ADALIMUMAB- adalimumab-adaz injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Adalimumab single-dose prefilled Sensoready Pen, adalimumab single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard and add-on finger flange and adalimumab single-dose prefilled syringe. Adalimumab (adalimumab-adaz) injection is supplied as a preservative-free, sterile, clear and colorless or slightly yellowish solution for subcutaneous administration. The following packaging configurations are available. 80 mg/0.8 mL single-dose prefilled Sensoready Pen with a fixed 29 gauge, ½ inch needle Carton of 2 NDC 61314-325-20 80 mg/0.8 mL single-dose prefilled Sensoready Pen with a fixed 29 gauge, ½ inch needle Crohn’s disease and Ulcerative colitis Starter Package Carton of 3 NDC 61314-349-36 80 mg/0.8 mL and 40 mg/0.4 mL single-dose prefilled Sensoready Pens with fixed 29 gauge, ½ inch needle each Plaque Psoriasis Starter Package Carton of 3 (1x 80 mg/0.8 mL, 2x 40 mg/0.4 mL) NDC 61314-345-36 80 mg/0.8 mL and 40 mg/0.4 mL single-dose prefilled Sensoready Pens with fixed 29 gauge, ½ inch needle each Crohn’s Disease and Ulcerative Colitis Starter Package Carton of 4 (3x 80 mg/0.8 mL, 1x 40 mg/0.4 mL) NDC 61314-359-84 80 mg/0.8 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle and with BD UltraSafe Passive™ Needle Guard Carton of 2 NDC 61314-325-64 80 mg/0.8 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle and with BD UltraSafe Passive™ Needle Guard Starter Pack for Pediatric Crohn’s Disease Carton of 3 NDC 61314-397-68 80 mg/0.8 mL and 40 mg/0.4 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle and with BD UltraSafe Passive™ Needle Guard Starter Pack for Pediatric Crohn’s Disease Carton of 2 NDC 61314-395-64 40 mg/0.4 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle and with BD UltraSafe Passive™ Needle Guard Carton of 2 NDC 61314-327-64 40 mg/0.4 mL single-dose prefilled Sensoready Pen with a fixed 29 gauge, ½ inch needle Carton of 2 NDC 61314-327-20 40 mg/0.4 mL single-dose prefilled Sensoready Pen with a fixed 29 gauge, ½ inch needle Carton of 4 NDC 61314-327-84 20 mg/0.2 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle Carton of 2 NDC 61314-332-64 10 mg/0.1 mL single-dose prefilled syringe with a fixed 29 gauge, ½ inch needle Carton of 2 NDC 61314-342-64 Prefilled syringes and injection devices are not made with natural rubber latex. Storage and Handling Do not use beyond the expiration date on the container. Adalimumab 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. Do not store adalimumab in extreme heat or cold. Adalimumab single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard (40 mg/0.4 mL, 80 mg/0.8 mL), adalimumab single-dose prefilled Sensoready Pen (40 mg/0.4 mL, 80 mg/0.8 mL) and adalimumab single-dose prefilled syringe (10 mg/0.1 mL, 20 mg/0.2 mL): If needed, for example when traveling, adalimumab 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 should be discarded if not used within the 14-day period. Record the date when adalimumab is first removed from the refrigerator in the spaces provided on the carton.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Sandoz Inc.
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MEDICATION GUIDE
Adalimumab (ay-dah-LIM-yoo-mab)
(adalimumab-adaz)
injection, for subcutaneous use
Read the Medication Guide that comes with adalimumab 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?
Adalimumab is a medicine that affects your immune system. Adalimumab
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.
•
Your doctor should check you closely for signs and symptoms of TB
during treatment with
adalimumab.
You should not start taking adalimumab if you have any kind of
infection unless your doctor says it is
okay.
Before starting adalimumab, tell your doctor if you:
•
think you have an infection or have symptoms of an infection such as:
o
fever, sweats or chills
o
warm, red, or painful skin or sores on your body
o
muscle aches
o
diarrhea or stomach pain
o
cough
o
burning when you urinate or urinate more often than normal
o
shortness of breath
o
feel very tired
o
blood in phlegm
o
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,
coccidioidom

Summary of Product characteristics

ADALIMUMAB- ADALIMUMAB-ADAZ INJECTION, SOLUTION
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADALIMUMAB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADALIMUMAB.
ADALIMUMAB (ADALIMUMAB-ADAZ) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2018
ADALIMUMAB (ADALIMUMAB-ADAZ) IS BIOSIMILAR* TO HUMIRA (ADALIMUMAB)
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS(5.1, 6.1):
•
•
•
•
MALIGNANCY (5.2):
•
•
RECENT MAJOR CHANGES
Indications and Usage,
Dosage and Administration,
INDICATIONS AND USAGE
Adalimumab is a tumor necrosis factor (TNF)-blocker indicated for:
•
•
•
•
•
•
®
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 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.
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE.
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.
Juvenile Idiopathic Arthritis (1.2), Crohn’s disease (1.5) 7/2022
Juvenile Idiopathic Arthritis (2.2), Crohn’s disease (2.3) 7/2022
Dosage and Administration,
Juvenile Idiopathic Arthritis (2.2), Crohn’s disease (2.3) 3/2023
RHEUMATOID ARTHRITIS (RA) (1.1): reducing signs and symptoms, inducing
major clinical response,
inhibiting the progression of structural da