EVEROLIMUS tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Par Pharmaceutical, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

EVEROLIMUS- everolimus tablet
Par Pharmaceutical, Inc.
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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

Charakteristika produktu

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