MYCOPHENOLATE MOFETIL capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Major Pharmaceuticals

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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) d

Резиме производа:

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. Follow applicable special handling and disposal procedures 1 . Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. NDC 0904-7074-61 Carton of 100 capsules (10 capsules per blister pack x 10) Storage and Dispensing Information Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Major Pharmaceuticals
----------
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 mycopheno

Карактеристике производа

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MAJOR PHARMACEUTICALS
----------
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_
•
•
•
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)
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions in clinical trials (20 % or greater)
include diarrhea, leukopenia,
infection, vomiting, and there is evidence of a higher frequency of
certain types of infections e.g.,
opportunistic infection. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACCORD HEALTHCARE INC.
AT 1-866-941-
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