Vizimpro (dacomitinib)

Vizimpro may cause serious side effects, including:

• Lung or breathing problems. Vizimpro may cause severe inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer.
  • Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing or shortness of breath, cough, or fever.
• Diarrhea. Diarrhea is common during treatment with Vizimpro, and can be severe and lead to death. Diarrhea can cause you to lose too much body fluid (dehydration). Your healthcare provider may tell you to start drinking more fluids or start taking your anti-diarrheal medicines.
  • Tell your healthcare provider right away, if you have any loose stools or have stools more often than is normal for you.
• Skin reactions. Skin reactions are common with Vizimpro and can be severe. These skin reactions may include: dry skin, redness, rash, acne, itching, and peeling or blistering of your skin.
  • Use moisturizers every day when taking Vizimpro. Use sunscreen and wear protective clothing that covers your skin, while exposed to sunlight, while you are taking Vizimpro.
  • Your healthcare provider may prescribe other medicines to help skin reactions. Tell your healthcare provider right away about any worsening skin reactions.

The most common side effects of Vizimpro include:

• rash
• diarrhea
• mouth pain and sores
• nail inflammation
• common cold
• dry skin
• decreased appetite
• decreased weight
• dry, red, itchy eyes
• hair loss
• itching

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with Vizimpro based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

• The recommended dosage of Vizimpro is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Vizimpro can be taken with or without food [see the Dosage Modifications For Acid-Reducing Agents section below].
• Take Vizimpro 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.

Dosage Modifications For Adverse Reactions

• Reduce the dose of Vizimpro for adverse reactions as described in Table 1. Dosage modifications for specific adverse reactions are provided in Table 2.

Table 1. Vizimpro Recommended Dose Reductions for Adverse Reactions

Table 2. Vizimpro Dosage Modifications for Adverse Reactions

Dosage Modifications For Acid-Reducing Agents

• Avoid the concomitant use of proton pump inhibitors (PPIs) while taking Vizimpro.
• As an alternative to PPIs, use locally-acting antacids or if using an histamine 2 (H2)-receptor antagonist, administer Vizimpro at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

Effect Of Other Drugs On Vizimpro

• Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce Vizimpro efficacy.
• Avoid the concomitant use of PPIs with Vizimpro. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist.
• Administer Vizimpro at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

Effect Of Vizimpro On CYP2D6 Substrates

• Concomitant use of Vizimpro increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs.
• Avoid concomitant use of Vizimpro with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

• Based on findings from animal studies and its mechanism of action, Vizimpro can cause fetal harm when administered to a pregnant woman.
• There are no available data on Vizimpro use in pregnant women. There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production.
• Because of the potential for serious adverse reactions in breastfed infants from Vizimpro, advise women not to breastfeed during treatment with Vizimpro and for at least 17 days after the last dose.