MYCOPHENOLATE MOFETIL powder, for suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Teva Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Mycophenolate mofetil for oral suspension 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, 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 for oral suspension 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 during pregnan

Dettagli prodotto:

Mycophenolate mofetil 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 (before or after constitution) [see Dosage and Administration (2.6)] . Follow applicable special handling and disposal procedures1 . 35 grams mycophenolate mofetil USP, supplied as a white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension. Supplied in the following presentation: NDC Number Size 0480-1175-22 225 mL bottle with bottle adapter and 2 oral dispensers Storage

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Teva Pharmaceuticals, Inc.
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MEDICATION GUIDE
Mycophenolate Mofetil (mye" koe fen' oh late moe' fe til)
for Oral Suspension
Read the Medication Guide that comes with mycophenolate mofetil for
oral suspension 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 for oral suspension?
Mycophenolate mofetil for oral suspension 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 for oral
suspension 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 for oral suspension. You should
have 1 pregnancy test immediately before starting mycophenolate
mofetil
for oral suspension 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 for oral suspension treatment and for 6 weeks after stopping
mycophenolate mofetil for oral suspension, unless at any time you
choose to avoid sexual intercourse (abstinence) with a man completely.
Mycophenolate mofetil for oral suspension 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 for oral
suspension, and you could become pregnant. If you take birth control
pills
while using mycophenolate mofetil for

Scheda tecnica

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION
TEVA PHARMACEUTICALS, 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)]_.
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 gram twice daily orally (2.2)
Heart
Transplant
1.5 grams twice daily orally (2.3)
Liver
Transplant
1.5 grams twice daily orally (2.4)
PEDIATRICS
Kidney
Transplant
600 mg/m orally twice daily, up to maximum of 2 grams 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)
Mycophenolate mofetil intravenous is a