MYFORTIC- mycophenolic acid tablet, delayed release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

MYCOPHENOLATE SODIUM (UNII: WX877SQI1G) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)

Tillgänglig från:

Novartis Pharmaceuticals Corporation

INN (International namn):

MYCOPHENOLATE SODIUM

Sammansättning:

MYCOPHENOLIC ACID 360 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Myfortic® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Myfortic is to be used in combination with cyclosporine and corticosteroids. Myfortic delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. Myfortic is contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. Reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing reports [see Adverse Reactions (6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors preg

Produktsammanfattning:

180 mg tablet: Lime-green, film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120…………………………………………………………………NDC 0078-0385-66 360 mg tablet: Pale orange-red, film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120…………………………………………………………………NDC 0078-0386-66 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP) . Handling Keep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [see Dosage and Administration (2.3)] . Teratogenic effects have been observed with mycophenolate sodium [see Warnings and Precautions (5.1)] . If for any reason the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

Bemyndigande status:

New Drug Application

Bipacksedel

Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: March 2022
MEDICATION GUIDE
MYFORTIC® (my-for-tic)
(mycophenolic acid)
delayed-release tablets
Read the Medication Guide that comes with Myfortic before you start
taking it and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking with your
healthcare provider about your medical condition or treatment. If you
have any questions about Myfortic,
ask your doctor.
What is the most important information I should know about Myfortic?
Myfortic can cause serious side effects, including:
•
Increased risk of loss of pregnancy (miscarriage) and higher risk of
birth defects. Females who take
Myfortic 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) while taking Myfortic.
•
you should have a pregnancy test immediately before starting Myfortic
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 Myfortic
therapy and for 6
weeks after stopping Myfortic, unless at any time you choose to avoid
sexual
intercourse (abstinence) with a man completely. Myfortic 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 Myfortic and you could become pregnant. If
you decide
to take birth control pills while using Myfortic, you must also use
another form of
birth control. Talk to your doctor about other birth control methods
that can be used
while taking Myfortic.
•
If you are a sexually

Produktens egenskaper

MYFORTIC- MYCOPHENOLIC ACID TABLET, DELAYED RELEASE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYFORTIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYFORTIC.
MYFORTIC (MYCOPHENOLIC ACID) DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
USE DURING PREGNANCY IS ASSOCIATED WITH INCREASED RISKS OF PREGNANCY
LOSS AND
CONGENITAL MALFORMATIONS. AVOID IF SAFER TREATMENT OPTIONS ARE
AVAILABLE. FEMALES OF
REPRODUCTIVE POTENTIAL MUST BE COUNSELED REGARDING PREGNANCY
PREVENTION AND
PLANNING. (5.1, 8.1, 8.3)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF
ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE MYFORTIC. (5.2)
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF
THE SKIN, DUE TO IMMUNOSUPPRESSION. (5.3)
INCREASED SUSCEPTIBILITY TO BACTERIAL, VIRAL, FUNGAL, AND PROTOZOAL
INFECTIONS, INCLUDING
OPPORTUNISTIC INFECTIONS. (5.4, 5.5)
RECENT MAJOR CHANGES
Warnings and Precautions, New or Reactivated Viral Infections (5.5)
3/2022
Warnings and Precautions, Acute Inflammatory Syndrome Associated with
Mycophenolate
Products (5.8)
3/2022
INDICATIONS AND USAGE
Myfortic is an antimetabolite immunosuppressant indicated for
prophylaxis of organ rejection in adult
patients receiving kidney transplants and in pediatric patients at
least 5 years of age and older who are
at least 6 months post kidney transplant. (1.1)
Use in combination with cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Myfortic delayed-release tablets and mycophenolate mofetil tablets and
capsules should not be used
interchangeably. (1.2)
DOSAGE AND ADMINISTRATION
In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on
an empty stomach, 1 hour
before or 2 hours after food intake. (2.1)
In children: 5 years of age and older