MYCOPHENOLATE MOFETIL capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Avet Pharmaceuticals Inc

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. 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 pregnanc

Produktsammanfattning:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Mycophenolate mofetil 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 (2.6)]. Follow applicable special handling and disposal procedures1 .

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Avet Pharmaceuticals Inc
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MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP
(mye'' koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil
capsules 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 mofetil 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 are a sexually active male whose f

Produktens egenskaper

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL CAPSULE
AVET PHARMACEUTICALS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MYCOPHENOLATE MOFETIL CAPSULES.
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
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 recipients of allogeneic kidney, heart or liver
transplants, and should be used in combination
with other immunosuppressants. (1) (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 twice daily, up to maximum of 2 g daily
(2.2)
Reduce or interrupt dosing in the event of neutropenia. (2.5)
See full prescribing information (FPI) for: adjustments for renal
impairment and neutropenia (2.5).
DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg
CONTRA