Dosage & Administration
| ADULTS | DOSAGE |
| Kidney Transplant | 1 g twice daily, orally or intravenously (IV) over no less than 2 h |
| Heart Transplant | 1.5 g twice daily orally or IV, over no less than 2 h |
| Liver Transplant | 1.5 g twice daily orally or 1g twice daily IV over no less than 2 h |
| PEDIATRICS | |
| Kidney Transplant | 600 mg/m2 orally twice daily, up to maximum of 2 g daily |
| Heart Transplant | 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension) |
| Liver Transplant | 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (3 g or 15 mL of oral suspension) |
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CellCept Prescribing Information
- 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)].
CELLCEPT [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.
Important Administration Instructions
CELLCEPT should not be used without the supervision of a physician with experience in immunosuppressive therapy.
CELLCEPT Capsules, Tablets and Oral Suspension
CELLCEPT oral dosage forms (capsules, tablets or oral suspension) 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 CELLCEPT oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent.
CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in CELLCEPT capsules and oral suspension. 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 CELLCEPT should be given as soon as possible following kidney, heart or liver transplant. It is recommended that CELLCEPT be administered on an empty stomach. In stable transplant patients, however, CELLCEPT may be administered with food if necessary [see Clinical Pharmacology (12.3)]. Once reconstituted, CELLCEPT Oral Suspension must not be mixed with any liquids prior to dose administration. If needed, CELLCEPT Oral Suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
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 CELLCEPT at the usual times.
CELLCEPT Intravenous
CELLCEPT Intravenous is recommended for patients unable to take oral CELLCEPT. CELLCEPT Intravenous should be administered within 24 hours following transplant. CELLCEPT Intravenous can be administered for up to 14 days; however, patients should be switched to oral CELLCEPT as soon as they can tolerate oral medication.
CELLCEPT Intravenous must be reconstituted before use [see Dosage and Administration (2.6)]. CELLCEPT Intravenous 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.
CELLCEPT Intravenous must not be administered as a bolus. Following reconstitution, CELLCEPT Intravenous 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 (6.1)].
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 CELLCEPT oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m2, administered twice daily (maximum total daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m2 may be dosed with capsules or tablets as follows:
| Body Surface Area | Dosage |
|---|---|
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
Dosage Recommendations for Heart Transplant Patients
Adults
The recommended dosage of CELLCEPT 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 CELLCEPT oral suspension for pediatric heart transplant patients 3 months and older is 600 mg/m2, administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 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 m2 may be started on therapy with capsules or tablets as follows:
| Body Surface Area | Starting Dosage * |
|---|---|
| |
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
Dosage Recommendations for Liver Transplant Patients
Adults
The recommended dosage of CELLCEPT 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 CELLCEPT oral suspension for pediatric liver transplant patients 3 months of age and older is 600 mg/m2, administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 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 m2 may be started on therapy with capsules or tablets as follows:
| Body Surface Area | Starting Dosage * |
|---|---|
| |
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
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 m2), do not administer doses of CELLCEPT 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 × 103/µL), dosing with CELLCEPT 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)].
Preparation Instructions of Oral Suspension and 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 procedures1 [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Use in Specific Populations (8.1, 8.3), How Supplied/Storage and Handling (16.1)].
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.
Alert patients that they and others should also avoid inhalation or contact of the skin or mucous membranes with the oral suspension. Advise them to wash the area thoroughly with soap and water if such contact occurs; if ocular contact occurs, rinse eyes with plain water.
CELLCEPT Oral Suspension
CELLCEPT Oral Suspension must be reconstituted by the pharmacist prior to dispensing to the patient. CELLCEPT Oral Suspension should not be mixed with any other medication. After reconstitution, the oral suspension contains 200 mg/mL MMF.
Before proceeding with the reconstitution steps read the general preparation instructions above [see General Preparation Instructions Before Handling the Formulations]. The following are the steps for reconstitution:
- Tap the closed bottle several times to loosen the powder.
- Measure 94 mL of water in a graduated cylinder.
- Add approximately half the total amount of water for reconstitution to the bottle and shake the closed bottle well for about 1 minute.
- Add the remainder of water and shake the closed bottle well for about 1 minute.
- Remove the child-resistant cap and push bottle adapter into neck of bottle.
- Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
- Write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)
- Dispense with the "Instruction for Use" and oral dispensers. Alert patients to read the important handling information described in the instructions for use.
Store reconstituted suspension at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.
