Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
Teva Pharmaceuticals USA, Inc.
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) during pregnancy is associated with an
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. Follow applicable special handling and disposal procedures1 . Mycophenolate mofetil tablets are available as follows: Tablets Lavender colored, film-coated biconvex tablets with ‘SZ’ on one side and ‘327’ on the other side. Storage: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant cap.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- Medication Guide Mycophenolate Mofetil Tablets (mye-koe-FIN-oh-late) Read the Medication Guide that comes with mycophenolate mofetil tablets 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 tablets? Mycophenolate mofetil tablets 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 tablets. You should have 1 pregnancy test immediately before starting mycophenolate mofetil tablets 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 tablets, and you could become pregnant. If you take birth control pills while using mycophenolate mofetil tablets you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking mycophenolate mofetil. • If you ar Baca dokumen lengkapnya
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MYCOPHENOLATE MOFETIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE MOFETIL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • • • RECENT MAJOR CHANGES Indications and Usage, Pediatric Heart or Warnings and Precautions, INDICATIONS AND USAGE Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months or 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 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 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 maximum of 900 mg/m twice daily (3 g or 15 mL of oral suspension) (2.4) • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • 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 Baca dokumen lengkapnya