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MYCOPHENOLATE MOFETIL FOR is a brand name for Mycophenolate Mofetil, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mycophenolate Mofetil for Injection, USP is indicated for: Adults The prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate Mofetil for Injection, USP is an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Mycophenolate Mofetil for Injection, USP should be used concomitantly with standard cyclosporine and corticosteroid therapy. Mycophenolate Mofetil for Injection, USP is an alternative dosage form to mycophenolate mofetil capsules and tablets recommended for patients unable to take mycophenolate mofetil capsules or tablets.
Mycophenolate Mofetil for Injection, USP should be administered within 24 hours following transplantation. Mycophenolate Mofetil for Injection, USP can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication.
Caution: Mycophenolate Mofetil for Injection, USP solution should never be administered by rapid or bolus intravenous injection. 2 Recommended Dose and Dosage Adjustment Adults Renal Transplantation A dose of 1 g administered intravenously (over 2 hours) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g per day of mycophenolate mofetil in these trials demonstrated an overall better safety profile than did patients receiving 3 g per day of mycophenolate mofetil.
5 g twice daily administered intravenously (over no less than 2 hours) is recommended for use in adult cardiac transplant patients. PrMycophenolate Mofetil for Injection Page 6 of 62 Hepatic Transplantation A dose of 1 g twice daily administered intravenously (over no less than 2 hours) is recommended for use in adult hepatic transplant patients.
*Pediatrics (2 to 18 years) The recommended dose of mycophenolate mofetil oral suspension for renal transplant patients is 600 mg/m2 body surface area twice daily (up to a maximum of 2 g daily). 5 g daily dose). 5 m2 may be dosed with mycophenolate mofetil capsules or tablets at a dose of 1 g twice daily (2 g daily dose).
*There is no data for the mycophenolate mofetil intravenous infusion (IV infusion) in children. ’s Mycophenolate Mofetil for Injection, USP is only available as a lyophilized powder for injection. Other mycophenolate mofetil products should be used for oral administration.
). 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 3 Reconstitution Parenteral products: Preparation of Infusion Solution (6 mg/mL) Mycophenolate Mofetil for Injection, USP does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
PrMycophenolate Mofetil for Injection Page 7 of 62 Mycophenolate Mofetil for Injection, USP infusion solution must be prepared in two steps: the first step is a reconstitution step with 5 % Dextrose Injection, USP and the second step is a dilution step with 5 % Dextrose Injection, USP.
A detailed description of the preparation is given below:
Step 1 a. 5 g dose. Reconstitute the contents of each vial by injecting 14 mL of 5 % Dextrose Injection, USP. b. Gently shake the vial to dissolve the drug. c. Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution.
Discard the vial if particulate matter or discoloration is observed. Step 2 a. To prepare a 1 g dose, further dilute the contents of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of 5 % Dextrose Injection USP. 5 g dose, further dilute the contents of the three reconstituted vials (approx.
3 x 15 mL) into 210 mL of 5 % Dextrose Injection USP. The final concentration of both solutions is 6 mg mycophenolate mofetil per mL. b. As with all parenteral drug products, diluted solution should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discard unused portion. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from reconstitution and dilution of the drug product.
, Immune 12/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .......................................................................................................
2 TABLE OF CONTENTS ......................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................................
4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics...............................................................................................................................
2 Geriatrics ............................................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 5 4 DOSAGE AND ADMINISTRATION ............................................................................................
1 Dosing Considerations .......................................................................................................... 2 Recommended Dose and Dosage Adjustment .....................................................................
3 Reconstitution ....................................................................................................................... 4 Administration ......................................................................................................................
7 5 OVERDOSAGE ........................................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................................
Mycophenolate Mofetil for Injection, USP is contraindicated in patients with a known hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Mycophenolate Mofetil for Injection, USP is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN) (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Mycophenolate Mofetil for Injection, USP is contraindicated during pregnancy due to its mutagenic and teratogenic potential (see 7 WARNINGS AND PRECAUTIONS).
Mycophenolate Mofetil for Injection, USP is contraindicated in women of childbearing potential not using highly effective contraceptive methods and without providing a pregnancy test result (see 7 WARNINGS AND PRECAUTIONS). Mycophenolate Mofetil for Injection, USP is contraindicated in women who are breastfeeding (see 7 WARNINGS AND PRECAUTIONS).
PrMycophenolate Mofetil for Injection Page 5 of 62
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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73 m2) outside the immediate post-transplant period, doses of mycophenolate mofetil greater than 1 g administered twice a day should be avoided. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Mycophenolate mofetil should be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks. 3 x 103/mcL), dosing with mycophenolate mofetil should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see 7 WARNINGS AND PRECAUTIONS, Immune, Monitoring and Laboratory Tests and 8 ADVERSE REACTIONS).
