What is mechanism of action?

mechanism of action is HER2/Neu/cerbB2 Antagonists [MoA]

Phesgo

(Pertuzumab, Trastuzumab, And Hyaluronidase-Zzxf)

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Dosage & Administration

For subcutaneous use in the thigh only. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use

[see Warnings and Precautions (5.5)].

)

PHESGO has different dosage and administration instructions than intravenous pertuzumab and trastuzumab products. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)

Do not administer intravenously. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)

* Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (

1 INDICATIONS AND USAGE

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for:

* Use in combination with chemotherapy as:
* 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.
* adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence

* Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

1.1 Early Breast Cancer (EBC)

PHESGO is indicated for use in combination with chemotherapy for

* the neoadjuvant treatment of adult 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

[see Dosage and Administration (2.2)and Clinical Studies (14.2)]

.
* the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence

[see Dosage and Administration (2.2)and Clinical Studies (14.2)]

Select patients for therapy based on an FDA-approved companion diagnostic test

[see Dosage and Administration (2.1)].

1.2 Metastatic Breast Cancer (MBC)

PHESGO is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

[see Dosage and Administration (2.2)and Clinical Studies (14.1)]

Select patients for therapy based on an FDA-approved companion diagnostic test

[see Dosage and Administration (2.1)].

2.1 Patient Selection

Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens

[see Indications and Usage (1)and Clinical Studies (14)]

. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.

Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.

)
* The initial dose of PHESGO is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase administered subcutaneously over approximately 5 minutes. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)
* Neoadjuvant: administer PHESGO by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion preoperatively for 3 to 6 cycles. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)
* Adjuvant: administer PHESGO by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion postoperatively for a total of 1 year (up to 18 cycles). (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)
* MBC: administer PHESGO by subcutaneous injection and docetaxel by intravenous infusion every 3 weeks. (

2.2 Important Dosage and Administration Information

PHESGO is for subcutaneous use only in the thigh. Do

not

administer intravenously.

PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.

Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.

PHESGO must always be administered by a healthcare professional.

In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.

In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.

In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.

[see Warnings and Precautions (5.5)].

)

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Phesgo Prescribing Information

WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

See full prescribing information for complete boxed warning.

Cardiomyopathy: PHESGO administration can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue PHESGO for cardiomyopathy. (

2.3 Recommended Doses and Schedules

The recommended dosage and administration schedule for PHESGO are shown in Table 1.

Table 1: Recommended Dosage and Administration Schedule
Dose	Strength	Administration Instructions
Initial dose	1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase in 15 mL	Administer subcutaneously over approximately 8 minutes
	(1,200 mg, 600 mg, and 30,000 units/15 mL)
Maintenance dose (administer every 3 weeks)	600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase in 10 mL (600 mg, 600 mg, and 20,000 units/10 mL)	Administer subcutaneously over approximately 5 minutes every 3 weeks

No dose adjustments for PHESGO are required for patient body weight or for concomitant chemotherapy regimen.

Patients currently receiving intravenous pertuzumab and trastuzumab can transition to PHESGO. In patients receiving intravenous pertuzumab and trastuzumab with < 6 weeks since their last dose, administer PHESGO as a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab and every 3 weeks for subsequent administrations. In patients receiving intravenous pertuzumab and trastuzumab with ≥ 6 weeks since their last dose, administer PHESGO as an initial dose of 1,200 mg pertuzumab/600 mg trastuzumab, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab every 3 weeks for subsequent administrations

Neoadjuvant Treatment of Breast Cancer

Administer PHESGO every 3 weeks for 3 to 6 cycles as part of a treatment regimen for early breast cancer

[see Clinical Studies (14.2)]

Refer to the prescribing information for pertuzumab, administered in combination with trastuzumab and chemotherapy, for recommended dose and dosage modifications.

Following surgery, patients should continue to receive PHESGO to complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first, as a part of a complete regimen for early breast cancer.

Adjuvant Treatment of Breast Cancer

Administer PHESGO every 3 weeks for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first, as part of a complete regimen for early breast cancer, including standard anthracycline- and/or taxane-based chemotherapy. Start PHESGO on Day 1 of the first taxane-containing cycle

[see Clinical Studies (14.2)]

Metastatic Breast Cancer (MBC)

When administered with PHESGO, the recommended initial dose of docetaxel is 75 mg/m²administered as an intravenous infusion. The dose may be escalated to 100 mg/m²administered every 3 weeks if the initial dose is well tolerated. Administer PHESGO until disease progression or unmanageable toxicity, whichever occurs first.

5.1 Cardiomyopathy

PHESGO can cause hypertension, arrhythmias, left ventricular cardiac dysfunction, disabling cardiac failure, cardiomyopathy, and cardiac death

[see Boxed Warning: Cardiomyopathy].

PHESGO can cause asymptomatic decline in LVEF.

