MYCOPHENOLATE MOFETIL tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Cardinal Health 107, LLC

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 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

Dettagli prodotto:

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 (before or after constitution) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 . Tablets Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. Available: Overbagged with 10 tablets per bag, NDC 55154-3571-0 Storage: • Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Dispense in light-resistant containers, such as the manufacturer's original containers.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Cardinal Health 107, LLC
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SPL MEDGUIDE
MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP and
Mycophenolate Mofetil Tablets, USP
(mye'' koe fen' oh late moe' fe til)
Read the Medication Guide that comes with mycophenolate mofetil
tablets and 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 myco

Scheda tecnica

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL CAPSULES AND MYCOPHENOLATE MOFETIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL CAPSULES AND
MYCOPHENOLATE
MOFETIL TABLETS.
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_
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.12, 5.13)
2/2019
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
(2)
DOSING
(2)
Kidney Transplant
(2)
1 g twice daily, orally (2.2)
(2)
Heart Transplant
(2)
1.5 g twice daily orally (2.3)
(2)
Liver Transplant
(2)
1.5 g twice daily orally (2.4)
(2)
PEDIATRICS
(2)
Kidney Transplant
(2)
600 mg/m twice daily, up
(2)
to maximum of 2 g daily (2.2)
(2)
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
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)]._
2
Reduce or i