pertuzumab/trastuzumab/hyaluronidase (Rx)

Brand and Other Names:Phesgo, pertuzumab-trastuzumab-hyaluronidase-zzxf
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

pertuzumab/trastuzumab/hyaluronidase

injectable solution

  • 600mg/600mg/30,000units/10 mL
  • 1,200mg/600mg/30,000units/15 mL

Early Breast Cancer

Neoadjuvant treatment

  • Indicated in combination with chemotherapy for neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either >2 cm in diameter or node positive as part of a complete treatment regimen for early breast cancer [EBC])
  • Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations
  • Treated with IV pertuzumab and trastuzumab ≥6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations
  • Administer for 3-6 cycles as part of a treatment regimen for EBC
  • Following surgery
    • Continue to receive pertuzumab/trastuzumab/hyaluronidase to complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first
    • Refer to the prescribing information for pertuzumab, administered in combination with trastuzumab and chemotherapy, for recommended dose and dosage modifications

Adjuvant treatment

  • Indicated in combination with chemotherapy for adjuvant treatment of adults with HER2-positive EBC at high risk of recurrence
  • Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations
  • Treated with IV pertuzumab and trastuzumab ≥6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations
  • Administer for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first
  • For taxane-based regimens: Start on Day 1

Metastatic Breast Cancer

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

Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations

Treated with IV pertuzumab and trastuzumab ≥6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations

When administered with Phesgo, start with docetaxel is 75 mg/m2 IV initially; may escalate dose to 100 mg/m2 IV q3Weeks if initial dose is well tolerated

Continue until disease progression or unmanageable toxicity, whichever occurs first

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

Dosage Modifications

Left ventricular dysfunction (LVEF)

  • If after a repeat assessment within ~3 weeks, the LVEF has not improved, has declined further, and/or the patient is symptomatic, permanently discontinue
  • EBC
    • Pretreatment LVEF: ≥55%
    • Monitor LVEF every ~12 weeks (once during neoadjuvant therapy)
    • Withhold for at least 3 weeks for an LVEF decrease to <50% with a fall of ≥10%-points below pretreatment value
    • Resume after 3 weeks if LVEF has recovered to either LVEF ≥50% OR <10%-points below pretreatment value
    • Before starting Phesgo, patients receiving anthracycline-based chemotherapy require an LVEF ≥50% after completion of anthracyclines
    • If after a repeat assessment within ~3 weeks, LVEF has not improved, has declined further, and/or the patient is symptomatic, permanently discontinue
    • Following completion of Phesgo, continue to monitor for cardiomyopathy and assess LVEF every 6 months for at least 2 years as a component of adjuvant therapy
  • MBC
    • Pretreatment LVEF: ≥50%
    • Monitor LVEF every ~12 weeks
    • Withhold for at least 3 weeks for either an LVEF decrease to <40% OR LVEF decrease to <40-45% with a fall of ≥10%-points below pretreatment value
    • Resume after 3 weeks if LVEF has recovered to either LVEF >40% OR LVEF decrease to <40-45% with a fall of <10%-points below pretreatment value
    • If after a repeat assessment within ~3 weeks, LVEF has not improved, has declined further, and/or the patient is symptomatic, permanently discontinue

Hypersensitivity and administration-related reactions

  • Discontinue immediately if the patient experiences a serious hypersensitivity reaction (eg, anaphylaxis)

Renal impairment

  • All severities: No clinically significant differences in the pharmacokinetics of pertuzumab and trastuzumab were observed

Hepatic impairment

  • Pharmacokinetics of pertuzumab and trastuzumab are unknown

Dosing Considerations

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

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

Patient selection

  • Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens by an FDA-approved companion diagnostic test
  • Information on the FDA-approved tests are available at: http://www.fda.gov/CompanionDiagnostics

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and pertuzumab/trastuzumab/hyaluronidase

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

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          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (3)

              • beclomethasone, inhaled

                beclomethasone, inhaled will decrease the level or effect of hyaluronidase by unspecified interaction mechanism. Avoid or Use Alternate Drug. Larger hyaluronidase doses may be required to achieve desired effect

