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Mycophenolate Mofetil (Mycophenolate Mofetil)

Trade Name : Mycophenolate Mofetil

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 250 mg/1

MYCOPHENOLATE MOFETIL Antimetabolite Immunosuppressant [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mycophenolate Mofetil (Mycophenolate Mofetil) which is also known as Mycophenolate Mofetil and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 250 mg/1 per ml. Read more

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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES andu00a0SERIOUS INFECTIONS
  • WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
  • See full prescribing information for complete boxed warning
  • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning .
  • Increased risk of development of lymphoma and other malignancies, particularly of the skin .
  • Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes .
  • Warnings and Precautions (, )u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 2/2019
  • Mycophenolate mofetil capsules (MMF) are indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney or liver transplants , in combination with other immunosuppressants.
  • Mycophenolate mofetil capsules are 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. ()
  • No data
  • Reduce or interrupt dosing in the event of neutropenia. ()
  • See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ()
  • Mycophenolate Mofetil Capsules USP are available in the following strength:
  • Capsules: 250 mg
  • Allergic reactions to mycophenolate mofetil capsules have been observed; therefore, mycophenolate mofetil capsules are 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 ()
  • No data
  • Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ()
  • Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ()
  • Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil capsules. ()
  • Immunizations: Avoid live attenuated vaccines. ()
  • Blood Donation: Avoid during therapy and for 6 weeks thereafter. ()
  • Semen Donation: Avoid during therapy and for 90 days thereafter. ()
  • Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil capsules may affect ability to drive or operate machinery. ()
  • 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 Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com
  • No data
  • See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil capsules efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders). ()
  • Mycophenolate mofetil capsules may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ()
  • See FPI for other important drug interactions. ()
  • No data
  • Pediatric Use: Safety and effectiveness in allogenic heart or liver transplants has not been established ()
  • Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment ()
  • 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 capsules 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, USP is an antimetabolite immunosuppressant. It isu00a0the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
  • The chemical name for mycophenolate mofetil, USP (MMF) is 2-morpholinoethyl ()-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has the following structural formula:
  • CHNOu00a0u00a0u00a0u00a0u00a0 M.W. 433.50
  • Mycophenolate mofetil, USP is a white to almost white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4), freely soluble in acetone, soluble in methanol, sparingly soluble in anhydrous ethanol, and practically insoluble in water. No polymorphic form was found. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil, USP are 5.6 for the morpholino group and 8.5 for the phenolic group.
  • Mycophenolate mofetil, USP is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, USP.
  • Inactive ingredients in Mycophenolate Mofetil Capsules USP, 250 mg include: black iron oxide, croscarmellose sodium, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, magnesium stearate, povidone, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide.
  • No data
  • 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 n
  • 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.
  • No data
  • 1. u201cOSHA Hazardous Drugs.u201d OSHA. n
  • No data
  • Information for Patients
  • See FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • No data
  • No data
  • No data

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