EVEROLIMUS tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

EVEROLIMUS (UNII: 9HW64Q8G6G) (EVEROLIMUS - UNII:9HW64Q8G6G)

Dostupné s:

Hikma Pharmaceuticals USA Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

EVEROLIMUS- EVEROLIMUS TABLET
Hikma Pharmaceuticals USA Inc.
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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

Charakteristika produktu

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.