MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Steriscience Pte. Limited

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Mycophenolate mofetil 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 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 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 mycop

Vörulýsing:

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 procedures 1 . 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 81293-000-04 Storage Store powder and reconstituted infusion solution at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Steriscience Pte. Limited
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MEDICATION GUIDE
Mycophenolate Mofetil (mye’’ koe fen’ oh late moe’ fe til) for
Injection
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 control

Vara einkenni

MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
STERISCIENCE PTE. LIMITED
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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)
06/2022
Dosage and Administration, Dosage Recommendations for Heart Transplant
Patients ( 2.3)
06/2022
Dosage and Administration, Dosage Recommendations for Liver Transplant
Patients ( 2.4)
06/2022
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 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 I