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pertuzumab (Rx)Brand and Other Names:Perjeta

 
 
 

Dosing & Uses

AdultPediatric

Metastatic Breast Cancer

Indicated in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

Initial dose: 840 mg IV infusion over 60 min, THEN 420 mg IV infusion over 30-60 min q3wk

Trastuzumab: 8 mg/kg IV infusion over 90 min initially, then 6 mg/kg IV infusion over 30-90 min q3wk

Docetaxel: 75 mg/m² IV infusion initially; may increase to 100 mg/m² IV infusion q3wk if initial dose is well tolerated

Neoadjuvant Treatment of Breast Cancer

Indicated in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer

Initial dose: 840 mg IV infusion over 60 min, THEN 420 mg IV infusion over 30-60 min q3wk

Trastuzumab: 8 mg/kg IV infusion over 90 min initially, then 6 mg/kg IV infusion over 30-90 min q3wk

Docetaxel: 75 mg/m² IV infusion initially; may increase to 100 mg/m² IV infusion q3wk if initial dose is well tolerated

Neoadjuvant dosage regimens

  • Administered q3wk for 3 to 6 cycles as part of 1 of the following treatment regimens for early breast cancer:
  • - 4 preoperative cycles of pertuzumab in combination with trastuzumab and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC)
  • -3 preoperative cycles of FEC alone followed by 3 preoperative cycles of pertuzumab in combination with docetaxel and trastuzumab
  • -6 preoperative cycles of pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH) (escalation of docetaxel above 75 mg/m2 is not recommended)
  • Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment

Dosage Modifications

Withhold or discontinue pertuzumab if trastuzumab is withheld or discontinued; may continue therapy with trastuzumab if docetaxel has been discontinued

Pertuzumab dose reductions are not recommended

Delayed or missed dose

  • Time between 2 doses <6 weeks: Administer 420 mg
  • Time between 2 doses >6 weeks: Administer initial dose of 840 mg, then subsequent doses of 420 q3wk

Hypersensitivity

  • Interrupt or decrease infusion rate if infusion-related reaction occurs
  • Discontinue immediately if severe hypersensitivity reaction occurs

Left ventricular ejection fraction (LVEF)

  • Withhold pertuzumab and trastuzumab for at least 3 weeks if:
  • -LVEF drops to <40% or,
  • -40-45% with >10% absolute decrease below pretreatment values
  • -Resume therapy if LVEF >45% or 40-45% with <10% absolute decrease below baseline
  • -If LVEF has worsened or not improved after 3 weeks, discontinue pertuzumab and trastuzumab, unless the benefits for the individual patient are deemed to outweigh the risks

Dosing Considerations

Safety as part of a doxorubicin-containing regimen has not been established

Neoadjuvant treatment of breast cancer

  • This indication is based on demonstration of an improvement in pathological complete response rate
  • No data are available demonstrating improvement in event-free survival or overall survival
  • Safety of administration for >6 cycles for early breast cancer has not been established

Gastric Cancer (Orphan)

Orphan designation for treatment of gastric cancer

Orphan sponsor

  • Genentech, Inc.; 1 DNA Way; South San Francisco, CA 94080-4990

Administration

For IV infusion only; do not administer as IV push or bolus

Monitor for infusion related adverse effects (eg, hypersensitivity, pyrexia, chills, headache, fatigue, asthenia, vomiting) for 60 minutes following first infusion, and for 30 minutes following subsequent infusions

Pertuzumab, trastuzumab, and docetaxel should be administered sequentially

Pertuzumab and trastuzumab can be given in any order

Safety and efficacy not established

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Adverse Effects

>10%

Diarrhea (66.8%)

Alopecia (60.9%)

Neutropenia (52.8%)

Nausea (42.3%)

Fatigue (37.6%)

Rash (33.7%)

Peripheral neuropathy (32.4%)

Decreased appetite (29.2%)

Mucosal inflammation (27.8%)

Asthenia (26%)

Vomiting (24.1%)

Anemia (23.1%)

Peripheral edema (23.1%)

Nail disorder (22.9%)

Myalgia (22.9%)

