ENBREL- etanercept solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

A-S Medication Solutions

Verabreichungsweg:

SUBCUTANEOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 (JIA) in patients ages 2 and older. Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in 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 phototherapy. Enbrel

Produktbesonderheiten:

Product: 50090-4590 NDC: 50090-4590-0 1 mL in a KIT

Berechtigungsstatus:

Biologic Licensing Application

Gebrauchsinformation

A-S Medication Solutions
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This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 03/2020
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 teenage patients
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.
•
P

Fachinformation

ENBREL- ETANERCEPT SOLUTION
A-S MEDICATION SOLUTIONS
----------
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)
INDICATIONS AND USAGE
Enbrel is a tumor necrosis factor (TNF) blocker indicated for the
treatment of:
Rheumatoid Arthritis (RA) (1.1)
Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2
years or older (1.2)
Psoriatic Arthritis (PsA) (1.3)
Ankylosing Spondylitis (AS) (1.4)
Plaque Psoriasis (PsO) in patients 4 years 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 (2.1)
50 mg once weekly
Adult PsO (2.1)
50 mg twice weekly for 3 months, followed by 50 mg
once weekly
Pediatric PsO or JIA (2.2)
0.8 mg/kg weekly, with a maximum of 50 mg per
week
DOSAGE FORMS AND STRENGTHS
Injection: 25 mg/0.5 mL and 50 mg/mL solution in a single-dose
prefilled syrin