fam-trastuzumab deruxtecan-nxki 100 mg intravenous solution

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Medication name

Generic name:
Trastuzumab deruxtecan - injection

Pronunciation
(tras-TOOZ-ue-mab DER-ux-TEE-kan)

Brand name(s)
Enhertu

Warning

This medication may sometimes cause serious lung problems. Tell your doctor right away if you have any new or worsening signs of lung problems (such as cough, fever, wheezing, shortness of breath).

Trastuzumab deruxtecan may cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor. See also Precautions section.

Uses

Trastuzumab deruxtecan is used to treat certain types of cancer (such as breast cancer, lung cancer, stomach cancer, esophageal cancer, certain other solid tumors). This medication is used to treat tumors which are involved with the HER2 protein.

This medication is called a monoclonal antibody and topoisomerase inhibitor conjugate. Trastuzumab deruxtecan works by attaching to the HER2 cancer cells and blocking them from dividing and growing.

How to use

Read the Medication Guide provided by your pharmacist before you start using trastuzumab deruxtecan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 3 weeks. Your first infusion will be given over at least 90 minutes.

The dosage, the speed of your injection, and the length of time you receive trastuzumab deruxtecan are based on your body weight, medical condition, and response to treatment.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Side effects

See also Warning section.

Diarrhea, dizziness, stomach/abdominal pain, constipation, nausea, vomiting, mouth sores, dry mouth, loss of appetite, tiredness, hair loss, nose bleeds, or headache 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:

  • unusual tiredness
  • pale skin
  • easy bruising/bleeding

Trastuzumab deruxtecan may lead to serious heart problems, including heart failure. Past use of certain other anti-cancer drugs (including anthracyclines such as doxorubicin) may increase your risk of heart problems. Tell your doctor right away if you have any symptoms of heart failure, including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.

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).

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.

Precautions

See also Warning section.

Before using trastuzumab deruxtecan, tell your doctor or pharmacist if you are allergic to it; or to any trastuzumab emtansine, trastuzumab, 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 infection
  • heart disease
  • lung problems

Trastuzumab deruxtecan 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 deruxtecan 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).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using trastuzumab deruxtecan. Trastuzumab deruxtecan may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 7 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes 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. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 7 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions

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.

If you will be using an anthracycline (such as doxorubicin) after stopping trastuzumab deruxtecan, if possible, wait at least 7 months.

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

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as heart exams, complete blood counts, liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

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.

Storage

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

Medical alert

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).

Important note

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.

Information last revised April 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.