              • daunorubicin

                trastuzumab, daunorubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              • palifermin

                palifermin increases toxicity of pertuzumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              Monitor Closely (67)

              • abatacept

                trastuzumab, abatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • abemaciclib

                trastuzumab, abemaciclib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • acalabrutinib

                trastuzumab, acalabrutinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • ado-trastuzumab emtansine

                trastuzumab, ado-trastuzumab emtansine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • alemtuzumab

                trastuzumab, alemtuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • alprazolam

                hyaluronidase, alprazolam. Other (see comment). Use Caution/Monitor. Comment: Drug combination has been found to be incompatible.

              • anakinra

                trastuzumab, anakinra. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • antithymocyte globulin equine

                trastuzumab, antithymocyte globulin equine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • antithymocyte globulin rabbit

                trastuzumab, antithymocyte globulin rabbit. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • articaine

                hyaluronidase, articaine. Other (see comment). Use Caution/Monitor. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

              • aspirin

                aspirin decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Salicylates, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • aspirin rectal

                aspirin rectal decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Salicylates, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Salicylates, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • azacitidine

                trastuzumab, azacitidine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • azathioprine

                trastuzumab, azathioprine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • azelastine

                azelastine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • baricitinib

                trastuzumab, baricitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • basiliximab

                trastuzumab, basiliximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • bazedoxifene/conjugated estrogens

                bazedoxifene/conjugated estrogens decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Enhanced tissue resistance to hyaluronidase.

              • beclomethasone, inhaled

                trastuzumab, beclomethasone, inhaled. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • beclomethasone, intranasal

                trastuzumab, beclomethasone, intranasal. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • belatacept

                trastuzumab, belatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • belimumab

                trastuzumab, belimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • betamethasone

                trastuzumab, betamethasone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • bleomycin

                trastuzumab, bleomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • blinatumomab

                trastuzumab, blinatumomab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • brentuximab vedotin

                trastuzumab, brentuximab vedotin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • brodalumab

                trastuzumab, brodalumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • brompheniramine

                brompheniramine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • budesonide

                trastuzumab, budesonide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • busulfan

                trastuzumab, busulfan. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cabazitaxel

                trastuzumab, cabazitaxel. Either increases levels of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • canakinumab

                trastuzumab, canakinumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • capecitabine

                trastuzumab, capecitabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • carbinoxamine

                carbinoxamine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • carboplatin

                trastuzumab, carboplatin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • carmustine

                trastuzumab, carmustine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • certolizumab pegol

                trastuzumab, certolizumab pegol. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cetirizine

                cetirizine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect. .

              • chlorambucil

                trastuzumab, chlorambucil. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • chloroprocaine

                hyaluronidase, chloroprocaine. Other (see comment). Use Caution/Monitor. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

              • chlorpheniramine

                chlorpheniramine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • cholera vaccine

                pertuzumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Salicylates, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect. .

              • cisplatin

                trastuzumab, cisplatin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cladribine

                trastuzumab, cladribine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • clemastine

                clemastine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • clofarabine

                trastuzumab, clofarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • clonazepam

                hyaluronidase, clonazepam. Other (see comment). Use Caution/Monitor. Comment: Drug combination has been found to be incompatible.

              • conjugated estrogens

                conjugated estrogens decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Enhanced tissue resistance to hyaluronidase.

              • conjugated estrogens, vaginal

                conjugated estrogens, vaginal decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Enhanced tissue resistance to hyaluronidase.

              • copanlisib

                trastuzumab, copanlisib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • corticotropin

                corticotropin decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Corticotropin (ACTH), when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect. .

                trastuzumab, corticotropin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cortisone

                cortisone decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Cortisone, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect. .

                trastuzumab, cortisone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cyclizine

                cyclizine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • cyclophosphamide

                trastuzumab, cyclophosphamide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cyclosporine

                trastuzumab, cyclosporine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • cyproheptadine

                cyproheptadine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect.