An increased incidence of LVEF decline has been observed in patients treated with intravenous pertuzumab, intravenous trastuzumab, and docetaxel. A 4-6 fold increase in the incidence of symptomatic myocardial dysfunction has been reported among patients receiving trastuzumab, with the highest absolute incidence occurring when trastuzumab was administered with an anthracycline.

Patients who receive anthracycline after stopping PHESGO may also be at increased risk of cardiac dysfunction

[see Drug Interactions (7)and Clinical Pharmacology (12.2)].

Cardiac Monitoring

Prior to initiation of PHESGO, conduct a thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.

During treatment with PHESGO, assess LVEF at regular intervals

[see Dosage and Administration (2.4)].

If after a repeat assessment within approximately 3 weeks, the LVEF has not improved, has declined further, and/or the patient is symptomatic, permanently discontinue PHESGO.

Following completion of PHESGO, continue to monitor for cardiomyopathy and assess LVEF measurements every 6 months for at least 2 years as a component of adjuvant therapy.

PHESGO

In the FeDeriCa trial, the percentage of patients with at least one cardiac disorder was 22% in the PHESGO arm. The most frequent cardiac adverse reaction in the PHESGO arm was ejection fraction decreased.

The incidence of cardiac failure (NYHA Class III/IV) with a LVEF decline ≥ 10% and a drop to less than 50% was 0.8% in the PHESGO arm. Confirmed asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥ 10% and a drop to less than 50% was 1.2% in the PHESGO arm

[see Adverse Reactions (6.1)]

PHESGO and/or intravenous pertuzumab and trastuzumab have not been studied in patients with a pretreatment LVEF value of < 55% (EBC) or <50% (MBC); a prior history of CHF, conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m²of doxorubicin or its equivalent.

)

Embryo-fetal Toxicity: Exposure to PHESGO can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. (

5.2 Embryo-Fetal Toxicity

PHESGO can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of intravenous trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In an animal reproduction study, administration of intravenous pertuzumab to pregnant cynomolgus monkeys during the period of organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryo-fetal death at exposures 2.5 to 20 times the exposure in humans at the recommended dose, based on C_max.

Verify the pregnancy status of females of reproductive potential prior to the initiation of PHESGO. Advise pregnant women and females of reproductive potential that exposure to PHESGO 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 PHESGO

[see Use in Specific Populations (8.1, 8.3)and Clinical Pharmacology (12.3)].

8.1 Pregnancy

Pregnancy Pharmacovigilance Program

There is a pregnancy pharmacovigilance program for PHESGO. If PHESGO is administered during pregnancy, or if a patient becomes pregnant while receiving PHESGO or within 7 months following the last dose of PHESGO, health care providers and patients should immediately report PHESGO exposure to Genentech at 1-888-835-2555.

Risk Summary

(see Data)

. In an animal reproduction study, administration of pertuzumab to pregnant cynomolgus monkeys during the period of organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryo-fetal deaths at clinically relevant exposures that were 2.5 to 20-fold greater than exposures in humans receiving the recommended dose, based on C_max

(see Data)

. Apprise the patient of the potential risks to a fetus. There are clinical considerations if PHESGO is used during pregnancy or within 7 months prior to conception

(see Clinical Considerations)

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Monitor women who received PHESGO during pregnancy or within 7 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care.

Data

Human Data

In post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after trastuzumab was stopped. In one case, trastuzumab therapy resumed after amniotic index improved and oligohydramnios recurred.

Animal Data

PHESGO for subcutaneous injection contains pertuzumab, trastuzumab, and hyaluronidase

[see Description (11)]

Pertuzumab:

Pregnant cynomolgus monkeys were treated on Gestational Day (GD) 19 with loading doses of 30 to 150 mg/kg pertuzumab, followed by bi-weekly doses of 10 to 100 mg/kg. These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than exposures in humans receiving the recommended dose, based on C_max. Intravenous administration of pertuzumab from GD19 through GD50 (period of organogenesis) was embryotoxic, with dose-dependent increases in embryo-fetal death between GD25 to GD70. The incidences of embryo-fetal loss were 33, 50, and 85%. At Caesarean section on GD100, oligohydramnios, decreased relative lung and kidney weights, and microscopic evidence of renal hypoplasia consistent with delayed renal development were identified in all pertuzumab dose groups. Pertuzumab exposure was reported in offspring from all treated groups, at levels of 29% to 40% of maternal serum levels at GD100.

Trastuzumab:

In studies where intravenous trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (Gestation Days 20 to 50) and late (Gestation Days 120 to 150) phases of gestation. The resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects.

Hyaluronidase:

In an embryo-fetal study, mice have been dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (recombinant human) at dose levels up to 2,200,000 U/kg, which is >2,400 and 3,600, based on loading and maintenance doses, respectively, times higher than the human dose. The study found no evidence of teratogenicity. Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which is >400 and 600, based on loading and maintenance doses, respectively, times higher than the human dose.

