Herceptin: Difference between revisions

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== '''What is Herceptin?''' ==
#REDIRECT [[Trastuzumab]]


* '''Herceptin''' ([[trastuzumab]]) is '''a HER2/neu receptor antagonist''' used in combination with other [[antineoplastic agents]] in the therapy of breast and gastric cancer. 
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[[File:Trastuzumab-HER2 complex 1N8Z.png|thumb|Trastuzumab-HER2 complex 1N8Z]]
[[Category:Drugs developed by Genentech]]
 
[[Category:Drugs developed by Hoffmann-La Roche]]
 
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== '''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?''' ==
 
 
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* 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:
* {{overdose}}
 
 
== '''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.|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.
 
 
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{{Extracellular chemotherapeutic agents}}
{{Monoclonals for tumors}}
{{Growth factor receptor modulators}}
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[[Category:Genentech brands]]
[[Category:Hoffmann-La Roche brands]]
[[Category:Immunology]]
[[Category:Merck & Co. brands]]
[[Category:Monoclonal antibodies for tumors]]
[[Category:Specialty drugs]]

Latest revision as of 16:44, 28 February 2025

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