US FDA approved new drug Ogivri that is a a biosimilar to Herceptin (trastuzumab) for the treatment of certain kind of metastatic cancers like metastatic breast cancer or metastatic stomach cancer. A biosimilar product is a pharmaceutical product that is similar to a reference product which already been approved by the US FDA and has no therapeutic differences in terms of safety, purity and potency.
Stomach cancer is also termed as gastric cancer. Early signs ans symptoms of stomach cancers are weight loss, loss of appetite, nausea and vomiting. In later stages patient may feel difficulty in swallowing and have blood in stool. Pain in upper abdominal area may also be a symptoms of gastric metastasis. In later stages it becomes difficult to treat stomach cancer because it spreads to other areas like bones, lungs, liver.
Breast cancer is one of the leading cause of death in females due to cancer. Initially, it appears as a lump inside the breast that growth with the passage of time and reaches to progressive metastatic stage. There are no obvious symptoms at initial stages that makes it hard to diagnose earlier. Later on patient may feel bone pain, swollen lymph nodes, fatigue, shortness of breath and mild fever in some cases also been reported.
This drug encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2.
Ogivri/trastuzumab-dkst Side effects
Following side effects were observed during clinical trials of this drug.
- Mild fever
- Rashes on body
- Less white blood cells count
- Less red blood cells count
- Abdominal discomfort
- Pain in abdomen
- Edema like condition
- Changes in taste sensation
Ogivri/trastuzumab-dkst Uses/Prescribing Information
Ogivri/trastuzumab-dkst is a a biosimilar to Herceptin (trastuzumab) for the treatment of certain kind of metastatic cancers like metastatic breast cancer or metastatic stomach cancer. According to data provided by health authorities this drug should be avoided in pregnancy due to fetal abnormalities.
This drug is administered via intravenous route.
It is dosage frequency is 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions in case of Metastatic HER2-Overexpressing Breast Cancer.
Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks in case of Metastatic HER2-Overexpressing Gastric Cancer.