Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
…
Reported infections include:
- Active tuberculosis, which may present
with pulmonary or extrapulmonary disease.
Patients, except those
with COVID-19, should be tested
for latent tuberculosis before TYENNE use and during therapy. Treatment for
latent infection should be initiated
prior to TYENNE use.
…
5
Warnings and Precautions
5.1 Serious
Infections
Additions and/or
revisions underlined:
…
COVID-19
In patients
with COVID-19, monitor for signs and symptoms of new infections during and
after treatment with TYENNE. There is limited information regarding the use of tocilizumab products in patients
with COVID-19 and concomitant active serious infections.
The risks and benefits of treatment with TYENNE in COVID-19 patients with other
concurrent infections should be considered.
Tuberculosis
Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TYENNE. In patients with COVID-19, testing for
latent infection is not necessary prior to initiating treatment with TYENNE.
…
5.3 Hepatotoxicity
Additions and/or revisions
underlined:
…
Patients hospitalized with COVID-19 may have elevated ALT or AST levels. Multi-organ failure with involvement of the liver is recognized as a complication of severe
COVID-19. The decision to administer TYENNE should balance the potential benefit
of treating COVID-19
against the potential
risks of acute treatment with TYENNE. It is not recommended to initiate TYENNE
treatment in COVID-19
patients with elevated
ALT or AST above 10 x
ULN. Monitor ALT and AST during treatment.
…
5.4
Changes in Laboratory Parameters
Additions and/or
revisions underlined:
Patients with Rheumatoid Arthritis, Giant Cell Arteritis and Coronavirus Disease
2019
…
Neutropenia
…
…
…
6
Adverse Reactions
6.9 Clinical Trials Experience in Patients with
Cytokine Release Syndrome Treated with Intravenous Tocilizumab (tocilizumab-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 (14.10)].
6.10 Clinical Trials Experience in COVID-19
Patients Treated with Intravenous Tocilizumab (tocilizumab-IV)
Newly added
subsection
Extensive
changes; please refer to label for complete information
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
TYENNE 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.
…
The safety and
effectiveness of TYENNE 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:
Of the 2644 patients
who received tocilizumab in Studies I to V [see Clinical Studies
(14)], a total of 435 rheumatoid arthritis
patients were 65 years of age and older, including 50 patients 75 years and older. Of the
1069 patients who received tocilizumab-SC in studies SC-I and SC-II there were
295 patients 65 years of age and older, including
41 patients 75 years and older. The frequency of serious infection
among tocilizumab treated subjects 65 years of age and older
was higher than those under the age of 65. As there is a higher incidence of infections
in the elderly population in general, caution should be used when treating the
elderly.
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.
In the EMPACTA, COVACTA,
and REMDACTA studies,
of the 974 COVID-19 patients
in the tocilizumab arm, 375
(39%) were 65 years of age or older. No overall differences in safety or
effectiveness of tocilizumab were
observed between patients 65 years of age and older and those under the age of
65 years of age in these studies [see
Adverse Reactions (6.1) and Clinical Studies (14.11)].
In the
RECOVERY study, of the 2022 COVID-19 patients in the tocilizumab arm, 930 (46%) were 65 years of age or
older. No overall differences in effectiveness of tocilizumab were observed between patients 65 years
of age and older and those under the age 65 years of age in this study [see Clinical Studies (14.11)].
1 Ravelli A, Minoia F, Davì S on behalf of the Paediatric
Rheumatology International Trials Organisation, the Childhood Arthritis and Rheumatology Research Alliance, the
Pediatric Rheumatology Collaborative Study
Group, and the Histiocyte Society, et al.
2016 Classification Criteria for Macrophage Activation Syndrome
Complicating Systemic Juvenile Idiopathic Arthritis. Annals of the Rheumatic
Diseases 2016;75:481-489.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
What is the most important information I should know about TYENNE?
TYENNE can cause serious
side effects including:
Serious Infections. TYENNE is a medicine that affects your immune system.
TYENNE can lower the ability
of your immune system to fight
infections. Some people
have serious infections while taking TYENNE, 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 TYENNE
(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 TYENNE.
…
What is TYENNE?
TYENNE
is a prescription medicine called
an Interleukin-6 (IL-6)
receptor antagonist. TYENNE
is used:
To treat adults
with moderately to severely active
rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used
and did not work well.
To treat adults with giant cell arteritis (GCA).
To treat people with active PJIA ages 2 and above.
To treat people with active SJIA ages 2 and above.
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.
To
treat hospitalized adults
with coronavirus disease
2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or
mechanical ventilation.
TYENNE is not approved for subcutaneous use in people
with CRS or COVID-19.
It is not known if TYENNE
is safe and effective in children with PJIA, SJIA or CRS under 2 years of age or in children
with conditions other than PJIA, SJIA or CRS.
…
How will I receive
TYENNE?
Into a vein (IV or intravenous infusion) for Rheumatoid Arthritis, Giant Cell Arteritis, PJIA, SJIA, CRS, or COVID-19:
If your healthcare provider
prescribes TYENNE as an IV infusion, you will receive
TYENNE from a healthcare
provider through a needle placed
in a vein in your arm. The infusion will take about 1 hour to give you the full
dose of medicine.
