Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (mycophenolic acid - UNII:HU9DX48N0T)
Mylan Institutional LLC
INTRAVENOUS
PRESCRIPTION DRUG
Mycophenolate mofetil (MMF) for injection is indicated for the prophylaxis of organ rejection, in adult 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 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 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
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 procedures1 . For injection: 500 mg mycophenolate mofetil in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials…………NDC 67457-386-81 Storage
Abbreviated New Drug Application
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION Mylan Institutional LLC ---------- MEDICATION GUIDE Mycophenolate Mofetil (mye” koe fen’ oh late moe’ fe til) for Injection, USP 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 Belgenin tamamını okuyun
MYCOPHENOLATE MOFETIL- MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MYLAN INSTITUTIONAL 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_ • • • RECENT MAJOR CHANGES 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 INDICATIONS AND USAGE Mycophenolate mofetil for injection is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult 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 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 a 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 a 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 • • • • • • • • • ADVERSE REACTIONS The most common adverse reactions in clinical trials (20% or greater) include diarrhea, leukopenia, infection, vomi Belgenin tamamını okuyun