TM Owner Biocon Biologics Inc.
Ogivri 420mg Injection
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Indications & Clinical Uses
- Ogivri 420mg is the brand name for trastuzumab-dkst, a biosimilar to the reference biologic Herceptin (trastuzumab), a HER2-targeted monoclonal antibody given by intravenous infusion.
- It is approved for adults with HER2-overexpressing breast cancer, used as part of adjuvant treatment for early-stage disease and for metastatic breast cancer, and for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.
- Treatment requires confirmation of HER2 overexpression using an FDA-approved companion diagnostic test before starting.
- As a biosimilar, Ogivri is highly similar to the originator Herceptin with no clinically meaningful differences in safety or effectiveness.
- It was launched jointly by Mylan and Biocon; following the 2022 transfer of Viatris's biosimilars portfolio, it is now marketed under the Biocon Biologics label.
- Ogivri is given only by intravenous infusion under the supervision of a healthcare provider experienced in cancer chemotherapy, never as a self-administered injection.
Side Effects
- Ogivri carries a boxed warning covering four serious risks: cardiomyopathy, with a risk of heart failure and reduced heart pumping function, especially when given with anthracycline chemotherapy; infusion reactions and severe or fatal hypersensitivity reactions that can occur during or shortly after the infusion; pulmonary toxicity; and embryo-fetal toxicity, which can cause low amniotic fluid, birth defects, and neonatal death if used during pregnancy.
- Common side effects include fever, chills, headache, diarrhea, weakness, nausea, and increased risk of infection.
- Seek urgent medical attention for shortness of breath, swelling of the legs, chest pain, sudden weight gain, fever with chills during or after an infusion, wheezing, or signs of an allergic reaction such as facial swelling.
- Heart function is checked before and periodically during treatment because of the cardiomyopathy risk, and infusion reactions are watched for closely during every dose, especially the first one.
Precautions & Warnings
- Left ventricular ejection fraction must be assessed before starting Ogivri and monitored regularly during treatment, since cardiomyopathy and heart failure can occur, particularly with prior or concurrent anthracycline use; treatment should be withheld for significant declines in heart function.
- Ogivri must be given only as an intravenous infusion, never as an IV push or bolus, and patients are monitored closely during and for at least six hours after the first infusion, and two hours after later infusions, because of the risk of severe infusion reactions and pulmonary toxicity.
- Ogivri is not recommended during pregnancy because it can cause fetal harm, including oligohydramnios; effective contraception is required during treatment and for seven months after the last dose.
- There are no specific contraindications listed on the label.
- Patients with pre-existing lung disease or extensive tumor involvement of the lungs are at higher risk of pulmonary toxicity and should be monitored closely.
Avoid Interactions
- Combining Ogivri with anthracycline chemotherapy, such as doxorubicin, substantially increases the risk of cardiac toxicity, so anthracyclines should generally be avoided during Ogivri treatment and for up to seven months after stopping.
- There are no other well-established drug-drug interactions specific to Ogivri, since it is a monoclonal antibody and does not undergo the same metabolic pathways as small-molecule drugs.
- However, because Ogivri is usually given alongside other chemotherapy agents, the healthcare team monitors for combined toxicities such as low blood counts and increased infection risk.
- Ogivri must not be mixed or diluted with dextrose (glucose) solutions, as this can cause the protein to clump; it should be diluted only in the solution specified in the preparation instructions.
- Patients should tell their healthcare provider about every other cancer treatment, prescription medicine, and supplement they are taking so that cumulative risks, especially to the heart and lungs, can be managed.
References
Frequently Asked Questions
Ogivri (trastuzumab-dkst) is a biosimilar to Herceptin used to treat HER2-positive breast cancer, including early-stage and metastatic disease, and HER2-positive metastatic stomach or gastroesophageal cancer. Your tumor must test positive for HER2 overexpression before treatment starts. It works the same way as the original Herceptin.
Ogivri is given only as an intravenous infusion by a healthcare provider, never as an injection you give yourself. It's usually given weekly or every three weeks, alongside other cancer treatments. The first infusion is given slowly with close monitoring for reactions; later doses may run faster.
Common effects include fever, chills, headache, diarrhea, and increased infection risk. Ogivri has a boxed warning covering heart failure (cardiomyopathy), severe infusion reactions, lung toxicity, and harm to an unborn baby. Get urgent help for chest pain, breathlessness, leg swelling, or a reaction during infusion.
Avoid anthracycline chemotherapy drugs like doxorubicin during and for up to 7 months after Ogivri, since combining them raises the risk of serious heart damage. Avoid pregnancy during treatment and for 7 months after the last dose, as Ogivri can cause fetal harm.
Ogivri is a biosimilar, not an identical copy, but it has no clinically meaningful differences from the original Herceptin (trastuzumab) in safety or effectiveness. It's manufactured by Biocon Biologics and approved through the FDA's biosimilar pathway after extensive comparative testing.
Your heart's pumping function (ejection fraction) is checked before you start Ogivri and regularly during treatment, since it can cause heart failure, especially if you've had anthracycline chemotherapy. Treatment may be paused or stopped if heart function drops significantly. Report shortness of breath or leg swelling promptly.
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