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:

Sandoz 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 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 with

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. Follow applicable special handling and disposal procedures1 . Mycophenolate mofetil capsules, USP are available as follows: Capsules Hard gelatin capsules with opaque blue cap and opaque white body. The cap and body are imprinted with "655" with black ink Mycophenolate mofetil tablets are available as follows: Tablets Lavender colored, film-coated biconvex tablets with ‘SZ’ on one side and ‘327’ on the other side. Storage: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant cap.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
Sandoz Inc
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Medication Guide
Mycophenolate Mofetil Capsules and Tablets
(mye-koe-FIN-oh-late)
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 that you can use while taking mycophenolate mofetil.
•
If you

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED
SANDOZ INC
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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
INITIAL U.S. APPROVAL: 1995
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
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RECENT MAJOR CHANGES
Indications and Usage,
Dosage and Administration, Dosage Recommendations
Dosage and Administration, Dosage Recommendations
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 or
IV, over no less than 2 h
(2.3)
Liver Transplant
1.5 g twice daily orally or
1 g twice daily IV over no
less than 2 h (2.4)
PEDIATRICS
Kidney Transplant
600 mg/m orally twice
daily, up to maximum of 2
g daily (2.2)
Heart Transplant
600 mg/m orally twice
daily (starting dose) up to
a maximum of 900
mg/m twice daily (3 g or
15 mL of oral suspension)
(2.3)
Liver Transplant
600 mg/m orally twice
daily (starting dose) up to
a maximum of 900
mg/m twice daily (3 g or
15 mL of oral suspension)
(2.4)
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DOSAGE FORMS AND STRENGTHS
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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