Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
INFLIXIMAB (UNII: B72HH48FLU) (INFLIXIMAB - UNII:B72HH48FLU)
Amgen Inc
INTRAVENOUS
PRESCRIPTION DRUG
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
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) .
Biologic Licensing Application
Amgen Inc ---------- 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 Leggi il documento completo
AVSOLA- INFLIXIMAB-AXXQ INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION AMGEN INC ---------- 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 Leggi il documento completo