MYCOPHENOLATE MOFETIL powder, for suspension

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

VistaPharm, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . 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 for Oral Suspension (before or after constitution), [see Dosage and Administration (2.6)] . Follow applicable special handling and disposal procedures1 . For oral suspension: 35 g Mycophenolate mofetil white to off-white powder blend for constitution to a white to off-white banana flavor suspension 250 mL bottle with bottle adapter and 2 oral dispensers ……………. NDC 66689-307-08 Storage

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

VistaPharm, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Mycophenolate mofetil (mye″ koe fen′ oh late moe′ fe til) for
Oral Suspension, USP
Read the Medication Guide that comes with mycophenolate mofetil 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 acti

Características técnicas

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
VISTAPHARM, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION.
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION
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
(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 allo