Mycophenolic acid

What is Mycophenolic acid?

• Mycophenolic acid (Myfortic) is an antimetabolite immunosuppressant used with other medications to help prevent the body from rejecting kidney transplants in adults and children 5 years of age and older.
• Mycophenolate (CellCept) is used with other medications to help prevent transplant organ rejection in adults and children 3 months of age and older who have received kidney, heart, or liver transplants.

Mycophenolic acid

Mycophenolic acid ball-and-stick

Mycophenolic acid Strucrural Formulae V.1

What are the uses of this medicine?

• Mycophenolic acid (Myfortic) 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.

Limitations of Use:

• Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably.
• 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.

How does this medicine work?

• An antineoplastic antibiotic derived from various Penicillium fungal species.
• Mycophenolic acid is an active metabolite of the prodrug mycophenolate mofetil.
• Mycophenolic acid inhibits inosine monophosphate dehydrogenase (IMPDH), preventing the formation of guanosine monophosphate and synthesis of lymphocyte DNA that results in inhibition of lymphocyte proliferation, antibody production, cellular adhesion, and migration of T and B lymphocytes. Mycophenolic acid also has antibacterial, antifungal, and antiviral activities.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to mycophenolic acid (MPA), mycophenolate sodium, mycophenolate mofetil, or any of the ingredients in mycophenolic acid delayed-release tablets.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• birth control pills (oral contraceptives).
• 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 ®)

Is this medicine FDA approved?

• Mycophenolic acid was initially discovered by Italian Bartolomeo Gosio in 1893.
• It was rediscovered in 1945 and 1968.
• It was approved for medical use in the United States in 1995 following the discovery of its immunosuppressive properties in the 1990s.

How should this medicine be used?

Recommended dosage: Dosage in Adult Kidney Transplant Patients:

• The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in Pediatric Kidney Transplant Patients:

• The recommended dose of mycophenolic acid delayed-release tablets in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m 2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily).

Administration:

• Take mycophenolic acid delayed-release tablets exactly as prescribed. Your healthcare provider will tell you how many mycophenolic acid 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Mycophenolic acid delayed-release tablets are available as 180 mg and 360 mg tablets.

This medicine is available in fallowing brand namesː

• Myfortic

What side effects can this medication cause?

The most common side effects of this medicine 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
• Less common side effects may in clude:
• Hypersensitivity Reactions
• Clostridium difficile-Associated Diarrhea
• Central Nervous System Reactions

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

• Increased risk of loss of pregnancy (miscarriage) and higher risk of birth defects
• Increased risk of getting serious infections
• Progressive Multifocal Leukoencephalopathy
• Fungal infections
• Increased risk of getting certain cancers

What special precautions should I follow?

• Use of mycophenolic acid delayed-release tablets during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Avoid use of mycophenolic acid delayed-release tablets during pregnancy if safer treatment options are available.
• Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets.
• Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. As usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.
• Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections, including opportunistic infections.
• Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including the mycophenolic acid (MPA) derivatives mycophenolic acid delayed-release tablets and MMF.
• Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives in combination with other immunosuppressive agents. If blood dyscrasias occur neutropenia develops (ANC < 1.3×10 3/mcL) or anemia], dosing with mycophenolic acid delayed-release tablets should be interrupted or the dose reduced, appropriate tests performed, and the patient managed accordingly.
• Gastrointestinal bleeding (requiring hospitalization), intestinal perforations, gastric ulcers, and duodenal ulcers have been reported in patients treated with mycophenolic acid delayed-release tablets. Mycophenolic acid delayed-release tablets should be administered with caution in patients with active serious digestive system disease.
• During treatment with mycophenolic acid delayed-release tablets, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective.
• Mycophenolic acid delayed-release tablets should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan and Kelley-Seegmiller syndromes because it may cause an exacerbation of disease symptoms.
• Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of mycophenolic acid delayed-release tablets because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman.
• Men should not donate semen during therapy and for 90 days following discontinuation of mycophenolic acid delayed-release tablets
• 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.
• You should know that mycophenolate may make you drowsy, confused, dizzy, lightheaded, or cause uncontrollable shaking of a part of the body. Do not drive a car or operate machinery until you know how this medication affects you.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hematological abnormalities, such as leukopenia and neutropenia, and gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• General supportive measures and symptomatic treatment should be followed in all cases of overdosage.
• Although dialysis may be used to remove the inactive metabolite mycophenolic acid glucuronide (MPAG), it would not be expected to remove clinically significant amounts of the active moiety, mycophenolic acid, due to the 98% plasma protein binding of mycophenolic acid.
• By interfering with enterohepatic circulation of mycophenolic acid, activated charcoal or bile sequestrates, such as cholestyramine, may reduce the systemic mycophenolic acid exposure.

Can this medicine be used in pregnancy?

• 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 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).

Can this medicine be used in children?

• The safety and effectiveness of mycophenolic acid delayed-release tablets in pediatric kidney transplant patients and in pediatric kidney transplant patients below the age of 5 years have not been established.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

Manufactured by:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

Distributed by:

• Mylan Institutional Inc.
• Rockford, IL U.S.A.

What should I know about storage and disposal of this medication?

• Store mycophenolic acid delayed-release tablets at room temperature, 20° to 25°C (68° to 77°F).
• Mycophenolic acid delayed-release tablets do not need to be refrigerated.
• Keep the container tightly closed.
• Store mycophenolic acid delayed-release tablets in a dry place.

• Dailymed label info on Mycophenolic acid
• FDA Mycophenolic acid

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