ENBREL- etanercept solution ENBREL- etanercept kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETANERCEPT (UNII: OP401G7OJC) (ETANERCEPT - UNII:OP401G7OJC)

Available from:

Immunex Corporation

INN (International Name):

ETANERCEPT

Composition:

ETANERCEPT 50 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone. Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA). Enbrel can be used with or without methotrexate. Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or photo

Product summary:

Enbrel (etanercept) injection is supplied as a clear and colorless sterile, preservative-free solution for subcutaneous administration in single-dose prefilled syringes, an Enbrel single-dose prefilled SureClick autoinjector with a 27-gauge, ½-inch needle, or a single-dose vial. The prefilled syringe and SureClick autoinjector are not made with natural rubber latex. Each Enbrel® Mini single-dose prefilled cartridge for use with the AutoTouch® reusable autoinjector contains 1.0 mL of 50 mg/mL of etanercept. The AutoTouch reusable autoinjector and Enbrel Mini single-dose prefilled cartridge are not made with natural rubber latex. The AutoTouch reusable autoinjector contains no drug and must use an Enbrel Mini single-dose prefilled cartridge. In addition, the AutoTouch Connect® reusable autoinjector would allow for data connectivity via Bluetooth wireless technology. Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage. Do not store Enbrel in extreme heat or cold. DO NOT SHAKE. DO NOT FREEZE. For convenience, storage of individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 30 days is permissible, with protection from light and sources of heat. Once a single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 30 days at room temperature, the single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge should be discarded. Do not use Enbrel beyond the expiration date stamped on the carton or barrel/cartridge label. Keep out of the reach of children. The AutoTouch reusable autoinjector should be stored at room temperature. Do not refrigerate the AutoTouch reusable autoinjector. Enbrel Lyophilized Powder (Used for Weight-based Dosing) Enbrel (etanercept) for Injection is supplied as lyophilized powder for reconstitution in a multiple-dose vial. Each vial is supplied in a carton containing four dose trays. Each dose tray contains one 25 mg vial of etanercept lyophilized powder, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27-gauge ½-inch needle, one vial adapter, and one plunger. Each carton contains four "Mixing Date:" stickers. Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage. Do not store Enbrel in extreme heat or cold. DO NOT SHAKE. DO NOT FREEZE. For convenience, storage of an individual dose tray containing Enbrel multiple-dose vial and diluent syringe at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 14 days is permissible, with protection from light, sources of heat, and humidity. Once the dose tray has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 14 days at room temperature, the dose tray should be discarded. Once a vial has been reconstituted, the solution must be used immediately or may be refrigerated for up to 14 days. Do not use Enbrel beyond the expiration date stamped on the dose tray. Keep out of the reach of children.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

ENBREL- ETANERCEPT
Immunex Corporation
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: 10/2023
Medication Guide
Enbrel® (en-brel)
(etanercept)
injection, for subcutaneous use
Enbrel® (en-brel)
(etanercept)
for injection, for subcutaneous use
Read the Medication Guide that comes with Enbrel before you start
using it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking with your
healthcare provider about your medical condition or treatment. It is
important to remain under your
healthcare provider's care while using Enbrel.
Enbrel is a prescription medicine called a Tumor Necrosis Factor (TNF)
blocker that affects your
immune system.
What is the most important information I should know about Enbrel?
Enbrel may cause serious side effects, including:
1. Risk of Infection
2. Risk of Cancer
1. Risk of infection
Enbrel can lower the ability of your immune system to fight
infections. Some people have serious
infections while taking Enbrel. These infections include tuberculosis
(TB), and infections caused by
viruses, fungi, or bacteria that spread throughout their body. Some
people have died from these
infections.
•
Your healthcare provider should test you for TB before starting
Enbrel.
•
Your healthcare provider should monitor you closely for symptoms of TB
during treatment with
Enbrel even if you tested negative for TB.
•
Your healthcare provider should check you for symptoms of any type of
infection before, during,
and after your treatment with Enbrel.
You should not start taking Enbrel if you have any kind of infection
unless your healthcare provider says
it is okay.
2. Risk of cancer
•
There have been cases of unusual cancers, some resulting in death, in
children and teenagers who
started using TNF-blocking agents at less than 18 years of age.
•
For children, teenagers, and adults taking TNF-blocker medicines,
including Enbrel, the chances
of getting lymphoma or other cancers may increase

Summary of Product characteristics

ENBREL- ETANERCEPT SOLUTION
ENBREL- ETANERCEPT
IMMUNEX CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENBREL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENBREL.
ENBREL (ETANERCEPT) INJECTION, FOR SUBCUTANEOUS USE
ENBREL (ETANERCEPT) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1998
WARNING: SERIOUS INFECTIONS AND MALIGNANCIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS
INCREASED RISK OF SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR
DEATH, INCLUDING
TUBERCULOSIS (TB), BACTERIAL SEPSIS, INVASIVE FUNGAL INFECTIONS (SUCH
AS
HISTOPLASMOSIS), AND INFECTIONS DUE TO OTHER OPPORTUNISTIC PATHOGENS.
(5.1)
ENBREL SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS
INFECTION OR SEPSIS
DURING TREATMENT. (5.1)
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING ENBREL.
(5.1)
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE. (5.1)
MALIGNANCIES
LYMPHOMA AND OTHER MALIGNANCIES, SOME FATAL, HAVE BEEN REPORTED IN
CHILDREN AND
ADOLESCENT PATIENTS TREATED WITH TNF-BLOCKERS, INCLUDING ENBREL. (5.3)
RECENT MAJOR CHANGES
Indications and Usage, Juvenile Psoriatic Arthritis (1.6)
10/2023
Dosage and Administration, Pediatric Patients (2.2)
10/2023
INDICATIONS AND USAGE
Enbrel is a tumor necrosis factor (TNF) blocker indicated for the
treatment of:
Adult patients with:
Rheumatoid Arthritis (RA) (1.1)
Psoriatic Arthritis (PsA) (1.3)
Ankylosing Spondylitis (AS) (1.4)
Plaque Psoriasis (PsO) (1.5)
Pediatric patients with:
Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or
older (1.2)
Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) (1.6)
Plaque Psoriasis, 4 years of age or older (1.5)
DOSAGE AND ADMINISTRATION
Enbrel is administered by subcutaneous injection.
PATIENT POPULATION
RECOMMENDED DOSE AND FREQUENCY
Adult RA and PsA (2.1)
50 mg once weekly with or without methotrexate
(MTX)
AS (