AVSOLA- infliximab-axxq injection, powder, lyophilized, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Amgen Inc

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

AVSOLA 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. AVSOLA 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. AVSOLA 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. AVSOLA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in

Ürün özeti:

How Supplied AVSOLA (infliximab-axxq) for injection is supplied as one single-dose vial individually packaged in a carton (NDC 55513-670-01). Each single-dose vial contains 100 mg of infliximab-axxq as a sterile, preservative-free, white to slightly yellow 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 AVSOLA vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. If needed, unopened AVSOLA 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 AVSOLA cannot be returned to the refrigerator. For storage conditions of the reconstituted and diluted product, see Dosage and Administration (2.11) .

Yetkilendirme durumu:

Biologic Licensing Application

Bilgilendirme broşürü

Amgen Inc
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MEDICATION GUIDE
AVSOLA®
(INFLIXIMAB-AXXQ)
FOR INJECTION, FOR INTRAVENOUS USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 9/2021
Read the Medication Guide that comes with AVSOLA before you receive
the first treatment, and before
each time you get a treatment of AVSOLA. 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 AVSOLA?
AVSOLA may cause serious side effects, including:
1. Risk of infection
AVSOLA is a medicine that affects your immune system. AVSOLA can lower
the ability of your
immune system to fight infections. Serious infections have happened in
patients receiving AVSOLA.
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 AVSOLA.
•
Your doctor should monitor you closely for signs and symptoms of TB
during treatment with
AVSOLA.
Before starting AVSOLA, tell your doctor if you:
•
think you have an infection. You should not start receiving AVSOLA 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 AVSOLA. If you do not know if you have lived in an

Ürün özellikleri

AVSOLA- INFLIXIMAB-AXXQ INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMGEN INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVSOLA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVSOLA.
AVSOLA (INFLIXIMAB-AXXQ) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
AVSOLA (INFLIXIMAB-AXXQ) IS BIOSIMILAR TO REMICADE (INFLIXIMAB).
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 AVSOLA IF A PATIENT DEVELOPS A SERIOUS INFECTION.
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING
AVSOLA. 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 PRODUCTS. (5.2)
POSTMARKETING CASES OF FATAL HEPATOSPLENIC T-CELL LYMPHOMA (HSTCL)
HAVE BEEN
REPORTED IN PATIENTS TREATED WITH TNF BLOCKERS INCLUDING INFLIXIMAB
PRODUCTS. ALMOST
ALL HAD RECEIVED AZATHIOPRINE OR 6-MERCAPTOPURINE CONCOMITANTLY WITH A
TNF BLOCKER
AT OR PRIOR TO DIAGNOSIS. THE MAJORITY OF CASES WERE REPORTED IN
PATIENTS WITH CROHN'S
DISEASE OR ULCERATIVE COLITIS, MOST OF WHOM WERE ADOLESCENT OR YOUNG
ADULT MALES.
(5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2.11)
9/2021
Contraindications (4)
9/2021
Warnings and Precautions: Heart Failure (5.5)
9/2021
Warnings and Precautions: Vaccinations and Use of Live
Vaccines/Therapeutic Infectious
Agents (5.13)
9/2021
INDICATIONS AND USAGE
AVSOLA is a tumor necrosis factor (TNF) blocker indicated for:
_Crohn's Disease_:
reducing signs and symptoms and inducing and maintaining clinical
rem