ADALIMUMAB kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Golden State Medical Supply, Inc.

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Adalimumab-fkjp 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-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-fkjp 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-fkjp can be used alone or in combination with methotrexate. Adalimumab-fkjp 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-fkjp can be used alone or in combination with non-biologic DMARDs. Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondyliti

ملخص المنتج:

Adalimumab-fkjp Prefilled Syringe Carton - 40 mg/0.8 mL Adalimumab-fkjp (injection) is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled plastic syringe with a fixed 29 gauge thin wall, ½ inch needle, providing 40 mg/0.8 mL of adalimumab-fkjp. The NDC number is 51407-835-02. Adalimumab-fkjp Prefilled Pen Carton - 40 mg/0.8 mL Adalimumab-fkjp (injection) is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose pen, containing a 1 mL prefilled plastic syringe with a fixed 29 gauge thin wall, ½ inch needle, providing 40 mg/0.8 mL of adalimumab-fkjp. The NDC number is 51407-834-02. Storage and Stability Do not use beyond the expiration date on the container. Adalimumab-fkjp 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-fkjp 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-fkjp should be discarded if not used within the 14-day period. Record the date when Adalimumab-fkjp is first removed from the refrigerator in the spaces provided on the carton and dose tray. Do not store Adalimumab-fkjp in extreme heat or cold.

الوضع إذن:

Biologic Licensing Application

نشرة المعلومات

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Adalimumab (ay″da lim′ue mab)-fkjp
Injection, for subcutaneous use
Read the Medication Guide that comes with Adalimumab-fkjp 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 healthcare provider about your medical condition or
treatment.
What is the most important information I should know about
Adalimumab-fkjp?
Adalimumab-fkjp is a medicine that affects your immune system.
Adalimumab-fkjp 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 healthcare provider should test you for TB before starting
Adalimumab-fkjp.
•
Your healthcare provider should check you closely for signs and
symptoms of TB during
treatment with Adalimumab-fkjp.
You should not start taking Adalimumab-fkjp if you have any kind of
infection unless your healthcare
provider says it is okay.
Before starting Adalimumab-fkjp, tell your healthcare provider 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
healthcare provider if you are not sure.
•
live or have lived in certain parts of the country (such as the Ohio
an

خصائص المنتج

ADALIMUMAB- ADALIMUMAB
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ADALIMUMAB-FKJP INJECTION. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION NEEDED TO
USE ADALIMUMAB-FKJP INJECTIONSAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ADALIMUMAB-FKJP INJECTION.
ADALIMUMAB-FKJP INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2020
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-FKJP 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-FKJP.
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, Juvenile Idiopathic Arthritis ( 1.2) 07/2022
Indications and Usage, Crohn’s Disease ( 1.5) 07/2022
Indications and Usage, Hidradenitis Suppurativa ( 1.8) 03/2023
Dosage and Administration, Rheumatoid Arthritis, Psoriatic
Arthritis, and Ankylosing Spondylitis ( 2.1) 07/2022
Dosage and Administration, Juvenile Idiopathic Arthritis ( 2.2)
07/2022
Dosage and Administration, Crohn’s Disease ( 2.3) 07/2022
Dosage and Administration, Hidradenitis Suppurativa ( 2.6) 03/2023
INDICATIONS AND USAGE
Adalimumab-fkjp is a tumor necrosis factor (TNF) block