Mycophenolate mofetil

What is Mycophenolate mofetil?

• Mycophenolate mofetil (CellCept) is an antimetabolite immunosuppressant used to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant.

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What are the uses of this medicine?

• Mycophenolate mofetil (CellCept) 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 (CellCept) is used with other medicines containing cyclosporine and corticosteroids.

How does this medicine work?

• The morpholinoethyl ester of mycophenolic acid (MPA) with potent immunosuppressive properties.
• Mycophenolate stops T-cell and B-cell proliferation through selective inhibition of the de novo pathway of purine biosynthesis.
• In vivo, the active metabolite, MPA, reversibly inhibits inosine 5'-monophosphate dehydrogenase, an enzyme involved in the de novo synthesis of guanine nucleotides.
• MPA displays high lymphocyte specificity and cytotoxicity due to the higher dependence of activated lymphocytes on both salvage and de novo synthesis of guanine nucleotides relative to other cell types.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.
• who are allergic to Polysorbate 80 (TWEEN).

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).
• sevelamer (Renagel®, Renvela™). These products should be taken at least 2 hours after taking CellCept.
• acyclovir (Zovirax®), valacyclovir (Valtrex®), ganciclovir (CYTOVENE®-IV, Vitrasert®), valganciclovir (VALCYTE®).
• rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®).
• antacids that contain magnesium and aluminum (CellCept 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®).

Is this medicine FDA approved?

• Initial U.S. Approval: 1995.

How should this medicine be used?

Recommended dosage:

In Adults:

• Kidney Transplant: 1 g twice daily, orally or intravenously (IV) over no less than 2 h.
• Heart Transplant: 1.5 g twice daily orally or IV, over no less than 2 h.
• Liver Transplant: 1.5 g twice daily orally or 1g twice daily IV over no less than 2 h.

In Pediatrics:

• Kidney Transplant: 600 mg/m2 orally twice daily, up to maximum of 2 g daily.
• Heart Transplant: 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension).
• Liver Transplant: 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension).

• CellCept Intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days.

Renal Impairment:

• No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively.
• In kidney transplant patients with severe chronic impairment of the graft (GFR <25 mL/min/1.73 m2), do not administer doses of CellCept greater than 1 g twice a day.
• These patients should be carefully monitored.

Neutropenia:

• If neutropenia develops (ANC <1.3 × 103/µL), dosing with CellCept should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately.

Administration:

• Take CellCept exactly as prescribed.
• Do not stop taking CellCept or change the dose unless your doctor tells you to.
• If you miss a dose of CellCept, or you are not sure when you took your last dose, take your prescribed dose of CellCept 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 CellCept capsules, tablets and oral suspension on an empty stomach, unless your doctor tells you otherwise.
• Do not crush CellCept tablets.
• Do not open or crush CellCept capsules.
• If you are not able to swallow CellCept tablets or capsules, your doctor may prescribe CellCept Oral Suspension. This is a liquid form of CellCept. Your pharmacist will mix the medicine before you pick it up from a pharmacy.
• Do not mix CellCept Oral Suspension with any other medicine.
• CellCept Oral Suspension should not be mixed with any type of liquids before taking the dose.
• Do not breathe in (inhale) or let CellCept 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.

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

This medicine is available in fallowing doasage form:

• As Capsules: 250 mg
• Tablets: 500 mg
• For Oral Suspension: 35 g mycophenolate mofetil, powder for reconstitution (200 mg/mL upon reconstitution)
• For Injection: 500 mg mycophenolate mofetil in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• CellCept

What side effects can this medication cause?

The most common side effects of this medicine 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 CellCept 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

CellCept may cause serious side effects, including:

• Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects
• Increased risk of getting serious infections
• Low blood cell counts
• Stomach problems
• Inflammatory reactions

What special precautions should I follow?

• Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Avoid use of MMF during pregnancy if safer treatment options are available.
• Patients receiving immunosuppressants, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. 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.
• Post-transplant lymphoproliferative disorder (PTLD) developed in patients receiving CellCept (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients.
• Patients receiving immunosuppressants, including CellCept, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. Consider dose reduction or discontinuation of CellCept in patients who develop new infections or reactivate viral infections.
• Severe neutropenia developed in transplant patients receiving CellCept 3 g daily. Monitor with blood tests; consider treatment interruption or dose reduction.
• Gastrointestinal bleeding requiring hospitalization, ulceration and perforations were observed in clinical trials. Physicians should be aware of these serious adverse effects particularly when administering CellCept to patients with a gastrointestinal disease.
• CellCept is an inosine monophosphate dehydrogenase (IMPDH) inhibitor; therefore it should be avoided in patients with hereditary deficiencies of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndromes.
• Acute inflammatory syndrome (AIS) has been reported with the use of MMF and mycophenolate products, and some cases have resulted in hospitalization. Monitor patients for symptoms and laboratory parameters of AIS when starting treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider other treatment alternatives based on the risk and benefit for the patient.
• During treatment with CellCept, the use of live attenuated vaccines should be avoided. Advise patients to discuss with the physician before seeking any immunizations.
• CellCept Intravenous solution must not be administered by rapid or bolus intravenous injection as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis.
• Phenylalanine can be harmful to patients with phenylketonuria (PKU). CellCept Oral Suspension contains aspartame, a source of phenylalanine. Before prescribing CellCept Oral Suspension to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including CellCept.
• Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of CellCept 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 CellCept.
• CellCept may impact the ability to drive and use machines. Patients should avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with CellCept.
• There are no data on the presence of mycophenolate in human milk, or the effects on milk production.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, 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.
• MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis.
• However, at high MPAG plasma concentrations (>100 µg/mL), small amounts of MPAG are removed.
• By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine.

Can this medicine be used in pregnancy?

• Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems.
• Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of CellCept should be discussed with the pregnant woman.

• If you become pregnant while taking CellCept, do not stop taking CellCept. 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

Can this medicine be used in children?

• Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants.

What are the active and inactive ingredients in this medicine?

Active ingredient: mycophenolate mofetil Inactive ingredients:

• CellCept 250 mg capsules: croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch. The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
• CellCept 500 mg tablets: black iron oxide, croscarmellose sodium, FD&C blue #2 aluminum lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), red iron oxide, talc, and titanium dioxide; may also contain ammonium hydroxide, ethyl alcohol, methyl alcohol, n-butyl alcohol, propylene glycol, and shellac.
• CellCept Oral Suspension: aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum.
• CellCept Intravenous: polysorbate 80, and citric acid. Sodium hydroxide and hydrochloric acid may have been used in the manufacture of CellCept Intravenous to adjust the pH.

Who manufactures and distributes this medicine?

Distributed by: Genentech USA, Inc.

• CellCept and VALCYTE are registered trademarks of Hoffmann-La Roche Inc.

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

• Store CellCept capsules and tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep CellCept tablets in the light resistant container that it comes in.
• Store CellCept 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 CellCept Oral Suspension in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.

• Dailymed label info on Mycophenolate mofetil
• FDA Mycophenolate mofetil

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