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Drug Catalog - Product Detail

MYCOPHENOLATE MOFETIL CP 250MG 100

NDC Mfr Size Str Form
00781-2067-01 SANDOZ 100 250MG CAPSULE
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Generic Name
MYCOPHENOLATE MOFETIL
Substance Name
MYCOPHENOLATE MOFETIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA065379
Description
11 DESCRIPTION Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-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-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil 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 mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Inactive Ingredients: Tablets - Mycophenolate mofetil tablets are available for oral administration as tablets containing 500 mg of mycophenolate mofetil. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, talc, hypromellose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, iron oxide black and iron oxide red. Capsules - Mycophenolate mofetil capsules, USP are available for oral administration as capsules containing 250 mg of mycophenolate mofetil. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, FD&C blue #2, gelatin, magnesium stearate, povidone (K-90), pregelatinized starch and titanium dioxide. The capsule is printed with edible black ink. The black ink is comprised of butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Handling and Disposal Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules. Follow applicable special handling and disposal procedures 1 . 16.2 Mycophenolate Mofetil Capsules, 250 mg Mycophenolate mofetil capsules, USP are available as follows: Capsules Hard gelatin capsules with opaque blue cap and opaque white body. The cap and body are imprinted with "655" with black ink NDC 0781-2067-01, bottle of 100 capsules NDC 0781-2067-72, bottle of 120 capsules NDC 0781-2067-05, bottle of 500 capsules NDC 0781-2067-89, package containing 12 bottles of 120 16.3 Mycophenolate Mofetil Tablets, 500 mg Mycophenolate mofetil tablets are available as follows: Tablets Lavender colored, film-coated biconvex tablets with ‘SZ’ on one side and ‘327’ on the other side. NDC 0781-5175-01, bottle of 100 tablets NDC 0781-5175-05, bottle of 500 tablets NDC 0781-5175-10, bottle of 1000 tablets Storage: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant cap.
Indications & Usage
1 INDICATIONS AND USAGE Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ( 14.1 )], heart [see Clinical Studies ( 14.2 )] or liver transplants [see Clinical Studies ( 14.3 )], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally or intravenously (IV) over no less than 2 h ( 2.2 ) Heart Transplant 1.5 g twice daily orally or IV, over no less than 2 h ( 2.3 ) Liver Transplant 1.5 g twice daily orally or 1 g twice daily IV over no less than 2 h ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Heart Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.4 ) • Mycophenolate mofetil Intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. ( 2.1 ) • Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) • See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ). 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules and Tablets Mycophenolate mofetil oral dosage forms (capsules or tablets) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water. The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary [see Clinical Pharmacology ( 12.3 )]. Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil at the usual times. 2.2 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: Table 1. Pediatric Kidney Transplant: Dosage Using Capsules or Tablets Body Surface Area Dosage 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) 2.3 Dosage Recommendations for Heart Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally or intravenously infused over no less than 2 hours administered twice daily (total daily dose of 3 g). Pediatrics (3 months and older) The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric heart transplant patients 3 months 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: Table 2. Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage* 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) *Maximum maintenance dose: 3 g total daily. 2.4 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: Table 3. Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage* 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) *Maximum maintenance dose: 3 g total daily. 2.5 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 ( 12.3 )]. 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 ( 12.3 )]. 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 ( 5.4 ) and Adverse Reactions ( 6.1 )].