Mycophenolate mofetil intravenous
Other products: Mycophenolate mofetil
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Boxed warning
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS 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 [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] .
Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . 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 [see Warnings and Precautions (5.1) ].
Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].
Handling and access
NIOSH hazardous drug
Table 1NIOSH lists mycophenolate mofetil as a hazardous drug. AHFS class: 92:44 immunosuppressive agents.
- The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Dosing in kidney impairment
Dosage Recommendations for Kidney Transplant Patients Adults The recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) Pediatric dosing is based on body surface area (BSA). The recommended dosage of mycophenolate mofetil oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m 2 , administered twice daily (maximum total daily dose of 2 g or 10 mL of the oral suspension).
Pediatric patients with BSA ≥ 1.25 m 2 may be dosed with capsules or tablets as follows: [See table below.]
Dosage Modifications: Patients with Renal Impairment, Neutropenia Renal Impairment No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively [see Clinical Pharmacology ] . In kidney transplant patients with severe chronic impairment of the graft (GFR <25 mL/min/1.73 m 2 ), do not administer doses of mycophenolate mofetil greater than 1 g twice a day.
These patients should be carefully monitored [see Clinical Pharmacology ]. Neutropenia If neutropenia develops (ANC <1.3 x 10 3 /μL), dosing with mycophenolate mofetil should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately [see Warnings and Precautions and Adverse Reactions].
Dosing in liver impairment
Dosage Recommendations for Liver Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g) or 1 g infused intravenously over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and older) The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric liver transplant patients 3 months of age and older is 600 mg/m 2 , administered twice daily.
If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m 2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment. Pediatric patients with BSA ≥1.25 m 2 may be started on therapy with capsules or tablets as follows: [See table below.] *Maximum maintenance dose: 3 g total daily.
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Preparation and administration
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Important Administration Instructions Mycophenolate mofetil for injection should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil for Injection Mycophenolate mofetil for injection is recommended for patients unable to take oral mycophenolate mofetil. Mycophenolate mofetil for injection should be administered within 24 hours following transplant.
Mycophenolate mofetil for injection can be administered for up to 14 days; however, patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. Mycophenolate mofetil for injection must be reconstituted before use [see Dosage and Administration ] . Mycophenolate mofetil for injection is incompatible with other intravenous infusion solutions and should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
Mycophenolate mofetil for injection must not be administered as a bolus. Following reconstitution, mycophenolate mofetil for injection must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein, as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis [see Adverse Reactions ] .
Preparation Instructions of Intravenous for Pharmacists General Preparation Instructions Before Handling the Formulations Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures 1 [see Warnings and Precautions , Adverse Reactions , Use in Specific Populations (8.1 , 8.3) , How Supplied/Storage and Handling ] .
Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension because MMF has demonstrated teratogenic effects in humans. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table surface after reconstitution.
If such contact occurs, wash hands thoroughly with soap and water; rinse eyes with water. Mycophenolate Mofetil for Injection Before proceeding with the preparation steps for mycophenolate mofetil for injection read the general preparation instructions [see General Preparation Instructions Before Handling the Formulations] and note the following: Mycophenolate mofetil for injection does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
This product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding the diluent, the vial should not be used. Mycophenolate mofetil for injection must be reconstituted and further diluted. A detailed description of the preparation is given below. [See table below.] Dilute the contents of the two reconstituted vials (approximately 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP.
Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed. Preparation of the 1.5 g dose Reconstitute three vials of mycophenolate mofetil for injection by injecting 14 mL of 5% Dextrose Injection USP into each vial. Gently shake the vial to dissolve the drug. Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution.
Discard the vials if particulate matter or discoloration is observed. Dilute the contents of the three reconstituted vials (approximately 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP. Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed. The administration of the infusion should be initiated within 4 hours of reconstitution and dilution of the drug product.
Keep solutions at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Discard unused portion of the reconstituted solutions. Mycophenolate mofetil for injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
| Table 4 Preparation Instructions of Mycophenolate Mofetil for Injection for Pharmacists | |
| Preparation of the 1g dose | Reconstitute two (2) vials of mycophenolate mofetil for injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.Gently shake the vial to dissolve the drug.Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.Dilute the contents of the two reconstituted vials (approximately 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP.Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed. |
| Preparation of the 1.5 g dose | Reconstitute three (3) vials of mycophenolate mofetil for injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.Gently shake the vial to dissolve the drug.Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.Dilute the contents of the three reconstituted vials (approximately 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP.Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed. |
Drug interactions
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- Mycophenolate mofetil intravenous
Label text (8 paragraphs)
See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ( 7.2 ) See FPI for other important drug interactions. ( 7 )
7.1 Effect of Other Drugs on Mycophenolate Mofetil Table 7 Drug Interactions with Mycophenolate Mofetil that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration.
Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with mycophenolate mofetil.
Examples Lansoprazole, pantoprazole Drugs that Interfere with Enterohepatic Recirculation Clinical Impact Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil.
Examples Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials Drugs Modulating Glucuronidation Clinical Impact Concomitant use with drugs inducing glucuronidation decreases MPA systemic exposure, potentially reducing mycophenolate mofetil efficacy, while use with drugs inhibiting glucuronidation increases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of mycophenolate mofetil related adverse reactions.
Prevention or Management Monitor patients for alterations in efficacy or mycophenolate mofetil related adverse reactions when these drugs are co-administered with mycophenolate mofetil. Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation). Calcium Free Phosphate Binders Clinical Impact Concomitant use with calcium free phosphate binders decrease MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Administer calcium free phosphate binders at least 2 hours after mycophenolate mofetil. Examples Sevelamer
7.2 Effect of Mycophenolate Mofetil on Other Drugs Table 8 Drug Interactions with Mycophenolate Mofetil that Affect Other Drugs Drugs that Undergo Renal Tubular Secretion Clinical Impact When concomitantly used with mycophenolate mofetil, its metabolite MPAG, may compete with drugs eliminated by renal tubular secretion which may increase plasma concentrations and/or adverse reactions associated with these drugs. Prevention or Management Monitor for drug-related adverse reactions in patients with renal impairment.
Examples Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir Combination Oral Contraceptives Clinical Impact Concomitant use with mycophenolate mofetil decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see Clinical Pharmacology (12.3) ] , which may result in reduced combination oral contraceptive effectiveness. Prevention or Management Use additional barrier contraceptive methods.
Contraindications
Mycophenolate mofetil is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions (5.8) ] . Mycophenolate mofetil is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). History of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid or any component of the drug product ( 4 ) Patients allergic to Polysorbate 80 (present in Mycophenolate Mofetil for Injection) ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible rare cause of clinically apparent liver injury.
Mycophenolate mofetil is an antimetabolite and potent immunosuppressive agent used as adjunctive therapy in prevention of allograft rejection and in the treatment of serious autoimmune diseases. Mycophenolate therapy can be associated with mild serum enzyme elevations and it has been linked to rare instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191. Risk Summary 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 [see Human Data ] .
Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ]. Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.
Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure. Animal Data In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.
Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced…
Breastfeeding (LactMed)
Information from 3 patients on the excretion of mycophenolate into milk is inconsistent. A few infants have reportedly been breastfed during mycophenolate therapy, with no adverse effects reported. Because little information is available on the use of mycophenolate during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
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