MYCOPHENOLATE MOFETIL tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

A-S Medication Solutions

INN (Nome Internazionale):

MYCOPHENOLATE MOFETIL

Composizione:

MYCOPHENOLATE MOFETIL 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Product: 50090-2541 NDC: 50090-2541-0 180 TABLET in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

A-S Medication Solutions
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Dispense with Medication Guide available at
www.accordhealthcare.us/medication-guides
MEDICATION GUIDE
Mycophenolate Mofetil Capsules 250 mg
Mycophenolate Mofetil Tablets 500 mg
(MYE koe FEN oh late MOE fe til)
Read the Medication Guide that comes with mycophenolate mofetil
capsules and 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 capsules and
tablets?
Mycophenolate mofetil capsules and 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. You
should have 1 pregnancy test immediately before starting mycophenolate
mofetil capsules and
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 capsules and tablets,
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 mycoph

Scheda tecnica

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MYCOPHENOLATE
MOFETIL.
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_
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)]._
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)
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
Tablets: 500 mg
CONTRAINDICATIONS
Hypersensitivity to mycophenolate mofetil, MPA acid or any component
of the drug product ( 4)
WARNINGS AND PRECAUTIONS
Blood