CELLCEPT- mycophenolate mofetil tablet, film coated CELLCEPT- mycophenolate mofetil capsule CELLCEPT- mycophenolate mofetil hydrochloride injection, powder, lyophilized, for solution CELLCEPT- mycophenolate mofetil powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Available from:

Genentech, Inc.

INN (International Name):

Mycophenolate Mofetil

Composition:

Mycophenolate Mofetil 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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). 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. 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 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)]. - Intrauterine devices (IUDs) - Tubal sterilization - Patient's partner vasectomy - Oral Contraceptive Pill - Transdermal patch - Vaginal ring - Injection - Implant - Diaphragm with spermicide - Cervical cap with spermicide - Contraceptive sponge - Male condom - Female condom - Diaphragm with spermicide - Cervical cap with spermicide - Contraceptive sponge - Male condom - Female condom 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)] . 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)] . 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 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 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. Read this Instructions for Use before you take or give CELLCEPT for the first time and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Important: - Always use the oral dispenser provided with CELLCEPT Oral Suspension to make sure you measure the right amount of medicine. If your CELLCEPT Oral Suspension does not come with the oral dispenser, contact your pharmacist. - Call your pharmacist if your oral dispenser is lost or damaged. - Your pharmacist will write the expiration date on your CELLCEPT Oral Suspension bottle label. Do not use CELLCEPT after the expiration date. - Ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - The CELLCEPT Oral Suspension should not be mixed with any type of liquids before taking or giving the dose. - Do not let the CELLCEPT Oral Suspension come in contact with the skin. If this happens, wash the skin well with soap and water. If the CELLCEPT Oral Suspension gets in the eyes, rinse the eyes with plain water. - If you spill any CELLCEPT Oral Suspension, wipe it up using paper towels wet with water. Put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. Supplies needed to take or give a dose of CELLCEPT Oral Suspension : To take or give a dose of CELLCEPT Oral Suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (See Figure 1 ). Your pharmacist will insert the bottle adapter in the CELLCEPT Oral Suspension bottle. Do not remove the bottle adapter from the bottle. Taking or giving a dose of CELLCEPT Oral Suspension: - Remove the plunger from the oral dispenser. - Rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. - When the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. Do not throw away the oral dispenser. Store the oral dispenser in a clean, dry place. - Do not boil the oral dispenser. Do not use solvent-containing wipes to clean the oral dispenser. Do not use cloths or wipes to dry the oral dispenser. How should I store CELLCEPT Oral Suspension? - Store the CELLCEPT Oral Suspension at room temperature between 59°F to 86°F (15°C to 30°C), for up to 60 days. You can also store the CELLCEPT Oral Suspension in the refrigerator between 36°F to 46°F (2°C to 8°C). ) - Do not freeze. Keep CELLCEPT Oral Suspension and all medicines out of the reach of children. Distributed by: Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 © 2022 Genentech, Inc. All rights reserved. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: August 2022

Product summary:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CELLCEPT capsules, CELLCEPT Oral Suspension (before or after constitution), or CELLCEPT Intravenous (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 .

Authorization status:

New Drug Application

Patient Information leaflet

CELLCEPT- MYCOPHENOLATE MOFETIL CAPSULE
CELLCEPT- MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
CELLCEPT- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
Genentech, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: August 2022
MEDICATION GUIDE
CELLCEPT® [SEL-sept]
(mycophenolate mofetil capsules)
(mycophenolate mofetil tablets)
CELLCEPT® [SEL-sept]
(mycophenolate mofetil for oral
suspension)
CELLCEPT® [SEL-sept]
(mycophenolate mofetil for
injection)
Read the Medication Guide that comes with CELLCEPT before you start
taking it and each time you
refill your prescription. There may be new information. This
Medication Guide does not take the place of
talking with your doctor about your medical condition or treatment.
What is the most important information I should know about CELLCEPT?
CELLCEPT can cause serious side effects, including:
Increased risk of loss of a pregnancy (miscarriage) and higher risk of
birth defects. Females who take
CELLCEPT during pregnancy have a higher risk of miscarriage during the
first 3 months (first
trimester), and a higher risk that their baby will be born with birth
defects.
•
If you are a female who can become pregnant, your doctor must talk
with you about acceptable
birth control methods (contraceptive counseling) to use while taking
CELLCEPT. You should
have 1 pregnancy test immediately before starting CELLCEPT and another
pregnancy test 8 to 10
days later. Pregnancy tests should be repeated during routine
follow-up visits with your doctor.
Talk to your doctor about the results of all of your pregnancy tests.
You must use acceptable birth control during your entire CELLCEPT
treatment and for 6 weeks
after stopping CELLCEPT, unless at any time you choose to avoid sexual
intercourse (abstinence)
with a man completely. CELLCEPT decreases blood levels of the hormones
in birth control pills
that you take by mouth. Birth control pills may not work as well while
you take CELLCEPT, and
you could bec

Summary of Product characteristics

CELLCEPT- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
CELLCEPT- MYCOPHENOLATE MOFETIL CAPSULE
CELLCEPT- MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
CELLCEPT- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CELLCEPT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CELLCEPT
CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULES, FOR ORAL USE
CELLCEPT (MYCOPHENOLATE MOFETIL) TABLETS, FOR ORAL USE
CELLCEPT ORAL SUSPENSION (MYCOPHENOLATE MOFETIL), FOR ORAL SUSPENSION
CELLCEPT INTRAVENOUS (MYCOPHENOLATE MOFETIL) FOR INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
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)]._
RECENT MAJOR CHANGES
Indications and Usage, Pediatric Heart or Liver Transplants (1)
6/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients (2.3)
6/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients (2.4)
6/2022
Warnings and Precautions, Serious Infections (5.3)
10/2021
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate Products (5.7)
10/2021
INDICATIONS AND USAGE
CELLCEPT is an antimetabolite immunosuppressant indicated for the
prophylaxis of organ rejection in adult and pediatric re