In a peri-and post-natal reproduction study, mice have been dosed daily by subcutaneous injection, with hyaluronidase (recombinant human) from implantation through lactation and weaning at dose levels up to 1,100,000 U/kg, which is >1,200 and 1,800, based on loading and maintenance doses, respectively, times higher than the human dose. The study found no adverse effects on sexual maturation, learning and memory or fertility of the offspring.

8.3 Females and Males of Reproductive Potential

PHESGO can cause embryo-fetal harm when administered during pregnancy.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to the initiation of PHESGO.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PHESGO

[see Use in Specific Populations (8.1)and Clinical Pharmacology (12.3)]

)

Pulmonary Toxicity: Discontinue PHESGO for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (

5.3 Pulmonary Toxicity

PHESGO can cause serious and fatal pulmonary toxicity. These adverse reactions have been reported with intravenous trastuzumab. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.

)

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for:

Use in combination with chemotherapy as:
- 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. (
  1.1 Early Breast Cancer (EBC)
  PHESGO is indicated for use in combination with chemotherapy for
  the neoadjuvant treatment of adult 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
  [see Dosage and Administration (2.2)and Clinical Studies (14.2)]
  .
  the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
  [see Dosage and Administration (2.2)and Clinical Studies (14.2)]
  .
  Select patients for therapy based on an FDA-approved companion diagnostic test
  [see Dosage and Administration (2.1)].
  )
- adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (
  1.1 Early Breast Cancer (EBC)
  PHESGO is indicated for use in combination with chemotherapy for
  the neoadjuvant treatment of adult 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
  [see Dosage and Administration (2.2)and Clinical Studies (14.2)]
  .
  the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
  [see Dosage and Administration (2.2)and Clinical Studies (14.2)]
  .
  Select patients for therapy based on an FDA-approved companion diagnostic test
  [see Dosage and Administration (2.1)].
  )
Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (
1.2 Metastatic Breast Cancer (MBC)
PHESGO is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
[see Dosage and Administration (2.2)and Clinical Studies (14.1)]
.
Select patients for therapy based on an FDA-approved companion diagnostic test
[see Dosage and Administration (2.1)].
)

For subcutaneous use in the thigh only. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
PHESGO has different dosage and administration instructions than intravenous pertuzumab and trastuzumab products. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
Do not administer intravenously. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
Perform HER2 testing using FDA-approved tests by laboratories with demonstrated proficiency. (
1 INDICATIONS AND USAGE
PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for:
Use in combination with chemotherapy as:
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.
adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence
Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
1.1 Early Breast Cancer (EBC)
PHESGO is indicated for use in combination with chemotherapy for
the neoadjuvant treatment of adult 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
[see Dosage and Administration (2.2)and Clinical Studies (14.2)]
.
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
[see Dosage and Administration (2.2)and Clinical Studies (14.2)]
.
Select patients for therapy based on an FDA-approved companion diagnostic test
[see Dosage and Administration (2.1)].
1.2 Metastatic Breast Cancer (MBC)
PHESGO is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
[see Dosage and Administration (2.2)and Clinical Studies (14.1)]
.
Select patients for therapy based on an FDA-approved companion diagnostic test
[see Dosage and Administration (2.1)].
,
2.1 Patient Selection
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
[see Indications and Usage (1)and Clinical Studies (14)]
. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
)
The initial dose of PHESGO is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase administered subcutaneously over approximately 5 minutes. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
Neoadjuvant: administer PHESGO by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion preoperatively for 3 to 6 cycles. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
Adjuvant: administer PHESGO by subcutaneous injection every 3 weeks and chemotherapy by intravenous infusion postoperatively for a total of 1 year (up to 18 cycles). (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)
MBC: administer PHESGO by subcutaneous injection and docetaxel by intravenous infusion every 3 weeks. (
2.2 Important Dosage and Administration Information
PHESGO is for subcutaneous use only in the thigh. Do
not
administer intravenously.
PHESGO has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
Do not substitute PHESGO for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan.
PHESGO must always be administered by a healthcare professional.
In patients receiving an anthracycline-based regimen for early breast cancer, administer PHESGO following completion of the anthracycline.
In patients receiving PHESGO for early breast cancer with docetaxel or paclitaxel, administer docetaxel or paclitaxel after PHESGO.
In patients receiving PHESGO for metastatic breast cancer with docetaxel, administer docetaxel after PHESGO.
Observe patients for a minimum of 30 minutes after initial dose of PHESGO and 15 minutes after each maintenance dose of PHESGO for signs or hypersensitivity symptoms or administration-related reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
[see Warnings and Precautions (5.5)].
)

Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of PHESGO. (

8.3 Females and Males of Reproductive Potential

PHESGO can cause embryo-fetal harm when administered during pregnancy.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to the initiation of PHESGO.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PHESGO

Phesgo

Dosage & Administration

Phesgo Prescribing Information

Phesgo Prior Authorization Resources

Most recent Phesgo prior authorization forms

Most recent state uniform prior authorization forms

Brand Resources

Benefits investigation

Reimbursement help (FRM)

Phesgo PubMed™ News

Phesgo Patient Education

Patient toolkit