Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)
Hikma Pharmaceuticals USA Inc.
ORAL
PRESCRIPTION DRUG
Everolimus is 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. Therapeutic drug monitoring (TDM) of everolimus and cyclosporine is recommended for all patients receiving these products [see Dosage and Administration (2.2 and 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 posttransplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see Warnings and Precautions (5.5) and Clinical Studies (14.2)] . 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 not been
Everolimus Tablets 0.25 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “414” debossed on the other side. NDC 0054-0470-21: Bottles of 60 Tablets 0.5 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “761” debossed on the other side. NDC 0054-0471-21: Bottles of 60 Tablets 0.75 mg tablets are supplied as white to off white, round standard convex tablets, plain on one side and “54” over “044” debossed on the other side. NDC 0054-0472-21: Bottles of 60 Tablets 1 mg are supplied as white to off white, round, flat faced beveled edge tablets, plain on one side and “54” over “206” debossed on the other side. NDC 0054-0604-21: Bottles of 60 Tablets Storage Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.] Protect from light and moisture.
Abbreviated New Drug Application
EVEROLIMUS- EVEROLIMUS TABLET Hikma Pharmaceuticals USA Inc. ---------- MEDICATION GUIDE Everolimus Tablets (e” ver oh’ li mus) Rx only What is the most important information I should know about everolimus? Everolimuscan cause serious side effects, including: • Increased risk of getting certain cancers. People who take everolimus 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 weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with everolimus that may lead to death. People taking everolimus 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. 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 without talking to your doctor if you have had a heart transplant. See the section “What are the possible side effects of everolimus?” for information about other serious side effects. What is everolimus? Everolimus is a prescription medicine used to prevent transplant rejection (antirejection medicine) in people who have received a kidney transplant or liver transplant. Tra Les hele dokumentet
EVEROLIMUS- EVEROLIMUS TABLET HIKMA PHARMACEUTICALS USA 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_ • • • • • RECENT MAJOR CHANGES Warnings and Precautions, Cannabidiol Drug Interactions (5.22) 9/2023 INDICATIONS AND USAGE Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: • • Limitations of Use (1.3) Safety and efficacy have not been established in the following: • • • DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS Everolimus Tablets are available as 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg tablets. (3) CONTRAINDICATIONS 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) 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 posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5) Kidney transplant patients at high immunologic risk. (1.3) Recipients of transplanted organs other than kidney or liver. Les hele dokumentet