Ogivri

Generic Name: Trastuzumab lyophilized
Dosage Form: IV Infusion
TG Name: Oncology

1. What is Ogivri^®?
Ogivri^® USFDA & EMA approved first biosimilar Trastuzumab which is a humanised IgG1 monoclonal antibody.

2. How Ogivri^® works in our body?

• Trastuzumab binds to HER2’s extracellular domain (Subdomain IV) & inhibits HER2 signaling and prevents the activation mechanism of HER2.
• Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
• Prevention of the formation of p95HER2, a truncated and very active form of HER2.
• Inhibition of HER2-regulated angiogenesis.

3. What is the indication of Ogivri^®?

• Metastatic Breast Cancer
• Early Breast Cancer
• Metastatic Gastric Cancer.

4. What are the dosage & administration of Ogivri^®?

• Weekly schedule: Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly.
• Three weekly schedule: Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30−90 minutes IV infusion every three weeks.

5. What are the adverse effects of Ogivri^®?

• 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.

7. What would be the storage condition of Ogivri^®?
Store Ogivri in the refrigerator at 2° to 8°C (36° to 46°F); discard unused Ogivri after 28 days.