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 3 Reconstitution Parenteral products: Preparation of Infusion Solution (6 mg/mL) Mycophenolate Mofetil for Injection, USP does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
PrMycophenolate Mofetil for Injection Page 7 of 62 Mycophenolate Mofetil for Injection, USP infusion solution must be prepared in two steps: the first step is a reconstitution step with 5 % Dextrose Injection, USP and the second step is a dilution step with 5 % Dextrose Injection, USP.
A detailed description of the preparation is given below:
Step 1 a. 5 g dose. Reconstitute the contents of each vial by injecting 14 mL of 5 % Dextrose Injection, USP. b. Gently shake the vial to dissolve the drug. c. Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution.
Discard the vial if particulate matter or discoloration is observed. Step 2 a. To prepare a 1 g dose, further dilute the contents of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of 5 % Dextrose Injection USP. 5 g dose, further dilute the contents of the three reconstituted vials (approx.
3 x 15 mL) into 210 mL of 5 % Dextrose Injection USP. The final concentration of both solutions is 6 mg mycophenolate mofetil per mL. b. As with all parenteral drug products, diluted solution should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discoloration or leakage should not be used. Discard unused portion. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from reconstitution and dilution of the drug product.
Keep solutions at 15°C to 30°C. Mycophenolate Mofetil for Injection, USP should not be mixed or administered […]
Keep solutions at 15°C to 30°C. Mycophenolate Mofetil for Injection, USP should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures. 3 Reconstitution, Preparation of Infusion Solution).
Mycophenolate Mofetil for Injection, USP is incompatible with other intravenous infusion solutions. Following reconstitution, Mycophenolate Mofetil for Injection, USP solution must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein.
5 OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre. Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience. In many of these cases, no adverse events were reported.
In those PrMycophenolate Mofetil for Injection Page 8 of 62 overdose cases in which adverse events were reported, the events fall within the known safety profile of the drug. It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see 7 WARNINGS AND PRECAUTIONS, Immune).
If neutropenia develops, dosing with Mycophenolate Mofetil for Injection, USP should be interrupted or the dose reduced (see 7 WARNINGS AND PRECAUTIONS, Immune). The highest dose administered to renal transplant patients in clinical trials has been 4 g per day.
In limited experience with cardiac and hepatic transplant patients in clinical trials, the highest doses used were 4 g or 5 g per day. At doses of 4 g or 5 g per day, there appears to be a higher rate, compared to the use of 3 g per day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, principally neutropenia, leading to a need to reduce or discontinue dosing.
At clinically encountered concentrations, MPA and MPAG are not removed by hemodialysis. However, at high MPAG plasma concentrations (> 100 mcg/mL), small amounts of MPAG are removed. By interfering with enterohepatic recirculation of the drug, bile acid sequestrants, such as cholestyramine reduce the MPA AUC.
5 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH.
Lyophilized Powder for Solution for Intravenous Infusion:
Composition: Mycophenolate Mofetil for Injection, USP is available as a sterile white to off-white lyophilized powder in vials containing mycophenolate mofetil for administration by intravenous infusion only. Each vial of Mycophenolate Mofetil for Injection, USP contains the equivalent of 500 mg mycophenolate mofetil.
Availability:
Mycophenolate Mofetil for Injection, USP is supplied in a 20 mL, sterile vial containing the equivalent of 500 mg mycophenolate mofetil (as mycophenolate mofetil hydrochloride) in cartons of 1 vial. Each vial is intended for single use only.
PrMycophenolate Mofetil for Injection Page 9 of 62 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Caution:
Mycophenolate Mofetil […]
8 7 WARNINGS AND PRECAUTIONS ............................................................................................. 1 Special Populations .............................................................................................................
1 Pregnant Women ............................................................................................................ 2 Breast-feeding .................................................................................................................
3 Pediatrics ......................................................................................................................... 4 Geriatric ...........................................................................................................................
13 8 ADVERSE REACTIONS ........................................................................................................... 1 Adverse Reaction Overview ................................................................................................
2 Clinical Trial Adverse Reactions .......................................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ...................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................................... 5 Post-Market Adverse Reactions..........................................................................................
20 PrMycophenolate Mofetil for Injection Page 3 of 62 9 DRUG INTERACTIONS ........................................................................................................... 2 Drug Interactions Overview ................................................................................................
3 Drug-Behavioural Interactions ............................................................................................ 4 Drug-Drug Interactions .......................................................................................................
5 Drug-Food Interactions ....................................................................................................... 6 Drug-Herb Interactions .......................................................................................................
7 Drug-Laboratory Test Interactions...................................................................................... 26 10 CLINICAL PHARMACOLOGY ..................................................................................................
1 Mechanism of Action ...................................................................................................... 2 Pharmacodynamics .........................................................................................................
3 Pharmacokinetics ............................................................................................................ 27 11 STORAGE AND STABILITY .....................................................................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................................... 32 PART II: SCIENTIFIC INFORMATION ..................................................................................................
34 13 PHARMACEUTICAL INFORMATION ....................................................................................... 34 14 CLINICAL TRIALS ...................................................................................................................
1 Trial Design and Study Demographics............................................................................. 2 Study Results […]