MYCOPHENOLATE MOFETIL tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Avet Pharmaceuticals Inc

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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 [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 .

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Avet Pharmaceuticals Inc
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MEDICATION GUIDE
Mycophenolate Mofetil Tablets, USP
(mye'' koe fen' oh late moe' fe til )
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 tablets 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
tablets treatment and for 6 weeks after stopping mycophenolate mofetil
tablets,
unless at any time you choose to avoid sexual intercourse (abstinence)
with a
man completely. Mycophenolate mofetil tablets 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 wh

Produktets egenskaber

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL TABLET, FILM COATED
AVET PHARMACEUTICALS 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_
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…………………………….
06/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients (2.3)
…………………………………………………………………………………………………..
06/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients (2.4)
…………………………………………………………………………………………………..
06/2022
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
Mycophenolate mofetil is an antimetabolite immunosuppressant indicate