Ogivri (Trastuzumab-Dkst) for Breast Cancer

Ogivri (trastuzumab-dkst) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with breast cancer.

How Ogivri Works and How It’s Taken

Ogivri is a type of medication called human epidermal growth factor receptor 2 (HER2)-targeted therapy. It attaches to the HER2 protein on some cancer cells. This can slow the growth of HER2-positive cancer cells and may also help the immune system find and attack them.

In breast cancer, this may help reduce abnormal cancer cell growth. Ogivri is a biosimilar of Herceptin. A biosimilar is a biologic medicine that is highly similar to an FDA-approved biologic. There are no clinically meaningful differences in safety or how well it works for the approved uses.

Doctors prescribe Ogivri when adults have certain HER2-positive breast cancers. The exact use depends on the stage of cancer and whether Ogivri is used with chemotherapy or on its own.

Ogivri may be used:

After initial treatment for early-stage breast cancer, with certain chemotherapy combinations
After initial treatment for early-stage breast cancer, by itself after anthracycline-based treatment
With paclitaxel as the first treatment for HER2-positive breast cancer that has spread
By itself for HER2-positive breast cancer that has spread after one or more chemotherapy treatments

Ogivri is given as an intravenous (IV) infusion. It is typically given weekly or once every three weeks, depending on the treatment plan and whether it is used for early-stage or metastatic disease.

For early-stage breast cancer, treatment usually continues for a total of 52 weeks. For metastatic breast cancer, treatment usually continues until the cancer gets worse or side effects become unacceptable.

Typical Dosing for Breast Cancer

For early-stage breast cancer, the recommended starting dose of Ogivri is 4 milligrams per kilogram by IV infusion. This is followed by 2 milligrams per kilogram weekly during chemotherapy, then 6 milligrams per kilogram every three weeks afterward.

When Ogivri is used by itself after anthracycline-based treatment, the recommended starting dose is 8 milligrams per kilogram. This is followed by 6 milligrams per kilogram every three weeks. Treatment usually continues for up to 52 weeks.

For metastatic breast cancer, the recommended starting dose of Ogivri is 4 milligrams per kilogram by IV infusion. After that, 2 milligrams per kilogram is given once weekly. Ogivri may be given by itself or with paclitaxel.

Doctors may pause treatment, slow an infusion, or stop treatment if side effects are serious or hard to manage.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Ogivri Side Effects

In clinical trials of Ogivri for HER2-overexpressing breast cancer in adults, the most common side effects differed between adjuvant breast cancer and metastatic breast cancer. This might be due to the different dosing schedules based on indication, or use as a single agent versus combinations of chemotherapy medications.

For adjuvant breast cancer, side effects reported in at least 5 percent of people include:

Headache
Diarrhea
Nausea
Chills

For metastatic breast cancer, side effects reported in at least 10 percent of people include:

Fever
Chills
Headache
Infection
Congestive heart failure
Trouble sleeping
Cough
Rash

Serious Side Effects and Warnings

Ogivri can cause serious side effects that may require immediate medical attention. These include:

Cardiomyopathy and heart failure — Serious heart problems, including decreased left ventricular ejection fraction (LVEF), can occur.
Infusion reactions and pulmonary toxicity — Serious reactions during or soon after the infusion and severe lung problems can occur, including anaphylaxis, angioedema, pneumonitis, severe breathing problems, or acute respiratory distress syndrome.
Embryo-fetal toxicity — Ogivri can harm your baby if you are pregnant.
Severe low white blood cell counts — Severe low white blood cell counts, including febrile neutropenia, can occur.
Severe allergic reactions — These can include anaphylaxis and angioedema.
Serious infusion-related problems — Serious low oxygen levels, low blood pressure, irregular heartbeat, or high blood pressure can occur during infusion.

Other serious problems have been reported after trastuzumab products were approved. These may occur at a very low frequency and include tumor lysis syndrome, immune thrombocytopenia, and glomerulopathy.

Tumor lysis syndrome can happen when cancer cells break down quickly. Immune thrombocytopenia means the immune system lowers the number of platelets, which help blood clot. Glomerulopathy is a kidney problem.

Get medical help right away if you think you are having a serious reaction.

How To Save on Ogivri

Biocon Biologics, the manufacturer of Ogivri, offers the My Biocon Biologics Patient Support Program. Eligible people with commercial insurance may pay as little as $0 per monthly fill. The copay assistance program is not valid for people covered in whole or in part by state or federally funded healthcare programs, including Medicare, Medicaid, VA or DOD coverage, or TRICARE.

The My Biocon Biologics Patient Support Program also offers support with coverage and claim concerns, as well as copay and financial assistance questions. To learn more, visit the Ogivri website, call 833-695-2623, or visit the My Biocon Biologics portal.

What To Know Before Taking Ogivri

Before starting Ogivri, your doctor will test or check for:

Heart function, including left ventricular ejection fraction (LVEF)
Pregnancy status if you can become pregnant
HER2 protein overexpression or HER2 gene amplification in your tumor

Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, and supplements.

Ogivri is also FDA-approved to treat gastric and gastroesophageal junction adenocarcinoma.

If you miss a dose by one week or less, it should be given as soon as possible. If you miss a dose by more than one week, your doctor may need to restart with a loading dose before continuing your regular schedule.

Ogivri can harm your baby if you are pregnant. Your doctor should verify pregnancy status before you start treatment. Females who can become pregnant should use effective birth control during treatment and for seven months after the last dose.

It is not known whether Ogivri passes into human breast milk. Because Ogivri may stay in the body after treatment ends, consider the seven-month washout period before breastfeeding.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Ogivri?

In studies of HER2-positive early breast cancer, adding trastuzumab to chemotherapy improved outcomes compared with chemotherapy alone. In one combined analysis of over 4,000 people, the overall survival rate at a median follow-up of 8.3 years was 86.9 percent with trastuzumab plus chemotherapy versus 79.4 percent with chemotherapy alone. In another study, people who received trastuzumab for one year were less likely to have their cancer come back or to die than people who were only observed after treatment.

In metastatic breast cancer, trastuzumab plus chemotherapy increased median time to disease progression to 7.2 months versus 4.5 months. It also increased median overall survival to 25.1 months versus 20.3 months.

What tests or monitoring are needed with Ogivri for breast cancer?

Before starting Ogivri, HER2 status should be confirmed using an FDA-approved test, and left ventricular ejection fraction (LVEF) should be checked. LVEF should also be monitored at regular intervals during treatment.

For adjuvant breast cancer, LVEF is measured every three months during treatment, at completion, every four weeks if treatment is withheld for heart problems, and every six months for at least two years after finishing treatment. Pregnancy status should also be checked before starting treatment in females of reproductive potential.