Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Archis Pharma LLC
116901480
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mycophenolic Acid
Product Details
Mycophenolic Acid
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
INDICATIONS & USAGE SECTION
Highlight: * Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1)
- Use in combination with cyclosporine and corticosteroids. ( 1.1)
Limitations of Use:
- Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2)
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
DRUG INTERACTIONS SECTION
Highlight: * Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. ( 7.1)
- Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. ( 7.2)
- Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations; concomitant use is not recommended. ( 7.3)
- Sevelamer: May decrease MPA concentrations; concomitant use is not recommended. ( 7.4)
- Cyclosporine: May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. ( 7.5)
- Norfloxacin and Metronidazole: May decrease MPA concentrations; concomitant use with both drugs is not recommended. ( 7.6)
- Rifampin: May decrease MPA concentrations; concomitant use is not recommended unless the benefit outweighs the risk. ( 7.7)
- Hormonal Contraceptives: May reduce the effectiveness of oral contraceptives. Additional barrier contraceptive methods must be used. ( 5.2, 7.8)
- Acyclovir, Valacyclovir, Ganciclovir, Valganciclovir, and Other Drugs that Undergo Renal Tubular Secretion: May increase concentrations of mycophenolic acid glucuronide (MPAG) and co-administered drug; monitor blood cell counts. ( 7.9)
7 DRUG INTERACTIONS
7.1 Antacids with Magnesium and Aluminum Hydroxides
Concomitant use of mycophenolic acid delayed-release tablets and antacids decreased plasma concentrations of mycophenolic acid (MPA). It is recommended that mycophenolic acid delayed-release tablets and antacids not be administered simultaneously [see Clinical Pharmacology (12.3)] .
7.2 Azathioprine
Given that azathioprine and MMF inhibit purine metabolism, it is recommended that mycophenolic acid delayed-release tablets not be administered concomitantly with azathioprine or MMF.
7.3 Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal and
Other Drugs that Interfere with Enterohepatic Recirculation
Drugs that interrupt enterohepatic recirculation may decrease MPA plasma concentrations when co-administered with MMF. Therefore, do not administer mycophenolic acid delayed-release tablets with cholestyramine or other agents that may interfere with enterohepatic recirculation or drugs that may bind bile acids, e.g., bile acid sequestrates or oral activated charcoal, because of the potential to reduce the efficacy of mycophenolic acid delayed-release tablets [see Clinical Pharmacology (12.3)] .
7.4 Sevelamer
Concomitant administration of sevelamer and MMF may decrease MPA plasma concentrations. Sevelamer and other calcium free phosphate binders should not be administered simultaneously with mycophenolic acid delayed-release tablets [see Clinical Pharmacology (12.3)] .
7.5 Cyclosporine
Cyclosporine inhibits the enterohepatic recirculation of MPA, and therefore, MPA plasma concentrations may be decreased when mycophenolic acid delayed- release tablets are co-administered with cyclosporine. Clinicians should be aware that there is also a potential change of MPA plasma concentrations after switching from cyclosporine to other immunosuppressive drugs or from other immunosuppressive drugs to cyclosporine in patients concomitantly receiving mycophenolic acid delayed-release tablets [see Clinical Pharmacology (12.3)] .
7.6 Norfloxacin and Metronidazole
MPA plasma concentrations may be decreased when MMF is administrated with norfloxacin and metronidazole. Therefore, mycophenolic acid delayed-release tablets are not recommended to be given with the combination of norfloxacin and metronidazole. Although there will be no effect on MPA plasma concentrations when mycophenolic acid delayed-release tablets are concomitantly administered with norfloxacin or metronidazole when given separately [see Clinical Pharmacology (12.3)] .
7.7 Rifampin
The concomitant administration of MMF and rifampin may decrease MPA plasma concentrations. Therefore, mycophenolic acid delayed-release tablets are not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk [see Clinical Pharmacology (12.3)] .
7.8 Hormonal Contraceptives
In a drug interaction study, mean levonorgestrel AUC was decreased by 15% when co-administered with MMF. Although mycophenolic acid delayed-release tablets may not have any influence on the ovulation-suppressing action of oral contraceptives, additional barrier contraceptive methods must be used when mycophenolic acid delayed-release tablets are co-administered with hormonal contraceptives (e.g., birth control pill, transdermal patch, vaginal ring, injection, and implant) [see Warnings and Precautions (5.1), Use in Specific Populations ( 8.3), Clinical Pharmacology (12.3)] .
7.9 Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), and Other Drugs
that Undergo Renal Tubular Secretion
The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence competes for tubular secretion. Both acyclovir/valacyclovir/ganciclovir/valganciclovir and MPAG concentrations will be also increased in the presence of renal impairment. Acyclovir/valacyclovir/ganciclovir/valganciclovir may be taken with mycophenolic acid delayed-release tablets; however, during the period of treatment, physicians should monitor blood cell counts [see Clinical Pharmacology (12.3)] .
