NULOJIX- belatacept injection, powder, lyophilized, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

belatacept (UNII: E3B2GI648A) (belatacept - UNII:E3B2GI648A)

Disponible desde:

E.R. Squibb & Sons, L.L.C.

Designación común internacional (DCI):

belatacept

Composición:

belatacept 250 mg

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

NULOJIX® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. Use NULOJIX only in patients who are EBV seropositive [see Contraindications (4) and Warnings and Precautions (5.1)] . Use of NULOJIX for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see Warnings and Precautions (5.6)] . NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) [see Boxed Warning and Warnings and Precautions (5.1)] . To monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants including NULOJIX or whose partners have received NULOJIX, healthcare providers are strongly encouraged to regis

Resumen del producto:

NULOJIX® (belatacept) lyophilized powder for intravenous infusion is supplied as a single-use vial with a silicone-free disposable syringe in the following packaging configuration: Description NDC Number One 250-mg vial One 12 mL Syringe 0003-0371-13 NULOJIX lyophilized powder is stored refrigerated at 2°C to 8°C (36°F to 46°F). Protect NULOJIX from light by storing in the original package until time of use. The reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately. The NULOJIX infusion must be completed within 24 hours of constitution of the NULOJIX lyophilized powder. If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F to 46°F) and protected from light for up to 24 hours (a maximum of 4 hours of the total 24 hours can be at room temperature: 20°C to 25°C [68°F to 77°F] and room light) [see Dosage and Administration (2.2)] .

Estado de Autorización:

Biologic Licensing Application

Información para el usuario

NULOJIX- belatacept injection, powder, lyophilized, for solution
E.R. Squibb & Sons, L.L.C.
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MEDICATION GUIDE
NULOJIX® (noo-LOJ-jiks)
(belatacept)
For Injection, For Intravenous Use
Read this Medication Guide before you start receiving NULOJIX and
before each treatment. There may be
new information. This Medication Guide does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about NULOJIX?
NULOJIX increases your risk of serious side effects, including:
•
Post-transplant lymphoproliferative disorder (PTLD). PTLD is a
condition that can happen if certain
white blood cells grow out of control after an organ transplant
because your immune system is weak.
PTLD can get worse and become a type of cancer. PTLD can lead to
death.
People treated with NULOJIX have a higher risk of getting PTLD. If you
get PTLD with NULOJIX
you are at especially high risk of getting it in your brain. Your risk
for PTLD is also higher if you:
•
have never been exposed to the Epstein-Barr virus (EBV). Your doctor
should test you for EBV.
Do not receive NULOJIX unless you are EBV positive (you have been
exposed to EBV).
•
get an infection with a virus called cytomegalovirus (CMV).
•
receive treatment for transplant rejection that lowers certain white
blood cells called T
lymphocytes.
•
Increased risk of getting cancers other than PTLD. People who take
medicines that weaken the immune
system, including NULOJIX, have a higher risk of getting other
cancers, including skin cancer. Talk to
your doctor about your risk for cancer. See "What should I avoid while
receiving NULOJIX?"
•
Progressive multifocal leukoencephalopathy (PML). PML is a rare,
serious brain infection caused by
JC virus. People with weakened immune systems are at risk for getting
PML. PML can result in death
or severe disability. There is no known prevention, treatment, or cure
for PML.
•
Increased risk of getting other serious infections, including
tuberculosis

Ficha técnica

NULOJIX- BELATACEPT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NULOJIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NULOJIX.
NULOJIX (BELATACEPT) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER
MALIGNANCIES, AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.10)
07/2021
INDICATIONS AND USAGE
•
•
_Limitations of Use_:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSING OF NULOJIX FOR KIDNEY TRANSPLANT RECIPIENTS (2.1)
DOSING FOR INITIAL PHASE
DOSE
Day 1 (day of transplantation, prior to implantation) and Day 5
(approximately 96 hours after Day 1 dose)
10 mg per kg
End of Week 2 and Week 4 after transplantation
10 mg per kg
End of Week 8 and Week 12 after transplantation
10 mg per kg
DOSING FOR MAINTENANCE PHASE
DOSE
End of Week 16 after transplantation and every 4 weeks (plus or minus
3
days) thereafter
5 mg per kg
•
•
DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection: 250 mg per vial (3)
CONTRAINDICATIONS
INCREASED RISK FOR DEVELOPING POST-TRANSPLANT LYMPHOPROLIFERATIVE
DISORDER (PTLD),
PREDOMINANTLY INVOLVING THE CENTRAL NERVOUS SYSTEM (CNS). RECIPIENTS
WITHOUT
IMMUNITY TO EPSTEIN-BARR VIRUS (EBV) ARE AT A PARTICULARLY INCREASED
RISK; THEREFORE,
USE IN EBV SEROPOSITIVE PATIENTS ONLY. DO NOT USE NULOJIX IN
TRANSPLANT RECIPIENTS
WHO ARE EBV SERONEGATIVE OR WITH UNKNOWN SEROSTATUS. (4, 5.1)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF
KIDNEY TRANSPLANT PATIENTS SHOULD PRESCRIBE NULOJIX. (5.2)
INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF
MALIGNANCIES
MAY RESULT FROM IMMUNOSUPPRESSION. (5.1, 5.3, 5.4, 5.5)
USE IN LIVER TRANSPLANT PATIENTS IS NOT RECOMMENDED DUE TO AN
INCREASED RISK OF
GRAFT LOSS AND DEATH. (5.6)
NULOJI