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Distribution and Supply Information for HERZUMA1

HERZUMA

  • Available for order from your primary distributor/wholesaler, upon product availability
  • Offered in a 420-mg multiple-dose vial or 150-mg single-dose vial1
  • Store in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution1

CODING

  • HERZUMA NDC*:

63459-0305-47 (420 mg/10 mL),

63459-0303-43 (150 mg/50 mL)

Q Code: Q5113

Effective July 1, 2019

It will be necessary to use the appropriate coding with your pharmacy and/or patient medication management systems

HERZUMA vial and packaging DOSING ADMINISTRATION

*Note that the product's NDC has been "zero-filled" to ensure the creation of an
11-digit code that meets CMS standards. The zero-filled location is indicated in
bold and underline.

Dose HERZUMA the Same as Herceptin1,2

Established dosing regimens for treatment settings in adjuvant and metastatic breast cancer and metastatic gastric cancer

Click one of the indications
below to learn more

Expand All
ADJUVANT BREAST CANCER†
WITH DOCETAXEL
AND CARBOPLATIN
INITIAL DOSESUBSEQUENT DOSES DURING WEEKLY ADMINISTRATIONSUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡
4 mg/kg 2 mg/kg 6 mg/kg
week 1 weeks 2-18 weeks 19-52
90 minutes 30 minutes 30-90 minutes

INITIAL DOSE

4 mg/kg (week 1)

90 minutes

SUBSEQUENT DOSES DURING WEEKLY ADMINISTRATION

2 mg/kg (weeks 2-18)

30 minutes

SUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡

6 mg/kg

(weeks 19-52)

30-90 minutes

WITH PACLITAXEL
OR DOCETAXEL
INITIAL DOSESUBSEQUENT DOSES DURING WEEKLY ADMINISTRATIONSUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡
4 mg/kg 2 mg/kg 6 mg/kg
week 1 weeks 2-12 weeks 13-52
90 minutes 30 minutes 30-90 minutes

INITIAL DOSE

4 mg/kg

week 1

90 minutes

SUBSEQUENT DOSES DURING WEEKLY ADMINISTRATION

2 mg/kg

weeks 2-12

30 minutes

SUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡

6 mg/kg

(weeks 13-52)

30-90 minutes

MONOTHERAPY§
INITIAL DOSESUBSEQUENT DOSES DURING WEEKLY ADMINISTRATIONSUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡
8 mg/kg N/A 6 mg/kg
week 1   weeks 4-52
90 minutes   30-90 minutes

INITIAL DOSE

8 mg/kg (week 1)

90 minutes

SUBSEQUENT DOSES DURING WEEKLY ADMINISTRATION

N/A

until disease progression

SUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡

6 mg/kg

(weeks 4-52)

30-90 minutes

METASTATIC BREAST CANCER
ALONE OR IN COMBINATION
WITH PACLITAXEL
INITIAL DOSESUBSEQUENT DOSES DURING WEEKLY ADMINISTRATIONSUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡
4 mg/kg 2 mg/kg N/A
week 1 30 minutes  
90 minutes until disease progression  

INITIAL DOSE

4 mg/kg (week 1)

90 minutes

SUBSEQUENT DOSES DURING WEEKLY ADMINISTRATION

2 mg/kg

30 minutes

until disease progression

SUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡

N/A

METASTATIC GASTRIC CANCER
INITIAL DOSESUBSEQUENT DOSES DURING WEEKLY ADMINISTRATIONSUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡
8 mg/kg N/A 6 mg/kg
week 1   30-90 minutes
90 minutes   until disease progression

INITIAL DOSE

8 mg/kg (week 1)

90 minutes

SUBSEQUENT DOSES DURING WEEKLY ADMINISTRATION

N/A

SUBSEQUENT DOSES DURING Q3W ADMINISTRATION‡

6 mg/kg

30-90 minutes

until disease progression

FOR COMPLETE DOSING INFORMATION REFER TO FULL PRESCRIBING INFORMATION

†Extending adjuvant treatment beyond one year is not recommended.

‡q3w=every 3 weeks.

§Within 3 weeks following completion of multi-modality, anthracycline-based chemotherapy regimens.