              • cytarabine

                trastuzumab, cytarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • dacarbazine

                trastuzumab, dacarbazine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • dactinomycin

                trastuzumab, dactinomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • dasatinib

                trastuzumab, dasatinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • daunorubicin

                trastuzumab, daunorubicin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • deflazacort

                trastuzumab, deflazacort. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • dengue vaccine

                pertuzumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

                trastuzumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • dexamethasone

                trastuzumab, dexamethasone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • siponimod

                siponimod and pertuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              Minor (4)

              • bupivacaine

                hyaluronidase, bupivacaine. Other (see comment). Minor/Significance Unknown. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

              • mepivacaine

                hyaluronidase, mepivacaine. Other (see comment). Minor/Significance Unknown. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

              • prilocaine

                hyaluronidase, prilocaine. Other (see comment). Minor/Significance Unknown. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

              • ropivacaine

                hyaluronidase, ropivacaine. Other (see comment). Minor/Significance Unknown. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

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              Adverse Effects

              >10%

              All grades

              • Low hemoglobin (90%)
              • Low absolute lymphocytes (89%)
              • High creatinine (84%)
              • Low total leukocytes (82%)
              • Alopecia (77%)
              • Low total absolute neutrophils (68%)
              • Nausea (60%)
              • Diarrhea (60%)
              • High ALT (58%)
              • High AST (50%)
              • Anemia (36%)
              • Asthenia (31%)
              • Fatigue (29%)
              • Low platelets (27%)
              • Stomatitis (25%)
              • Myalgia (25%)
              • Arthralgia (24%)
              • Constipation (22%)
              • Neutropenia (22%)
              • Vomiting (20%)
              • Radiation skin injury (19%)
              • Decreased appetite (17%)
              • Dysgeusia (17%)
              • Headache (17%)
              • Insomnia (17%)
              • Low potassium (17%)
              • Low albumin (16%)
              • Peripheral sensory neuropathy (16%)
              • Rash (16%)
              • Mucosal inflammation (15%)
              • Injection site reaction (15%)
              • Dry skin (15%)
              • Cough (15%)
              • Dyspepsia (14%)
              • Pyrexia (13%)
              • Dizziness (13%)
              • Procedural pain (13%)
              • High potassium (13%)
              • Low sodium (13%)
              • Epistaxis (12%)
              • Peripheral neuropathy (12%)
              • Hot flush (12%)
              • Decreased weight (11%)
              • Upper respiratory tract infection (11%)

              Grade 3-4

              • Low absolute lymphocytes (37%)
              • Low total absolute neutrophils (30%)
              • Low total leukocytes (25%)
              • Neutropenia (14%)

              1-10%

              All grades

              • Paresthesia (10%)
              • Back pain (10%)
              • High bilirubin (9%)
              • Low glucose (9%)
              • Nail discoloration (9%)
              • Erythema (9%)
              • Hemorrhoids (9%)
              • Abdominal pain (9%)
              • Leukopenia (9%)
              • Upper abdominal pain (8%)
              • Peripheral edema (8%)
              • High sodium (7%)
              • Malaise (7%)
              • Febrile neutropenia (7%)
              • Dermatitis (7%)
              • Nail disorder (7%)
              • Bone pain (7%)
              • Pain in extremity (6%)
              • Muscle spasms (6%)
              • Musculoskeletal pain (6%)
              • Palmoplantar erythrodysesthesia syndrome (6%)
              • Influenza-like illness (5%)

              Grade 3-4

              • Febrile neutropenia (7%)
              • Diarrhea (7%)
              • Low potassium (5.2%)
              • Low hemoglobin (2.8%)
              • Leukopenia (2.4%)
              • Fatigue (2%)
              • Nausea (2%)
              • Anemia (1.6%)
              • High ALT (1.6%)
              • Hypokalemia (1.6%)
              • High potassium (1.2%)
              • Dyspnea (1.2%)

