Trade Name: Mycophenolate Mofetil

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: POWDER, FOR SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 200 mg/mL

Storage and handling

MYCOPHENOLATE MOFETIL Antimetabolite Immunosuppressant [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • Warnings and Precautions (, )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 2/2019
  • Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney , heart or liver transplants , in combination with other immunosuppressants.
  • Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. ()
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  • Mycophenolate mofetil is available in the following dosage form and strength:
  • For Oral Suspension: 35 g mycophenolate mofetil, powder for reconstitution (200 mg/mL upon reconstitution)
  • Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.
  • Hypersensitivity to mycophenolate mofetil, MPA acid or any component of the drug product ()
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  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com
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  • Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia.
  • The experience with overdose of mycophenolate mofetil in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug. The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia .
  • Treatment and Management
  • MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 mcg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine n
  • Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2u00ad morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
  • The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3u00addihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of CHNO, a molecular weight of 433.50, and the following structural formula:
  • MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group.
  • Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF.
  • Inactive ingredients in Mycophenolate mofetil for Oral Suspension include aspartame, banana flavor (contains arabic gum, natural flavor, potato maltodextrin, medium chain triglycerides), citric acid anhydrous, colloidal silicon dioxide, isopropyl alcohol*, lecithin granular, methylparaben, sodium citrate dihydrate, sorbitol, and xanthan gum.
  • *evaporated during processing; negligible amount may be present.
  • Net contents after constitution: 175 mL, containing 35 grams mycophenolate mofetil.
  • Deliverable volume after constitution: 160-165 mL.
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  • In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.4 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.3 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic. The highest dose was 0.07 times the recommended clinical dose in kidney transplant patients and 0.05 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk.
  • The genotoxic potential of MMF was determined in five assays. MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay.
  • MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. This dose represents 0.1 times the recommended clinical dose in renal transplant patients and 0.06 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.02 times the recommended clinical dose in renal transplant patients and 0.01 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
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  • Information for Patients
  • See FDA-approved patient labeling (and ).
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  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771, USA
  • VP2180R2
  • 01/2020
  • Mycophenolate mofetil (myeu2033 koe fenu2032 oh late moeu2032 fe til) for Oral Suspension, USP
  • Be sure that you read, understand and follow these instructions carefully to ensure proper dosing of Mycophenolate mofetil for Oral Suspension.
  • Important:
  • To take a dose of Mycophenolate mofetil for Oral Suspension, you will need the bottle of medicine and an oral dispenser provided with the medicine (). Your pharmacist will insert the bottle adapter in the Mycophenolate mofetil for Oral Suspension bottle.
  • Figure 1n
  • Step 1: With the child-resistant cap on the bottle, shake the bottle well for about 5 secondsu00a0before each use.
  • Step 2: Open the bottle by pressing down on the child-resistant bottle cap and turning it counter-clockwise (to the left). throw away the child-resistant bottle cap.
  • Step 3: Before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Insert the tip firmly into the opening of the bottle adapter.
  • Step 4: Carefully turn the bottle upside down with the oral dispenser in place. Slowly pull the plunger down to withdraw your prescribed dose. Do not pull the plunger out of the oral dispenser (See Figure 2).
  • Figure 2n
  • Step 5: Leave the oral dispenser in the bottle and turn the bottle to an upright position. Slowly remove the oral dispenser from the bottle.
  • Step 6: Place the tip of the oral dispenser in the patientu2019s mouth and slowly push the plunger down until the oral dispenser is empty. The mycophenolate mofetil for oral suspension that is in the oral dispenser should not be mixed with any type of liquids before taking the dose.
  • Step 7: Put the child-resistant bottle cap back on the bottle after each use.
  • Step 8: Rinse the oral dispenser under running tap water after each use:
  • Important:
  • NDC 66689-307-08
  • Mycophenolate Mofetil
  • for Oral Suspension, USP
  • u00a0200 mg/mL
  • Each mL contains 200 mg mycophenolate
  • mofetil after constitution.
  • Attention Pharmacist: n- Dispense the accompanying Medication
  • Guide to each patient.
  • Rx Only
  • VistaPharm
  • NDC 66689-307-08
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  • Mycophenolate Mofetil
  • for Oral Suspension, USP
  • u00a0200 mg/mL
  • Each mL contains 200 mg mycophenolate
  • mofetil after constitution.
  • Attention Pharmacist: Dispense the
  • accompanying Medication Guide to
  • each patient. For additional Medication
  • Guides, call 1-888-655-1505.
  • Rx Only
  • VistaPharm

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Mycophenolate Mofetil (Mycophenolate Mofetil) which is also known as Mycophenolate Mofetil and Manufactured by VistaPharm, Inc.. It is available in strength of 200 mg/mL.

Mycophenolate Mofetil (Mycophenolate Mofetil) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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