CIMZIA- certolizumab pegol kit CIMZIA- certolizumab pegol injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CERTOLIZUMAB PEGOL (UNII: UMD07X179E) (CERTOLIZUMAB PEGOL - UNII:UMD07X179E)

Tilgjengelig fra:

UCB, Inc.

INN (International Name):

certolizumab pegol

Sammensetning:

certolizumab pegol 200 mg in 1 mL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). CIMZIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA). CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis (AS). [see Clinical Studies (14.4)] CIMZIA is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation [see Clinical Studies (14.5)]. CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy [see Clinical Studies (14.6)] CIMZIA is con

Produkt oppsummering:

Storage and Stability Refrigerate carton between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not separate contents of carton prior to use. Do not use beyond expiration date, which is located on the drug label and carton. Protect solution from light. Unopened CIMZIA vials may also be stored at room temperature up to a maximum of 25°C (77°F) for 6 months, but not exceeding the original expiration date. If stored at room temperature, do not place back in refrigerator and write the new expiration date on the carton in the space provided. Lyophilized Powder for Reconstitution: NDC 50474-700-62 CIMZIA (certolizumab pegol) for injection is supplied as a sterile white, lyophilized powder in a single-dose vial for subcutaneous use. Prefilled Syringe NDC 50474-710-79 CIMZIA (certolizumab pegol) injection is supplied as a sterile, clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe for subcutaneous use. 2 alcohol swabs and 2 single-dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200 mg (1 mL) of CIMZIA. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause allergic reactions and should be handled with caution by latex-sensitive individuals [see Warnings and Precautions (5.4)]. Prefilled Syringe Starter Kit NDC 50474-710-81 6 alcohol swabs and 6 single dose prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle. The Starter Kit contains 3 sets of 2 prefilled syringes to provide sufficient drug supply for the initial 3 induction doses at the start of treatment. Each prefilled syringe contains 200 mg (1 mL) of CIMZIA. When necessary, CIMZIA prefilled syringes may be stored at room temperature up to 77 °F (25 °C) in the original carton to protect from light for a single period of up to 7 days. Once a CIMZIA prefilled syringe has been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within the 7-day period.

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

CIMZIA- CERTOLIZUMAB PEGOL INJECTION, SOLUTION
UCB, Inc.
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: April 2020
MEDICATION GUIDE
CIMZIA ® (CIM-zee-uh)
(certolizumab pegol)
injection for subcutaneous use
What is the most important information I should know about CIMZIA?
CIMZIA may cause serious side effects, including:
•
CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF)
blocker that can lower
the ability of your immune system to fight infections. Some people who
received CIMZIA have
developed serious infections, including tuberculosis (TB) and
infections caused by viruses, fungi,
or bacteria that have spread throughout the body. Some of these
serious infections have caused
hospitalization and death.
•
Your healthcare provider should test you for TB before starting
CIMZIA.
•
Your healthcare provider should monitor you closely for signs and
symptoms of TB
during treatment with CIMZIA.
Before starting CIMZIA, tell your healthcare provider if you:
•
think you have an infection or have symptoms of an infection such as:
•
fever, sweat, or chills
•
cough
•
blood in phlegm
•
warm, red, or painful skin or sores
on your body
•
burning when you urinate or urinate
more often than normal
•
muscle aches
•
shortness of breath
•
weight loss
•
diarrhea or stomach pain
•
feeling very tired
•
are being treated for an infection.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes, HIV-1 or a weak immune system. People with these
conditions have a higher
chance for infections.
•
have tuberculosis (TB), or have been in close contact with someone
with TB.
•
were born in, live, have lived, or traveled to certain countries where
there is more risk for
getting TB. Ask your healthcare provider if you are not sure.
•
live, have lived, or traveled to certain parts of the country (such as
the Ohio and Mississippi
River valleys and the Southwest) where there is an increased risk for
getting cert

Preparatomtale

CIMZIA- CERTOLIZUMAB PEGOL
CIMZIA- CERTOLIZUMAB PEGOL INJECTION, SOLUTION
UCB, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIMZIA® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIMZIA.
CIMZIA (CERTOLIZUMAB PEGOL) FOR INJECTION, FOR SUBCUTANEOUS USE
CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2008
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).
CIMZIA SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS
INFECTION OR SEPSIS (
5.1).
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING CIMZIA
( 5.1).
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 TNF BLOCKERS, OF WHICH CIMZIA IS A
MEMBER ( 5.2) _._
CIMZIA IS NOT INDICATED FOR USE IN PEDIATRIC PATIENTS. ( 8.4)
INDICATIONS AND USAGE
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:
Reducing signs and symptoms of Crohn's disease and maintaining
clinical response in adult patients
with moderately to severely active disease who have had an inadequate
response to conventional
therapy ( 1.1)
Treatment of adults with moderately to severely active rheumatoid
arthritis ( 1.2)
Treatment of adult patients with active psoriatic arthritis. ( 1.3)
Treatment of adults with active ankylosing spondylitis ( 1.4)
Treatment of adults with active non-radiographic axial
spondyloarthritis with objective signs of
inflammation ( 1.5)
Treatment of adults with moderate-to-severe plaque psoriasis who are
candidates for systemic therapy
or phototherapy ( 1.6)
DOSAGE AND ADM