Respiratory and thoracic cancers:
Indications for: VIZIMPRO
First-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Adult Dosage:
Take at same time each day. 45mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
VIZIMPRO Warnings/Precautions:
Monitor for pulmonary symptoms; withhold and evaluate if worsening symptoms indicative of interstitial lung disease (ILD); permanently discontinue if ILD confirmed. Withhold if Grade 2–4 diarrhea occurs; resume after recovery to Grade ≤1 at same dose or reduced dose based on severity; promptly treat with antidiarrheal. Withhold if persistent Grade 2 or any Grade 3/4 dermatologic adverse reactions occur; resume after recovery to Grade ≤1 at same dose or reduced dose based on reaction severity. Limit sun exposure; initiate moisturizer and appropriate measures at treatment start. If development of Grade 1 rash: treat with topical antibiotics/steroids; if Grade ≥2: treat with oral antibiotics. Severe renal impairment: not established. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥17 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥17 days after the last dose).
VIZIMPRO Classification:
Kinase inhibitor.
VIZIMPRO Interactions:
Potentiates CYP2D6 substrates; avoid. May be antagonized by proton pump inhibitors (PPIs); avoid or use alternative locally-acting antacids or H2-receptor antagonist (give Vizimpro ≥6hrs before or 10hrs after).
Adverse Reactions:
Diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, pruritus; ILD, dermatologic reactions.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
