Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Severe and Fatal
Immune-Mediated Adverse Reactions
Additions and/or
revisions underlined:
…
Other: Myocarditis-Myositis-Myasthenia Gravis
(or Myasthenia-Like) Overlap
Syndrome, reported as the co-occurrence of either two or all three
adverse reactions.
6
Adverse Reactions
6.1 Clinical
Trials Experience
Extensive changes; please refer to label for
complete information
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or
revisions underlined:
…
TEVIMBRA in Combination with Zanidatamab-hrii and Chemotherapy
Of the 302 patients who received
TEVIMBRA in combination with zanidatamab-hrii and chemotherapy for GEA, there
were 139 (46%)
patients 65 years of age and older,
106 (35%) were 65 to 74 years old, and 33 (11%) were 75 years and
older.
There was a higher incidence of Grade greater than or
equal to 3 adverse reactions observed
in patients 65 years of age and older (87%) as compared to younger patients (80%). The incidence of
Grade 3 or 4 diarrhea was higher in patients 65 years and older (32%) compared
to patients younger than 65 years (20%). There was an increased incidence of fatal
adverse reactions in patients 65 years and older
(4.4%), including acute kidney injury (N=2), cardiac failure, dehydration,
hypovolemic shock and intestinal obstruction (all N=1), compared to younger
patients (0.6%), including diarrhea (N=1).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
What is TEVIMBRA?
TEVIMBRA
is a prescription medicine used to treat adults with:
…
cancer of the stomach
(gastric cancer), or cancer
where the esophagus
joins the stomach
(gastroesophageal junction cancer), or of the tube that connects your
throat to your stomach (esophageal cancer).
TEVIMBRA may be used in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing
chemotherapy as your first treatment when your gastric, gastroesophageal, or
esophageal adenocarcinoma:
cannot be removed with surgery or has spread to other
parts of the body (metastatic), and
is
human epidermal growth
factor receptor 2 (HER2)-positive (IHC 3+ or IHC 2+/ISH+). You should also read the
Medication Guide that comes with zanidatamab-hrii.
…
The most common side effects of TEVIMBRA in combination with zanidatamab-hrii and fluoropyrimidine and platinum -based chemotherapy include:
diarrhea
decreased white blood cell count
decreased platelet count
nausea
numbness, pain, tingling,
or burning in your hands or feet
decreased red blood cell count (anemia)
decreased potassium in your blood
infusion reactions
decreased appetite
tiredness
increase in certain
liver blood tests
vomiting
rash
…
Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
How will I receive
TEVIMBRA?
Your healthcare provider
will give you TEVIMBRA into your vein through an intravenous (IV) line over 30 to 120
minutes depending on the dose you are receiving.
TEVIMBRA is usually given every 2, 3, 4, or 6
weeks depending on the dose you are
receiving.
Your healthcare provider will decide
how many treatments you need.
Your healthcare provider will do blood tests to check you for certain side effects.
If you miss any appointment, call your healthcare provider as soon as possible
to reschedule your appointment.
…
Approved Drug Label (PDF)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or
revisions underlined:
…
How will I receive
TEVIMBRA?
Your healthcare provider
will give you TEVIMBRA into your vein through an intravenous (IV) line over 30 to 120
minutes depending on the dose you are receiving.
TEVIMBRA is usually given every 2, 3, 4, or 6
weeks depending on the dose you are
receiving.
Your healthcare provider will decide
how many treatments you need.
Your healthcare provider will do blood tests to check you for certain side effects.
If you miss any appointment, call your healthcare provider as soon as possible
to reschedule your appointment.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Severe and Fatal Immune-Mediated Adverse Reactions
Extensive
changes; please refer to label for complete information
6
Adverse Reactions
6.2 Postmarketing Experience
Newly
added section
The
following adverse reactions have been identified during postapproval use of
TEVIMBRA. 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.
Skin and subcutaneous
tissue disorders: Stevens-Johnson
syndrome, toxic epidermal necrolysis (including fatal cases).
Immune system disorders:
Immune-mediated
cystitis.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Severe and Fatal Immune-Mediated Adverse Reactions
Extensive additions and/or
revisions, please refer to label for complete information.
5.2 Infusion-Related Reactions
Additions and/or revisions underlined:
TEVIMBRA can cause severe
or life-threatening infusion-related reactions. Infusion-related reactions occurred
in 5% (99/1972) patients receiving TEVIMBRA, including Grade 3 or higher
(0.2%) reactions. Monitor patients for signs and symptoms of infusion-related
reactions.
…
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive additions and revisions, please refer to label for complete
information.
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or revisions underlined:
TEVIMBRA as a Single Agent
Of the 255 patients who were treated with TEVIMBRA
for previously treated unresectable or metastatic ESCC in the clinical study
RATIONALE-302, 98 (38%) were 65 years and older and 13 (5%) were 75 years
and older. No overall differences in safety or effectiveness were observed between
elderly patients and younger patients.
TEVIMBRA in Combination with Chemotherapy
Of
the 324 patients who were treated with TEVIMBRA and platinum-containing
chemotherapy as first-line treatment for unresectable advanced or metastatic ESCC
in the clinical study RATIONALE-306, 149 (46%) were 65 years and older and 13
(4%) were 75 years and older. No overall differences in safety or effectiveness
were observed between elderly patients and younger patients.
Of
the 498 patients who were treated with TEVIMBRA in combination with platinum-containing
chemotherapy for G/GEJ adenocarcinoma in the clinical study RATIONALE-305, 161
(32%) were 65 years and older, and 28 (6%) were 75 years and older. No overall
differences in safety or effectiveness were observed between elderly patients
and younger patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What is TEVIMBRA?
TEVIMBRA
is a prescription medicine used to treat adults with:
cancer
of the tube that connects your throat to your stomach (esophageal cancer).
cancer of the stomach (gastric cancer) or cancer where
the esophagus joins the stomach (gastroesophageal junction cancer).
decreased white blood cell count
tiredness
increase in certain kidney blood tests
decreased salt (sodium) in your blood
decreased appetite
increase in certain liver blood tests
decreased calcium in your blood
increased glucose in your blood tests
diarrhea
decreased red blood cell count
decreased potassium in your blood
mouth sores (anemia)
vomiting
The most common side
effects of TEVIMBRA when used alone include:
increased blood sugar
decreased albumin in the blood
muscle and bone pain
decreased red blood cell (anemia) and white blood cell
counts
increase in certain liver blood tests
decreased weight
tiredness
Cough
decreased salt (sodium) in your blood
The most common side
effects of TEVIMBRA in combination with platinum and fluoropyrimidine-based
chemotherapy include:
nausea
vomiting
diarrhea
tiredness
decreased platelet count
stomach-area (abdominal) pain
decreased appetite
decreased white blood cell count
decreased weight
decreased red blood cell count
increase in certain liver blood tests
fever (anemia)
numbness, pain, tingling, or burning in your hands or feet
These
are not all the possible side effects of TEVIMBRA.
Call
your doctor for medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.
…
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