• HER2-overexpressing metastatic gastric or gastroesophageal adenocarcinoma in patients who have not received prior treatment for metastatic disease (in combination with cisplatin and capecitabine or 5-fluorouracil).
• HER2-overexpressing node-positive or node-negative breast cancer (as part of one of the following regimens: doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or docetaxel and carboplatin) (as adjuvant therapy).
• HER2-overexpressing node-positive or node-negative breast cancer (to be used alone after multi-modality anthracycline-based therapy) (as adjuvant therapy).
• HER2-overexpressing metastatic breast cancer (as first-line therapy) (in combination with paclitaxel).
• HER2-overexpressing metastatic breast cancer in patients who have already received ≥1 other chemotherapy regimens for metastatic disease (as monotherapy).

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Pre-existing pulmonary conditions
• Hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or other components of the product
• Hypersensitivity to benzyl alcohol (use sterile water for injection instead of bacteriostatic water, which accompanies the vial)
• Rep: Women of reproductive potential
• Pedi: Safety not established in children
• Geri: Older adults may have ↑ risk of cardiotoxicity.

Exercise Extreme Caution in:

• Patients with pre-existing cardiac dysfunction.

CV: ARRHYTHMIAS, HF, hypertension, tachycardia.

Derm: rash, acne, herpes simplex.

EENT: pharyngitis, rhinitis, sinusitis.

F and E: edema.

GI: abdominal pain, anorexia, diarrhea, nausea, vomiting.

Hemat: anemia, leukopenia.

MS: pain, arthralgia, bone pain.

Neuro: depression, dizziness, headache, insomnia, neuropathy, paresthesia, peripheral neuritis, weakness.

Resp: cough, dyspnea, INTERSTITIAL PNEUMONITIS, PULMONARY EDEMA, PULMONARY FIBROSIS.

Misc: chills, fever, infection, flu-like syndrome, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Concurrent use of anthracyclines, including daunorubicin, doxorubicin, or idarubicin, may ↑ risk of cardiotoxicity.
• Paclitaxel may ↑ levels and risk of toxicity.

• Lyophilized powder for injection: 150 mg/vial; 420 mg/vial;

Adjuvant Treatment of Breast Cancer

• IV (Adults): During and following paclitaxel, docetaxel, or docetaxel/carboplatin: 4 mg/kg initially, then 2 mg/kg once weekly during chemotherapy for the first 12 wk (paclitaxel or docetaxel) or 18 wk (docetaxel/carboplatin); 1 wk after the last weekly dose, give 6 mg/kg every 3 wk. Do not exceed treatment duration of 1 yr; As single agent within 3 wk following completion of multi-modality, anthracycline-based chemotherapy regimens: 8 mg/kg initially, then 6 mg/kg every 3 wk. Do not exceed treatment duration of 1 yr.

Metastatic Breast Cancer

• IV (Adults): 4 mg/kg initially, then 2 mg/kg once weekly until disease progression.

Metastatic Gastric Cancer

• IV (Adults): 8 mg/kg initially, then 6 mg/kg every 3 wk until disease progression.

Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera

• A monoclonal antibody that binds to HER2 sites in breast cancer tissue and inhibits proliferation of cells that overexpress HER2 protein.

• Regression of breast, gastric, or gastroesophageal cancer and metastases.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

(plasma concentrations)

• Explain purpose of trastuzumab to patient.
• Instruct patient to notify health care professional promptly if new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hr, dizziness or loss of consciousness occur. Caution patient to avoid crowds and persons with known infections.
• Advise patient not to receive any vaccinations without advice of health care professional.
• Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional immediately if pregnancy is planned or suspected or if breastfeeding. Caution patient to use effective contraception during and for 7 mo following last dose. Monitor infants exposed to trastuzumab for oligohydramnios, pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise women who are breastfeeding to discontinue nursing or discontinue trastuzumab. Encourage women who may be exposed during pregnancy to report exposure to the Genentech Adverse Event Line at 1-888-835-2555.

traz-TOO-zoo-mab

NDC Code^*

• 50242- Genentech, Inc.
  • 50242-132- Herceptin
    • 50242-132-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-01) > 15 mL in 1 VIAL, SINGLE-DOSE

• 50242- Genentech, Inc.
  • 50242-132- Herceptin
    • 50242-132-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-10) > 15 mL in 1 VIAL, SINGLE-DOSE

• 50242- Genentech, Inc.
  • 50242-134- Herceptin
    • 50242-134-68- 1 KIT in 1 CARTON (50242-134-68) * 20 mL in 1 VIAL, MULTI-DOSE * 20 mL in 1 VIAL

• 50242- Genentech, Inc.
  • 50242-333- Herceptin
    • 50242-333-01- 1 KIT in 1 CARTON (50242-333-01) * 20 mL in 1 VIAL, MULTI-DOSE * 20 mL in 1 VIAL

• 67457- Mylan Institutional LLC
  • 67457-847- OGIVRI
    • 67457-847-44- 1 KIT in 1 CARTON (67457-847-44) * 20 mL in 1 VIAL, MULTI-DOSE (67457-845-50) * 20 mL in 1 VIAL (67457-846-20)

• 67457- Mylan Institutional LLC
  • 67457-991- OGIVRI
    • 67457-991-15- 1 VIAL in 1 CARTON (67457-991-15) > 15 mL in 1 VIAL