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MYFORTIC is a brand name for Mycophenolic Acid, supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Single oral doses of MPA are moderately well tolerated in rats (LD50 of 350-700 mg/kg), well tolerated in mice or monkeys (LD50 of more than 1000 mg/kg), and extremely well tolerated in rabbits (LD50 of more than 6000 mg/kg).
Carcinogenicity:
In a 104-week oral carcinogenicity study in rats, mycophenolate sodium at daily doses up to 9mg/kg was not tumorigenic. 44g/day. Similar results were observed in a parallel study in rats performed with mycophenolate mofetil. In a 26- week oral carcinogenicity assay in a P53± (heterozygous) transgenic mouse model, mycophenolate sodium at daily doses up to 200 mg/kg was not tumorigenic.
44 g/day) Genotoxicity: The genotoxic potential of mycophenolate sodium was determined in five assays. MPA 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 or the chromosomal aberration assay in human lymphocytes. 44 g of MYFORTIC per day. It is probable that the mutagenic activity observed was due to a shift in the relative abundance of the nucleotides in the cellular pool used for DNA synthesis.
Reproductive and Developmental Toxicology:
Mycophenolate sodium had no effect on fertility of male rats at oral doses up to 40 mg/kg/day. 44 g of MYFORTIC per day. No effects on female fertility were seen up to a dose of 20 mg/kg/day, a dose at which maternal toxicity and embryotoxicity were already observed.
In a teratology study performed with mycophenolate sodium in rats, at a dose as low as 1mg/kg, malformations in the offspring were observed, including anophthalmia, exencephaly and umbilical hernia. 44 g/day of MYFORTIC. In a pre- and postnatal development study in rat, mycophenolic acid (as sodium salt) caused developmental delays (abnormal pupillary reflex in females and preputial separation in males) at the highest dose of 3 mg/kg.
MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 26 of 34 Unclassified / Non classifié Patient Medication Information READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PrMYFORTIC® Mycophenolic acid Delayed-Release Tablets This Patient Medication Information is written for the person who will be taking MYFORTIC®.
This may be you or a person you are caring for. Read this information carefully. Keep it as you may need to read it again. This Patient Medication Information is a summary. It will not tell you everything about this medication. If you have more questions about this medication or want more information about MYFORTIC, talk to a healthcare professional.
What MYFORTIC is used for:
, Hematologic). 4 Administration • Patients are to be instructed that MYFORTIC tablets should not be crushed, chewed, or cut prior to ingesting but to be swallowed whole in order to maintain the integrity of the enteric coating. 5 Missed Dose • Not applicable 5 Overdose There have been anecdotal reports of deliberate or accidental overdoses with MYFORTIC, whereas not all patients experienced related adverse events.
In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the class. Accordingly, an overdose of MYFORTIC could possibly result in over suppression of MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 6 of 34 Unclassified / Non classifié the immune system and may increase the susceptibility to infection including opportunistic infections, fatal infections and sepsis.
g. 2 Clinical Trial Adverse Reactions). Possible signs and symptoms of acute overdose could include the following: hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.
General supportive measures and symptomatic treatment should be followed in all cases of over dosage. Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety MPA due to the 98% plasma protein binding of MPA.
By interfering with enterohepatic circulation of MPA, activated charcoal or bile acid sequestrants, such as cholestyramine, may reduce the systemic MPA exposure. For management of a suspected drug overdose, contact your regional poison control centre.
6 Dosage Forms, Strengths, Composition and Packaging Table 1 – Dosage Forms, Strengths, Composition MYFORTIC Delayed-Release Tablets are available in the following strengths which are equivalent to mycophenolic acid 180 mg and 360 mg: 180 mg Delayed-Release tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) ‘C’ on one side, containing 180 mg mycophenolic acid as mycophenolate sodium.
5 Post Market Adverse Reactions). MYFORTIC is a powerful teratogen and mutagen. Spontaneous abortion (rate of 45-49% compared to a reported rate between 12 and 33% in solid organ transplant patients treated with other immunosuppressants) and congenital malformations (estimated rate of 23-27%) have been reported following mycophenolate mofetil (MMF) exposure MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 10 of 34 Unclassified / Non classifié during pregnancy.
5 Post Market Adverse Reactions). Studies in animals have shown reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY: Reproductive and Developmental Toxicity). 2 Breastfeeding MYFORTIC is contraindicated during breastfeeding due to the potential for serious adverse reactions in nursing infants (see 2 CONTRAINDICATIONS).
Studies in rats have shown mycophenolate mofetil is excreted in milk. It is not known whether this drug is excreted in human milk. 1 Pediatrics. 2 Geriatrics. 1 Adverse Reaction Overview The most common (>25%) adverse events from clinical trial data from de novo kidney transplant patients treated with MYFORTIC include constipation, nausea, and urinary tract infection.
Clinical trial data from maintenance patients treated with MYFORTIC show that nausea, diarrhea and nasopharyngitis were the most frequently observed adverse reactions (> 15%). 5%) in controlled clinical trials. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The incidence of adverse events for MYFORTIC Delayed-Release Tablets was determined in randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and maintenance kidney transplant patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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MYFORTIC is used in adults to supress the immune system to prevent your body from rejecting a transplanted kidney.
