What is Ogivri™ ? (trastuzumab-dkst)

Ogivri is a targeted treatment used to treat breast cancer that is positive for the human epidermal growth factor receptor 2 (HER2+). Ogivri is a biosimilar of Herceptin® (trastuzumab) and is manufactured by Mylan.1

What is a biosimilar?

Biosimilars are highly similar to an already approved biological product. Biological products (including biosimilars) are typically made from living organisms. Biological products may be generated from various sources, including human, animal, bacteria, or yeast origins.2

Unlike generics, which have the same active ingredient and are equivalent copies of a reference medicine, biosimilars aren’t exactly like their reference biologics. Biosimilars are generally less expensive than their reference medicine, and they provide another treatment option for patients. Biosimilars must undergo a thorough evaluation to ensure safety, quality, and effectiveness before they receive approval, and the FDA only approves biosimilars that have no clinically meaningful differences from the approved reference product.2

What is the active ingredient in Ogivri?

The active ingredient in Ogivri is trastuzumab-dkst, a monoclonal antibody which blocks the HER2 receptor.1

How does Ogivri work?

Ogivri is a monoclonal antibody. Antibodies are a normal part of the immune system that attach to antigens (such as germs) to mark them for destruction by other components in the immune system. Monoclonal antibodies are created in a laboratory to attach to specific antigens on the surface of cancer cells. Ogivri attaches to the HER2 receptor.

Breast cancers that are classified as HER2+ have a surplus of HER2 receptors, which can cause the cancer to grow and spread quickly. Ogivri targets these receptors and can slow or block the growth and spread of HER2+ breast cancers.1

What are some of the possible side effects of Ogivri?

Ogivri may cause serious side effects, including1:

  • Heart problems, such as congestive heart failure or reduced heart function
  • Infusion reactions, which may cause fever, chills, nausea, vomiting, pain, headache, dizziness, and/or shortness of breath
  • Serious harm to an unborn baby, which may cause serious birth defects or death

The most common side effects experienced by women with metastatic breast cancer receiving Ogivri include1:

  • Fever
  • Chills
  • Headache
  • Infection
  • Congestive heart failure
  • Insomnia
  • Cough
  • Rash

Patients should talk to their doctor about these or any other potential side effects they experience while receiving Ogivri.

Things to know about Ogivri

Because Ogivri can cause birth defects or fatal harm to an unborn fetus, women who can become pregnant who receive Ogivri should use birth control during their treatment and for 7 months after treatment is completed.1

Because Ogivri may cause heart damage, heart function tests may be performed before and during treatment with Ogivri. Based on the results of these tests, your treatment with Ogivri may be paused or stopped.1

Dosing information

Ogivri is given as an intravenous (IV) infusion, and the infusion usually takes between 30 and 90 minutes. Other additional treatments, such as chemotherapy, will take additional time for infusion administration when given in combination with the Ogivri infusion. For women with metastatic breast cancer, the recommended initial dose is 4 mg/kg as a 90-minute infusion, followed by weekly doses of 2 mg/kg as 30-minute infusions.1

For more information, read the full prescribing information for Ogivri.

Patients should talk to their doctor if they have any questions, or if they have questions regarding their Ogivri regimen.

View References
  1. Ogivri prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761074s000lbl.pdf. Accessed 9/11/18.
  2. FDA approves first biosimilar for the treatment of certain breast and stomach cancers. U.S. Food and Drug Administration. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm. Accessed 9/11/18.