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:

REMEDYREPACK INC.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 mycopheno

Dettagli prodotto:

Mycophenolate Mofetil Tablets, USP 500 mg Tablets Pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. NDC: 70518-2767-00 NDC: 70518-2767-01 NDC: 70518-2767-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

REMEDYREPACK INC.
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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 mycophenolate
mofetil.
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Scheda tecnica

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
REMEDYREPACK INC.
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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_
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, Serious Infections (5.3)
……………………………………………………...
10/2021
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate
Products (5.7)
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