Home About

OGIVRI

TRASTUZUMAB-DKST

Manufacturer: Biocon Biologics Inc.

Score: 144.0

Quick Summary

OGIVRI (TRASTUZUMAB-DKST) is a humanized IgG1 kappa monoclonal antibody used for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The drug has been shown to inhibit the proliferation of human tumor cells that overexpress HER2 and is a mediator of antibody-dependent cellular cytotoxicity. Important safety information includes the risk of cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. The recommended dose is 4 mg/kg as an initial dose, followed by 2 mg/kg weekly for 12 weeks, and then 6 mg/kg every 3 weeks for a total of 52 weeks of therapy in adjuvant breast cancer. Special population considerations include use during pregnancy, 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

Important Safety Information

Warning

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

Contraindications

  • None

Adverse Reactions

  • Cardiomyopathy
  • Infusion reactions
  • Embryo-fetal toxicity
  • Pulmonary toxicity
  • Neutropenia
  • Anemia
  • Diarrhea
  • Fatigue

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with cardiomyopathy or infusion reactions

Adjuvant breast cancer

Adult Dose

4 mg/kg initial dose, followed by 2 mg/kg weekly for 12 weeks, and then 6 mg/kg every 3 weeks for a total of 52 weeks of therapy

Pediatric Dose

Metastatic breast cancer

Adult Dose

4 mg/kg initial dose, followed by 2 mg/kg weekly until disease progression

Pediatric Dose

Metastatic gastric cancer

Adult Dose

8 mg/kg initial dose, followed by 6 mg/kg every 3 weeks until disease progression

Pediatric Dose

Special Population Considerations

Pregnancy

  • Use during pregnancy can cause fetal harm
  • Oligohydramnios and oligohydramnios sequence have been reported in post-marketing experience

Nursing Mothers

  • Unknown whether trastuzumab is excreted in human milk

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients

Geriatric Use

  • Increased risk of cardiac dysfunction in geriatric patients
  • No overall differences in safety or effectiveness were observed in geriatric patients in clinical trials