HUMIRA- adalimumab kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

A-S Medication Solutions

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

HUMIRA® (adalimumab) is supplied as a preservative-free, sterile, clear and colorless solution for subcutaneous administration. The following packaging configurations are available. Storage and Stability Do not use beyond the expiration date on the container. HUMIRA 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, HUMIRA 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. HUMIRA should be discarded if not used within the 14-day period. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray. Do not store HUMIRA in extreme heat or cold.

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

A-S Medication Solutions
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MEDICATION GUIDE
HUMIRA® (Hu-MARE-ah)
(adalimumab)
injection, for subcutaneous use
Read the Medication Guide that comes with HUMIRA 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 HUMIRA?
HUMIRA is a medicine that affects your immune system. HUMIRA can lower
the ability of your
immune system to fight infections. Serious infections have happened in
people taking HUMIRA.
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 HUMIRA.
•
Your doctor should check you closely for signs and symptoms of TB
during treatment with
HUMIRA.
You should not start taking HUMIRA if you have any kind of infection
unless your doctor says it
is okay.
Before starting HUMIRA, tell your doctor if you:
•
think you have an infection or have symptoms of an 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
•
feel 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 there is an increased risk for getting certain kinds of
fungal infections
(histoplasmosis, coccidioidomycosis, or blastomycosis).

Preparatomtale

HUMIRA- ADALIMUMAB
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HUMIRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HUMIRA.
HUMIRA (ADALIMUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2002
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 HUMIRA 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
HUMIRA.
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 HUMIRA.
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 HUMIRA.
RECENT MAJOR CHANGES
Indications and Usage, Ulcerative Colitis (1.6)
2/2021
Dosage and Administration, Rheumatoid Arthritis, Psoriatic Arthritis,
and Ankylosing Spondylitis
(2.1)
12/2020
Dosage and Administration, Ulcerative Colitis (2.4)
2/2021
Dosage and Administration, Hidradenitis Suppurativa (2.6)
12/2020
INDICATIONS AND USAGE
HUMIRA is a tumor necrosis factor (TNF) blocker indicated for:
RHEUMATOID ARTHRITIS (RA) (1.1): 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 RA.
JUVENILE IDIOPATHIC ARTHRITIS (JIA) (1.2): reducing signs and symptoms
of moderatel