Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL HYDROCHLORIDE (UNII: UXH81S8ZVB) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
BPI Labs LLC
INTRAVENOUS
PRESCRIPTION DRUG
Mycophenolate Mofetil [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. 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 inform
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 USP (during or after preparation) [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedure 1 . For injection: 500 mg mycophenolate mofetil as the hydrochloride salt in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials NDC 54288-141-04 Storage
Abbreviated New Drug Application
SOLUTION BPI Labs LLC ---------- MEDICATION GUIDE Mycophenolate Mofetil for injection (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 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 Mycophenolate Mofetil 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 are a sexually active male whose female pa Διαβάστε το πλήρες έγγραφο
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BPI LABS 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_ 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) 6/2022 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 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 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 DOSAGE Kidney Transplant 1 g twice daily, orally or intravenously (IV) over no less than 2 h ( 2.2) Διαβάστε το πλήρες έγγραφο