dacomitinib (Rx)

Brand and Other Names:Vizimpro
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 15mg
  • 30mg
  • 45mg

Non-small Cell Lung Cancer

Indicated for first-line treatment of patients with metastatic non-small 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

45 mg PO qDay

Continue until disease progression or unacceptable toxicity occurs

Also see Administration

Dosage Modifications

First dose reduction: 30 mg qDay

Second dose reduction: 15 mg qDay

Interstitial lung disease (ILD)

  • Any grade: Permanently discontinue treatment

Diarrhea

  • Grade 2: Withhold treatment until recovery to Grade ≤1; then resume treatment at the same dose level
  • For recurrent Grade 2 OR Grade ≥3: Withhold until recovery to Grade ≤1; then resume treatment at a reduced dose

Dermatologic adverse reactions

  • Grade 2: Withhold treatment for persistent dermatologic adverse reactions; upon recovery to Grade ≤1, resume treatment at same dose level
  • For recurrent persistent Grade 2 OR Grade ≥3 dermatologic adverse reactions, withhold until recovery to Grade ≤1; then resume treatment at a reduced dose

Other adverse reactions

  • Grade 3 or 4: Withhold treatment until recovery to Grade ≤2; then resume treatment at a reduced dose

Renal impairment

  • Mild or moderate (CrCl 30-89 mL/min estimated by Cockcroft-Gault equation): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Recommended dose not established

Hepatic impairment

  • No dosage modification recommended in patients with mild, moderate or severe hepatic impairment (Child-Pugh A, B or C)

Dosing Considerations

Patient selection

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

Safety and efficacy not established

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Interactions

Interaction Checker

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              Serious - Use Alternative (64)

              • amitriptyline

                dacomitinib will increase the level or effect of amitriptyline by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • amoxapine

                dacomitinib will increase the level or effect of amoxapine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • aripiprazole

                dacomitinib will increase the level or effect of aripiprazole by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • atomoxetine

                dacomitinib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • brexpiprazole

                dacomitinib will increase the level or effect of brexpiprazole by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • captopril

                dacomitinib will increase the level or effect of captopril by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • carvedilol

                dacomitinib will increase the level or effect of carvedilol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • chlordiazepoxide

                dacomitinib will increase the level or effect of chlordiazepoxide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • chloroquine

                dacomitinib will increase the level or effect of chloroquine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • chlorpromazine

                dacomitinib will increase the level or effect of chlorpromazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • cinacalcet

                dacomitinib will increase the level or effect of cinacalcet by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • citalopram

                dacomitinib will increase the level or effect of citalopram by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • clomipramine

                dacomitinib will increase the level or effect of clomipramine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • codeine

                dacomitinib will increase the level or effect of codeine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • desipramine

                dacomitinib will increase the level or effect of desipramine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • dexlansoprazole

                dexlansoprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • doxepin

                dacomitinib will increase the level or effect of doxepin by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • doxepin cream

                dacomitinib will increase the level or effect of doxepin cream by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • doxorubicin

                dacomitinib will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • doxorubicin liposomal

                dacomitinib will increase the level or effect of doxorubicin liposomal by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • duloxetine

                dacomitinib will increase the level or effect of duloxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • eliglustat

                dacomitinib will increase the level or effect of eliglustat by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • esomeprazole

                esomeprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • flecainide

                dacomitinib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • fluoxetine

                dacomitinib will increase the level or effect of fluoxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • fluphenazine

                dacomitinib will increase the level or effect of fluphenazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • fluvoxamine

                fluvoxamine will increase the level or effect of dacomitinib by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP3D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities

              • haloperidol

                dacomitinib will increase the level or effect of haloperidol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • iloperidone

                dacomitinib will increase the level or effect of iloperidone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • imipramine

                dacomitinib will increase the level or effect of imipramine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • lansoprazole

                lansoprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • maprotiline

                dacomitinib will increase the level or effect of maprotiline by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • methamphetamine

                dacomitinib will increase the level or effect of methamphetamine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • metoclopramide intranasal

                dacomitinib will increase the level or effect of metoclopramide intranasal by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Concurrent use of metoclopramide intranasal and strong CYP2D6 inhibitors is not recommended since the metoclopramide intranasal dose cannot be adjusted.

              • metoprolol

                dacomitinib will increase the level or effect of metoprolol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • mirtazapine

                dacomitinib will increase the level or effect of mirtazapine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • nebivolol

                dacomitinib will increase the level or effect of nebivolol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • nortriptyline

                dacomitinib will increase the level or effect of nortriptyline by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • omeprazole

                omeprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • palifermin

                palifermin increases toxicity of dacomitinib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • pantoprazole

                pantoprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • paroxetine

                dacomitinib will increase the level or effect of paroxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • perphenazine

                dacomitinib will increase the level or effect of perphenazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • pimozide

                dacomitinib will increase the level or effect of pimozide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • procainamide

                dacomitinib will increase the level or effect of procainamide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • promethazine

                dacomitinib will increase the level or effect of promethazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • propafenone

                dacomitinib will increase the level or effect of propafenone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • propranolol

                dacomitinib will increase the level or effect of propranolol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • protriptyline

                dacomitinib will increase the level or effect of protriptyline by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • rabeprazole

                rabeprazole will increase the level or effect of dacomitinib by unspecified interaction mechanism. Avoid or Use Alternate Drug. