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Perjeta

pertuzumab
HER2 Dimerization Inhibitor FDA Approved 2012 Genentech / Roche
Route
IV
Half-Life
18 days
FDA Approved
2012
Manufacturer
Genentech / Roche
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1. Indications and Usage

Breast cancer: With trastuzumab + chemo for HER2+ BC (neoadjuvant, adjuvant, first-line metastatic).

2. Dosage and Administration

Loading: 840 mg IV. Maintenance: 420 mg IV Q3W.

3. Dosage Forms and Strengths

Injection: 420 mg/14 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Cardiomyopathy: Assess LVEF.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
  • Infusion Reactions: Anaphylaxis reported.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (67%), Alopecia (61%), Neutropenia (53%), Nausea (42%), Fatigue (38%), Rash (36%), Peripheral Neuropathy (30%), Decreased Appetite (29%)

Diarrhea
67%
Alopecia
61%
Neutropenia
53%
Nausea
42%
Fatigue
38%
Rash
36%
Peripheral Neuropathy
30%
Decreased Appetite
29%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No PK interactions with trastuzumab or docetaxel.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Humanized mAb targeting HER2 subdomain II, blocking ligand-dependent heterodimerization and mediating ADCC.

Pharmacokinetics

t½: 18 days. Vd: 4.6 L. Steady state by Cycle 7.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Perjeta has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Perjeta. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Perjeta (pertuzumab) approved for?

Perjeta (pertuzumab) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Perjeta (pertuzumab) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Perjeta (pertuzumab) work?

Humanized mAb targeting HER2 subdomain II, blocking ligand-dependent heterodimerization and mediating ADCC.

What are the most common side effects?

Diarrhea (67%), Alopecia (61%), Neutropenia (53%), Nausea (42%), Fatigue (38%), Rash (36%), Peripheral Neuropathy (30%), Decreased Appetite (29%) Diarrhea 67% Alopecia 61% Neutropenia 53% Nausea 42% Fatigue 38% Rash 36% Peripheral Neuropathy 30% Decreased Appetite 29%