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Enhertu Side Effects

Generic name: fam-trastuzumab deruxtecan

Medically reviewed by Drugs.com. Last updated on Jul 20, 2021.

Note: This document contains side effect information about fam-trastuzumab deruxtecan. Some of the dosage forms listed on this page may not apply to the brand name Enhertu.

For the Consumer

Applies to fam-trastuzumab deruxtecan: intravenous powder for solution

Warning

Intravenous route (Powder for Solution)

Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms. Exposure to fam-trastuzumab deruxtecan-nxki during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Side effects requiring immediate medical attention

Along with its needed effects, fam-trastuzumab deruxtecan (the active ingredient contained in Enhertu) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fam-trastuzumab deruxtecan:

More common

  • Black, tarry stools
  • bloody nose
  • chest pain or tightness
  • chills
  • cough
  • decreased urine output
  • difficult breathing
  • dilated neck veins
  • dry mouth
  • fever
  • general feeling of discomfort or illness
  • increased thirst
  • irregular breathing
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • seizures
  • sneezing
  • sore throat
  • swelling of the face, fingers, feet, or lower legs
  • thickening of bronchial secretions
  • trouble breathing
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain

Side effects not requiring immediate medical attention

Some side effects of fam-trastuzumab deruxtecan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to fam-trastuzumab deruxtecan: intravenous powder for injection

Hematologic

Very common (10% or more): Anemia (e.g., anemia, hemoglobin decreased, hematocrit decreased, red blood cell count decreased) (31%), neutropenia (e.g., neutropenia, neutrophil count decreased) (30%), leukopenia (e.g., leukopenia, lymphopenia, white blood cell count decreased) (22%), thrombocytopenia (e.g., thrombocytopenia, platelet count decreased) (20%)[Ref]

Immunologic

Frequency not reported: As with all therapeutic proteins there is potential for immunogenicity[Ref]

Ocular

Very common (10% or more): Dry eye (11%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (32%), hypokalemia (12%)[Ref]

Hepatic

Very common (10% or more): Aspartate aminotransferase increased (14%), alanine aminotransferase increased (14%)[Ref]

Respiratory

Very common (10% or more): Cough (20%), dyspnea (13%), epistaxis (13%)

Common (1% to 10%): Interstitial lung disease (ILD) (e.g., pneumonitis, ILD, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis), upper respiratory tract infection (e.g., influenza, influenza like illness, upper respiratory tract infection) (15%)[Ref]

Other

Very common (10% or more): Fatigue/asthenia (59%)[Ref]

Nervous system

Very common (10% or more): Headache (e.g., headache, sinus headache, migraine) (19%)[Ref]

Cardiovascular

Frequency not reported: Left ventricular dysfunction (LVEF)[Ref]

Dermatologic

Very common (10% or more): Alopecia (46%), rash (e.g., rash, rash pustular, rash maculopapular) (10%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (79%), vomiting (47%), constipation (35%), diarrhea (29%), abdominal pain (e.g., abdominal discomfort, GI pain, abdominal pain, abdominal pain lower, abdominal pain upper) (19%), stomatitis (e.g., stomatitis, aphthous ulcer, mouth ulceration, oral mucosa erosion, oral mucosa blistering) (14%), dyspepsia (12%)[Ref]

Frequently asked questions

References

1. "Product Information. Enhertu (fam-trastuzumab deruxtecan)." Daiichi Sankyo, Inc., Parsippany, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.