ADALIMUMAB-ADBM kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Boehringer Ingelheim Pharmaceuticals, Inc.

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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

الوضع إذن:

Biologic Licensing Application

نشرة المعلومات

Boehringer Ingelheim Pharmaceuticals, Inc.
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MEDICATION GUIDE
ADALIMUMAB-ADBM
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Issued: 09/2023
Read the Medication Guide that comes with Adalimumab-adbm 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
Adalimumab-adbm?
Adalimumab-adbm is a medicine that affects your immune system.
Adalimumab-adbm 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 Adalimumab-adbm.
•
Your doctor should check you closely for signs and symptoms of TB
during treatment with
Adalimumab-adbm.
You should not start taking Adalimumab-adbm if you have any kind of
infection unless your doctor says
it is okay.
Before starting Adalimumab-adbm, 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 (su

خصائص المنتج

ADALIMUMAB-ADBM- ADALIMUMAB-ADBM
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADALIMUMAB-ADBM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ADALIMUMAB-ADBM.
ADALIMUMAB-ADBM INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2017
ADALIMUMAB-ADBM IS INTERCHANGEABLE WITH 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 ADALIMUMAB-ADBM 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
ADALIMUMAB-ADBM.
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)
03/2023
Indications and Usage, Uveitis (1.9)
06/2023
Dosage and Administration, Plaque Psoriasis or Adult Uveitis (2.5)
06/2023
Dosage and Administration, Hidradenitis Suppurativa (2.6)
03/2023
Dosage and Administration,
General Considerations for Administration (2.8)
05/2023
Warnings and Precautions, Malignancies (5.2)
06/2023
Warnings and Precautions, Neurologic Reactions (5.5)
06/2023
INDICATIONS AND USAGE
Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated
for:
RHE