AMJEVITA- adalimumab-atto injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ADALIMUMAB (UNII: FYS6T7F842) (ADALIMUMAB - UNII:FYS6T7F842)

Commercializzato da:

Amgen USA Inc.

Via di somministrazione:

SUBCUTANEOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

AMJEVITA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. AMJEVITA is indicated for the treatment of mod

Dettagli prodotto:

AMJEVITA™ (adalimumab-atto) injection is supplied as a preservative-free, sterile, clear, colorless to slightly yellow solution for subcutaneous administration. AMJEVITA is supplied in a single-dose prefilled syringe (PFS) or single-dose prefilled SureClick autoinjector (AI). The AMJEVITA prefilled syringe and prefilled SureClick autoinjector are not made with natural rubber latex. The following packaging configurations are available. Storage and Stability Do not use beyond the expiration date on the container. AMJEVITA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light. If needed, for example when traveling, AMJEVITA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. AMJEVITA should be discarded if not used within the 14-day period. Record the date when AMJEVITA is first removed from the refrigerator in the spaces provided on the carton. Do not store AMJEVITA in extreme heat or cold.

Stato dell'autorizzazione:

Biologic Licensing Application

Foglio illustrativo

Amgen USA Inc.
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MEDICATION GUIDE
AMJEVITA™ (AM-JEH-VEE'-TAH)
(ADALIMUMAB-ATTO)
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: 7/2023
Read the Medication Guide that comes with AMJEVITA before you start
taking 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 doctor about your medical condition or treatment.
What is the most important information I should know about AMJEVITA?
AMJEVITA is a medicine that affects your immune system. AMJEVITA can
lower the ability of your
immune system to fight infections. Serious infections have happened in
people taking adalimumab
products. These serious infections include tuberculosis (TB) and
infections caused by viruses, fungi or
bacteria that have spread throughout the body. Some people have died
from these infections.
•
Your doctor should test you for TB before starting AMJEVITA.
•
Your doctor should check you closely for signs and symptoms of TB
during treatment with
AMJEVITA.
You should not start taking AMJEVITA if you have any kind of infection
unless your doctor says it is
okay.
Before starting AMJEVITA, tell your doctor if you:
•
think you have an infection or have symptoms of infection such as:
•
fever, sweats, or chills
•
muscle aches
•
cough
•
shortness of breath
•
blood in phlegm
•
warm, red, or painful skin or sores on your
body
•
diarrhea or stomach pain
•
burning when you urinate or urinate more often
than normal
•
feeling very tired
•
weight loss
•
are being treated for an infection.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes.
•
have TB, or have been in close contact with someone with TB.
•
were born in, lived in, or traveled to countries where there is more
risk for getting TB. Ask your
doctor if you are not sure.
•
live or have lived in certain parts of the country (such as the Ohio
and Mississippi River valleys)
where

Scheda tecnica

AMJEVITA- ADALIMUMAB-ATTO INJECTION
AMGEN USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMJEVITA™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMJEVITA.
AMJEVITA (ADALIMUMAB-ATTO) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2016
AMJEVITA (ADALIMUMAB-ATTO) IS BIOSIMILAR TO HUMIRA (ADALIMUMAB).
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS (5.1, 6.1):
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.
DISCONTINUE AMJEVITA IF A PATIENT DEVELOPS A SERIOUS INFECTION OR
SEPSIS DURING
TREATMENT.
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING
AMJEVITA.
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE.
MALIGNANCY (5.2):
LYMPHOMA AND OTHER MALIGNANCIES, SOME FATAL, HAVE BEEN REPORTED IN
CHILDREN AND
ADOLESCENT PATIENTS TREATED WITH TNF-BLOCKERS INCLUDING ADALIMUMAB
PRODUCTS.
POST-MARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA (HSTCL), A RARE
TYPE OF T-
CELL LYMPHOMA, HAVE OCCURRED IN ADOLESCENT AND YOUNG ADULTS WITH
INFLAMMATORY
BOWEL DISEASE TREATED WITH TNF-BLOCKERS INCLUDING ADALIMUMAB PRODUCTS.
RECENT MAJOR CHANGES
Indications and Usage, Hidradenitis Suppurativa (1.8)
3/2023
Indications and Usage, Uveitis (1.9)
7/2023
Dosage and Administration, Juvenile Idiopathic Arthritis (2.2)
4/2023
Dosage and Administration, Plaque Psoriasis or Adult Uveitis (2.5)
7/2023
Dosage and Administration, Hidradenitis Suppurativa (2.6)
3/2023
Warnings and Precautions, Malignancies (5.2)
7/2023
Warnings and Precautions, Neurologic Reactions (5.5)
7/2023
INDICATIONS AND USAGE
AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for:
RHEUMATOID ARTHRITIS (RA) (1.1): reducing signs and symptoms, in