Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or
revisions underlined:
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.
Adverse Reactions in Adult and Pediatric Patients
12 Years of Age and Older with Asthma
The safety of TEZSPIRE in asthma was based
on the pooled safety population from PATHWAY and NAVIGATOR, which consists of
665 adult and pediatric patients 12 years of age and older with severe asthma
who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4
weeks. The two placebo-controlled clinical trials were of 52 weeks duration. In
addition, a similar safety profile was seen in a trial that enrolled 150 adult
patients with severe asthma who required treatment with daily oral
corticosteroids [see Clinical Studies (14.1)].
Adverse reactions that occurred at an incidence
greater than or equal to 3% and more common than in the placebo group from the
pooled safety population (PATHWAY and NAVIGATOR) are shown in Table 1.
. . .
Adverse Reactions in Adult Patients with Chronic
Rhinosinusitis with Nasal Polyps
The safety of TEZSPIRE in CRSwNP was based on
WAYPOINT, a randomized, double-blind, parallel group, multicenter,
placebo-controlled trial of 52 weeks duration, which consisted of 203 adult
patients aged 18 years and older on standard of care treatment for CRSwNP who
received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks
[see Clinical
Studies (14.2)].
Adverse reactions that occurred at an incidence
greater than or equal to 3% and more common than in the placebo group from the
safety population (WAYPOINT) are shown in Table 2.
Table 2 Adverse Reactions
with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than
Placebo in Patients with CRSwNP (WAYPOINT)
Newly added table,
please refer to label for complete information.
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
Asthma
The safety and effectiveness of TEZSPIRE for the
add-on maintenance treatment of severe asthma
have been established in pediatric patients aged 12 years and older [see Adverse
Reactions (6.1)
and Clinical
Studies (14.1)]. Use of
TEZSPIRE for this indication is supported by evidence from a total of 82
pediatric patients aged 12 to 17 years enrolled in NAVIGATOR and received
treatment with TEZSPIRE 210 mg subcutaneously every 4 weeks (n=41) or placebo
(n=41). Compared with placebo, improvements in annualized asthma exacerbation
(rate ratio 0.70; 95% CI 0.34, 1.46) and FEV1 (LS mean change versus placebo
0.17 L; 95% CI -0.01, 0.35) were observed in pediatric patients treated with
TEZSPIRE. The safety profile and pharmacodynamic responses in pediatric
patients were generally similar to the overall study population.
The safety and effectiveness of TEZSPIRE
have not been established in patients younger than 12 years of age with
asthma.
CRSwNP
The safety and effectiveness of TEZSPIRE for the
add-on maintenance treatment of inadequately controlled CRSwNP have been
established in pediatric patients aged 12 years and older. Use of TEZSPIRE for
this indication is supported by evidence from the adequate and well-controlled
study of TEZSPIRE in adults (WAYPOINT) [see Clinical
Studies (14.2)]
with the following additional data:
- Pharmacokinetic (PK) data from adult and pediatric
patients aged 12 years and older with severe asthma and adult patients with
CRSwNP [see Clinical Pharmacology (12.3)].
- Safety data in pediatric patients aged 12 years and
older with severe asthma [see Adverse Reactions (6.1)].
The safety and effectiveness of TEZSPIRE have not
been established in patients younger than 12 years of age with CRSwNP.
8.5 Geriatric Use
Additions and/or
revisions underlined:
Asthma
Of the 665 patients with asthma treated with
TEZSPIRE in clinical trials (PATHWAY and
NAVIGATOR) for severe asthma, 119 patients (18%) were 65 years or older. No
overall differences in safety or effectiveness of TEZSPIRE have been observed
between patients 65 years of age and older and younger patients [see Adverse
Reactions (6.1)
and Clinical Studies (14.1)].
CRSwNP
Of the 203 patients with CRSwNP treated with
TEZSPIRE in a clinical trial (WAYPOINT) for CRSwNP, 29 patients (14%) were 65
years or older. No overall differences in safety or effectiveness of TEZSPIRE
have been observed between patients 65 years of age and older and younger adult
patients [see Adverse Reactions (6.1) and Clinical
Studies (14.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or
revisions underlined:
What is TEZSPIRE?
