OGIVRI 420 Lyophilisate for solution for infusion Vial

OGIVRI 420mg Lyophilisate for Solution for Infusion Vial

OGIVRI 420mg is a prescription medication in the form of a lyophilisate for solution for infusion, containing trastuzumab.
As a biosimilar, OGIVRI is a targeted therapy designed to treat certain types of HER2-positive breast cancer and metastatic gastric cancer.
It works by specifically targeting the HER2 protein, which is overexpressed in these cancer types, thereby inhibiting cancer cell growth and proliferation.
OGIVRI offers an effective treatment option for patients, providing a biosimilar alternative to reference trastuzumab products.

Benefits of Use

• Targets HER2-positive cancers specifically, leading to more effective treatment with potentially fewer side effects compared to non-targeted chemotherapy.
• Approved for use in various stages of HER2-positive breast cancer, including early-stage and metastatic, as well as metastatic gastric or gastroesophageal junction adenocarcinoma.
• Offers a biosimilar option for trastuzumab, potentially improving access to this vital therapy.
• Administered by healthcare professionals ensuring proper dosing and monitoring.

How to Use

OGIVRI 420mg is administered intravenously by a qualified healthcare professional.
The specific dosage, duration, and frequency of treatment will be determined by your doctor based on your medical condition, body weight, and the type of cancer being treated.
It is crucial to follow your doctor's instructions meticulously.

1. OGIVRI is reconstituted and diluted by a healthcare professional in a sterile environment.
2. The solution is then administered as an intravenous infusion over a specified period.
3. Infusion duration typically ranges from 30 to 90 minutes for subsequent doses, with the initial dose often being longer.
4. Regular monitoring by your healthcare team is essential throughout the treatment period to manage any potential side effects and assess treatment efficacy.
5. Do not attempt to self-administer this medication.

Caution & Warnings

• Cardiotoxicity: OGIVRI can cause heart problems, including a decrease in heart function. Regular cardiac monitoring (e.g., echocardiograms) is required before and during treatment.
• Pulmonary Toxicity: Serious and fatal pulmonary toxicity has been reported, including acute respiratory distress syndrome and interstitial pneumonitis.
• Infusion-Related Reactions: Severe infusion-related reactions, including anaphylaxis, can occur. Patients should be monitored during and after infusion.
• Embryo-Fetal Toxicity: OGIVRI can cause fetal harm when administered to a pregnant woman. Effective contraception must be used during treatment and for 7 months after the last dose.
• Hypersensitivity: Do not use if you have a known hypersensitivity to trastuzumab or any of the excipients.
• Neurological Symptoms: Monitor for any new or worsening neurological symptoms, as rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported.
• Combination Therapy: Exercise caution when using OGIVRI in combination with other cardiotoxic agents.

Ingredients

• Active Ingredient: Trastuzumab 420mg
• Excipients: L-Histidine, Sucrose, Polysorbate 20 (The specific excipients may vary slightly by manufacturer and formulation, but these are common components for trastuzumab lyophilisate.)

Product Details

• Form: Lyophilisate for solution for infusion
• Strength: 420mg per vial
• Package Size: 1 Vial
• Storage: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton to protect from light.
• Manufacturer: Biocon Biologics
• Drug Type: Prescription Medication (Rx)