MYCOPHENOLATE MOFETIL capsule MYCOPHENOLATE MOFETIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Accord Healthcare Inc.

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. 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 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 mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil 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 to 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 mycophenolate mofetil 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 mycophenolate mofetil. 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 mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see Table 9 for acceptable contraception methods). Patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence. Patients should be aware that mycophenolate mofetil 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 mycophenolate mofetil 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 mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil 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 mycophenolate mofetil 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 mycophenolate mofetil 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 m 2 ), 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. Mycophenolate mofetil 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.

Product summary:

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. 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 mycophenolate mofetil capsules. Follow applicable special handling and disposal procedures 1 . Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. Storage and Dispensing Information 1.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 2.Dispense in light-resistant containers, such as the manufacturer's original containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET
Accord Healthcare Inc.
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Dispense with Medication Guide available at
www.accordhealthcare.us/medication-guides
MEDICATION GUIDE
Mycophenolate Mofetil Capsules 250 mg
Mycophenolate Mofetil Tablets 500 mg
(MYE koe FEN oh late MOE fe til)
Read the Medication Guide that comes with mycophenolate mofetil
capsules and tablets 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
mycophenolate mofetil capsules and
tablets?
Mycophenolate mofetil capsules and tablets can cause serious side
effects, including:
Increased risk of loss of a pregnancy (miscarriage) and higher risk of
birth defects. Females who take
mycophenolate mofetil 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
mycophenolate mofetil. You
should have 1 pregnancy test immediately before starting mycophenolate
mofetil capsules and
tablets 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 mycophenolate
mofetil treatment and for
6 weeks after stopping mycophenolate mofetil capsules and tablets,
unless at any time you choose
to avoid sexual intercourse (abstinence) with a man completely.
Mycophenolate mofetil 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 mycophenolate mofetil, and you could
become pregnant.

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET
ACCORD HEALTHCARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEMYCOPHENOLATE
MOFETILSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MYCOPHENOLATE
MOFETIL.MYCOPHENOLATEMOFETILCAPSULES, FOR ORAL
USEMYCOPHENOLATEMOFETILTABLETS,
FOR ORAL 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 ( 5.11)
10/2021
INDICATIONS AND USAGE
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
ADULTS
DOSAGE
Kidney Transplant
1 g twice daily, orally ( 2.2)
Heart Transplant
1.5 g twice daily or