• First-line treatment of metastatic non-small cell lung cancer (NSCLC) in patient with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Severe renal impairment
• Women of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of adverse reactions in older adults.

Derm: alopecia, dermatitis, dry skin, nail infection, palmar-plantar erythrodysesthesia syndrome, pruritus, rash.

EENT: conjunctivitis, epistaxis, nasal inflammation, nasal mucosal ulcer, rhinitis, keratitis, skin fissures.

Endo: hyperglycemia.

F and E: hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia.

GI: ↓appetite, ↑liver enzymes, constipation, diarrhea, hyperbilirubinemia, nausea, stomatitis, metallic taste, vomiting.

GU: ↑serum creatinine.

Hemat: anemia, lymphopenia.

Metab: hypoalbuminemia, weight loss.

MS: pain.

Neuro: fatigue, insomnia.

Resp: cough, dyspnea, INTERSTITIAL LUNG DISEASE (ILD).

Drug-Drug:

• Proton pump inhibitors, H₂ antagonists, or antacids may ↓ levels and effectiveness; avoid concurrent use with proton pump inhibitor; take 6 hr before or 10 hr after H₂ antagonist.
• May ↑ levels and risk of toxicity of CYP2D6 substrates; avoid concurrent use with narrow-therapeutic index CYP2D6 substrates.

• Tablets: 15 mg; 30 mg; 45 mg;

• PO (Adults): 45 mg once daily until disease progression or unacceptable toxicity.

Vizimpro

• Irreversible EGFR tyrosine kinase inhibitor; blocks growth stimulation signals in cancer cells.

• Improved progression-free survival in NSCLC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: 80% absorbed after oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP2D6 isoenzyme to an active metabolite and to a lesser extent by the CYP3A4 isoenzyme. 79% excreted in feces (20% as unchanged drug), 3% in urine.

Half-life: 70 hr.

(plasma concentrations)

• Instruct patient to take dacomitinib at the same time each day as directed. If vomiting occurs after dose or dose is missed, skip dose and resume the next day as scheduled; do not take an additional dose or make up a missed dose. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to avoid use of proton pump inhibitors. Antacids or H₂ antagonists may be used. Instruct patient to take dacomitinib at least 6 hr before or 10 hr after taking an H₂ antagonist.
• Advise patient to notify health care professional immediately if signs and symptoms of ILD or diarrhea occur.
• Advise patient to use sunscreen and wear protective clothing to prevent skin reactions. Instruct patient use moisturizers and to notify health care professional if new or worsening rash, redness, or exfoliative reactions occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• May cause fetal harm. Advise females of reproductive potential to use effective contraception and to avoid breastfeeding during and for at least 17 days after last dose. Advise patient to notify health care professional immediately if pregnancy is suspected.

DAK-ohMI-ti-nib