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Hercessi (trastuzumab-strf)
trastuzumab
Black Box Warnings .
Cardiomyopathy
subclinical and clinical cardiac failure can occur; incidence and severity highest in combo with anthracyclines; evaluate left ventricular function prior to and during tx; if clinically significant decr. left ventricular function, D/C tx in patients receiving adjuvant tx and withhold tx in patients with metastatic breast CA
Infusion Reactions and Pulmonary Toxicity
can result in serious and fatal cases; signs/symptoms occur during or within 24h of administration of trastuzumab products in most cases; interrupt infusion if dyspnea or clinically significant hypotension, monitor patients until signs/symptoms resolve completely; D/C tx if anaphylaxis, angioedema, interstitial pneumonitis, or ARDS
Embryo-Fetal Toxicity
exposure during pregnancy or within 7mo prior to conception can result in embryo-fetal death and birth defects, including oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death; advise patients of risks and need for effective contraception
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = trastuzumab-strf
- [equivalency or interchangeability info]
- Info: not interchangeable with ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, SC trastuzumab/hyaluronidase, or SC pertuzumab/trastuzumab/hyaluronidase
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
HER2-positive breast CA, adjuvant tx
- [combo with docetaxel or paclitaxel]
- Dose: 4 mg/kg/dose IV x1 on wk 1, then 2 mg/kg/dose IV qwk on wk 2-12, then 6 mg/kg/dose IV q3wk on wk 13-52; Info: use with docetaxel or paclitaxel on wk 1-12
- [combo with carboplatin and docetaxel]
- Dose: 4 mg/kg/dose IV x1 on wk 1, then 2 mg/kg/dose IV qwk on wk 2-18, then 6 mg/kg/dose IV q3wk on wk 19-52; Info: use with carboplatin and docetaxel on wk 1-18
- [monotherapy following anthracycline-based regimen]
- Dose: 8 mg/kg/dose IV x1 on day 1 of 21-day cycle for cycle 1, then 6 mg/kg/dose IV x1 on day 1 of 21-day cycle for cycles 2-17
HER2-positive breast CA, metastatic
- [combo with paclitaxel]
- Dose: 2 mg/kg/dose IV qwk, starting wk 2; Start: 4 mg/kg/dose IV x1 on wk 1
- [monotherapy]
- Dose: 2 mg/kg/dose IV qwk, starting wk 2; Start: 4 mg/kg/dose IV x1 on wk 1; Info: for recurrent disease
- [combo with pertuzumab (off-label)]
- Dose: 6 mg/kg/dose IV x1 on day 1 of 21-day cycle, starting cycle 2; Start: 8 mg/kg/dose IV x1 on day 1 of 21-day cycle for cycle 1
HER2-positive gastric CA, metastatic
- [6 mg/kg/dose IV x1 on day 1 of 21-day cycle, starting cycle 2]
- Start: 8 mg/kg/dose IV x1 on day 1 of 21-day cycle for cycle 1; Info: for patients with gastric or gastroesophageal junction adenocarcinoma; part of multi-drug chemo regimen
HER2-positive, RAS wild-type colorectal CA, unresectable or metastatic (off-label)
- [6 mg/kg/dose IV x1 on day 1 of 21-day cycle, starting cycle 2]
- Start: 8 mg/kg/dose IV x1 on day 1 of 21-day cycle for cycle 1; Info: give with tucatinib
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x7mo after D/C
- avoid: anthracycline use for up to 7mo after D/C
- caution: cardiotoxic agent use, concurrent
- caution: cardiotoxic agent use history
- caution: adjuvant tx use >1y
- caution: patients >65 yo
- caution: patients of childbearing potential
- caution: intrinsic lung disease, symptomatic
- caution: lung metastases
- caution: tumor burden, high
Drug Interactions .
