Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (4)
- axicabtagene ciloleucel
trastuzumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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
- brexucabtagene autoleucel
trastuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
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
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
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
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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.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
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
Images
Formulary
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.
