Trastuzumab Side Effects

Brand Names: Herceptin

Please note - some side effects for Trastuzumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trastuzumab - for the Consumer

Trastuzumab

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trastuzumab:

Abnormal skin sensations; back pain; cough; diarrhea; dizziness; headache; loss of appetite; muscle, bone, or joint pain; nose, sinus, or throat inflammation; runny nose; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; difficult or painful urination; fainting; fast or irregular heartbeat; fever and chills; mood or mental changes (eg, depression); nausea; new or worsening shortness of breath; pain, redness, or swelling at the injection site; persistent cough; severe or persistent dizziness, lightheadedness, or headache; skin infection (eg, skin discharge, redness, swelling, or warmth); sore throat; sudden unexplained weight gain; swelling of feet or ankles; unusual fatigue or weakness; vomiting; weakness; wheezing.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects including congestive heart failure (7%), tachycardia (5%), angioedema, asymptomatic drops in LVEF, and elevated blood pressure have been reported. Trastuzumab has also been associated with an increased risk of asymptomatic decreases in ejection fraction and a case report of peripheral vascular toxicity.

A randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer demonstrated a significant increase in cardiotoxicity in patients who were randomized to the trastuzumab-containing arm as compared to patients who received chemotherapy alone. Preliminary analysis of safety data revealed a statistically significant increase in the 3 year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the trastuzumab-containing regimen (4.1%) compared with control (0.8%). There were no cardiac deaths observed in patients who received the trastuzumab-containing regimen and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in these studies is ongoing.

The infusion of trastuzumab should be interrupted for patients experiencing clinically significant hypotension. Discontinuation of therapy should be strongly considered for patients who develop angioedema.

Trastuzumab is associated with an increased risk of cardiac dysfunction which is greatest in patients receiving concurrent anthracyclines.

General

General side effects including pain (47%), asthenia (42%), fever (36%), chills (32%), headache (26%), abdominal pain (22%), back pain (22%), infection (20%), flu syndrome (10%), and accidental injury (6%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (33%), diarrhea (25%), vomiting (23%), anorexia (14%), and nausea with vomiting (8%) have been reported.

Respiratory

Adverse reactions requiring interruption or discontinuation of trastuzumab treatment include pulmonary toxicity. The infusion of trastuzumab should be interrupted for patients experiencing dyspnea. Discontinuation of therapy should be strongly considered for patients who develop acute respiratory distress syndrome.

Respiratory side effects including adult respiratory distress syndrome have been reported. Fifteen patients have been reported to have experienced pulmonary and other adverse events which lead to fatalities. Increased cough (26%), dyspnea (22%), rhinitis (14%), pharyngitis (12%), and sinusitis (9%) have also been reported.

Hypersensitivity

Patients should be monitored closely until signs and symptoms of the hypersensitivity reaction completely resolve. Discontinuation of therapy should be strongly considered for patients who develop anaphylaxis.

Hypersensitivity side effects including fatal anaphylaxis have been reported. There have been sixty-two postmarketing reports of serious adverse events related to the use of trastuzumab. These events have been hypersensitivity, infusion, and/or pulmonary reactions.

Local

Local side effects including infusion reactions (some of which had fatal outcomes) have been reported.

Dermatologic

Dermatologic side effects including rash (18%), herpes simplex (2%), and acne (2%) have been reported.

Nervous system

Nervous system side effects including insomnia (14%), dizziness (13%), paresthesia (9%), depression (6%), peripheral neuritis (2%), and neuropathy (1%) have been reported.

Metabolic

Metabolic side effects including peripheral edema (10%) and edema (8%) have been reported.

Musculoskeletal

Musculoskeletal side effects including bone pain (7%) and arthralgia (6%) have been reported.

Genitourinary

Genitourinary side effects including urinary tract infection (5%) have been reported.

Hematologic

Hematologic side effects including anemia (4%), leukopenia (3%), neutropenia, and febrile neutropenia have been reported. A case of thrombocytopenia has also been reported.

Deaths due to sepsis in patients with severe neutropenia have been reported in patients receiving trastuzumab and myelosuppressive chemotherapy.

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