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Rybrevant Faspro (amivantamab/ hyaluronidase-lpuj)
amivantamab/ hyaluronidase
Adult Dosing .
Dosage forms: INJ: 160 mg/2000 units per mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = amivantamab/hyaluronidase-lpuj
- [equivalency or interchangeability info]
- Info: not interchangeable with IV amivantamab; do not substitute on a mg to mg basis
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic meds, concomitant meds, and dosing including toxicity-related dose adjustments
non-small cell lung CA, locally advanced or metastatic
- [EGFR exon 19 deletion mutation-positive disease or exon 21 (L858R) substitution mutation-positive disease, first-line tx, <80 kg]
- Dose: 1600 mg/20,000 units SC qwk on day 1 at wk 1-4, then 1600 mg/20,000 units SC q2wk starting at wk 5; Alt: 1600 mg/20,000 units SC qwk on day 1 at wk 1-4, then 3520 mg/44,000 units SC q4wk starting at wk 5; Info: give anticoagulant prophylaxis x4mo; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; use with lazertinib
- [EGFR exon 19 deletion mutation-positive disease or exon 21 (L858R) substitution mutation-positive disease, first-line tx, >80 kg]
- Dose: 2240 mg/28,000 units SC qwk on day 1 at wk 1-4, then 2240 mg/28,000 units SC q2wk starting at wk 5; Alt: 2240 mg/28,000 units SC qwk on day 1 at wk 1-4, then 4640 mg/58,000 units SC q4wk starting at wk 5; Info: give anticoagulant prophylaxis x4mo; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; use with lazertinib
- [EGFR exon 19 deletion mutation-positive disease or exon 21 (L858R) substitution mutation-positive disease, progressive disease, <80 kg]
- Dose: 1600 mg/20,000 units SC x1 on day 1 at wk 1, then 2400 mg/30,000 units SC qwk on day 1 at wk 2 and 3, then 2400 mg/30,000 units SC q3wk starting at wk 4; Info: for patients with disease progression on or after EGFR TKI; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; part of multi-drug chemo regimen
- [EGFR exon 19 deletion mutation-positive disease or exon 21 (L858R) substitution mutation-positive disease, progressive disease, >80 kg]
- Dose: 2240 mg/28,000 units SC x1 on day 1 at wk 1, then 3360 mg/42,000 units SC qwk on day 1 at wk 2 and 3, then 3360 mg/42,000 units SC q3wk starting at wk 4; Info: for patients with disease progression on or after EGFR TKI; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; part of multi-drug chemo regimen
- [EGFR exon 20 insertion mutation-positive disease, first-line tx, <80 kg]
- Dose: 1600 mg/20,000 units SC x1 on day 1 at wk 1, then 2400 mg/30,000 units SC qwk on day 1 at wk 2 and 3, then 2400 mg/30,000 units SC q3wk starting at wk 4; Info: give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; part of multi-drug chemo regimen
- [EGFR exon 20 insertion mutation-positive disease, first-line tx, >80 kg]
- Dose: 2240 mg/28,000 units SC x1 on day 1 at wk 1, then 3360 mg/42,000 units SC qwk on day 1 at wk 2 and 3, then 3360 mg/42,000 units SC q3wk starting at wk 4; Info: give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo; part of multi-drug chemo regimen
- [EGFR exon 20 insertion mutation-positive disease, progressive disease, <80 kg]
- Dose: 1600 mg/20,000 units SC qwk on day 1 at wk 1-4, then 1600 mg/20,000 units SC q2wk starting at wk 5; Alt: 1600 mg/20,000 units SC qwk on day 1 at wk 1-4, then 3520 mg/44,000 units SC q4wk starting at wk 5; Info: for patients with disease progression on or after platinum-based chemo; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo
- [EGFR exon 20 insertion mutation-positive disease, progressive disease, >80 kg]
- Dose: 2240 mg/28,000 units SC qwk on day 1 at wk 1-4, then 2240 mg/28,000 units SC q2wk starting at wk 5; Alt: 2240 mg/28,000 units SC qwk on day 1 at wk 1-4, then 4640 mg/58,000 units SC q4wk starting at wk 5; Info: for patients with disease progression on or after platinum-based chemo; give oral antibiotic prophylaxis x12wk then topical antibiotic prophylaxis x9mo
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: sun exposure during tx and x2mo after D/C
- avoid: artificial UV light exposure during tx and x2mo after D/C
- avoid: breastfeeding during tx and x3mo after D/C
- caution: patients of childbearing potential
Drug Interactions .
Overview
amivantamab
EGFR antagonist; MET antagonist
- immunomodulatory effects
- photosensitivity
hyaluronidase
dispersion agent
-
None
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
- aminolevulinic acid topical
- porfimer
- rabies vaccine
Monitor/Modify Tx
- anthrax vaccine
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Caution Advised
- acitretin
- methoxsalen
- verteporfin
Adverse Reactions .
Serious Reactions
- injection-related reaction
- interstitial lung disease
- pneumonitis
- rash, severe
- toxic epidermal necrolysis
- ocular toxicity
- venous thromboembolism (combo with lazeritinib)
- cerebrovascular event
- cardiopulmonary arrest
- pneumonia
- sepsis
- hemorrhage
- photosensitivity
Common Reactions
- rash
- infusion reaction
- nail toxicity
- musculoskeletal pain
- dyspnea
- nausea
- fatigue
- edema
- stomatitis
- cough
- constipation
- vomiting
- hemorrhage
- pruritus
- diarrhea
- appetite decr.
- xerosis
- fever
- peripheral neuropathy
- dizziness
- abdominal pain
- pneumonia
- headache
- interstitial lung disease
- pulmonary embolism
- skin ulcer
- albumin decr.
- glucose incr.
- alk phos incr.
- Cr incr.
- ALT or AST incr.
- lymphocytes decr.
- phosphate decr.
- magnesium decr.
- GGT incr.
- sodium decr.
- potassium decr.
- Plt decr.
- Hgb decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test before tx start; signs/symptoms of infusion reaction, interstitial lung disease; signs/symptoms of thromboembolism if combo tx with lazertinib
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of impaired embryo-fetal development and fetal death based on animal data with other EGFR antagonists, MET inhibitors, and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x3mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x3mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for amivantamab: unknown; CYP450: unknown; for hyaluronidase: local; CYP450: unknown
Excretion: for amivantamab: unknown; Half-life: 19 days; for hyaluronidase: unknown; Half-life: unknown; Info: permeability of tissue restored within 24-48h
Subclass: EGFR Antagonists ; Immunotherapy, EGFR Inhibitors ; Immunotherapy, MET Inhibitors
Mechanism of Action
for amivantamab: binds to extracellular domains of epidermal growth factor (EGF) and mesenchymal-epithelial transition (MET) receptors, blocking EGFR and MET signaling functions and inducing tumor cell death via immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and trogocytosis (bispecific antibody); for hyaluronidase: incr. subcutaneous tissue permeability by temporarily depolymerizing hyaluronan, leading to incr. absorption of amivantamab
Formulary .
No Formulary Selected
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