Usual Adult Dose for Non-Small Cell Lung Cancer

45 mg orally once a day until disease progression or unacceptable toxicity

Use: For the first-line treatment of patients with 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

Renal Dose Adjustments

Mild (60 to less than 90 mL/min) and moderate (30 less than 60 mL/min) renal impairment: No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild (total bilirubin less than or equal to the upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN with any AST) or moderate (total bilirubin greater than 1.5 to 3 x ULN and any AST) hepatic impairment: No adjustment recommended.
Severe (total bilirubin greater than 3 to 10 x ULN and any AST) hepatic impairment: Data not available

Dose Adjustments

DOSE REDUCTIONS FOR ADVERSE REACTIONS:

• First dose reduction: 30 mg orally once a day
• Second dose reduction: 15 mg orally once a day

• Any Grade: Permanently discontinue therapy.

• Grade 2: Withhold therapy until recovery to Grade 1 or less; resume at same dose level. For recurrent Grade 2 diarrhea, withhold until recovery to Grade 1 or less; resume at reduced dose.
• Grade 3 or 4: Withhold therapy until recovery to Grade 1 or less; resume at reduced dose.

• Grade 2: Withhold therapy until recovery to Grade 1 or less; resume at same dose level. For recurrent persistent Grade 2 reactions, withhold until recovery to Grade 1 or less; resume at reduced dose.
• Grade 3 or 4: Withhold therapy until recovery to Grade 1 or less; resume at reduced dose.

• Grade 3 or 4: Withhold therapy until recovery to Grade 2 or less; resume at reduced dose.

• Avoid concomitant use of proton pump inhibitors (PPIs) with this drug.
• Use locally acting antacids or if using a histamine 2 (H2)-receptor antagonist, administer this drug at least 6 hours before or 10 hours after.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be taken with or without food.
• Take this drug at the same time each day.
• If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose.

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).

• Concomitant use of proton pump inhibitors (PPIs) with this drug should be avoided.
• Treatment with this drug should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Frequently asked questions

• What type of lung cancer is Vizimpro used to treat?