MYCOPHENOLATE MOFETIL capsule MYCOPHENOLATE MOFETIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.   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

Product summary:

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 [see Dosage and Administration (2)] .Follow applicable special handling and disposal procedures 1 . Mycophenolate Mofetil Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP. The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body. They are available as follows: NDC 51079-721-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP. The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side. They are available as follows: NDC 51079-379-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Mylan Institutional 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 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

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
MYLAN INSTITUTIONAL 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
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)
DOSAGE AND ADMINISTRATION
ADULTS
DOSING
Kidney Transplant
1 g twice daily orally ( 2.2)
Heart Transplant
1.5 g twice daily orally ( 2.3)
Liver Transplant
1.5 g twice daily orally ( 2.4)
PEDIATRICS
Kidney Transplant
600 mg/m
orally twice daily, up
to maximum of 2 g daily ( 2.2)
Reduce or interrupt dosing in the event of neutropenia. ( 2.5)
See full prescribing information (FPI) for: adjustments for renal
impairment and ne