MYCOPHENOLATE MOFETIL tablet, film coated MYCOPHENOLATE MOFETIL capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hisun Pharmaceuticals USA, Inc.

INN (International Nazwa):

MYCOPHENOLATE MOFETIL

Skład:

MYCOPHENOLATE MOFETIL 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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) duri

Podsumowanie produktu:

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. 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 . Storage and Dispensing Information:

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
Hisun Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.hisunusa.com/medguide/mycophenolate-mofetil-capsules-tablets.pdf
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 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
your 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 mycophenola

Charakterystyka produktu

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
HISUN PHARMACEUTICALS USA, INC.
----------
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
RX ONLY
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)
11/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients ( 2.3)
11/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients ( 2.4)
11/2022
Warnings and Precautions, Serious Infections ( 5.3)
11/2022
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate
Products ( 5.7)
11/2022
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 allogeneic kidney, heart or liver
transplants, in combination with other immunosuppressants. ( 1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSING
Kidney
Transplant
1 g twice daily, orally or