Usual Adult Dose for Breast Cancer

Metastatic HER2-Overexpressing Breast Cancer:
Initial dose: 4 mg/kg IV over 90 minutes, alone or with paclitaxel
Maintenance dose: 2 mg/kg IV over 30 minutes once weekly
Duration of therapy: Until disease progression

Comments:

• Do not administer as an IV push or bolus.

Use: In combination with paclitaxel for first line treatment of HER2 overexpressing metastatic breast cancer, OR as a single agent for treatment of HER2 overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Usual Adult Dose for Breast Cancer - Adjuvant

Adjuvant Treatment of HER2-Overexpressing Breast Cancer:
Administer according to one of the following doses and schedules for a total of 52 weeks of therapy:
4 mg/kg IV over 90 minutes, then at 2 mg/kg IV over 30 minutes weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel/carboplatin); one week following the last weekly dose, administer 6 mg/kg IV over 30 to 90 minutes every 3 weeks for 52 weeks
OR
As a single agent within 3 weeks following completion of multi-modality, anthracycline based chemotherapy regimens: 8 mg/kg IV over 90 minutes, then 6 mg/kg IV over 30 to 90 minutes every 3 weeks for 52 weeks; extending adjuvant therapy beyond one year is not recommended

Comments:

• Do not administer as an IV push or bolus.

Use: 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 consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, OR with docetaxel and carboplatin, OR as a single agent following multi-modality anthracycline based therapy

Usual Adult Dose for Esophageal Carcinoma

Metastatic Gastric Cancer:
Initial dose: 8 mg/kg IV over 90 minutes
Maintenance dose: 6 mg/kg IV over 30 to 90 minutes every 3 weeks
Duration of therapy: Until disease progression

Comments:

• Do not administer as an IV push or bolus.

Use: 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

Usual Adult Dose for Gastric Cancer

Metastatic Gastric Cancer:
Initial dose: 8 mg/kg IV over 90 minutes
Maintenance dose: 6 mg/kg IV over 30 to 90 minutes every 3 weeks
Duration of therapy: Until disease progression

Comments:

• Do not administer as an IV push or bolus.

Use: 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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Missed Doses:

• If a dose is missed by one week or less, then the usual maintenance dose (weekly schedule: 2 mg/kg; three-weekly schedule: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
• If a dose is missed by more than one week, a reloading dose should be administered over approximately 90 minutes (weekly schedule: 4 mg/kg; three-weekly schedule: 8 mg/kg) as soon as possible. Subsequent maintenance doses (weekly schedule: 2 mg/kg; three-weekly schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.

Infusion Reactions:

• Decrease the rate of infusion for mild or moderate infusion reactions.
• Interrupt the infusion in patients with dyspnea or significant hypotension.
• Discontinue therapy for severe or life-threatening infusion reactions.

Cardiomyopathy:

• Assess left ventricular ejection fraction (LVEF) prior to initiation of therapy and at regular intervals during therapy. Withhold dosing for at least 4 weeks for either of the following:
• Greater than or equal to 16% absolute decrease in LVEF from pretreatment values.
• LVEF below institutional limits of normal and 10% or more absolute decrease in LVEF from pretreatment values.
• Therapy may be resumed if, within 4 to 8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is 15% or less.
• Permanently discontinue therapy for a persistent (greater than 8 weeks) LVEF decline or for suspension of dosing on more than 3 occasions for cardiomyopathy.

Precautions

US BOXED WARNINGS:
CARDIOMYOPATHY:

• This drug can cause subclinical and clinical cardiac failure. The incidence and severity is highest in patients receiving this drug with anthracycline-containing chemotherapy regimens.
• Evaluate left ventricular function in all patients prior to and during therapy.
• Discontinue this drug in patients receiving adjuvant therapy and withhold this drug in patients with metastatic disease for clinically significant decrease in left ventricular function.

INFUSION REACTIONS:

• Pulmonary Toxicity: This drug can cause serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt the infusion for dyspnea or significant hypotension. Monitor patients until symptoms completely resolve. Discontinue this drug for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

EMBRYOFETAL TOXICITY:

• Exposure to this drug 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.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not give IV push or bolus.

Storage requirements: Refrigerate

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility:

• Do not mix with other drugs.
• Do not use dextrose (5%) solution.

General:

• To prevent medication errors, check the vial labels to ensure that the drug is trastuzumab and not trastuzumab emtansine.
• HER2 testing is mandatory for all conditions prior to initiation of therapy.
• This drug should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy, and should only be administered by a healthcare professional.
• It is important to check the product labels to ensure that the correct formulation (IV or subcutaneous) is being administered. The IV formulation is not intended for subcutaneous administration and should be administered via an IV infusion only.

Patient advice:

• Advise patients to immediately report any new onset or worsening shortness of breath, cough, swelling of ankles or legs, swelling of face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness.
• Advise women that exposure can result in fetal harm.
• Advise women of childbearing potential to use effective contraception during and for a minimum of 6 months after treatment.

Frequently asked questions

• How many biosimilars have been approved in the United States?
• What is Herceptin? Is Herceptin a chemo drug? How does it work?
• How long can I stay on Herceptin?
• How long can you stay on Herceptin and Perjeta?
• How long does Herceptin stay in your body?
• What happens after Herceptin treatment?
• What is tdm1 chemotherapy?
• How do Herceptin (trastuzumab) and Perjeta (pertuzumab) work together?
• How effective is Herceptin for Breast & Gastric Cancer?
• Does Herceptin (trastuzumab) stop menstrual periods?
• Do Herceptin (trastuzumab) injections hurt?
• How is Herceptin Injection and Herceptin Hylecta administered?
• What is the difference between Ogivri and Herceptin?