Ogivri

Ogivri is a prescription medication used to treat breast cancer and stomach cancer where a receptor called HER2 is overexpressed. It may be used alone or in combination with other medications. 

Ogivri belongs to a group of drugs called monoclonal antibodies. These work by stopping the growth of cancer cells.

Ogivri is a biosimilar (closely related) product to Herceptin (trastuzumab).

This medication comes in injectable form and is given into the vein (IV) by a healthcare provider once every week or once every 3 weeks.

Common side effects of Ogivri include headache, fever, and diarrhea.

Ogivri is a prescription medication used to treat breast cancer and stomach cancer where a receptor called HER2 is overexpressed. It may be used alone or in combination with other medications. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ogivri. See the “Ogoivri Precautions” section.

Common side effects of Ogivri include the following:

• headache
• diarrhea
• nausea
• chills
• fever
• infections
• congestive heart failure
• difficulty falling asleep or insomnia
• cough
• rash
• tiredness
• low blood cell counts
• sores in the mouth
• weight loss
• cold
• change or distortion of taste

This is not a complete list of Ogivri side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• daunorubicin (Daunoxome, Cerubidine)
• doxorubicin (Doxil)
• epirubicin (Ellence)
• idarubicin (Idamycin)
• paclitaxel (Abraxane, Taxol)

This is not a complete list of Ogivri drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ogivri including the following:

Heart Problems

• Ogivri treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Ogivri and a certain type of chemotherapy (anthracycline). 
• Ogivri can cause serious heart problems, including:
  • a decline in heart function
  • irregular heartbeats
  • high blood pressure
  • serious heart attack
  • death
• Your doctor will stop Ogivri therapy if you have a weakening of the heart muscle or changes in the heart muscle structure.
• Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment.
• Your doctor may run tests, such as an echocardiogram or a MUGA scan, and will review your health history to see how well the heart muscle is working.
• If you are taking Ogivri and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently.

Infusion Reactions

• Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported
• Symptoms usually happen during or within 24 hours of taking Ogivri 
• Your infusion should be temporarily stopped if you experience shortness of breath or very low blood pressure
• Your doctor should monitor you until these symptoms completely go away
• Your doctor may have you completely stop Ogivri treatment if you have:
  • a severe allergic reaction
  • swelling
  • lung problems
  • swelling of the lungs
  • severe shortness of breath
• Infusion reaction symptoms include
  • fever and chills
  • nausea
  • vomiting
  • pain (in some cases at tumor sites)
  • headache
  • dizziness
  • shortness of breath
  • very low blood pressure
  • rash
  • lack of energy and strength

Pregnancy

• Ogivri can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman
• You should use effective birth control methods while receiving Ogivri and for at least 7 months after you finish taking Ogivri

Lung Problems

• Taking Ogivri can result in serious and potentially deadly lung problems, including:
  • severe shortness of breath
  • fluid in or around the lungs
  • weakening of the valve between the heart and the lungs
  • too little oxygen in the body
  • swelling of the lungs
  • scarring of the lungs
• Problems like these may occur after an infusion reaction. If you have trouble breathing at rest due to existing lung disease, or large lung tumors appear, you may have more serious lung problems. Your doctor should stop Ogivri if you experience lung problems.

Worsening of Low White Blood Cell Counts Due to Chemotherapy

• Worsening of low white blood cell counts to serious and life-threatening levels and associated fever was higher in patients taking Ogivri in combination with chemotherapy when compared with those who received chemotherapy alone. The likelihood that a patient will die from infection was similar among patients who received Ogivri and those who did not

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ogivri, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Ogivri, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ogivri or to any of its ingredients
• have lung problems
• have heart problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It has been shown that use of Ogivri in pregnant women caused some babies to be born with problems. It is recommended that females who are capable of getting pregnant to use effective contraception during treatment with Ogivri and for at least 7 months after the last dose of Ogivri.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ogivri crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ogivri.

Ogivri is given into a vein (IV) by a healthcare provider in a medical setting (healthcare provider's office, or hospital). The first dose is usually given over 90 minutes. Subsequent maintenance doses may be given over 30 minutes if the first dose is well-tolerated.

Ogivri is given once a week or every three weeks, depending on the chosen dosing regimen.

Treatment of HER2-overexpressing breast cancer with other medications:

• The recommended dose of Ogivri is based on weight and how well you tolerate the medication. Ogivri can be given weekly or every 3 weeks for 52 weeks for HER2-overexpressing breast cancer.

HER2-overexpressing breast cancer that has spread to other parts of the body:

• The recommended dose of Ogivri is based on weight. It is given once weekly for HER2-overexpressing breast cancer that has spread to other parts of the body.

HER2-overexpressing gastric (or stomach) cancer that has spread to other parts of the body:

• The recommended dose of Ogivri is based on weight. It is given every 3 weeks for HER2-overexpressing gastric (or stomach) cancer that has spread to other parts of the body.

If Ogivri is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

While you are receiving Ogivri, your doctor may require you have certain lab tests to check your body's response to Ogivri. Be certain to keep all appointments with your doctor and the laboratory.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY 

Cardiomyopathy

• Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens.
• Evaluate left ventricular function in all patients prior to and during treatment with Ogivri. Discontinue Ogivri treatment in patients receiving adjuvant therapy and withhold Ogivri in patients with metastatic disease for clinically significant decrease in left ventricular function.

Infusion Reactions; Pulmonary Toxicity

• Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt Ogivri infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Ogivri for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

• Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.