious side effects, including:

  • Increased risk of loss of pregnancy (miscarriage) and higher risk of birth defects. Females who take mycophenolic acid delayed-release tablets 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) while taking mycophenolic acid delayed-release tablets.
      • You should have a pregnancy test immediately before starting mycophenolic acid delayed-release tablets 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 mycophenolic acid delayed-release tablets therapy and for 6 weeks after stopping mycophenolic acid delayed-release tablets, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolic acid delayed-release tablets 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 mycophenolic acid delayed-release tablets and you could become pregnant. If you decide to take birth control pills while using mycophenolic acid delayed-release tablets, you must also use another form of birth control. Talk to your doctor about other birth control methods that can be used while taking mycophenolic acid delayed-release tablets.
    • If you are a sexually active male whose female partner can become pregnant while you are taking mycophenolic acid delayed-release tablets, use effective contraception during treatment and for at least 90 days after stopping mycophenolic acid delayed-release tablets
  • 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 mycophenolic acid delayed-release tablets, do not stop taking mycophenolic acid delayed-release tablets. 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

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

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

  • Increased risk of getting serious infections. Mycophenolic acid delayed-release tablets weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with mycophenolic acid delayed-release tablets and can lead to 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 mycophenolic acid delayed-release tablets 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 mycophenolic acid delayed-release tablets 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 healthcare provider 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 cannot control your muscles
    • Fungal infections. Yeast and other types of fungal infections can happen with mycophenolic acid delayed-release tablets and cause serious tissue and blood infections. See “What are the possible side effects of mycophenolic acid delayed-release tablets?”

Call your doctor right away if you have any of these 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 or you need to urinate often
  • White patches in the mouth or throat
  • Unexpected bruising or bleeding
  • Cuts, scrapes, or incisions that are red, warm, and oozing pus
  • Increasedrisk of getting certain cancers. People who take mycophenolic acid delayed-release tablets have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:
    • unexplained fever, tiredness that does not go away, 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 other parts
    • a change in the size or 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 mycophenolic acid delayed-release tablets?” for other serious side effects.

What are mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets are a prescription medicine given to prevent rejection (antirejection medicine) in people who have received a kidney transplant. Rejection is when the body’s immune system senses the new organ as “foreign” and attacks it.

Mycophenolic acid delayed-release tablets are used with other medicines containing cyclosporine (Sandimmune® , Gengraf® , and Neoral®) and corticosteroids.

Mycophenolic acid delayed-release tablets can be used to prevent rejection in children who are 5 years or older and are stable after having a kidney transplant. It is not known if mycophenolic acid delayed-release tablets is safe and works in children younger than 5 years.

It is not known how mycophenolic acid delayed-release tablets works in children who have just received a new kidney transplant.

Who should not take mycophenolic acid delayed-release tablets?

Do not take mycophenolic acid delayed-release tablets if you are allergic to mycophenolic acid (MPA), mycophenolate sodium, mycophenolate mofetil, or any of the ingredients in mycophenolic acid delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients in mycophenolic acid delayed-release tablets.

What should I tell my doctor before I start taking mycophenolic acid delayed-release tablets?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have any digestive problems, such as ulcers
  • plan to receive any vaccines. You should not receive live vaccines while you take mycophenolic acid delayed-release tablets. Some vaccines may not work as well during treatment with mycophenolic acid delayed-release tablets.
  • have Lesch-Nyhan or Kelley-Seegmiller syndrome or another rare inherited deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT). You should not take mycophenolic acid delayed-release tablets if you have one of these disorders.
  • are pregnant or planning to become pregnant. See “What is the most important information I should know about mycophenolic acid delayed-release tablets?”
    • are breastfeeding or plan to breastfeed. It is not known if mycophenolic acid passes into breast milk. You and your doctor will decide if you will breastfeed while taking mycophenolic acid delayed-release tablets.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Some medicines may affect the way mycophenolic acid delayed-release tablets works and mycophenolic acid delayed-release tablets 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 mycophenolic acid delayed-release tablets?”
  • antacids that contain aluminum or magnesium. mycophenolic acid delayed-release tablets and antacids should not be taken at the same time.
  • acyclovir (Zovirax®), Ganciclovir (Cytovene® IV, Valcyte®)
  • azathioprine (Azasan® , Imuran®)
  • cholestyramine (Questran® Light, Questran® , Locholest Light, Prevalite®)

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

How should I take mycophenolic acid delayed-release tablets?