7.10 Ciprofloxacin, Amoxicillin plus Clavulanic Acid and Other Drugs that
Alter the Gastrointestinal Flora
Drugs that alter the gastrointestinal flora, such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption when mycophenolic acid delayed-release tablets is concomitantly administered with ciprofloxacin or amoxicillin plus clavulanic acid. The clinical relevance of this interaction is unclear; however, no dose adjustment of mycophenolic acid delayed-release tablets is needed when co- administered with these drugs [see Clinical Pharmacology (12.3)] .
7.11 Pantoprazole
Administration of a pantoprazole at a dose of 40 mg twice daily for 4 days to healthy volunteers did not alter the pharmacokinetics of a single dose of mycophenolic acid delayed-release tablets [see Clinical Pharmacology (12.3)] .
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 104-week oral carcinogenicity study in rats, mycophenolate sodium was not tumorigenic at daily doses up to 9 mg per kg, the highest dose tested. This dose resulted in approximately 0.6 to 1.2 times the systemic exposure (based on plasma AUC) observed in renal transplant patients at the recommended dose of 1440 mg per day. Similar results were observed in a parallel study in rats performed with MMF. In a 104-week oral carcinogenicity study in mice, MMF was not tumorigenic at a daily dose level as high as 180 mg per kg (which corresponds to 0.6 times the recommended mycophenolate sodium therapeutic dose, based on body surface area).
The genotoxic potential of mycophenolate sodium was determined in five assays. Mycophenolate sodium was genotoxic in the mouse lymphoma/thymidine kinase assay, the micronucleus test in V79 Chinese hamster cells, and the in vivo mouse micronucleus assay. Mycophenolate sodium was not genotoxic in the bacterial mutation assay ( Salmonella typhimurium TA 1535, 97a, 98, 100, and 102) or the chromosomal aberration assay in human lymphocytes.
Mycophenolate mofetil generated similar genotoxic activity. The genotoxic activity of mycophenolic acid (MPA) is probably due to the depletion of the nucleotide pool required for DNA synthesis as a result of the pharmacodynamic mode of action of MPA (inhibition of nucleotide synthesis).
Mycophenolate sodium had no effect on male rat fertility at daily oral doses as high as 18 mg per kg and exhibited no testicular or spermatogenic effects at daily oral doses of 20 mg per kg for 13 weeks (approximately 2 times the systemic exposure of MPA at the recommended therapeutic dose). No effects on female fertility were seen up to a daily dose of 20 mg per kg (approximately 3 times the systemic exposure of MPA at the recommended therapeutic dose).
INFORMATION FOR PATIENTS SECTION
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 [seeWarnings 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 days 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 [seeWarnings 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)]
SPL MEDGUIDE SECTION
Medication Guide
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** Mycophenolic Acid * Delayed-Release Tablets, USP** ** (mye″ koe fe nole′ ik as′ id)** ** as mycophenolate sodium* |
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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.
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 weaken 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. |
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***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
Call your doctor right away if you have any of these signs and symptoms of infection:
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See the section “What are the possible side effects of mycophenolic acid delayed-release tablets?” for other serious side effects. |
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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 are safe and work in children younger than 5 years. It is not known how mycophenolic acid delayed-release tablets work in children who have just received a new kidney transplant. |
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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. |
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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 work and mycophenolic acid delayed-release tablets may affect how some medicines work. Especially tell your doctor if you take:
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. |
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How should I take mycophenolic acid delayed-release tablets?
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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?”**
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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:
In people who take mycophenolic acid delayed-release tablets for a long time (long-term) after transplant:
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 MedWatch at 1-800-FDA-1088 or *RK Pharma at 1-844-757-4276 (1-844-4-RKPHARM) How should I store mycophenolic acid delayed-release tablets?
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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 they were not prescribed. Do not give mycophenolic acid delayed-release tablets to other people, even if they have the same symptoms you have. They 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. You can also call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). |
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What are the ingredients in mycophenolic acid delayed-release tablets? Active ingredient: mycophenolic acid (as mycophenolate sodium) Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Blue No. 2 Aluminum Lake, hypromellose, hypromellose acetate succinate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (corn), propylene glycol, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 180 mg tablet strength contains yellow iron oxide and the 360 mg tablet strength contains FD&C Red No. 40 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. In addition, the black imprinting ink contains black iron oxide, hypromellose and propylene glycol. The imprinting ink may also contain ammonium hydroxide and shellac glaze. This Medication Guide has been approved by the U.S. Food and Drug Administration. The brands listed are trademarks of their respective owners. |
Distributed by:
Archis Pharma LLC,
15 Corporate PI S Ste 108
Piscataway, NJ 08854
Revised: 01/2022
MG-MPA-00
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Mycophenolic Acid Delayed-Release Tablets, USP are available containing mycophenolate sodium, USP equivalent to 180 mg or 360 mg of mycophenolic acid.
The 180 mg tablets are sage green, film-coated, round, unscored tablets with M overMC1 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:
NDC 72819-155-08
bottle of 120 tablets
The 360 mg tablets are reddish-orange, film-coated, modified capsule-shaped, unscored tablets withM MC2 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows:
NDC 72819-156-08
bottle of 120 tablets
Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from moisture.
**PHARMACIST:**Dispense a Medication Guide with each prescription.
**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.