TEZSPIRE is a prescription medicine used:
- with other asthma medicines for the maintenance
treatment of severe asthma in people 12 years of age and older whose asthma is
not controlled with their current asthma medicine.
- with other medicines for the maintenance treatment
of chronic rhinosinusitis with nasal polyps (CRSwNP) in people 12 years of age
and older whose CRSwNP is not controlled with their current CRSwNP medicine.
TEZSPIRE helps:
- prevent severe asthma attacks (exacerbations) and
can improve your breathing.
- reduce the size of your polyps, improve symptoms
i.e. nasal congestion and loss of smell, and reduce the need for oral
corticosteroids and surgery for your nasal polyps.
TEZSPIRE is not used to treat sudden breathing
problems. Tell your healthcare provider if your asthma does not get better or
if it gets worse after you start treatment with TEZSPIRE.
It is not known if TEZSPIRE is safe and effective
in children under 12 years of age for the treatment of asthma.
It is not known if TEZSPIRE is safe and effective
in children under 12 years of age for the treatment of CRSwNP.
. . .
Do not change or stop your other medicines, including
corticosteroid medicines or other asthma medicines unless your healthcare
provider tells you to. This may cause other symptoms that were controlled by
those medicines to come back.
How should I use TEZSPIRE?
. . .
- Do not try to
inject TEZSPIRE until you or your caregiver have been shown the right
way by your healthcare provider.
. . .
The most common side effects of TEZSPIRE include:
- sore throat (pharyngitis)
- joint pain (arthralgia)
- back pain
- common cold symptoms (nasopharyngitis)
- upper respiratory tract infections
- nose bleeds
- flu
- injection site reactions
. . .
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
…
Specific Adverse Reactions
Cardiovascular
EventsIn a randomized, double-blind, long term
extension trial, patients 12 years and older with severe asthma from trials
NAVIGATOR and the additional trial [see Clinical
Studies (14)] received TEZSPIRE 210 mg subcutaneously every 4 weeks or
placebo for up to 104 weeks. In the trial, the incidence rates (IR) per 100
patient-years (PY) for serious cardiac adverse events in patients treated with
TEZSPIRE or placebo were 1.08 and 0.21, respectively, with an incidence rate
difference (IRD) of 0.88 (95% CI: 0.24, 1.53). The types of serious cardiac
adverse events were heterogeneous. In the trial, the IR per 100 PY for
adjudicated major adverse cardiovascular events (MACE, defined as cardiovascular
deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated
with TEZSPIRE or placebo were 0.60 and 0.42, respectively, with an IRD of 0.18
(95% CI: -0.51, 0.75).
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Hypersensitivity Reactions
Additions and/or
revisions underlined:
Hypersensitivity reactions were
observed in the clinical trials (e.g., rash and allergic conjunctivitis)
following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have also been reported [see Contraindications (4) and Adverse Reactions (6)]. These reactions can occur within hours of
administration, but in some instances have a delayed onset (i.e., days). In the
event of a hypersensitivity reaction, consider the benefits and risks for the
individual patient to determine whether to continue or discontinue treatment
with TEZSPIRE.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following
clinically significant adverse
reactions are described
elsewhere in the labeling:
6.1 Clinical Trials Experience
Additions and/or
revisions underlined:
…
Specific Adverse Reaction
Injection Site Reactions
In
the pooled safety population (PATHWAY and NAVIGATOR), in which TEZSPIRE or
placebo was administered using the vial by a healthcare provider, injection
site reactions (e.g., injection site erythema, injection site swelling, injection site pain) occurred
at a rate of 3.3% in patients
treated with TEZSPIRE
compared with 2.7% in patients
treated with placebo.