Overview
trastuzumab
HER2/neu antagonist
- cardiotoxic effects
- immunomodulatory effects
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- ado-trastuzumab emtansine
- chloramphenicol
- cladribine oral
- daunorubicin
- deferiprone
- dexrazoxane
- doxorubicin
- epirubicin
- fam-trastuzumab deruxtecan
- fexinidazole
- ganciclovir
- idarubicin
- mitoxantrone
- palifermin
- penicillamine
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- trastuzumab
- valganciclovir
Monitor/Modify Tx
- adalimumab
- aficamten
- albendazole
- aldesleukin
- alemtuzumab
- allopurinol
- alogliptin
- anagrelide
- anthrax vaccine
- anti-thymocyte globulin
- asciminib
- atidarsagene autotemcel
- auranofin
- avelumab
- axitinib
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bezlotoxumab
- binimetinib
- bortezomib
- bosutinib
- capecitabine
- carfilzomib
- certolizumab pegol
- chikungunya vaccine
- cidofovir
- cilostazol
- clozapine
- cobimetinib
- colchicine
- copper histidinate
- COVID-19 vaccine
- cyclophosphamide
- dabrafenib
- dapsone
- deferasirox
- deuruxolitinib
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dronedarone
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- encorafenib
- entrectinib
- etanercept
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluorouracil
- fluphenazine
- foscarnet
- fosfomycin injection
- fostamatinib
- givinostat
- golimumab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ifosfamide
- imatinib
- infliximab
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- itraconazole
- Japanese encephalitis vaccine
- lapatinib
- leflunomide
- lenvatinib
- linagliptin
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- margetuximab
- marnetegragene autotemcel
- mavacamten
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mirdametinib
- mobocertinib
- mycophenolate mofetil
- mycophenolic acid
- olsalazine
- osimertinib
- pazopanib
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pertuzumab
- pioglitazone
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- proguanil
- propafenone
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- ripretinib
- rituximab
- rosiglitazone
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- saxagliptin
- selumetinib
- sirolimus
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- stiripentol
- succimer
- sulfasalazine
- sunitinib
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tivozanib
- tocilizumab
- tofacitinib
- trabectedin
- trametinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- vandetanib
- zanidatamab
- zenocutuzumab
- zidovudine
- zongertinib
Caution Advised
- erlotinib
Adverse Reactions .
Serious Reactions
- cardiac failure
- left ventricular dysfunction
- cardiomyopathy
- CHF
- arrhythmia
- thromboembolism
- infusion reaction, severe
- hypersensitivity reaction
- anaphylaxis
- angioedema
- ARDS
- interstitial pneumonitis
- pulmonary infiltrates
- pulmonary fibrosis
- respiratory failure
- pleural effusion
- pulmonary edema
- hypoxia
- anemia
- neutropenia
- febrile neutropenia
- infection
- thrombocytopenia, autoimmune
- tumor lysis syndrome
- glomerulonephritis
- renal failure
Common Reactions
- headache
- arthralgia
- diarrhea
- nausea
- fever
- cough
- pain
- edema
- rigors
- asthenia
- HTN
- dizziness
- influenza
- myalgia
- rash
- vomiting
- arrhythmia
- dyspnea
- URI
- muscle spasms
- UTI
- CHF
- epistaxis
- constipation
- dyspepsia
- paresthesia
- nail disorder
- pruritus
- fatigue
- anemia
- neutropenia
- infection
- anorexia
- insomnia
- depression
- peripheral neuropathy
- infusion reaction
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; cardiac assessment including LVEF at baseline, then LVEF q3mo during tx, then q6mo after tx D/C for at least 2y; signs/symptoms of infusion reaction during and within 24h of infusion
Look/Sound-Alike Drug Names
trastuzumab confused with: ado-trastuzumab emtansine, fam-trastuzumab deruxtecan
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of oligohydramnios and oligohydramnios sequence based on limited human data; no known risk of fetal harm based on animal data at up to 25x recommended human dose
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x7mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x7mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for trastuzumab: unknown; CYP450: unknown
Excretion: for trastuzumab: other; Half-life: 22 days
Subclass: HER2 Antagonists ; Immunotherapy, HER2 Inhibitors
Mechanism of Action
for trastuzumab: inhibits HER2-expressing tumor cell proliferation, mediates antibody-dependent cytotoxicity
Formulary .
No Formulary Selected
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