Administer HERZUMA the Same as Herceptin1

ADMINISTRATION GUIDELINES
A clipboard with a list of check boxes on it
  • Reconstitute the same as Herceptin
  • Do not administer HERZUMA as an intravenous push or bolus
  • Do not mix HERZUMA with other drugs
  • Do not substitute HERZUMA for or with ado-trastuzumab emtansine
  • In the adjuvant clinical trials, HERZUMA was given concurrently with hormonal and/or radiation therapy (after completion of chemotherapy cycles) to eligible patients
  • Discontinue HERZUMA for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
  • If a dose of HERZUMA therapy is missed by ≤1 week:
    • The usual maintenance dose (based on the patient's schedule) should be administered as soon as possible
    • Do not wait until the next planned cycle
  • If a dose of HERZUMA therapy is missed by >1 week, HERZUMA should be reloaded using the appropriate loading dose:
    • 4 mg/kg for weekly dosing
    • 8 mg/kg for dosing every 3 weeks

INDICATIONS

Adjuvant Breast Cancer

HERZUMA is indicated for the 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
  • as part of a treatment regimen with docetaxel and carboplatin
  • as a single agent following multi-modality anthracycline based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

Metastatic Breast Cancer

HERZUMA is indicated:

  • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

Metastatic Gastric Cancer

HERZUMA is indicated:

  • 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

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO FETAL TOXICITY, AND PULMONARY TOXICITY

Cardiomyopathy - Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with HERZUMA. Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion Reactions; Pulmonary Toxicity - Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt HERZUMA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity - Exposure to trastuzumab products 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.

Warnings and Precautions

Cardiomyopathy

  • Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline containing chemotherapy regimens
  • Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
  • Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF)
  • Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA in patients with metastatic disease for clinically significant decrease in left ventricular function
  • The safety of continuation or resumption of HERZUMA in patients with trastuzumab product-induced LV cardiac dysfunction has not been studied

Cardiac Monitoring

  • Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of HERZUMA
  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Monitor frequently for decreased left ventricular function during and after HERZUMA treatment
  • Monitor more frequently if HERZUMA is withheld for significant left ventricular cardiac dysfunction

Infusion Reactions

  • Administration of trastuzumab products can result in serious and fatal infusion reactions
  • Symptoms usually occur during or within 24 hours of administration
  • Interrupt HERZUMA infusion for dyspnea or clinically significant hypotension
  • Monitor patients until symptoms completely resolve
  • Discontinue HERZUMA for anaphylaxis or angioedema. Strongly consider permanent discontinuation in all patients with severe infusion reactions
  • Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

Embryo-Fetal Toxicity

  • Exposure to trastuzumab products 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
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA
  • Advise pregnant women and females of reproductive potential that exposure to HERZUMA during pregnancy or within 7 months prior to conception can result in fetal harm
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of HERZUMA. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERZUMA treatment and any potential adverse effects on the breastfed child from HERZUMA or from the underlying maternal condition

Pulmonary Toxicity

  • Administration of trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
  • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
  • Discontinue HERZUMA in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

Adjuvant Breast Cancer

  • Most common adverse reactions (≥5%) are headache, diarrhea, nausea, and chills

Metastatic Breast Cancer

  • Most common adverse reactions (≥10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash

Metastatic Gastric Cancer

  • Most common adverse reactions (≥10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

Please see full Prescribing Information, including BOXED WARNINGS.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Embryo-Fetal Toxicity

  • Exposure to trastuzumab products 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
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA
  • Advise pregnant women and females of reproductive potential that exposure to HERZUMA during pregnancy or within 7 months prior to conception can result in fetal harm
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of HERZUMA. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERZUMA treatment and any potential adverse effects on the breastfed child from HERZUMA or from the underlying maternal condition

Pulmonary Toxicity

  • Administration of trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
  • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
  • Discontinue HERZUMA in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

Adjuvant Breast Cancer

  • Most common adverse reactions (≥5%) are headache, diarrhea, nausea, and chills

Metastatic Breast Cancer

  • Most common adverse reactions (≥10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash

Metastatic Gastric Cancer

  • Most common adverse reactions (≥10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

Please see full Prescribing Information, including BOXED WARNINGS.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

References: 1. HERZUMA® (trastuzumab-pkrb) for injection, for intravenous use Prescribing Information. Incheon, Republic of Korea: Celltrion, Inc. 2. Herceptin® (trastuzumab) Prescribing Information. Genentech, Inc. 2018.
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