IMRALDI- adalimumab injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Adalimumab (UNII: FYS6T7F842) (Adalimumab - UNII:FYS6T7F842)

Dostupno od:

Samsung Bioepis Co., Ltd.

Administracija rute:

SUBCUTANEOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

IMRALDI 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. IMRALDI can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). IMRALDI is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and ≥ 30 kg (66 lbs). IMRALDI can be used alone or in combination with methotrexate. IMRALDI is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IMRALDI can be used alone or in combination with non-biologic DMARDs. IMRALDI is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. IMRALDI is indicated for reduci

Proizvod sažetak:

IMRALDI (adalimumab-xxxx) is supplied as a preservative-free, sterile solution for subcutaneous administration. The following packaging configurations are available. Storage and Stability Do not use beyond the expiration date on the container. IMRALDI 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, IMRALDI 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. IMRALDI should be discarded if not used within the 14-day period. Do not store IMRALDI in extreme heat or cold.

Status autorizacije:

Export only

Uputa o lijeku

Samsung Bioepis Co., Ltd.
----------
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Issued: MM/YYYY
MEDICATION GUIDE
IMRALDI (Im-RAL-di)
(adalimumab-xxxx)
injection
Read the Medication Guide that comes with IMRALDI 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 IMRALDI?
IMRALDI is a medicine that affects your immune system. IMRALDI can
lower the ability of your
immune system to fight infections. Serious infections have happened in
people taking TNF blockers
including 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 IMRALDI.
•
Your doctor should check you closely for signs and symptoms of TB
during treatment with
IMRALDI.
You should not start taking IMRALDI if you have any kind of infection
unless your doctor says it is
okay.
Before starting IMRALDI, 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
•
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

Svojstava lijeka

IMRALDI- ADALIMUMAB INJECTION, SOLUTION
SAMSUNG BIOEPIS CO., LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMRALDI SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IMRALDI.
IMRALDI (ADALIMUMAB-XXXX) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: YYYY
IMRALDI (adalimumab-xxxx) is biosimilar
to HUMIRA (adalimumab) for the indications listed. (1)
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 IMRALDI 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 IMRALDI.
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.
INDICATIONS AND USAGE
IMRALDI is a tumor necrosis factor (TNF) blocker indicated for
treatment of:
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 moderately to severely active
polyarticular JIA in patients from 4 to 17 years of age and ≥30 kg
(66 lbs).
PSORIATIC ARTHRITIS (PSA) (1.3): Reducing sign