ACTEMRA- tocilizumab injection, solution, concentrate ACTEMRA- tocilizumab injection, solution ACTEMRA ACTPEN- tocilizumab inj

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOCILIZUMAB (UNII: I031V2H011) (TOCILIZUMAB - UNII:I031V2H011)

Available from:

Genentech, Inc.

INN (International Name):

tocilizumab

Composition:

tocilizumab 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ACTEMRA® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). ACTEMRA® (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. ACTEMRA® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. ACTEMRA® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. ACTEMRA® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. ACTEMRA® (toci

Product summary:

For Intravenous Infusion ACTEMRA (tocilizumab) injection is a preservative-free, sterile clear, colorless to pale yellow solution. ACTEMRA is supplied as 80 mg/4 mL (NDC 50242-135-01), 200 mg/10 mL (NDC 50242-136-01), and 400 mg/20 mL (NDC 50242-137-01) individually packaged 20 mg/mL single-dose vials for further dilution prior to intravenous infusion. For Subcutaneous Injection ACTEMRA (tocilizumab) injection is supplied as a preservative-free, sterile, clear, colorless to slightly yellowish solution for subcutaneous administration. The following packaging configurations are available: Storage and Handling: Do not use beyond expiration date on the container, package, prefilled syringe, or autoinjector. ACTEMRA must be refrigerated at 36°F to 46°F (2ºC to 8ºC). Do not freeze. Protect the vials, syringes, and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry. Once removed from the refrigerator, the prefilled syringe and autoinjector can be stored up to 2 weeks at or below 86°F (30°C). The prefilled syringe and autoinjector must always be kept in the carton.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION
ACTEMRA ACTPEN- TOCILIZUMAB INJECTION, SOLUTION
Genentech, Inc.
----------
Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 12/2022
Medication Guide
ACTEMRA® (AC-TEM-RA)
(tocilizumab) injection
for intravenous use
ACTEMRA® (AC-TEM-RA)
(tocilizumab) injection
for subcutaneous use
What is the most important information I should know about ACTEMRA?
ACTEMRA can cause serious side effects including:
1.
Serious Infections. ACTEMRA is a medicine that affects your immune
system. ACTEMRA can
lower the ability of your immune system to fight infections. Some
people have serious infections
while taking ACTEMRA, including tuberculosis (TB), and infections
caused by bacteria, fungi, or
viruses that can spread throughout the body. Some people have died
from these infections. Your
healthcare provider should assess you for TB before starting ACTEMRA
(except if you have
COVID-19).
If you have COVID-19, your healthcare provider should monitor you for
signs and symptoms of new
infections during and after treatment with ACTEMRA.
Your healthcare provider should monitor you closely for signs and
symptoms of TB during treatment
with ACTEMRA.
•
You should not start taking ACTEMRA if you have any kind of infection
unless your healthcare
provider says it is okay.
Before starting ACTEMRA, tell your healthcare provider if you:
•
think you have an infection or have symptoms of an infection, with or
without a fever, such as:
•
sweating or chills
•
shortness of breath
•
warm, red, or painful skin or
sores on your body
•
feel very tired
•
muscle aches
•
blood in phlegm
•
diarrhea or stomach pain
•
cough
•
weight loss
•
burning when you
urinate or urinating
more often than
normal
•
are being treated for an infection.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes, HIV, or a weak immune system. People with these
conditions have a higher chance
for infections.
•
have TB, or have been in close contact wi

Summary of Product characteristics

ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION, CONCENTRATE
ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION
ACTEMRA ACTPEN- TOCILIZUMAB INJECTION, SOLUTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACTEMRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACTEMRA.
ACTEMRA (TOCILIZUMAB) INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2010
WARNING: RISK OF SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR DEATH INCLUDING
TUBERCULOSIS (TB),
BACTERIAL, INVASIVE FUNGAL, VIRAL, AND OTHER OPPORTUNISTIC INFECTIONS
HAVE OCCURRED IN
PATIENTS RECEIVING ACTEMRA. (5.1)
IF A SERIOUS INFECTION DEVELOPS, INTERRUPT ACTEMRA UNTIL THE INFECTION
IS CONTROLLED.
(5.1)
PERFORM TEST FOR LATENT TB (EXCEPT PATIENTS WITH COVID-19); IF
POSITIVE, START
TREATMENT FOR TB PRIOR TO STARTING ACTEMRA. (5.1)
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.7)
12/2022
Dosage and Administration (2.1, 2.3, 2.9, 2.11)
02/2022
Dosage and Administration (2.1, 2.8, 2.9)
12/2022
Warnings and Precautions (5.1, 5.3, 5.4)
12/2022
INDICATIONS AND USAGE
ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist
indicated for treatment of:
RHEUMATOID ARTHRITIS (RA) (1.1)
Adult patients with moderately to severely active rheumatoid arthritis
who have had an inadequate
response to one or more Disease-Modifying Anti-Rheumatic Drugs
(DMARDs).
GIANT CELL ARTERITIS (GCA) (1.2)
Adult patients with giant cell arteritis.
SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
(1.3)
Slowing the rate of decline in pulmonary function in adult patients
with systemic sclerosis-associated
interstitial lung disease (SSc-ILD)
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) (1.4)
Patients 2 years of age and older with active polyarticular juvenile
idiopathic arthritis.
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