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:

Take at same time each day. 45mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

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 hepatic or renal impairment: not established. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for ≥17 days after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥17 days after final dose).

Pharmacologic Class:

Kinase inhibitor.

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 Availability:

NO

How Supplied:

Tabs—30