MYCOPHENOLATE MOFETIL tablet, film coated MYCOPHENOLATE MOFETIL capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Ascend Laboratories, LLC

INN (International Name):

MYCOPHENOLATE MOFETIL

Sammensetning:

MYCOPHENOLATE MOFETIL 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. Mycophenolate mofetil 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 mycophenolate mofetil treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com

Produkt oppsummering:

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, mycophenolate mofetil oral suspension (before or after constitution), or mycophenolate mofetil intravenous (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 .

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL TABLET, FILM COATED
MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL CAPSULE
Ascend Laboratories, LLC
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MEDICATION GUIDE
Mycophenolate Mofetil (MYE-koe-FEN-oh-late MOE-fe-til) Capsules USP
250 mg
Mycophenolate Mofetil (MYE-koe-FEN-oh-late MOE-fe-til) Tablets USP 500
mg
Read the Medication Guide that comes with mycophenolate mofetil
capsules or 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?
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.
•
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
mo

Preparatomtale

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL TABLET, FILM COATED
MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL CAPSULE
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL TABLETS AND MYCOPHENOLATE MOFETIL CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL TABLETS AND
MYCOPHENOLATE
MOFETIL CAPSULES
MYCOPHENOLATE MOFETIL TABLETS, FOR ORAL USE
MYCOPHENOLATE MOFETIL CAPSULES, 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 (5.7)
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 ADMINISTRATI