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Zegfrovy
sunvozertinib
Adult Dosing .
Dosage forms: TAB: 150 mg, 200 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, concomitant meds, and dosing including toxicity-related dose adjustments
non-small cell lung CA, locally advanced or metastatic
- [200 mg PO qd]
- Info: for patients with EGFR exon 20 insertion mutations with disease progression on or after platinum-containing chemo; give with food; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: 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 x2wk after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: patients 65 yo and older
Drug Interactions .
Overview
sunvozertinib
kinase inhibitor
- CYP3A4 substrate
- BCRP inhibitor
- P-gp inhibitor, weak
- CYP3A4 inducer, weak
- immunomodulatory effects
- skin irritant/drying agent
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- interstitial lung disease
- pneumonitis
- diarrhea, severe
- nausea, severe
- vomiting, severe
- rash, severe
- ocular toxicity
- pancreatitis
- pneumonia
- arrhythmia
Common Reactions
- diarrhea
- rash
- appetite decr.
- fatigue
- stomatitis
- vomiting
- nausea
- paronychia
- constipation
- weight decr.
- pruritus
- musculoskeletal pain
- pneumonia
- UTI
- xeroderma
- abdominal pain
- ocular toxicity
- abdominal distension
- peripheral neuropathy
- arrhythmia
- edema
- malaise
- Cr incr.
- Hgb decr.
- CK incr.
- lymphocytes decr.
- lipase incr.
- ALT or AST incr.
- neutrophils decr.
- proteinuria
- amylase incr.
- sodium decr.
- albumin decr.
- potassium decr.
- magnesium incr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test before tx start; signs/symptoms of interstitial lung disease
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, including teratogenicity, based on animal data at 0.02-0.6x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective non-hormonal contraception during tx and x2wk after D/C in patients of childbearing potential and using effective contraception during tx and x2wk after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x2wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for sunvozertinib: liver primarily; CYP450: 3A substrate; Info: active metabolite
Excretion: for sunvozertinib: feces 79% (7.3% unchanged), urine 10% (5.6% unchanged); Half-life: 50h
Subclass: EGFR Antagonists ; Kinase Inhibitors, EGFR Inhibitors
Mechanism of Action
for sunvozertinib: binds to epidermal growth factor receptor (EGFR), inhibiting kinase activity and cancer cell signal transduction
Formulary .
No Formulary Selected
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