              <1%

              Grade 3-4

              • High sodium (0.8%)
              • Mucosal inflammation (0.8%)
              • High AST (0.8%)
              • Decreased appetite (0.8%)
              • Decreased weight (0.8%)
              • Paresthesia (0.8%)
              • Peripheral sensory neuropathy (0.8%)
              • Vomiting (0.8%)
              • Stomatitis (0.8%)
              • Palmoplantar erythrodysesthesia syndrome (0.8%)
              • Asthenia (0.4%)
              • Abdominal pain (0.4%)
              • Peripheral neuropathy (0.4%)
              • Low sodium (0.4%)
              • Lacrimation increased (0.4%)
              • Dry eye (0.4%)
              • Radiation skin injury (0.4%)
              • Paronychia (0.4%)
              • Urinary tract infection (0.4%)
              • Cough (0.4%)
              • Musculoskeletal pain (0.4%)
              • Myalgia (0.4%)
              • Dry skin (0.4%)
              • Rash (0.4%)

              Postmarketing Reports

              Glomerulopathy

              Immune thrombocytopenia

              Tumor lysis syndrome

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              Warnings

              Black Box Warnings

              Cardiomyopathy

              • Administration can result in subclinical and clinical cardiac failure
              • Incidence and severity was highest in patients receiving Phesgo with anthracycline-containing chemotherapy regimens
              • Evaluate cardiac function before and during treatment
              • Discontinue Phesgo in patients receiving adjuvant therapy and withhold in patients with metastatic disease for clinically significant decrease in LVEF

              Embryofetal toxicity

              • Exposure to Phesgo can result in embryofetal death and birth defects, including oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death
              • Advise patients of these risks and the need for effective contraception

              Pulmonary toxicity

              • Administration can result in serious and fatal pulmonary toxicity
              • Discontinue for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome; monitor until symptoms completely resolve

              Contraindications

              Hypersensitivity to pertuzumab, trastuzumab, hyaluronidase, or any of its excipients

              Cautions

              Hypertension, arrhythmias, left ventricular cardiac dysfunction, disabling cardiac failure, cardiomyopathy, and cardiac death may occur

              May cause fetal harm when administered to a pregnant female

              Serious and fatal pulmonary toxicity reported

              May cause exacerbation of chemotherapy-induced neutropenia

              Severe administration-related reactions, including hypersensitivity, anaphylaxis, and events with fatal outcomes, have been associated with IV pertuzumab and trastuzumab

              Drug interaction overview

              • Patients who receive anthracycline after stopping Phesgo may be at increased risk of cardiac dysfunction because of the long washout period of Phesgo
              • If possible, avoid anthracycline-based therapy for up to 7 months after stopping Phesgo
              • If anthracyclines are used, carefully monitor cardiac function
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              Pregnancy & Lactation

              Pregnancy

              May cause fetal harm when administered to a pregnant female

              In postmarketing reports, use of IV trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death

              Verify pregnancy status of females of reproductive potential before initiation

              Animal data

              • Pertuzumab
                • In an animal reproduction study, administration of pertuzumab to pregnant cynomolgus monkeys during organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryofetal deaths at clinically relevant exposures that were 2.5- to 20-fold greater than exposures in humans receiving the recommended dose, based on peak plasma concentration
              • Trastuzumab
                • In studies in which IV trastuzumab was administered to pregnant cynomolgus monkeys during organogenesis at doses up to 25 mg/kg given twice weekly (up to 25x 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

              Contraception

              • Females of reproductive potential: Use effective contraception during treatment and for 7 months after the last dose

              Clinical considerations

              • Monitor females who received treatment 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

              Pregnancy pharmacovigilance program

              • If administered during pregnancy, or if a patient becomes pregnant during treatment or within 7 months following the last dose, healthcare providers and patients should immediately report exposure to Genentech at 1-888-835-2555

              Lactation

              No information available on the presence of pertuzumab, trastuzumab, or hyaluronidase in human milk, the effects on the breastfed infant, or the effects on milk production

              Published data suggest that human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts

              Trastuzumab was present in the milk of lactating cynomolgus monkeys but was not associated with neonatal toxicity