  • Take mycophenolic acid delayed-release tablets exactly as prescribed. Your healthcare provider will tell you how much mycophenolic acid delayed-release tablets to take.
  • Do not stop taking or change your dose of mycophenolic acid delayed-release tablets without talking to your healthcare provider.
  • Take mycophenolic acid delayed-release tablets on an empty stomach, either 1 hour before or 2 hours after a meal.
  • Swallow mycophenolic acid delayed-release tablets whole. Do not crush, chew, or cut mycophenolic acid delayed-release tablets. The mycophenolic acid delayed-release tablets have a coating so that the medicine will pass through your stomach and dissolve in your intestine.
    • If you forget to take mycophenolic acid delayed-release tablets, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your doctor or pharmacist if you are not sure what to do.
    • If you take more than the prescribed dose of mycophenolic acid delayed-release tablets, call your doctor right away.
    • Do not change (substitute) between using mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets, capsules, or oral suspension for one another unless your healthcare provider tells you to. These medicines are absorbed differently. This may affect the amount of medicine in your blood.
    • Be sure to keep all appointments at your transplant clinic. During these visits, your doctor may perform regular blood tests.

What should I avoid while taking mycophenolic acid delayed-release tablets?

  • Avoid pregnancy. See “What is the most important information I should know about mycophenolic acid delayed-release tablets?”
  • Limit the amount of time you spend in sunlight. Avoid using tanning beds and sunlamps. People who take mycophenolic acid delayed-release tablets have a higher risk of getting skin cancer. See “What is the most important information I should know about mycophenolic acid delayed-release tablets?” Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen with a high sun protection factor (SPF 30 and above). This is especially important if your skin is fair (light colored) or you have a family history of skin cancer.
  • You should not donate blood while taking mycophenolic acid delayed-release tablets and for at least 6 weeks after stopping mycophenolic acid delayed-release tablets.
  • You should not donate sperm while taking mycophenolic acid delayed-release tablets and for 90 days after stopping mycophenolic acid delayed-release tablets.
  • Elderly patients 65 years of age or older may have more side effects with mycophenolic acid delayed-release tablets because of a weaker immune system.

What are the possible side effects of mycophenolic acid delayed-release tablets?

Mycophenolic acid delayed-release tablets can cause serious side effects.

See “What is the most important information I should know about mycophenolic acid delayed-release tablets?”

Stomach and intestinal bleeding can happen in people who take mycophenolic acid delayed-release tablets. Bleeding can be severe and you may have to be hospitalized for treatment.

The most common side effects of taking mycophenolic acid delayed-release tablets include:

In people with a new transplant:

  • low blood cell counts
    • red blood cells
    • white blood cells
    • platelets
  • constipation
  • nausea
  • diarrhea
  • vomiting
  • urinary tract infections
  • stomach upset

In people who take mycophenolic acid delayed-release tablets for a long time (long-term) after transplant:

  • low blood cell counts
    • red blood cells
    • white blood cells
  • nausea
  • diarrhea
  • sore throat

Your healthcare provider will do blood tests before you start taking mycophenolic acid delayed-release tablets and during treatment with mycophenolic acid delayed-release tablets to check your blood cell counts. Tell your healthcare provider right away if you have any signs of infection (see “What is the most important information I should know about mycophenolic acid delayed-release tablets?”) , or any unexpected bruising or bleeding. Also, tell your healthcare provider if you have unusual tiredness, dizziness, or fainting.

These are not all the possible side effects of mycophenolic acid delayed-release tablets. Your healthcare provider may be able to help you manage these side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or

You may also report side effects to Concord Biotech Limited, at Telephone: 1-844-553-5534, Fax : 1-844-552-5515.

How should I store mycophenolic acid delayed-release tablets?

  • Store mycophenolic acid delayed-release tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Mycophenolic acid delayed-release tablets does not need to be refrigerated.
  • Keep the container tightly closed. Store mycophenolic acid delayed-release tablets in a dry place.
  • Mycophenolic acid delayed-release tablets, bottle of 120 comes in a child-resistant package.
  • Keep mycophenolic acid delayed-release tablets and all medicines out of the reach of children.

General information about mycophenolic acid delayed-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mycophenolic acid delayed-release tablets for a condition for which it was not prescribed. Do not give mycophenolic acid delayed-release tablets to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about mycophenolic acid delayed-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about mycophenolic acid delayed-release tablets that is written for healthcare professionals.

What are the ingredients in mycophenolic acid delayed-release tablets?

Active ingredient: mycophenolic acid (as mycophenolate sodium)

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2(180mg) or iron oxide red (360mg).

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

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

Manufactured by:

Concord Biotech Limited

Valthera, Ahmedabad-382225

Gujarat, India.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

June — 2020

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