MYCOPHENOLATE MOFETIL powder, for suspension

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Lannett Company, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 wit

পণ্য সারাংশ:

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 0527-5160-82 Storage

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Lannett Company, Inc.
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This Medication Guide has been approved by the
U.S. Food and Drug Administration.
CIB71992D
Rev. 08/2022
Dispense with Medication Guide available
at: www.lannett.com/med-guide/mycophenolate
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 mofetil you mus

পণ্য বৈশিষ্ট্য

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
LANNETT COMPANY, INC.
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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 o