Herceptin

What is Herceptin?

• Herceptin (trastuzumab) is a HER2/neu receptor antagonist used in combination with other antineoplastic agents in the therapy of breast and gastric cancer.

Trastuzumab-HER2 complex 1N8Z

What are the uses of this medicine?

Herceptin (trastuzumab) is used for:

• The treatment of HER2-overexpressing breast cancer.
• The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

How does this medicine work?

• Trastuzumab (tras tooz’ ue mab) is humanized monoclonal antibody to HER2 which is a human growth factor receptor that is overexpressed in 20% to 25% of breast cancers.
• The interaction of epidermal growth factor (EGF) with HER2 results in rapid cell growth and proliferation via intracellular pathways that include MAP and PI3 kinase.
• Binding of trastuzumab to the HER2 receptor blocks this cell signaling pathway and causes growth arrest.
• Trastuzumab was shown to decrease recurrences and prolong survival in women with breast cancer that were HER2 positive.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Patients who receive anthracycline after stopping Herceptin may be at increased risk of cardiac dysfunction.
• If anthracyclines are used, the patient's cardiac function should be monitored carefully.

Is this medicine FDA approved?

• Trastuzumab was approved for use in the United States in 1998 and current indications include breast and gastric cancers that express HER2.

How should this medicine be used?

• Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens.

Recommended dosage:

Adjuvant Treatment of HER2-Overexpressing Breast Cancer:

• Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel/carboplatin).
• One week after the last weekly dose of Herceptin, administer 6 mg/kg as an IV infusion over 30–90 minutes every three weeks to complete a total of 52 weeks of therapy, or
• Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30–90 minutes IV infusion every three weeks for 52 weeks.

Metastatic HER2-Overexpressing Breast Cancer:

• Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.

Metastatic HER2-Overexpressing Gastric Cancer:

• Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.

Administration:

• For intravenous (IV) infusion only.
• Do not administer as an IV push or bolus.
• Do not substitute Herceptin (trastuzumab) for or with ado-trastuzumab emtansine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Herceptin

What side effects can this medication cause?

The most common side effects of this medicine include: In Adjuvant Breast Cancer:

• headache, diarrhea, nausea, and chills

In Metastatic Breast Cancer:

• fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash

In Metastatic Gastric Cancer:

• neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

What special precautions should I follow?

• Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
• Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.
• Herceptin can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential that exposure to Herceptin during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Herceptin.
• Herceptin use can result in serious and fatal pulmonary toxicity.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no experience with overdosage in human clinical trials.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Herceptin can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Herceptin in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• TRASTUZUMAB

Inactive ingredients:

• HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
• HISTIDINE
• TREHALOSE DIHYDRATE
• POLYSORBATE 20

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc.
• A Member of the Roche Group
• 1 DNA Way
• South San Francisco, CA

• Herceptin® is a registered trademark of Genentech, Inc.

What should I know about storage and disposal of this medication?

• Store Herceptin vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.

• Dailymed label info on Herceptin
• FDA Herceptin