For rheumatoid arthritis, giant cell arteritis or PJIA you will receive
a dose of TYENNE about every 4 weeks.
For SJIA you will receive a dose of TYENNE about every 2 weeks.
For CRS you will receive
a single dose of TYENNE,
and if needed, additional doses.
For COVID-19, you will receive
a single dose of TYENNE,
and if needed one additional dose.
While taking TYENNE,
you may continue
to use other medicines that help treat
your rheumatoid arthritis, PJIA, SJIA, or COVID-19 such as methotrexate,
non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Gastrointestinal Perforations
Additions and revisions underlined:
Events of gastrointestinal
perforation have been reported in clinical trials, primarily as complications
of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution
in patients who may be at increased risk for gastrointestinal perforation.
Promptly evaluate patients presenting with fever, new onset abdominal
symptoms, and a change in bowel habits for early identification of
gastrointestinal perforation [see Adverse
Reactions (6.1)].
8
Use in Specific Populations
8.1 Pregnancy
Additions and revisions underlined:
Risk Summary
The available
data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study,
pharmacovigilance, and published
literature are insufficient to draw conclusions about a drug-associated risk of major birth
defects, miscarriage, or other adverse maternal
or fetal outcomes.
These studies had methodological
limitations, including small sample size of tocilizumab exposed groups, missing
exposure and outcomes information, and lack of adjustment for cofounders.
.
. .
Disease-associated Maternal Risk
Published data suggest that the
risk of adverse pregnancy outcomes in women with rheumatoid arthritis is associated
with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of
gestation), low birth weight (less than 2500 g) infants, and small for
gestational age at birth.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide
Additions and revisions underlined:
Your healthcare provider should
monitor you closely
for signs and symptoms of TB during and after treatment with TYENNE.
. . .
- Tell your healthcare provider right away if you have fever and new
onset stomach-area pain that does not go away, and a change in your bowel habits.
PATIENT COUNSELING INFORMATION
Additions and revisions underlined:
. . .
Inform patients that some patients
who have been treated with TYENNE have had serious side effects in the stomach and intestines [see Warnings
and Precautions (5.2)]. Instruct the patient
of the importance of contacting their doctor immediately when symptoms of fever, severe,
persistent abdominal pain,
and change in bowel habits appear to assure rapid
evaluation and appropriate treatment.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.6 Hypersensitivity Reactions, Including Anaphylaxis
Additions and/or revisions underlined:
…
In the postmarketing
setting, events of hypersensitivity reactions, including anaphylaxis and death
have occurred in patients treated with a range of doses of intravenous
tocilizumab products, with or without concomitant therapies. Events have
occurred in patients who received premedication. Hypersensitivity, including
anaphylaxis events, have occurred both with and without previous
hypersensitivity reactions and as early as the first infusion of tocilizumab
products. In addition, serious cutaneous reactions, including Drug Reaction
with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients
with autoinflammatory conditions treated with tocilizumab products.
TYENNE for intravenous
use should only be infused by a healthcare professional with appropriate
medical support to manage anaphylaxis. For TYENNE subcutaneous injection,
advise patients to seek immediate medical attention if they experience any
symptoms of a hypersensitivity reaction. If a hypersensitivity reaction occurs, immediately discontinue TYENNE; treat
promptly and monitor until signs and symptoms resolve.
6
Adverse Reactions
6.9 Postmarketing Experience
Additions and/or revisions underlined:
…
Hypersensitivity Reactions: Fatal anaphylaxis, Stevens-Johnson Syndrome, Drug Reaction with
Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.6)]
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Hypersensitivity and Serious Allergic Reactions
Inform
patients that some patients who have been treated with TYENNE have developed
serious allergic reactions, including anaphylaxis and serious skin reactions
[see Warnings and Precautions (5.6)].
Advise patients to stop taking TYENNE and seek immediate medical attention if
they experience any symptom of serious allergic reactions (including rash,
hives, and swelling of the face, lips, tongue, and throat that may cause
difficulty in breathing or swallowing).…
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What are the
possible side effects with TYENNE?
TYENNE can cause
serious side effects, including:
…
Serious Allergic
Reactions. Serious
allergic reactions, including death, can happen with TYENNE. These reactions
can happen with any infusion or injection of TYENNE, even if they did not occur
with an earlier infusion or injection. Stop taking TYENNE, contact your
healthcare provider, and get emergency help right away if you have any
of the following signs of a serious allergic reaction:
trouble
breathing
swelling
of your mouth, lips, tongue, or face
wheezing
severe
itching
skin rash, hives, redness, or swelling outside of the
injection site area
dizziness or fainting
fast heartbeat or pounding in your chest
(tachycardia)
sweating
…
Tell your healthcare provider about any
side effect that bothers you or does not go away. These are not all the
possible side effects of TYENNE. For more information, ask your healthcare
provider or pharmacist.
…
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