Drug Information

Herceptin Side Effects

Generic Name: trastuzumab

Please note - some side effects for Herceptin 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 Herceptin - for the Consumer

Herceptin

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 Herceptin:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Herceptin:

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.

Top

Herceptin Side Effects - for the Professional

Herceptin

Adjuvant Breast Cancer

Adverse reactions ( ≥ 2% higher incidence with Herceptin‑containing treatment compared with control treatment) are fatigue, infection, neutropenia, anemia, myalgia, dyspnea, rash/desquamation, headache, diarrhea, and nausea. (6.1)

Metastatic Breast Cancer

Adverse reactions (≥ 15% incidence with Herceptin monotherapy or ≥ 5% with Herceptin/ paclitaxel) are nausea, fever, infection, rash, increased cough, vomiting, diarrhea, headache, and anemia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION
Revised: 06/2008

FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, AND PULMONARY TOXICITY 1 INDICATIONS AND USAGE 1.1 Adjuvant Breast Cancer 1.2 Metastatic Breast Cancer 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Doses and Schedules 2.2 Dose Modifications 2.3 Preparation for Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Cardiomyopathy 5.2 Infusion Reactions 5.3 Exacerbation of Chemotherapy‑Induced Neutropenia 5.4 Pulmonary Toxicity 5.5 HER2 Testing 5.6 Embryo‑Fetal Toxicity (Pregnancy Category D) 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Post‑Marketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Adjuvant Breast Cancer 14.2 Metastatic Breast Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Stability and Storage 17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION: CONTENTS*

* Sections or subsections omitted from the full prescribing information are not listed

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, AND PULMONARY TOXICITY

1 INDICATIONS AND USAGE

1.1 Adjuvant Breast Cancer

1.2 Metastatic Breast Cancer

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Doses and Schedules

2.2 Dose Modifications

2.3 Preparation for Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Cardiomyopathy

5.2 Infusion Reactions

5.3 Exacerbation of Chemotherapy‑Induced Neutropenia

5.4 Pulmonary Toxicity

5.5 HER2 Testing

5.6 Embryo‑Fetal Toxicity (Pregnancy Category D)

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

6.3 Post‑Marketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Adjuvant Breast Cancer

14.2 Metastatic Breast Cancer

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Stability and Storage

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

Top

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.

Top

More resources:

Drugs.com Herceptin

MedFacts Herceptin

Micromedex Herceptin - Includes detailed dosage instructions.

FDA Herceptin

Facts & Comparisons Trastuzumab

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.