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Related to Herceptin: HER2



Pharmacologic class: Recombinant DNA-derived monoclonal antibody

Therapeutic class: Antineoplastic

Pregnancy risk category B

FDA Box Warning

Drug can result in subclinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction.

Incidence and severity of left ventricular dysfunction were highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens.

Discontinue trastuzumab in patients receiving adjuvant therapy and strongly consider discontinuing in patients with metastatic breast cancer who develop clinically significant decrease in left ventricular function.

Monitor patients for decreased left ventricular function before starting trastuzumab and frequently during and after treatment. Monitor more frequently if drug is withheld in patients who develop significant left ventricular dysfunction.

Serious infusion reactions, some fatal, and pulmonary toxicity have occurred. In most cases, signs and symptoms occurred during or within 24 hours of administration. Interrupt infusion for patients experiencing dyspnea or clinically significant hypotension.

Discontinue drug for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Exacerbation of chemotherapy-induced neutropenia has also occurred.


Selectively binds to human epidermal growth factor receptor 2 (HER2), inhibiting proliferation of human tumor cells that overexpress HER2


Lyophilized powder: 440-mg vial (each vial contains 20 ml bacteriostatic water for injection, 1.1% benzyl alcohol)

Indications and dosages

Metastatic breast cancer in patients whose tumors overexpress HER2

Adults: As monotherapy, loading dose of 4 mg/kg I.V. infusion over 90 minutes, followed by weekly maintenance dose of 2 mg/kg I.V. infusion given over 30 minutes if loading dose was tolerated. Don't give by I.V. push.




Use cautiously in:

• hypersensitivity to Chinese hamster ovary cell protein or to benzyl alcohol

• cardiac disease, anemia, leukopenia

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).


• Be aware that baseline left ventricular ejection fraction (LVEF) measurement should be performed immediately before starting drug.

• Follow facility policy for handling, administering, and disposal of carcinogenic, mutagenic, and teratogenic agents.

• Give antiemetic, as prescribed, before administering trastuzumab.

Administer by I.V. infusion only. Don't give by I.V. push or bolus.

• To reconstitute, add 20 ml of bacteriostatic water for injection to vial, pointing diluent stream at lyophilized cake. Swirl vial gently; don't shake. Withdraw prescribed dose and add it to 250 ml of normal saline solution. (Don't use dextrose 5% in water.)

• Infuse loading dose I.V. over 90 minutes. Infuse weekly doses I.V. over 30 minutes.

• Immediately after reconstituting, write a date that is 28 days from reconstitution date in the space after "Do not use after" on vial label.

• If patient has benzyl alcohol hypersensitivity, reconstitute with sterile water for injection. Use immediately after reconstitution; discard unused portion.

Never administer intrathecally; doing so causes death.

• Know that for patient who hasn't previously received chemotherapy for metastatic disease, drug is given at same dosage but in combination with paclitaxel.

Adverse reactions

CNS: dizziness, headache, depression, paresthesia, insomnia, ataxia, confusion, manic reaction, seizures

CV: peripheral edema, hypotension, tachycardia, syncope, arrhythmias, shock, pericardial effusion, vascular thrombosis, heart failure, cardiotoxicity, cardiac arrest, cardiomyopathy

EENT: amblyopia, hearing loss

GI: nausea, vomiting, diarrhea, gastroenteritis, hematemesis, colitis, esophageal ulcer, stomatitis, ileus, anorexia, intestinal obstruction, pancreatitis

GU: urinary tract infection, hematuria, hemorrhagic cystitis, hydronephrosis, pyelonephritis, renal failure

Hematologic: coagulation disorder, pancytopenia, leukemia, exacerbation of chemotherapy-induced neutropenia

Hepatic: ascites, hepatitis, hepatic failure

Metabolic: hypothyroidism, hypercalcemia, hyponatremia

Musculoskeletal: back, bone, or joint pain; myopathy; fractures; bone necrosis

Respiratory: upper respiratory infection, dyspnea, pulmonary toxicity (dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis)

Skin: cellulitis, rash, acne, herpes simplex, herpes zoster, skin ulcers

Other: weight loss, edema, infection, fever, chills, flulike syndrome, lymphangitis, hypersensitivity reactions including anaphylaxis, infusion reaction


Drug-drug. Anthracyclines, cyclophosphamide: cardiotoxicity

Patient monitoring

Monitor closely for signs and symptoms of infusion reaction (including respiratory distress). Halt infusion if these occur.

• Monitor vital signs, especially for hypotension and bradycardia.

Use with extreme caution in patients with cardiac dysfunction. Assess cardiovascular status carefully; stay alert for heart failure, cardiomyopathy, and peripheral edema.