In an open-label trial of 216 patients with asthma in which TEZSPIRE was
administered by healthcare providers and patients or caregivers using either
the pre-filled pen or pre-filled syringe, injection site reactions (e.g.,
injection site erythema, injection site swelling, injection
site pain) were observed in 5.7% patients
using the pre-filled pen and 0% using
the pre-filled syringe. However, the trial was not designed to compare
injection site reactions between patients who received TEZSPIRE by the
pre-filled pen versus pre-filled syringe.
6.2 Postmarketing Experience
Subsection title
revised
Newly added
information
The following adverse reactions have been identified during post approval
use of TEZSPIRE. 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: anaphylaxis
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient
Information and Instructions for Use).
Hypersensitivity Reactions
Inform patients that hypersensitivity reactions (e.g., anaphylaxis,
rash and allergic conjunctivitis) can occur following administration of
TEZSPIRE [see Contraindications (4) and Adverse
Reactions (6)]. These reactions can occur within hours of administration, but in some instances have a delayed
onset (i.e., days). Instruct patients
to contact their healthcare
provider if they experience symptoms of an allergic reaction [see Warnings
and Precautions (5.1)].
…
Proper Storage and Disposal
Advise patients to refrigerate
TEZSPIRE at 36°F to 46°F (2°C to 8°C). TEZSPIRE may be kept at room temperature
between 68°F to 77?F (20°C to 25°C) for a maximum of 30 days [see How Supplied/Storage
and Handling (16)]. Inform patients and caregivers of the need for proper disposal of the pre-filled pen after use, including the use of a sharps
disposal container.
PATIENT INFORMATION
PATIENT
INFORMATION
Additions and/or
revisions underlined:
…
Do not use TEZSPIRE
if you:
are allergic
to tezepelumab-ekko or
any of the ingredients in TEZSPIRE. See the end of this Patient Information leaflet for a complete list of ingredients in TEZSPIRE.
Before using
TEZSPIRE, tell your healthcare provider
about all of your medical
conditions, including if you:
…
…
How should I use TEZSPIRE?
See the detailed
Instructions for Use that comes with TEZSPIRE
pre-filled pen for information on how to prepare and inject TEZSPIRE.
Use TEZSPIRE exactly
as prescribed by your healthcare provider.
TEZSPIRE is injected
under your skin (subcutaneously) 1 time every 4 weeks.
TEZSPIRE comes in a single-dose vial, in a single-dose pre-filled syringe, and in a single-dose pre-filled pen.
Your healthcare provider
can inject you with TEZSPIRE
in a healthcare setting.
If your healthcare provider
decides that you or a caregiver can give the injections of TEZSPIRE, you or your caregiver
should receive training on the right way to prepare and inject the TEZSPIRE
single dose pre-filled pen.
Do not try to inject TEZSPIRE until you have been shown the right
way by your healthcare provider.
If you
miss a dose, inject a dose as soon as possible. After that, you can continue to
use TEZSPIRE on your usual injection day. If you did not notice that you missed
a dose until it is time for your next
scheduled dose, skip the missed
dose and inject the next scheduled
dose as planned.
Do not inject more than one dose in a day. If you have questions about when to inject TEZSPIRE,
contact your healthcare provider.
What are the
possible side effects of TEZSPIRE? TEZSPIRE may cause serious side effects, including:
allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your TEZSPIRE
injection. Allergic reactions
can sometimes happen
hours or days after you get a dose of TEZSPIRE. Call your healthcare provider or get emergency medical care if you get
any of the following symptoms of allergic reaction:
rash o breathing problems
hives o red, itchy,
swollen, or inflamed
eyes
swelling of your face,
mouth, and tongue o fainting, dizziness, feeling lightheaded
…
General information about the safe and effective
use of TEZSPIRE
Medicines are sometimes prescribed
for purposes other than those listed in a Patient Information leaflet. Do
not use TEZSPIRE for a condition for which it was not prescribed. Do not give
TEZSPIRE to other people, even if they have the same
symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider
for information about TEZSPIRE
that is written for health professionals.
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