国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
Hisun Pharmaceuticals USA, Inc.
MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL 500 mg
ORAL
PRESCRIPTION DRUG
Mycophenolate mofetil (MMF) 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 is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. 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 Use of mycophenolate mofetil (MMF) duri
Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.1)] . Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules. Follow applicable special handling and disposal procedures 1 . Storage and Dispensing Information:
Abbreviated New Drug Application
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE Hisun Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: www.hisunusa.com/medguide/mycophenolate-mofetil-capsules-tablets.pdf Mycophenolate Mofetil Capsules, USP and Mycophenolate Mofetil Tablets, USP (mye” koe fen’oh late moe’fe til) Read the Medication Guide that comes with mycophenolate mofetil 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 your treatment. What is the most important information I should know about mycophenolate mofetil? Mycophenolate mofetil 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 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. You should have 1 pregnancy test immediately before starting mycophenolate mofetil 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 treatment and for 6 weeks after stopping mycophenolate mofetil, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. Mycophenolate mofetil 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, and you could become pregnant. If you take birth control pills while using mycophenola 完全なドキュメントを読む
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL CAPSULE HISUN PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MYCOPHENOLATE MOFETIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULES, FOR ORAL USE MYCOPHENOLATE MOFETIL TABLETS, FOR ORAL USE RX ONLY 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) 11/2022 Dosage and Administration, Dosage Recommendations for Heart Transplant Patients ( 2.3) 11/2022 Dosage and Administration, Dosage Recommendations for Liver Transplant Patients ( 2.4) 11/2022 Warnings and Precautions, Serious Infections ( 5.3) 11/2022 Warnings and Precautions, Acute Inflammatory Syndrome Associated with Mycophenolate Products ( 5.7) 11/2022 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 DOSING Kidney Transplant 1 g twice daily, orally or 完全なドキュメントを読む