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.
…