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:

Mylan Institutional LLC

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Mycophenolate mofetil (MMF) for injection is indicated for the prophylaxis of organ rejection, in adult recipients 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 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 registry, visit www.mycophenolateREMS.com or call

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 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 injection (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures1 . For injection: 500 mg mycophenolate mofetil in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials…………NDC 67457-386-81 Storage

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
Mylan Institutional 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.
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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

Résumé des caractéristiques du produit

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
----------
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_
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RECENT MAJOR CHANGES
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
INDICATIONS AND USAGE
Mycophenolate mofetil for injection is an antimetabolite
immunosuppressant indicated for the prophylaxis
of organ rejection in adult recipients 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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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in clinical trials (20% or greater)
include diarrhea, leukopenia,
infection, vomi