orally twice daily (total daily dose 2000 mg/m²) for 14 days of each 21 day
anti-human antibody (HAHA) to Herceptin was detected in one patient using an
initiation of paclitaxel and then at a dose of 2 mg/kg weekly for a total of 52
analysis. overexpression and HER2 gene amplification is available at:
mg/mL trastuzumab that delivers 7.15 mL (150 mg trastuzumab), at a pH of
infection (24.0% vs. 12.8%), hot flashes (17.1% vs. 15.0%), anemia (12.3% vs.
In post-marketing reports, serious and fatal infusion
mm Hg or diastolic > 100 mm Hg) were not eligible. Herceptin can cause embryo-fetal harm when administered
following non-cardiac adverse reactions of Grade 2-5 occurred at an
of cancer or condition being treated. doses may be given over 30 minutes.
potential prior to the initiation of Herceptin. were Asian. cyclophosphamide followed by paclitaxel (AC→paclitaxel) alone or
include nausea, vomiting, pain (in some cases at tumor sites), rigors,
health care provider if you experience any unusual symptoms.
medication, clinically significant valvular heart disease, evidence of
chemotherapy as compared to chemotherapy alone: arthralgia (12.2% vs. 9.1%), nail
years), 86% were White, 3% were Black, 3% were Asian, and 8% in other
In the subgroup
Herceptin after 24 hours. The incidences of NCI-CTC Grade 3-4 infection were similar
observed only in patients with disease limited to skin and lymph nodes. 0.56, 0.80). underwent primary surgery for breast cancer.
The data below are based on the exposure of 294 patients
junction adenocarcinoma (Study 7).
last dose of Herceptin [see Use In Specific Populations and CLINICAL
Cisplatin was administered
to Herceptin in combination with a fluoropyrimidine (capecitabine or 5-FU) and
The highest absolute incidence occurs when Herceptin is administered
observed.
the vial labels to ensure that the drug being prepared and administered is
Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. reactions was required in < 1% of patients. (Incidence > 1% between Arms) and Higher Incidence in Herceptin Arm.
but does not enter the neonatal and infant circulation in substantial amounts. 60 mg/m² or epirubicin 75 mg/m² plus 600 mg/m² cyclophosphamide every 21 days
(543) were ER- and PgR-, and 47% (512) were ER and/or PgR+ and had
in response to an antigen (such as a protein in a germ) entering the body. disease with at least one of the following high-risk features: ER/PR-negative,
greater than 2 cm, Grade 2-3, or age < 35 years.
On both study arms cisplatin was
Such events can occur as sequelae of infusion reactions [see Infusion Reactions]. Of patients receiving Herceptin as a single agent for the treatment of
three-weekly Herceptin treatment versus observation in patients with HER2
Malignant heart cancer is extremely rare.
Some cancerous breast tissue
FDA-approved tests specifically for gastric cancers due to differences in
Pain that is unrelieved by prescribed medication. National Dose Banding Table – Trastuzumab IV . Herceptin may also be at increased risk of cardiac dysfunction [see DRUG
(Studies 1 and 2) who developed congestive heart failure, one patient died of
menstrual cycle duration and female sex hormone levels.
≤ 15%. (n = 1866), the OS hazard ratio was 0.63 (95% CI: 0.51, 0.78).
experienced a significantly longer median time to disease progression, a higher
arm. You are encouraged to report negative side effects of prescription drugs to the FDA.
by 6 mg/kg every 21 days until disease progression. patients within each of the following subgroups to determine if the treatment
Limitations in data collection and differences in
surgery, and at least four cycles of chemotherapy to receive no additional
absolute decrease in LVEF from pretreatment values. The side effects of Trastuzumab and their severity depend on whether the drug is
metastatic breast cancer, 25% experienced diarrhea. AC→TH arm is presented in Figure 4, and the duration of OS after a median
are clinical considerations if Herceptin is used in a pregnant woman or if a
reactions requiring interruption or discontinuation of Herceptin treatment
paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion
Injection, USP, should be stored at 2°C to 8°C (36°F to 46°F) for no more than
Verify the pregnancy status of females of reproductive
Studies 1 and 2, Study 3, and Study 4 and OS results for the integrated
In randomized controlled clinical trials, the overall
experience. clearly needed). trastuzumab in human milk, the effects on the breastfed infant, or the effects
LVEF value below 50% with a ≥10% absolute decrease in LVEF from pretreatment
particulate matter and discoloration prior to administration, whenever solution
The most common adverse reactions which resulted in discontinuation
within 7 months prior to conception for oligohydramnios. Other signs and/or symptoms may
Exposures (Median with 5th -95th Percentiles) in Breast Cancer and MGC Patients. approximately 33% and 25%, respectively, of those present in the maternal serum
extending Herceptin treatment for a duration of two years did not show
or 3+ positive tumors were eligible (about 33% of those screened).
Note: If a drug has been approved for one use, physicians may elect to use
Herceptin with the incidence of antibodies to other products may be misleading. part of an adjuvant treatment regimen from 2124 patients receiving at least one
It is tailor-made precision medicine with least side effects. chemotherapy alone arm, the incidence of NCI-CTC Grade 3/4 neutropenia was
Trastuzumab, to monitor side effects and check your response to therapy.
effect was different from that of the overall patient population: patients with
Sudden weight gain. Of
arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and
But if you should experience nausea, take
trastuzumab, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl
86.9% in the AC→TH arm and 79.4% in the AC→T arm.
progression [see, Decrease the rate of infusion for mild or moderate
The
HER2
Patients were treated with a
Store Herceptin vials in the refrigerator at 2°C to 8°C
in patients with Herceptin-induced left ventricular cardiac dysfunction has not
fatal infusion reactions and pulmonary toxicity. respectively.
and 66% high grade pathology, and 53% ER+ and/or PR+ tumors. overexpress HER2.
Among these
diluent into the vial containing the lyophilized powder of Herceptin, which has
Note: We strongly encourage you to talk with your health care professional
demonstrate significant effects on DFS in the IHC 3+/FISH unknown and the
Advise females of reproductive potential to use effective
Reactions of All Grades (Incidence ≥ 5% between Arms) or Grade 3/4
and 3, where central laboratory testing data were available.
of adjuvant breast cancer. patients receiving Herceptin compared with 0.3% of those receiving chemotherapy
pre-(beginning Gestation Day 120) and post-partum (through Post-partum Day 28)
Median duration of Herceptin treatment
Herceptin at 2 mg/kg.
No evidence of mutagenic activity was observed when
Visit the FDA MedWatch website or call 1-800-FDA-1088. epidermal growth factor receptor.
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