How MYFORTIC works:
Your body’s immune system works to protect you from infections and other foreign material. When you receive a transplant, your immune system recognizes the new organ as “foreign” and will try to reject it. MYFORTIC works to suppress your immune system, so that your body is more likely to accept the transplanted kidney.
g. Serious Warnings and Precautions • MYFORTIC will only be prescribed for you by a healthcare professional with experience in transplantation medicine. • Serious Immune System Problems: MYFORTIC can have an effect on your immune system, which can lead to death.
This can cause: o Blood Problems:
MYFORTIC can cause serious blood problems. This includes; low levels of white blood cells that fight infections (Leukopenia), low levels of red blood cells (Anemia) and low levels of platelets, the cells that help the blood to clot (Thrombocytopenia).
o Progressive Multifocal Leukoencephalopathy: An infection of the brain. o Hepatitis B or C: If you have had the liver disease hepatitis B or C in the past taking MYFORTIC might make it come back. o Cancer: MYFORTIC can increase your risk of developing certain types of cancer such as cancer of the lymph nodes (lymphoma) and skin cancer.
o Kidney Infection: A viral infection of the kidneys. See the Serious side effect and what to do about them table, below for more information on these and other serious side effects. • Pregnancy: Do not take MYFORTIC if you are pregnant.
Taking MYFORTIC during pregnancy increases the risk of birth defects and pregnancy loss (miscarriage). If you are a woman who is able to get pregnant you must use two effective forms of birth control at the same time while you are taking MYFORTIC and for six weeks after your last dose.
MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 27 of 34 Unclassified / Non classifié prednisone, prednisolone, methyl prednisolone, prednisolone acetate, methyl prednisolone acetate) which also suppress your immune system.
Together these drugs help prevent the rejection of your transplanted kidney.
The ingredients in MYFORTIC are:
Medicinal ingredient: mycophenolate sodium Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose phthalate, indigotine (180 mg tablets), iron oxide yellow, iron oxide red (360 mg tablets), lactose anhydrous, magnesium stearate, povidone (K-30), starch and titanium […]
Provided in unit dose of 10 tablets/blister pack; 12 packs/carton. 360 mg Delayed-Release tablet: Pale orange red film-coated ovaloid tablet with imprint (debossing) ‘CT’ on one side, containing 360 mg mycophenolic acid as mycophenolate sodium.
Provided in unit dose of 10 tablets/blister pack; 12 packs/carton. 7 Warnings and Precautions General Patients receiving MYFORTIC should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Delayed-Release Tablets 180 mg and 360 mg colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K- 30), and starch.
The enteric coating of the tablet consists of hypromellose phthalate, iron oxide yellow, indigotine (180 mg Delayed-Release tablet) or iron oxide red (360 mg Delayed-Release tablet) and titanium dioxide. MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 7 of 34 Unclassified / Non classifié Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate. Carcinogenesis and Genotoxicity Patients receiving immunosuppressive regimens involving combinations of drugs, including MYFORTIC, as part of an immunosuppressive regimen are at an increased risk of developing lymphomas and other malignancies, particularly of the skin.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. As general advice to minimize the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Endocrine and Metabolism On theoretical grounds, because MYFORTIC is an IMPDH Inhibitor, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch- Nyhan and Kelley-Seegmiller syndrome.
Gastrointestinal Because mycophenolic acid derivatives have been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, hemorrhage, and perforation, MYFORTIC should be administered with caution in patients with active serious digestive system disease.
Gastrointestinal adverse events are common in patients receiving MPA treatment. Gastrointestinal bleeding (requiring hospitalization), gastrointestinal tract ulceration, and perforation have rarely been reported in de novo renal transplant patients or maintenance patients treated with MYFORTIC Delayed-Release Tablets during clinical trials.
Most patients receiving MYFORTIC were also receiving other drugs known to be associated with these complications. Patients with active peptic ulcer disease were excluded from enrollment in studies with MYFORTIC. 5 Post- Market Adverse Reactions).
The mechanism for MYFORTIC or MMF-induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppressive regimen is also unknown. In some cases PRCA was found to be reversible with dose reduction or cessation of therapy with MYFORTIC.
In transplant patients, however, reduced immunosuppression may place […]
Adverse events reported in > 10% of patients receiving MYFORTIC or MMF in the 12-months de novo renal study and maintenance renal study, when used in combination with cyclosporine are listed in Table 2. Adverse event rates were similar between MYFORTIC and MMF in both de novo and maintenance patients.
1 - - MYFORTIC (Mycophenolic Acid Delayed Release Tablets) Page 12 of 34 Unclassified / Non classifié Table 3 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups.
6 0 Long term administration of MYFORTIC (up to 30 months of exposure) did not show any unexpected changes in the pattern of adverse events including infections and malignancies. The following adverse events were reported between 3% to <10% incidence in de novo and maintenance patients treated with MYFORTIC in combination with cyclosporine and corticosteroids are listed in Table 4.
Table 4:
Adverse Events Reported in 3% to <10% of Patients Treated with MYFORTIC in Combination with cyclosporine and Corticosteroids de novo Renal Study Maintenance Renal Study Blood and lymphatic disorders Lymphocele, thrombocytopenia Leukopenia, anemia Cardiac disorder Tachycardia - Eye disorder Vision blurred - Endocrine disorders Cushingoid, hirsutism - Gastrointestinal disorder Flatulence, abdominal distension, sore throat, abdominal pain lower, abdominal pain, gingival hyperplasia, loose stool Abdominal pain, constipation, gastroesophageal […]