CELLCEPT Intravenous
Before proceeding with the preparation steps for CELLCEPT Intravenous read the general preparation instructions [see General Preparation Instructions Before Handling the Formulations] and note the following:
- CELLCEPT Intravenous 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.
CELLCEPT Intravenous must be reconstituted and further diluted. A detailed description of the preparation is given below.
| Preparation of the 1g dose |
|
| Preparation of the 1.5 g dose |
|
The administration of the infusion should be initiated within 4 hours of reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Discard unused portion of the reconstituted solutions.
CELLCEPT Injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
CELLCEPT is available in the following dosage forms and strengths:
| Capsules | 250 mg mycophenolate mofetil, two-piece hard gelatin capsules, blue-brown, "CELLCEPT 250" printed in black on the blue cap and "Roche" on the brown body |
| Tablets | 500 mg mycophenolate mofetil, lavender-colored, caplet-shaped, film-coated tablets engraved with "CELLCEPT 500" on one side and "Roche" on the other |
| For oral suspension | 35 g mycophenolate mofetil white to off-white powder for reconstitution (200 mg/mL upon reconstitution) |
| For injection | 500 mg mycophenolate mofetil white to off-white lyophilized powder, in a single-dose vial for reconstitution |
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 CELLCEPT 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 CELLCEPT 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 increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.
Lactation
Risk Summary
There are no data on the presence of mycophenolate in human milk, or the effects on milk production. There are limited data in the National Transplantation Pregnancy Registry on the effects of mycophenolate on a breastfed child [see Data]. Studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk. Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CELLCEPT and any potential adverse effects on the breastfed infant from CELLCEPT or from the underlying maternal condition.
Data
Limited information is available from the National Transplantation Pregnancy Registry. Of seven infants reported by the National Transplantation Pregnancy Registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. No adverse events were reported.
Females and Males of Reproductive Potential
Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
Pregnancy Planning
For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. Risks and benefits of CELLCEPT should be discussed with the patient.
Pregnancy Testing
To prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL immediately before starting CELLCEPT. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. Results of all pregnancy tests should be discussed with the patient. In the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.
Contraception
Female Patients
Females of reproductive potential taking CELLCEPT must receive contraceptive counseling and use acceptable contraception (see Table 9 for acceptable contraception methods). Patients must use acceptable birth control during the entire CELLCEPT therapy, and for 6 weeks after stopping CELLCEPT, unless the patient chooses abstinence.
Patients should be aware that CELLCEPT reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see Drug Interactions (7.2)].
| Pick from the following birth control options: | |||
| Option 1 | |||
| Methods to Use Alone |
| ||
| OR | |||
| Option 2 | Hormone Methods choose 1 | Barrier Methods choose 1 | |
| Choose One Hormone Method AND One Barrier Method | Estrogen and Progesterone
| AND |
|
| OR | |||
| Option 3 | Barrier Methods choose 1 | Barrier Methods choose 1 | |
| Choose One Barrier Method from each column (must choose two methods) |
| AND |
|
Male Patients
Genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. Thus, the risk of genotoxic effects on sperm cells cannot be excluded. Based on this potential risk, 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. Also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with CELLCEPT and for at least 90 days after cessation of treatment [see Use in Special Populations (8.1), Nonclinical Toxicology (13.1), Patient Counseling Information (17.9)].
Pediatric Use
Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants.
Kidney Transplant
Use of CELLCEPT in this population is supported by evidence from adequate and well-controlled studies of CELLCEPT in adults with additional data from one open-label, pharmacokinetic and safety study of CELLCEPT in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)].
Heart Transplant and Liver Transplant
Use of CELLCEPT in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. Additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see Dosage and Administration (2.3, 2.4), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)].
Geriatric Use
Clinical studies of CELLCEPT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see Adverse Reactions (6.1), Drug Interactions (7)].
Patients with Renal Impairment
Patients with Kidney Transplant
No dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see Clinical Pharmacology (12.3)]. In kidney transplant patients with severe chronic impairment of the graft (GFR <25 mL/min/1.73 m2), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided.
Patients with Heart and Liver Transplant
No data are available for heart or liver transplant patients with severe chronic renal impairment. CELLCEPT may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
Patients with Hepatic Impairment
Patients with Kidney Transplant
No dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. However, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see Clinical Pharmacology (12.3)].
Patients with Heart Transplant
No data are available for heart transplant patients with severe hepatic parenchymal disease.
Allergic reactions to CELLCEPT have been observed; therefore, CELLCEPT is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. CELLCEPT Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).