IC SYSTEM DISORDERS
Anemia* 8 < 1
Table 4
Adverse Reactions* (≥ 5% Incidence) Reported in SafeHER
Adverse Reactions *,†
HERCEPTIN HYLECTA
600 mg (once every 3 weeks)
n=1864
All Grades
%
Grades 3 to 5
%
Neutropenia 6 4
PSYCHIATRIC DISORDERS
Insomnia* 7 < 1 * Contains grouped terms
† Includes adverse reactions reported throughout study treatment and follow-up.
‡ ISR includes injection related reaction and injection site joint pain, bruising, dermatitis, discoloration, discomfort, erythema,extravasation, fibrosis, hematoma, hemorrhage, hypersensitivity, induration, inflammation, irritation, macule, mass, nodule, edema,pallor, paresthesia, pruritus, rash, reaction, swelling, ulcer, vesicles and warmth.
Metastatic Breast Cancer (based on intravenous trastuzumab)
The data below reflect exposure to intravenous trastuzumab in one randomized, open-label study, H0648g, ofchemotherapy with (n=235) or without (n=234) intravenous trastuzumab in patients with metastatic breastcancer, and one single-arm study (H0649g; n=222) in patients with metastatic breast cancer. Data in Table 5 are
based on H0648g and H0649g.
Among the 464 patients treated in H0648g, the median age was 52 years (range: 25−77 years). Eighty-ninepercent were white, 5% black, 1% Asian, and 5% other racial/ethnic groups. All patients received 4 mg/kginitial dose of intravenous trastuzumab followed by 2 mg/kg weekly. The percentages of patients who received
intravenous trastuzumab treatment for ≥ 6 months and ≥ 12 months were 58% and 9%, respectively.
Among the 352 patients treated in single agent studies (213 patients from H0649g), the median age was50 years (range 28−86 years), 86% were white, 3% were black, 3%were Asian, and 8% in other racial/ethnicgroups. Most of the patients received 4 mg/kg initial dose of intravenous trastuzumab followed by 2 mg/kgweekly. The percentages of patients who received intravenous trastuzumab treatment for ≥ 6 monthsand ≥ 12 months were 31% and 16%, respectively.
Table 5
Per-Patient Incidence of Adverse Reactions Occurring in ≥ 5% of Patients inUncontrolled Studies or at Increased Incidence in the Intravenous Trastuzumab
Arm (H0648g and H0649g)
Intravenous Intravenous
trastuzumab Paclitaxel trastuzumab
Single agent* + paclitaxel alone + AC† AC† alone
n=352 n=91 n=95 n=143 n=135
Body as a Whole
Pain 47% 61% 62% 57% 42%
Asthenia 42% 62% 57% 54% 55%
Fever 36% 49% 23% 56% 34%
Chills 32% 41% 4% 35% 11%
Headache 26% 36% 28% 44% 31%
Abdominal pain 22% 34% 22% 23% 18%
Back pain 22% 34% 30% 27% 15%
Infection 20% 47% 27% 47% 31%
Flu syndrome 10% 12% 5% 12% 6%
Accidental injury 6% 13% 3% 9% 4%
Allergic reaction 3% 8% 2% 4% 2%
Cardiovascular
Tachycardia 5% 12% 4% 10% 5%
Congestive heart failure 7% 11% 1% 28% 7%
Digestive
Nausea 33% 51% 9% 76% 77%
Diarrhea 25% 45% 29% 45% 26%
Vomiting 23% 37% 28% 53% 49%
Nausea and vomiting 8% 14% 11% 18% 9%
Anorexia 14% 24% 16% 31% 26%
Heme & Lymphatic
Anemia 4% 14% 9% 36% 26%
Leukopenia 3% 24% 17% 52% 34%
Metabolic
Peripheral edema 10% 22% 20% 20% 17%
Edema 8% 10% 8% 11% 5%
Musculoskeletal
Bone pain 7% 24% 18% 7% 7%
Arthralgia 6% 37% 21% 8% 9%
Table 5
Per-Patient Incidence of Adverse Reactions Occurring in ≥ 5% of Patients inUncontrolled Studies or at Increased Incidence in the Intravenous |
