MYCOPHENOLATE MOFETIL powder, for suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Mycophenolate Mofetil (UNII: 9242ECW6R0) (mycophenolic acid - UNII:HU9DX48N0T)

Tersedia dari:

NorthStar RxLLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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, USP (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 or almost white powder blend for constitution to a white or almost white tutti-frutti flavor suspension 225 mL bottle with bottle adapter and 2 oral dispensers                                                        NDC 16714-345-01 Storage

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

NorthStar RxLLC
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This Medication Guide has been approved by the U.S.
Food and Drug Administration.
CIB72084C
Rev. 08/2022
Dispense with Medication Guide available at:
www.northstarrxllc.com/products or call 1-800-206-7821
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 mofeti

Karakteristik produk

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
NORTHSTAR RXLLC
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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)
06/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients (2.3)
06/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients (2.4)
06/2022
Warnings and Precautions, Serious Infections (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 allogeneic kidney, heart or liver
transplants, in combination with other immunosuppressants. (1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSAGE
Kidney Transplant
1 g twice daily, orally or intravenously (IV) over no
less than 2 h (2.2)
Heart Transplant
1.5 g twice daily orally