Kanjinti

KANJINTI- trastuzumab injection, powder, lyophilized, for solution
KANJINTI- trastuzumab-anns
Amgen Inc

1 INDICATIONS AND USAGE

1.1 Adjuvant Breast Cancer

KANJINTI is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies ( 14.1)]) 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 [ see Dosage and Administration ( 2.1) ].

1.2 Metastatic Breast Cancer

KANJINTI 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 [see Dosage and Administration ( 2.1)]

1.3 Metastatic Gastric Cancer

KANJINTI 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 [see Dosage and Administration ( 2.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Usage ( 1) and Clinical Studies ( 14)]. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast or gastric cancers by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.

Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.

Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.

2.2 Recommended Doses and Schedules

• Do not administer as an intravenous push or bolus. Do not mix KANJINTI with other drugs.
  
• Do not substitute KANJINTI ( trastuzumab –anns ) for or with ado –trastuzumab emtansine.

Adjuvant Treatment, Breast Cancer:

Administer according to one of the following doses and schedules for a total of 52 weeks of KANJINTI therapy:

During and following paclitaxel, docetaxel, or docetaxel and carboplatin:

• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel and carboplatin).
  
• One week following the last weekly dose of KANJINTI, administer KANJINTI at 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks.

As a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens:

• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes.
  
• Subsequent doses at 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks [see Dosage and Administration ( 2.3)].
  
• Extending adjuvant treatment beyond one year is not recommended [see Adverse Reactions ( 6.1)].

Metastatic Treatment, Breast Cancer:

• Administer KANJINTI, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.

Metastatic Gastric Cancer:

• Administer KANJINTI at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks until disease progression [see Dosage and Administration ( 2.3)].