MYCOPHENOLATE MOFETIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hisun Pharmaceuticals USA, Inc.

INN (International Name):

MYCOPHENOLATE MOFETIL

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. Mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. Mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product.

Product summary:

Hard gelatin capsule size “1” with a powder blue colored cap and a light orange colored body, printed “MMF 250” on the cap and “HISUN” on the body with black ink. Supplied in the following presentations: NDC Number           Size NDC 42658-501-05 Bottle of 100 NDC 42658-501-06 Bottle of 120 NDC 42658-501-07 Bottle of 500 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure. Revised: February 2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
Hisun Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Mycophenolate Mofetil Capsules, USP 250 mg
(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:
•
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 one 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 therapy
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
mycophen

Summary of Product characteristics

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE
HISUN PHARMACEUTICALS USA, INC.
----------
MYCOPHENOLATE MOFETIL CAPSULES, FOR ORAL USE
RX ONLY
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS
INFECTIONS
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF FIRST
TRIMESTER PREGNANCY LOSS
AND CONGENITAL MALFORMATIONS. FEMALES OF REPRODUCTIVE POTENTIAL (FRP)
MUST BE COUNSELED
REGARDING PREGNANCY PREVENTION AND PLANNING (SEE WARNINGS AND
PRECAUTIONS).
IMMUNOSUPPRESSION MAY LEAD TO INCREASED SUSCEPTIBILITY TO INFECTION
AND POSSIBLE
DEVELOPMENT OF LYMPHOMA. ONLY PHYSICIANS EXPERIENCED IN
IMMUNOSUPPRESSIVE THERAPY
AND MANAGEMENT OF RENAL, CARDIAC OR HEPATIC TRANSPLANT PATIENTS SHOULD
PRESCRIBE
MYCOPHENOLATE MOFETIL. PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED
IN FACILITIES EQUIPPED
AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES.
THE PHYSICIAN
RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION
REQUISITE FOR THE
FOLLOW-UP OF THE PATIENT (SEE WARNINGS AND PRECAUTIONS).
DESCRIPTION
Mycophenolate mofetil, USP is the 2-morpholinoethyl ester of
mycophenolic acid (MPA), an
immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH)
inhibitor.
The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl
(E)-6-(1,3-dihydro-4-
hydroxy-6-methoxy-7-methyl-3
-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical
formula of C23H31NO7, a molecular weight of 433.50, and the following
structural formula:
Mycophenolate mofetil, USP is a white to off-white crystalline powder.
It is slightly soluble in water
(43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27
mg/mL at pH 3.6). It is freely
soluble in acetone, soluble in methanol, and sparingly soluble in
ethanol. The apparent partition
coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The
pKa values for mycophenolate
mofetil are 5.6 for the morpholino group and 8.5 for the phenolic
group.
Mycophenolate mofetil is available for oral administration as capsules
containing