Headache (20.9%)

Stomatitis (18.9%)

Pyrexia (18.7%)

Dysgeusia (18.4%)

Leukopenia (18.2%)

Upper respiratory tract infection (16.7%)

Arthralgia (15.5%)

Constipation (15%)

Pruritus (14%)

Dyspnea (14%)

Increased lacrimation (14%)

Febrile neutropenia (13.8%)

Insomnia (13.3%)

Dizziness (12.5%)

Nasopharyngitis (11.8%)

Dry skin (10.6%)

1-10%

Hypersensitivity (10%)

Paronychia (7.1%)

Pleural effusion (5.2%)

Left ventricular dysfunction (4.4%)

Congestive heart failure (1%)

Postmarketing Reports

Thrombocytopenia

Infusion reactions

Note: Adverse reaction were reported less frequently after discontinuing docetaxel; all adverse reactions in the pertuzumab/trastuzumab treatment group occurred in <10% of patients with the exception of diarrhea (19.1%), UTI (12.8%), rash (11.75%), headache (11.4%), and fatigue (11.1%)

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Warnings

Black Box Warnings

Exposure in pregnant women may result in embryo-fetal death and birth defects

Animal studies have observed oligohydramnios, delayed renal development, and death

Advise patients of these risks and the need for effective contraception

Therapy can result in subclinical and clinical cardiac failure; evaluate left ventricular function in all patients prior to and during therapy; discontinue therapy if significant decrease in left ventricular function confirmed

Contraindications

Hypersensitivity

Cautions

Verify pregnancy status of females of reproductive potential prior to the initiation of therapy; advise pregnant women and females of reproductive potential that therapy during pregnancy or within 7 months prior to conception can result in fetal harm; if pertuzumab administered during pregnancy or if patient becomes pregnant while receiving pertuzumab or within 7 months following last dose of pertuzumab in combination with trastuzumab, immediately report exposure to Genentech Adverse Event Line at 1-888-835-2555; encourage women who may be exposed during pregnancy or within 7 months for pertuzumab in combination with trastuzumab prior to conception, to enroll in the MOTHER Pregnancy Registry by contacting 1-800-690-6720; if pregnancy occurs during treatment, monitor for oligohydramnios

Infusion related adverse effects reported; monitor during and after infusion (see Administration)

Decreased left ventricular ejection fraction (LVEF) reported with HER2 blockers; assess LVEF at baseline and q3 months (also see Dosage Modifications)

Severe hypersensitivity, including anaphylaxis observed

HER2 testing: Detection of HER2 protein overexpression required for selection of patients appropriate for pertuzumab therapy

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Pregnancy & Lactation

Pregnancy Category: D; based on animal studies, may cause fetal harm including oligohydramnios, delayed fetal kidney development, and embryofetal death (see Black Box Warnings)

Lactation: Unknown whether distributed in breast milk; because of potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breast feeding or discontinue the drug, taking into account the importance of the drug to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Monoclonal antibody that binds to the extracellular dimerization domain of the human epidermal growth factor receptor 2 protein (HER2); mediates antibody-dependent cellular cytotoxicity by inhibiting proliferation of cells that overexpress HER2

Elimination

Half-life: 18 days

Total body clearance: 0.24 L/day

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Administration

IV Compatibilities

0.9% NaCl

IV Preparation

Withdraw appropriate volume for desired dose from vial(s)

Dilute measured dose into 0.9% NaCl 250 ml infusion bag (dilute with 0.9% NaCl only, do not use dextrose solution)

Do not shake; mix diluted solution by gentle inversion

Administer immediately once prepared or store refrigerated (see Storage)

IV Administration

Administer initial dose as IV infusion over 60 minutes; subsequent doses may be administered over 30-60 minutes

Interrupt or decrease infusion rate if infusion-associated reaction occurs

Administer by IV infusion only; do not give IV push

Storage

Unopened vials are stable until date indicated on package when stored refrigerated 2-8°C (36-46°F) in carton and protected from light

Diluted solution: May be stored refrigerated at 2-8°C (36-46°F) for up to 24 hr

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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