Pertuzumab: Difference between revisions
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|genericName=Pertuzumab | |||
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|drugClass=[[monoclonal antibody]] | |||
|indicationType=treatment | |||
|indication=metastatic breast cancer and as a neoadjuvant treatment of breast cancer | |||
|hasBlackBoxWarning=Yes | |||
|adverseReactions=diarrhea, alopecia, neutropenia, nausea, vomiting, fatigue, rash, and peripheral neuropathy in combination with trastuzumab and docetaxel. | |||
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | ||
Revision as of 17:51, 22 January 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
Disclaimer
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Black Box Warning
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TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Pertuzumab is a monoclonal antibody that is FDA approved for the treatment of metastatic breast cancer and as a neoadjuvant treatment of breast cancer. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, alopecia, neutropenia, nausea, vomiting, fatigue, rash, and peripheral neuropathy in combination with trastuzumab and docetaxel..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pertuzumab FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pertuzumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pertuzumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pertuzumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pertuzumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pertuzumab in pediatric patients.
Contraindications
There is limited information regarding Pertuzumab Contraindications in the drug label.
Warnings
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TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
|
There is limited information regarding Pertuzumab Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pertuzumab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Pertuzumab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pertuzumab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pertuzumab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pertuzumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pertuzumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pertuzumab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pertuzumab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pertuzumab in geriatric settings.
Gender
There is no FDA guidance on the use of Pertuzumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pertuzumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pertuzumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pertuzumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pertuzumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pertuzumab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pertuzumab Administration in the drug label.
Monitoring
There is limited information regarding Pertuzumab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pertuzumab and IV administrations.
Overdosage
There is limited information regarding Pertuzumab overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Pertuzumab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pertuzumab Mechanism of Action in the drug label.
Structure
There is limited information regarding Pertuzumab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pertuzumab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pertuzumab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pertuzumab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pertuzumab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pertuzumab How Supplied in the drug label.
Storage
There is limited information regarding Pertuzumab Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Pertuzumab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Pertuzumab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Pertuzumab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pertuzumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Pertuzumab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pertuzumab Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Pertuzumab (also called 2C4, formerly known as Omnitarg) is a monoclonal antibody. The first of its class in a line of agents called "HER dimerization inhibitors". By binding to HER2, it inhibits the dimerization of HER2 with other HER receptors, which is hypothesized to result in slowed tumor growth.[1] Omnitarg is currently being developed by Genentech.
Early clinical trials of pertuzumab in prostate, breast, and ovarian cancers have been met with limited success.[2]
References
- ↑ 1.0 1.1 de Bono, Johann S. (20 January 2007). "Open-Label Phase II Study Evaluating the Efficacy and Safety of Two Doses of Pertuzumab in Castrate Chemotherapy-Naive Patients With Hormone-Refractory Prostate Cancer". Journal of Clinical Oncology. 25 (3): 257–262.
- ↑ Genentech press release - May 15, 2005