Herzuma: Difference between revisions

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


* '''Herzuma''' ([[trastuzumab]]-pkrb) is '''a HER2/neu receptor antagonist''' used for the treatment of [[HER2]]-overexpressing [[breast cancer]], HER2-overexpressing [[metastatic]] gastric or [[gastroesophageal junction adenocarcinoma]].
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[[File:Trastuzumab-HER2 complex 1N8Z.png|thumb|Trastuzumab-HER2 complex 1N8Z]]
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== '''What are the uses of this medicine?''' ==
 
Herzuma (trastuzumab-pkrb) is used for the treatment of:
* HER2-overexpressing [[breast cancer]].
* 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 trastuzumab products 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 medical use in the United States in September 1998, and in the European Union in August 2000.
 
 
== '''How should this medicine be used?''' ==
 
'''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 and carboplatin).
* One week after the last weekly dose of Herzuma, 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 minute IV infusion, then 6 mg/kg over 30-90 minute 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 minute IV infusion, followed by 6 mg/kg over 30 to 90 minute IV infusion every 3 weeks.
 
'''Administration:'''
* For intravenous (IV) infusion only.
* Do not administer as an IV push or bolus.
 
 
== '''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]].
* '''For Injection:''' 420 mg lyophilized powder in a multiple-dose vial for reconstitution.
 
This medicine is available in fallowing brand namesː
* '''Herzuma'''
 
 
=='''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?''' ==
 
* Administration of trastuzumab products can result in sub-clinical and clinical [[cardiac failure]]. The incidence and severity was highest in patients receiving trastuzumab with [[anthracycline]]-containing chemotherapy regimens. Discontinue Herzuma for cardiomyopathy.
* Administration of trastuzumab products can result in serious and fatal infusion reactions and [[pulmonary toxicity]]. Discontinue Herzuma for [[anaphylaxis]], [[angioedema]], [[interstitial pneumonitis]], or [[acute respiratory distress syndrome]]. 
* Exposure to trastuzumab products during pregnancy can result in [[oligohydramnios]] and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.  Advise patients of these risks and the need for effective [[contraception]].
* Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes [[dyspnea]], [[interstitial pneumonitis]], [[Pulmonary infiltrate|pulmonary infiltrates]], [[pleural effusions]], non-cardiogenic [[pulmonary edema]], pulmonary insufficiency and [[hypoxia]], [[acute respiratory distress syndrome]], and [[pulmonary fibrosis]].
 
 
== '''What to do in case of emergency/overdose?''' ==
 
* {{overdose}}
 
 
== '''Can this medicine be used in pregnancy?''' ==
 
* Trastuzumab products can cause fetal harm when administered to a pregnant woman.
 
 
=='''Can this medicine be used in children?'''==
 
* The safety and effectiveness of trastuzumab products in pediatric patients have not been established.
 
 
== '''What are the active and inactive ingredients in this medicine?''' ==
 
'''Active ingredient:'''
* TRASTUZUMAB
 
Inactive ingredients:
* TREHALOSE DIHYDRATE
* HISTIDINE MONOHYDROCHLORIDE
* HISTIDINE
* POLYSORBATE 20
 
 
== '''Who manufactures and distributes this medicine?''' ==
 
'''Manufactured by:'''
* [[Celltrion Inc.|CELLTRION, Inc]].
* 23, Academy-ro,
* Yeonsu-gu, Incheon
* 22014, Republic of Korea
 
* Herzuma® is a registered trademark of CELLTRION, Inc.
 
 
== '''What should I know about storage and disposal of this medication?''' ==
 
* Store Herzuma vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of [[reconstitution]].
 
 
{{coststubd}}
{{Extracellular chemotherapeutic agents}}
{{Monoclonals for tumors}}
{{Growth factor receptor modulators}}
{{portal bar|Medicine}}
 
[[Category:Genentech brands]]
[[Category:Hoffmann-La Roche brands]]
[[Category:Immunology]]
[[Category:Merck & Co. brands]]
[[Category:Monoclonal antibodies for tumors]]
[[Category:RTT]]
[[Category:Specialty drugs]]
[[Category:World Health Organization essential medicines]]

Revision as of 21:47, 24 March 2024

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