MYCOPHENOLATE MOFETIL capsule MYCOPHENOLATE MOFETIL tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Cardinal Health 107, LLC

INN (Nama Internasional):

MYCOPHENOLATE MOFETIL

Komposisi:

MYCOPHENOLATE MOFETIL 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients 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.   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. 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 (0.02 to 0.1 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. 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. 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 0.03 and 0.02 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 0.1 and 0.06 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA. 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. 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. 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. 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. Females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see Table 7 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)] . 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   Progesterone-only AND OR Option 3 Barrier Methods choose 1 Barrier Methods choose 1 Choose One Barrier Method from each column (must choose two methods) AND Genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 2.5 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 of mycophenolate mofetil have been established in pediatric patients 3 months and older for the prophylaxis of kidney rejection after allogeneic 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 [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.1)] . Safety and effectiveness in pediatric patients receiving allogeneic heart or liver transplants have not been established. 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 the elderly and younger patients. In general, dose selection for an elderly 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)] . No dose 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. 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. No dose adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. However, it is not known whether dose adjustments are needed for hepatic disease with other etiologies [see Clinical Pharmacology (12.3)] . No data are available for heart transplant patients with severe hepatic parenchymal disease.

Ringkasan produk:

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 [see Dosage and Administration (2)] .Follow applicable special handling and disposal procedures 1 . Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body. They are available as follows: Overbagged with 10 capsules per bag, NDC 55154-6262-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5382-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Cardinal Health 107, LLC
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MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP
and
Mycophenolate Mofetil Tablets, USP
(mye'' koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil 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?
Mycophenolate mofetil 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.
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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 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, 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.
If you take birth control
pills while using mycophenolate mofetil you must also use another form
of birth control. Talk to
your doctor about other birth control methods

Karakteristik produk

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL CAPSULES AND
MYCOPHENOLATE
MOFETIL TABLETS.
MYCOPHENOLATE MOFETIL CAPSULES, FOR ORAL USE
MYCOPHENOLATE MOFETIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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RECENT MAJOR CHANGES
Warnings and Precautions ( 5.12, 5.13) 2/2019
INDICATIONS AND USAGE
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated
for the prophylaxis of organ
rejection in recipients of allogeneic kidney, heart or liver
transplants, and should be used in combination
with other immunosuppressants. ( 1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSING
Kidney Transplant
1 g twice daily orally ( 2.2)
Heart Transplant
1.5 g twice daily orally ( 2.3)
Liver Transplant
1.5 g twice daily orally ( 2.4)
PEDIATRICS
Kidney Transplant
600 mg/m
orally twice daily, up
to maximum of 2 g daily ( 2.2)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in clinical trials (20% or greater)
include diarrhea, leukopenia,
infection, vomiting, and there is evidence of a higher frequency of
certain types of infections e.g.,
opportunistic infection. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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