Approved Drug Label (PDF)
6
Adverse Reactions
6.10 Clinical
Trials Experience in
COVID-19 Patients Treated with Intravenous Tocilizumab (Tocilizumab-IV)
Addition of adult
to Table 3 title; please refer to label for complete information
Additions and/or
revisions underlined:
The
safety of tocilizumab in hospitalized adult COVID-19 patients was evaluated
in a pooled safety population that includes patients enrolled in EMPACTA, COVACTA,
AND REMDACTA.
…
In the pooled adult safety population of
EMPACTA, COVACTA, and REMDACTA, neutrophil counts <1000 cells/mcl occurred
in 3.4% of patients who received tocilizumab and 0.5% of patients who received
placebo.
…
8.4 Pediatric Use
Additions and/or revisions underlined:
AVTOZMA by intravenous use is indicated for the
treatment of pediatric patients with:
- Active systemic juvenile idiopathic arthritis in
patients 2 years of age and older
- Active polyarticular juvenile idiopathic arthritis
in patients 2 years of age and older
- Severe or life-threatening CAR T cell-induced
cytokine release syndrome (CRS) in patients 2 years of age and older.
- Hospitalized Coronavirus
disease 2019 (COVID-19) patients 2 years of age and older who are receiving
systemic corticosteroids and require supplemental oxygen, non-invasive or
invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
…
The
safety and effectiveness of AVTOZMA in pediatric patients with conditions other
than PJIA, SJIA, CRS or COVID-19 have not been established. The safety
and effectiveness in pediatric patients below the age of 2 have not been
established in PJIA, SJIA, CRS or COVID-19.
…
COVID-19
– Intravenous Use
The
safety and effectiveness of AVTOZMA have been established for the treatment of
pediatric patients aged 2 years and older with COVID-19. Use of AVTOZMA in
these age groups is supported by evidence from adequate and well-controlled
studies of tocilizumab in adults with COVID-19 [See Adverse Reactions (6.10)
and Clinical Studies (14.10)], predicted pharmacokinetic data modeling and
simulation for pediatric patients aged 2 years and older with COVID-19 [See
Clinical Pharmacology (12.3)], safety data from a randomized, double-blind,
placebo-controlled study of tocilizumab in pediatric patients aged 2 years and
older with systemic juvenile idiopathic arthritis, and additional uncontrolled
pharmacovigilance data in pediatric patients aged 2 years and older with
COVID-19 who received tocilizumab under Emergency Use Authorization.
The
safety and effectiveness of AVTOZMA has not been established in pediatric
COVID-19 patients younger than 2 years of age.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined
What
is AVTOZMA?
…
- To treat hospitalized people ages 2 years and
above with coronavirus disease 2019 (COVID-19) receiving systemic
corticosteroids and requiring supplemental oxygen or mechanical ventilation.
…
It is not known if AVTOZMA is safe and effective in
children with PJIA, SJIA, CRS or COVID-19 under 2 years of age or in
children with conditions other than PJIA, SJIA, CRS or COVID-19.
Approved Drug Label (PDF)
6
Adverse Reactions
6.11 Postmarketing
Experience
Additions and/or
revisions underlined:
The following
adverse reactions have been identified during post-approval use of tocilizumab products. Because
these reactions are reported voluntarily from a population of uncertain size,
it is not always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure.
Hypersensitivity
Reactions: Fatal anaphylaxis, Stevens-Johnson Syndrome, Drug Reaction with
Eosinophilia and Systemic Symptoms (DRESS) [see
Warnings and Precautions (5.6)]
Pancreatitis
Drug-induced liver injury, Hepatitis, Hepatic failure, Jaundice
[see Warnings and Precautions (5.3)]
Hypofibrinogenemia
Approved Drug Label (PDF)
6
Adverse Reactions
6.9 Clinical
Trials Experience in Patients with Cytokine Release Syndrome Treated with
Intravenous Toclizumab (Toclizumab-IV)
Newly
added subsection
In a retrospective analysis of pooled outcome data
from multiple clinical trials 45 patients were treated with tocilizumab 8 mg/kg
(12 mg/kg for patients less than 30 kg) with or without additional high-dose
corticosteroids for severe or life-threatening CAR T-cell-induced CRS. A median
of 1 dose of tocilizumab (range, 1-4 doses) was
administered. No adverse reactions related to tocilizumab were reported [see Clinical Studies (14.9)].
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions
underlined:
AVTOZMA by intravenous use is indicated for the
treatment of pediatric patients with:
. . .
- Severe or life-threatening
CAR T cell-induced cytokine release syndrome (CRS) in patients 2 years of age
and older.
. . .
The safety and effectiveness of AVTOZMA in pediatric
patients with conditions other than PJIA, SJIA or CRS have not
been established. The safety and effectiveness in pediatric patients below the
age of 2 have not been established in PJIA, SJIA or CRS.
. . .
Cytokine Release Syndrome – Intravenous Use
In the retrospective analysis of pooled outcome data
for patients treated with tocilizumab for CAR T cell-induced CRS, 25 patients
were children (2 years up to 12 years of age), and 17 patients were adolescents
(12 years up to 18 years of age). There were no differences between the
pediatric patients and the adults for safety or efficacy.
8.5 Geriatric Use
Additions and/or
revisions underlined:
. . .
Clinical studies that included tocilizumab for CRS
did not include sufficient numbers of patients aged 65 and over to determine
whether they respond differently from younger patients.
. . .
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
.
. .
What is AVTOZMA?
.
. .
- To treat people age 2 years and above who experience
severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric
antigen receptor (CAR) T cell treatment.
.
. .
How will I receive
AVTOZMA?
Into a vein (IV or
intravenous infusion) for Rheumatoid Arthritis, Giant Cell Arteritis, PJIA,
SJIA, CRS or COVID- 19:
.
. .
For CRS you will receive a single dose of AVTOZMA, and
if needed, additional doses.
.
. .
Get Email Alerts |
Guide
