MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Zydus Pharmaceuticals USA Inc.

INN (Tên quốc tế):

MYCOPHENOLATE MOFETIL

Thành phần:

MYCOPHENOLATE MOFETIL 500 mg in 20 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in 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 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 1-800-617-8191.   Risk Summary

Tóm tắt sản phẩm:

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 disposable procedures1 .  

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MYCOPHENOLATE MOFETIL - MYCOPHENOLATE MOFETIL INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYCOPHENOLATE MOFETIL
FOR INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MYCOPHENOLATE
MOFETIL FOR INJECTION, USP
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
Warnings and Precautions (5.12, 5.13) 2/2019
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, and should be used in combination
with other immunosuppressants. (1)
DOSAGE AND ADMINISTRATION
ADULTS
DOSING
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)
Mycophenolate mofetil for Injection is an alternative when patients
cannot tolerate oral medication.
Administer within 24 hours following transplantation, until patients
can tolerate oral medicatio