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Kanjinti

TRASTUZUMAB-ANNS

Manufacturer: Amgen Inc

Score: 144.0

Quick Summary

Kanjinti (Trastuzumab-anns) is a humanized IgG1 kappa monoclonal antibody used for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. It works by selectively binding to the extracellular domain of the HER2 protein, inhibiting the proliferation of human tumor cells that overexpress HER2. The most common adverse reactions include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Important safety information includes the risk of cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. The recommended dose for adjuvant treatment of HER2-overexpressing breast cancer is 4 mg/kg over 90 minutes IV infusion, then 2 mg/kg over 30 minutes IV infusion weekly for 12 weeks, followed by 6 mg/kg over 30-90 minutes IV infusion every three weeks. For metastatic HER2-overexpressing breast cancer, the initial dose is 4 mg/kg as a 90-minute IV infusion, followed by subsequent weekly doses of 2 mg/kg as 30-minute IV infusions. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of HER2-overexpressing breast cancer
  • Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
  • Adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer
  • Metastatic breast cancer treatment

Important Safety Information

Warning

Cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity

Contraindications

  • None

Adverse Reactions

  • Fever
  • Nausea
  • Vomiting
  • Infusion reactions
  • Diarrhea
  • Infections
  • Increased cough
  • Headache
  • Fatigue
  • Dyspnea
  • Rash
  • Neutropenia
  • Anemia
  • Myalgia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with cardiac dysfunction or infusion reactions

Adjuvant treatment of HER2-overexpressing breast cancer

Adult Dose

4 mg/kg over 90 minutes IV infusion, then 2 mg/kg over 30 minutes IV infusion weekly for 12 weeks

Pediatric Dose

Not established

Metastatic HER2-overexpressing breast cancer

Adult Dose

4 mg/kg as a 90-minute IV infusion, followed by subsequent weekly doses of 2 mg/kg as 30-minute IV infusions

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy can result in oligohydramnios and embryo-fetal toxicity

Nursing Mothers

  • Unknown whether trastuzumab is excreted in human milk

Pediatric Use

  • Safety and effectiveness not established in pediatric patients

Geriatric Use

  • Increased risk of cardiac dysfunction in geriatric patients