MYCOPHENOLATE MOFETIL tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Teva Pharmaceuticals USA, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

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. Follow applicable special handling and disposal procedures1 . 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. 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Teva Pharmaceuticals USA, Inc.
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Medication Guide
Mycophenolate Mofetil Tablets
(mye-koe-FIN-oh-late)
Read the Medication Guide that comes with mycophenolate mofetil
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 tablets?
Mycophenolate mofetil 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
tablets. You should have 1 pregnancy test immediately before starting
mycophenolate mofetil
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, 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 tablets, and you
could become pregnant. If
you take birth control pills while using mycophenolate mofetil tablets
you must also use another
form of birth control. Talk to your doctor about other birth control
methods that you can use while
taking mycophenolate mofetil.
•
If you ar

Ապրանքի հատկությունները

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MYCOPHENOLATE MOFETIL TABLETS.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
Indications and Usage, Pediatric Heart or
Warnings and Precautions,
INDICATIONS AND USAGE
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated
for the prophylaxis of organ
rejection in adult and pediatric recipients 3 months or 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 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 orally twice daily, up
to maximum of 2 g daily (2.2)
Heart Transplant
600 mg/m orally twice daily (starting dose) up
to maximum of 900 mg/m twice daily (3 g or 15 mL
of oral suspension) (2.3)
Liver Transplant
600 mg/m orally twice daily (starting dose) up
to maximum of 900 mg/m twice daily (3 g or 15 mL
of oral suspension) (2.4)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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