Important Safety Information
Boxed WARNINGS: Cardiomyopathy- Trastuzumab products administration can result in sub-clinical and clinical
cardiac
failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing
chemotherapy regimens
Infusion Reactions; Pulmonary Toxicity- Trastuzumab products administration can result in serious and fatal
infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration.
Interrupt KANJINTI® infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms
completely resolve. Discontinue KANJINTI® for anaphylaxis, angioedema, interstitial pneumonitis, or acute
respiratory distress syndrome
Embryo-Fetal Toxicity- Exposure to trastuzumab products during pregnancy can result in oligohydramnios and
oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities,
and neonatal death. Advise patients of these risks and the need for effective contraception
Additional Important Safety Information
Cardiomyopathy
-
Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The
incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing
chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of
cardiomyopathy
-
Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling
cardiac failure, cardiomyopathy, and cardiac death
-
Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF)
-
Discontinue KANJINTI® treatment in patients receiving adjuvant breast cancer therapy and withhold KANJINTI® in
patients with metastatic disease for clinically significant decrease in left ventricular function
Cardiac Monitoring
-
Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also
evaluate cardiac function after completion of KANJINTI®
-
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by
echocardiogram or MUGA scan
-
Monitor frequently for decreased left ventricular function during and after KANJINTI® treatment
-
Monitor more frequently if KANJINTI® is withheld for significant left ventricular cardiac dysfunction
Infusion Reactions
-
KANJINTI® administration can result in serious and fatal infusion reactions
-
Symptoms usually occur during or within 24 hours of KANJINTI® administration
-
Interrupt KANJINTI® infusion for dyspnea or clinically significant hypotension
-
Monitor patients until symptoms completely resolve
-
Discontinue KANJINTI® for infusion reactions manifesting as anaphylaxis, angioedema, interstitial
pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all
patients with severe infusion reactions
-
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include
nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and
asthenia
Embryo-Fetal Toxicity
-
Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios
sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of
these risks and the need for effective contraception
-
Verify the pregnancy status of females of reproductive potential prior to the initiation of KANJINTI®
-
Advise pregnant women and females of reproductive potential that exposure to KANJINTI® during pregnancy or
within 7 months prior to conception can result in fetal harm
-
Advise females of reproductive potential to use effective contraception during treatment and for at least 7
months following the last dose of KANJINTI®. Advise female patients to contact their healthcare provider with a
known or suspected pregnancy
-
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for
KANJINTI® treatment and any potential adverse effects on the breastfed child from KANJINTI® or from the
underlying maternal condition
Pulmonary Toxicity
-
Trastuzumab products can result in serious and fatal pulmonary toxicity, which includes
dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema,
pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events
can occur as sequelae of infusion reactions
-
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in
dyspnea at rest, appear to have more severe toxicity
-
Discontinue KANJINTI® in patients experiencing pulmonary toxicity
Exacerbation of Chemotherapy-Induced
Neutropenia
-
In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of
febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive
chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar
among patients who received trastuzumab and those who did not
Most Common Adverse Reactions
-
The most common adverse reactions associated with trastuzumab products in breast cancer were fever, nausea,
vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash,
neutropenia, anemia, and myalgia
-
The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were
neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever,
thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at
1-800-772-6436.
Indications
Adjuvant Breast Cancer
KANJINTI® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative
or with one high-risk feature*) breast cancer:
-
As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
-
As part of treatment with docetaxel and carboplatin
-
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab product.
*High-risk is defined as ER/PR positive with one of the following features: tumor size > 2 cm, age
<
35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
KANJINTI® is indicated:
-
In combination with paclitaxel for the first line treatment of
HER2-overexpressing metastatic breast cancer
-
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or
more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab product.
Metastatic Gastric Cancer
KANJINTI® is indicated, in combination with cisplatin and capecitabine or
5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal
junction adenocarcinoma, who have
not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab product.
Herceptin® (trastuzumab) is a registered trademark of Genentech USA, Inc.
Please see full Prescribing Information, including Boxed WARNINGS.