INFLIXIMAB injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLIXIMAB (UNII: B72HH48FLU) (INFLIXIMAB - UNII:B72HH48FLU)

Available from:

Janssen Biotech, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Infliximab is indicated for: - reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy. - reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD. Infliximab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. Infliximab is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. Infliximab is indicated for reducing signs and symptoms and inducing and maintaining clini

Product summary:

How Supplied Infliximab for injection is supplied in a carton containing one single-dose vial (NDC 57894-160-01). Each single-dose vial contains 100 mg of infliximab as a sterile, preservative-free, white lyophilized powder for reconstitution and dilution (more than one vial may be needed for a full dose) [see Dosage and Administration (2.11)]. Storage and Handling Store unopened Infliximab vials in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, unopened Infliximab vials may be stored at room temperatures up to a maximum of 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date. The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator, Infliximab cannot be returned to the refrigerator. For storage conditions of the reconstituted and diluted product for administration, see Dosage and Administration (2.11) .

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Janssen Biotech, Inc.
----------
MEDICATION GUIDE
Infliximab
for injection, for intravenous use
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: October 2021
Read the Medication Guide that comes with Infliximab before you
receive the first treatment, and before
each time you get a treatment of Infliximab. 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 Infliximab?
Infliximab may cause serious side effects, including:
1. Risk of infection
Infliximab is a medicine that affects your immune system. Infliximab
can lower the ability of your immune
system to fight infections. Serious infections have happened in
patients receiving Infliximab. These
infections include tuberculosis (TB) and infections caused by viruses,
fungi or bacteria that have spread
throughout the body. Some patients have died from these infections.
•
Your doctor should test you for TB before starting Infliximab.
•
Your doctor should monitor you closely for signs and symptoms of TB
during treatment with
Infliximab.
Before starting Infliximab, tell your doctor if you:
•
think you have an infection. You should not start receiving Infliximab
if you have any kind of
infection.
•
are being treated for an infection.
•
have signs of an infection, such as a fever, cough, flu-like symptoms.
•
have any open cuts or sores on your body.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes or an immune system problem. People with these
conditions have a higher chance for
infections.
•
have TB, or have been in close contact with someone with TB.
•
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). These infections may develop or
become more severe if you
receive Infli

Summary of Product characteristics

INFLIXIMAB- INFLIXIMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
JANSSEN BIOTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFLIXIMAB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFLIXIMAB.
INFLIXIMAB FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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.
(5.1)
DISCONTINUE INFLIXIMAB IF A PATIENT DEVELOPS A SERIOUS INFECTION.
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING
INFLIXIMAB. MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN
IF INITIAL LATENT
TB TEST IS NEGATIVE. (5.1)
LYMPHOMA AND OTHER MALIGNANCIES, SOME FATAL, HAVE BEEN REPORTED IN
CHILDREN AND
ADOLESCENT PATIENTS TREATED WITH TUMOR NECROSIS FACTOR (TNF) BLOCKERS,
INCLUDING
INFLIXIMAB. (5.2)
POSTMARKETING CASES OF FATAL HEPATOSPLENIC T-CELL LYMPHOMA (HSTCL)
HAVE BEEN
REPORTED IN PATIENTS TREATED WITH TNF BLOCKERS INCLUDING INFLIXIMAB.
ALMOST ALL HAD
RECEIVED AZATHIOPRINE OR 6-MERCAPTOPURINE CONCOMITANTLY WITH A TNF
BLOCKER AT OR
PRIOR TO DIAGNOSIS. THE MAJORITY OF INFLIXIMAB CASES WERE REPORTED IN
PATIENTS WITH
CROHN'S DISEASE OR ULCERATIVE COLITIS, MOST OF WHOM WERE ADOLESCENT OR
YOUNG ADULT
MALES. (5.2)
INDICATIONS AND USAGE
Infliximab is a tumor necrosis factor (TNF) blocker indicated for:
_Crohn's Disease_:
reducing signs and symptoms and inducing and maintaining clinical
remission in adult patients with
moderately to severely active disease who have had an inadequate
response to conventional
therapy. (1.1)
reducing the number of draining enterocutaneous and rectovaginal
fistulas and maintaining fistula
closure in adult patients with fistulizing disease. (1.1)
_Pediatric Croh