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Enhertu (Generic Fam-trastuzumab deruxtecan-nxki Injection)

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WARNING

Injection of fam-trastuzumab deruxtecan-nxki may result in significant or fatal lung damage, such as interstitial lung disease (a condition in which the lungs get scarred) or pneumonitis (lung tissue swelling). If you have lung illness or breathing issues, let your doctor know. Call your doctor right away if you have any of the following symptoms: Chest tightness, wheezing, fever, a new or worsening cough, breathing problems, or shortness of breath.

Inform your physician if you are expecting, intend to become pregnant, or intend to father a child. While getting fam-trastuzumab deruxtecan-nxki injection, neither you nor your partner should become pregnant. Before administering the fam-trastuzumab deruxtecan-nxki injection, your doctor may do a pregnancy test to make sure you are not pregnant if you are able to become pregnant. During treatment and for seven months following your last dose, female patients should utilize birth control. If you’re a man, you should use birth control while receiving therapy and for four months following your last dose, together with your female partner. Discuss effective birth control options with your doctor. Call your doctor if you or your partner becomes pregnant while getting the fam-trastuzumab deruxtecan-nxki injectable. The fetus can suffer from fam-trastuzumab deruxtecan-nxki.

Keep all of your appointments with your physician and the lab. Before and during treatment, your doctor will request specific tests to monitor your body’s reaction to famDeruxtecan-nxki trastuzumab.

When you start taking fam-trastuzumab deruxtecan-nxki, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the potential risks of receiving fam-trastuzumab deruxtecan-nxki with your doctor.

Why is this medication prescribed?

An injection called fam-trastuzumab deruxtecan-nxki is used to treat a certain type of breast cancer that cannot be surgically removed, has spread to other body parts, or has returned after undergoing another breast cancer treatment. Additionally, it is used to treat specific types of adult gastric cancer (carcinoma of the stomach) that, after receiving another form of treatment, has migrated to neighboring tissues or to other areas of the body. A specific type of non-small cell lung cancer (NSCLC) in people that cannot be surgically removed or that has spread to other parts of the body after receiving another treatment is also treated with fam-trastuzumab deruxtecan-nxki injection. The drug fam-trastuzumab deruxtecan-nxki belongs to the category of drugs known as antibody-drug conjugates. It eliminates cancer cells to work.

How should this medicine be used?

Fam-trastuzumab deruxtecan-nxki is administered intravenously (into a vein) over the course of 30 to 90 minutes by a physician or nurse in a hospital or other healthcare setting. For as long as your doctor advises you to get treatment, it is typically injected once every three weeks.

Depending on your reaction to the drug and any side effects you have, your doctor may postpone or discontinue your therapy with fam-trastuzumab deruxtecan-nxki injection or administer extra medication. Tell your doctor how you are feeling as you receive treatment.

Vomiting and nausea during and after therapy with fam-trastuzumab deruxtecan-nxki injection are possible side effects. To help you avoid nausea and vomiting, your doctor may provide you with another drug.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving fam-trastuzumab deruxtecan-nxki injection,

  • If you have an allergy to fam-trastuzumab deruxtecan-nxki, drugs derived from Chinese hamster ovary cell protein, any other drugs, or any of the ingredients in fam-trastuzumab deruxtecan-nxki injection, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section, a fever or other infection-related symptoms, heart failure, heart disease, liver or kidney issues, or any other medical concerns.
  • Inform your doctor if you are nursing a baby. While receiving fam-trastuzumab deruxtecan-nxki injection and for 7 months following your final dosage, you shouldn’t breastfeed.
  • You should be aware that this drug may reduce male fertility. The dangers of receiving an injection of fam-trastuzumab deruxtecan-nxki should be discussed with your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The drug deruxtecan-nxki fam-trastuzumab may have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Lesions in the mouth, throat, or lips
  • Abdominal pain
  • Heartburn
  • Reduced appetite
  • Reduced weight
  • Hair fall
  • Headache
  • Dizziness
  • Tiredness
  • Bone and muscle discomfort
  • The dry eye
  • Tingling or numbness in the feet or hands
  • Rash

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Pale skin or breathing difficulty
  • Shortness of breath that is either new or worsening, coughing, fatigue, swelling in the legs or ankles, an irregular heartbeat, gaining weight, dizziness, or fainting
  • Blood from the nose or other odd bruises or bleeding
  • Fever, chills, cough, or other infection-related symptoms

Other adverse effects of fam-trastuzumab deruxtecan-nxki are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What other information should I know?

If you have any inquiries regarding fam-trastuzumab deruxtecan-nxki, ask your pharmacist.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.

Brand names

  • Enhertu®
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