MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Amneal Pharmaceuticals LLC

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Mycophenolate mofetil for injection 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 for injection have been observed; therefore, mycophenolate mofetil for injection is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate mofetil for injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). 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 reg

Descriptif du produit:

Mycophenolate mofetil (MMF) 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 of mycophenolate mofetil injection and when wiping the outer surface of the vial and the table after reconstitution. Avoid direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil for injection (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 . Mycophenolate Mofetil for Injection, USP, supplied in a 20 mL sterile single-dose vial, is a white to off-white lyophilized powder containing equivalent of 500 mg mycophenolate mofetil, USP and is supplied in a cartons of 4 single-dose vials. 500 mg/vial 4 Single-dose Vials in 1 Carton:                                 NDC 70121-1584-4 Storage Store powder and reconstituted infusion solution at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Amneal Pharmaceuticals LLC
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MEDICATION GUIDE
Mycophenolate Mofetil (mye’’ koe fen’ oh late moe’ fe til) for
Injection, USP
Read the Medication Guide that comes with mycophenolate mofetil for
injection 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 injection?
Mycophenolate mofetil for injection 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 injection 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
injection. You should have 1 pregnancy test immediately before
starting mycophenolate mofetil
for injection 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 injection
treatment and for 6 weeks after stopping mycophenolate mofetil for
injection, unless at any time
you choose to avoid sexual intercourse (abstinence) with a man
completely. Mycophenolate
mofetil for injection 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
injection, and you could become pregnant. If you take birth control
pills while using
mycophenolate mofetil for injection you must also use another form of
birth c

Résumé des caractéristiques du produit

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE
MOFETIL FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MYCOPHENOLATE MOFETIL FOR INJECTION.
MYCOPHENOLATE MOFETIL FOR INJECTION, FOR INTRAVENOUS 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
Indications and Usage, Pediatric Heart or Liver
Transplants (1) 6/2022
Dosage and Administration, Dosage Recommendations
for Heart Transplant Patients (2.3) 6/2022
Dosage and Administration, Dosage
Recommendations for Liver Transplant Patients (2.4) 6/2022
Warnings and Precautions, Serious Infections (5.3) 10/2021
Warnings and Precautions, Acute Inflammatory Syndrome
Associated with Mycophenolate Products (5.7) 10/2021
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
Tr