              Take into account that the elimination half-life of pertuzumab and trastuzumab washout period is 7 months when considering the mother’s clinical need for treatment

              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

              Pertuzumab

              • 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

              Trastuzumab

              • Monoclonal antibody; inhibits growth of tumor cells that overexpress HER2

              Hyaluronidase

              • Human hyaluronidase increases permeability of SC tissue by temporarily depolymerizing hyaluronan
              • Effects are reversible and permeability of SC tissue is restored within 24-48 hr

              Absorption

              Plasma trough concentration

              • Pertuzumab (Cycle 7): 88.7 mcg/mL (SC); 72.4 mcg/mL (IV)
              • Trastuzumab (Cycle 7): 58.7 mcg/mL (SC); 44.1 mcg/mL (IV)

              Absolute bioavailability

              • Pertuzumab: 0.7
              • Trastuzumab: 0.8

              Peak plasma time

              • Pertuzumab: 4 days
              • Trastuzumab: 4 days

              Distribution

              Vd

              • Pertuzumab: 2.8 L
              • Trastuzumab: 2.9L

              Elimination

              Clearance

              • Pertuzumab: 0.2 L/day
              • Trastuzumab: 0.1 L/day
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              Administration

              SC Compatibility

              Compatible with stainless steel, polypropylene, polycarbonate, polyethylene, polyurethane, polyvinyl chlorid and fluorinated ethylene polypropylene

              SC Preparation

              Check vial labels to ensure the drug being prepared and administered is Phesgo and not IV pertuzumab, IV trastuzumab, or SC trastuzumab

              Visually inspect vials for particulate matter and discoloration before administration, whenever solution and container permit; do not use if particulates or discoloration is present

              Do not shake

              Discard any unused portion remaining in the vial

              Each vial is ready-to-use for one SC injection and should not be diluted

              Withdraw dose from the vial

              Use 25- to 27-gauge (3/8-5/8 inch) hypodermic injection needles to inject dose

              To avoid needle clogging, attach needle to the syringe immediately before administration, followed by volume adjustment to 15 mL (initial dose) and 10 mL (maintenance dose)

              Replace the transfer needle with a syring-closing cap if the dose is not administered immediately and the drug has been withdrawn into the syringe; label syringe

              Label the syringe with the peel-off sticker

              SC Administration

              SC use only; do not administer IV

              Phesgo has different dosage and administration instructions than IV pertuzumab, IV trastuzumab, and SC trastuzumab when administered alone

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

              Observe for a minimum of 30 min after initial dose and 15 min after each maintenance dose 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

              During the treatment course, other SC medications should be injected at different sites

              Administration site

              • Alternate between the left and right thigh only
              • Administer new injections at least 1 inch (2.5 cm) from the previous site on healthy skin and never into areas where the skin is red, bruised, tender, or hard
              • Do not split the dose between 2 syringes or between 2 sites of administration

              Administration time

              • 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units /15 mL: Administer SC over ~8 min
              • 600 mg pertuzumab/600 mg trastuzumab/30,000 units/10 mL: Administer SC over ~5 min

              Sequence of administration

              • Anthracycline-based regimen (EBC): Administer Phesgo following completion of the anthracycline
              • Docetaxel- or paclitaxel- based regimen (EBC): Administer docetaxel or paclitaxel after Phesgo
              • Docetaxel-based regimen (MBC): Administer docetaxel after Phesgo

              Missed or delayed dose

              • Time between 2 sequential injections is <6 weeks: Administer 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC; do not wait until the next planned dose
              • Time between 2 sequential injections is ≥6 weeks: Re-administer 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC, followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks
              • For chemotherapy dose modifications, see relevant prescribing information

              Storage

              Unopened vial

              • Refrigerate at 2-8ºC (36-46ºF)
              • Protect from light
              • Do not freeze; do not shake

              Drug withdrawn from vial into syringe

              • Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr and store at room temperature (20-25ºC [68-77ºF]) for up to 4 hr
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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              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.
              • Manage and view all your plans together – even plans in different states.
              • 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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.