Ogivri 420 mg intravenous solution

Generic name:
Trastuzumab - injection

Pronunciation
(tras-TOOZ-ue-mab)

Brand name(s)
Herceptin , Hercessi , Herzuma , Kanjinti , Ogivri , Trazimera

Trastuzumab may cause serious heart problems, including heart failure. The risk of heart problems is increased if you also use an anthracycline (such as doxorubicin). Your doctor may stop treatment with this medication if heart problems occur.

Reactions may happen with your injection, usually during or within 24 hours of the dose. Careful monitoring may decrease your risk. Tell your health care professional right away if you have symptoms such as fever, chills, flushing, headache, nausea/vomiting, trouble breathing, dizziness, weakness, or feeling faint. Your doctor may slow down or temporarily stop your injection.

Trastuzumab can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor.

Trastuzumab is used to treat certain types of breast, stomach, or esophagus cancer. Trastuzumab belongs to a class of medications known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

This monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp, trastuzumab-strf.

This medication is given by slow injection into a vein by a health care professional, usually once every week or once every 3 weeks. The first injection is given over at least 90 minutes.

The dosage is based on your medical condition, response to treatment, weight, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) for you to take before each dose to help prevent serious side effects. Follow your doctor's directions carefully.

See also Warning section.

Redness/irritation at the injection site, diarrhea, muscle/joint/back pain, stomach/abdominal pain, headache, trouble sleeping, nausea, vomiting, mouth sores, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• bone pain
• numbness/tingling
• mental/mood changes
• fast/irregular heartbeat
• easy bruising/bleeding

Get medical help right away if you have any very serious side effects, including:

• chest pain
• weakness on one side of the body
• trouble speaking
• vision changes
• confusion

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Trastuzumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using trastuzumab, tell your doctor or pharmacist if you are allergic to it; or to any trastuzumab, trastuzumab deruxtecan, trastuzumab emtansine, or trastuzumab-hyaluronidase products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent infection
• heart disease
• lung problems
• previous cancer treatments (including radiation treatment)

Trastuzumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using trastuzumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for heart problems (such as heart failure) while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using trastuzumab. Trastuzumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 7 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding while using this medication and for 7 months after stopping treatment.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Trastuzumab is very similar to trastuzumab deruxtecan, trastuzumab emtansine, and trastuzumab-hyaluronidase. Do not use a trastuzumab deruxtecan, trastuzumab emtansine, or trastuzumab-hyaluronidase product while using a trastuzumab product.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as heart exams, complete blood count) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.