Classes
DEA Class; Rx
Common Brand Names; Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, trastuzumab-dkst, trastuzumab-pkrb, trastuzumab-dttb, trastuzumab-qyyp, trastuzumab-anns
- Antineoplastics, Anti-HER2;
- Antineoplastics, Monoclonal Antibody
Description
Recombinant DNA-derived humanized IgG1 kappa monoclonal antibody against the HER2 protein
Used for breast and gastric cancers that overexpress HER2
Monitor left ventricular ejection fraction in all patients before, during, and after treatment; also watch for infusion-related reactions
Indications
Breast Cancer
Adjuvant treatment
- Indicated for adjuvant treatment of HER-2 overexpressing breast cancer
Metastatic breast cancer
- Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti
- Indicated for HER2-overexpressing metastatic breast cancer as first-line treatment in combination with paclitaxel OR as a single agent for patients who have received 1 or more chemotherapy regimens for metastatic disease
Indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease
Contraindications
Hypersensitivity to drug/class/component or hamster protein
Adverse Effects
- Pain (47%)
- Asthenia (42%)
- Fever (36%)
- Nausea (33%)
- Chills (32%)
- Cough (26%)
- Headache (26%)
- Diarrhea (25%)
- Vomiting (23%)
- Abdominal pain (22%)
- Back pain (22%)
- Dyspnea (22%)
- Infection (20%)
- Rash (18%)
- Anorexia (14%)
- Insomnia (14%)
- Dizziness (13%)
Warnings
Use extreme caution in cardiac disease, cardiotoxic agent history, ejection fraction decrease, pulmonary disease, elderly (see Black Box Warnings)
Verify pregnancy status of females of reproductive potential prior to the initiation of therapy (see Pregnancy)
CHF: At a median follow-up duration of 8 yr, the incidence of severe CHF (NYHA III and IV) was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%
Exposure to trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm; females of reproductive potential should use effective contraception during treatment and for 7 months following last dose of trastuzumab
Tumor lysis syndrome (TLS) reported; patients with significant tumor burden (eg, bulky metastases) may be at a higher risk; patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS; providers should consider additional monitoring and/or treatment as clinically indicated
Pregnancy and Lactation
May cause fetal harm when administered to a pregnant woman
In postmarketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death
Advise patient of the potential risks to a fetus
No information regarding the presence of trastuzumab in human milk, the effects on breastfed infants, or the effects on milk production
Maximum Dosage
Every-3-week dosing: 8 mg/kg IV initially, then 6 mg/kg IV every 3 weeks.
Weekly dosing: 4 mg/kg IV initially, then 2 mg/kg IV every 2 weeks.
Every-3-week dosing: 8 mg/kg IV initially, then 6 mg/kg IV every 3 weeks.
Weekly dosing: 4 mg/kg IV initially, then 2 mg/kg IV every 2 weeks.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Trastuzumab
injection, powder for reconstitution
- 150mg/single-dose vial (Herceptin, Ontruzant)
- 420mg/multidose vial (Herceptin, Ogivri, Herzuma, Trazimera, Kanjinti, Ontruzant)
Biosimilars to Herceptin
- Ogivri (trastuzumab-dkst)
- Herzuma (trastuzumab-pkrb)
- Ontruzant (trastuzumab-dttb)
- Trazimera (trastuzumab-qyyp)
- Kanjinti (trastuzumab-anns)
