Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)
Par Pharmaceutical, Inc.
ORAL
PRESCRIPTION DRUG
Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see Clinical Studies (14.1) ] Everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. TDM of everolimus and cyclosporine is recommended for all patients receiving these products. [see Dosage and Administration (2.2, 2.3) ] Everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [See Warnings and Precautions (5.5) and Clinical Studies (14.2) ]. Therapeutic drug monitoring (TDM) of everolimus and tacrolimus is recommended for all patients receiving these products. [See Dosage and Administration (2.3, 2.5) ] The safety and efficacy of everolimus has no
Everolimus Tablets are packed in child-resistant blisters. Table 11. Description of Everolimus Tablets “P” on one side and “158” on the other “P” on one side and “159” on the other “P” on one side and “160” on the other “P” on one side and Each strength is available in boxes of 60 tablets (6 blister strips of 10 tablets each). Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature] Protect from light and moisture.
Abbreviated New Drug Application
EVEROLIMUS- everolimus tablet Par Pharmaceutical, Inc. ---------- Medication Guide MEDICATION GUIDE Everolimus Tablets (e ver OH li mus) What is the most important information I should know about everolimus tablet? Everolimus tablet can cause serious side effects, including: • Increased risk of getting certain cancers. People who take everolimus tablet have a higher chance of getting lymphoma and other cancers, especially skin cancer. Talk to your doctor about your risk for cancer. • Increased risk of serious infections. Everolimus tablet weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with everolimus tablet that may lead to death. People taking everolimus tablet have a higher chance of getting infections caused by viruses, bacteria, and fungi (yeast). o Call your doctor if you have symptoms of infection including fever or chills. • Blood clot in the blood vessels of your transplanted kidney. If this happens, it usually occurs within the first 30 days after your kidney transplant. Tell your doctor right away if you: o have pain in your groin, lower back, side or stomach (abdomen) o make less urine or you do not pass any urine o have blood in your urine or dark colored urine (tea-colored) o have fever, nausea, or vomiting • Serious problems with your transplanted kidney (nephrotoxicity). You will need to start with a lower dose of cyclosporine when you take it with everolimus tablet. Your Doctor should do regular blood tests to check your levels of both everolimus and cyclosporine. • Increased risk of death that can be related to infection, in people who have had a heart transplant. You should not take everolimus tablet if you have had a heart transplant without talking to your doctor. See the section “What are the possible side effects of everolimus tablet?” for information about other serious side effects. What is everolimus tablet? Everolimus tablet is a prescription medicine used to prevent transplant rejection (antirejection medicine Lire le document complet
EVEROLIMUS- EVEROLIMUS TABLET PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EVEROLIMUS TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVEROLIMUS TABLETS. EVEROLIMUS TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF TRANSPLANT PATIENTS SHOULD USE EVEROLIMUS. (5.1) INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF MALIGNANCIES MAY RESULT FROM IMMUNOSUPPRESSION. (5.2, 5.3) INCREASED INCIDENCE OF KIDNEY GRAFT THROMBOSIS. (5.4) REDUCED DOSES OF CYCLOSPORINE ARE REQUIRED FOR USE IN COMBINATION WITH EVEROLIMUS IN ORDER TO REDUCE NEPHROTOXICITY. (2.4, 2.5, 5.6, 12.7, 12.8) INCREASED MORTALITY IN A HEART TRANSPLANT CLINICAL TRIAL. USE IN HEART TRANSPLANTATION IS NOT RECOMMENDED. (5.7) INDICATIONS AND USAGE Everolimus is a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. (1.1) Liver transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5) Limitations of Use (1.3) Safety and efficacy has not been established in the following: Kidney transplant patients at high immunologic risk. (1.3) Recipients of transplanted organs other than kidney or liver. (1.3, 5.7) Pediatric patients (less than 18 years). (1.3) DOSAGE AND ADMINISTRATION Kidney transplantation: starting oral dose of 0.75 mg twice daily as soon as possible after transplantation. (2.1) Liver transplantation: starting oral dose of 1 mg twice daily starting 30 days after transplantation. (2.2) Monitor ev Lire le document complet