• Assess neurologic status for depression and paresthesia.

• Monitor respiratory status. Report increased dyspnea or flulike symptoms.

• Watch closely for signs and symptoms of infection, including herpes simplex.

• Monitor electrolyte levels and CBC with white cell differential.

• Monitor LVEF measurement every 3 months during and at completion of therapy; measure LVEF at 4-week intervals if drug is withheld for significant left ventricular cardiac dysfunction. Continue LVEF measurement every 6 months for at least 2 years after completion of therapy.

Patient teaching

Instruct patient to immediately report difficulty breathing, flulike symptoms, and fever, chills, and other signs and symptoms of infection.

Advise patient to monitor weight. Tell him to report sudden weight gain as well as swelling and other signs and symptoms of heart failure.

Instruct patient to immediately report abdominal pain, change in bowel habits, yellowing of skin or eyes, and easy bruising or bleeding.

• Tell patient drug may cause depression. Advise him (or significant other as appropriate) to contact prescriber if this occurs.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.


A monoclonal antibody used in treating her 2 neu-positive carcinoma of breast.
Synonym(s): transluzumab


A trademark for the drug trastuzumab.


Trastuzumab Molecular oncology A humanized monoclonal antibody to the HER-2 growth factor receptor used to treat metastatic breast CA that overexpresses HER-2. See Breast cancer, Monoclonal antibody.


A brand name for the monoclonal antibody drug TRASTUZUMAB.


A brand name for TRASTUZUMAB.

Patient discussion about Herceptin

Q. Can anyone tell me about herceptin? Can anyone tell me about herceptin? What kind of treatment it is and why it’s popular? Who can be treated? Does it have any side effects?

A. It is a monoclonal antibody. Patients somewhere between 15 – 25 % with breast cancer responded well to this treatment. The patients have in their cancer cells a large amount of a protein called HER2. The treatment for breast cancer patient will depend on the stage of cancer. Side effects of this Herceptin also called trastuzumab are Fatigue, diarrhea, pain, heart problems and reaction to the drug - causing chills, fever and possibly an itchy rash, feeling sick, breathlessness, wheezing, a headache, flushes and faintness. This happens to about half of patients with the first treatment but usually wears off with further treatments.

Q. What side effects are possible with chemotherapy and herceptin? My sister is taking chemotherapy now. Earlier the doctors prescribed herceptin and she had very severe vomiting and anemia. What side effects are possible with chemotherapy and herceptin?

A. The breast cancer treatment mainly focus on the removal of cancer cells and further treatment to prevent its occurance in future. Generally herceptin is the treatment given to destroy cancer cells which have high level of HER2 protein. And chemotherapy is also given to kill cancer cells, which again depends on the type & stage of cancer cells. Herceptin may have the side effects of severe anemia and nausea/ vomiting. Chemotherapy will also have the side effect such as vomiting, hair loss, fatigue, diarrhea, some infections, anemia, swellings, soreness, joint ache. But there is nothing to worry as this is the only treatment available for cancer.

More discussions about Herceptin
References in periodicals archive ?
According to the company, it is potentially the first company to provide patient access to a biosimilar to Herceptin, representing a significant milestone for the overall healthcare system.
In 2006, diagnosed with HER2-positive breast cancer, Walsh was told herceptin might help but was not fully funded in New Zealand.
Genentech requests authorization from the FDA to administer Herceptin as an investigational drug.
Detailed information on Herceptin including product description, safety and efficacy profiles as well as a SWOT analysis.
Adding Perjeta to treatment with Herceptin and chemotherapy resulted in the longest survival observed to date in a clinical study of people with HER2-positive metastatic breast cancer," said Sandra Horning, M.
gt;the new Herceptin Nicola Marshall, of Heaton, Newcastle, was diagnosed with HER2-positive breast cancer more than a year ago and has been part of the region's clinical trial.
An international study found cancer was half as likely to return in women treated with Herceptin.
But the study of Perjeta, which has been approved in the US, found those receiving the treatment were a third less likely to have passed away than those receiving Herceptin and chemotherapy alone.
Doctors are hailing the Herceptin-plus combination, saying it will change treatment in the same way Herceptin did five years ago.
Combining Adriamycin and Herceptin has been shown to cause permanent heart damage.
Herceptin has become something of a watershed drug by signalling both the start of the use of targeted therapies in the fight against cancer and a shift in the way that we consider whether breakthrough new drugs should be available on the NHS.
Based on the Herceptin ToGA phase III study results, presented in May at the American Society for Clinical Oncology Annual Meeting in Orlando, Florida, Genentech may seek regulatory approvals for the use of Herceptin to treat stomach-cancer patients.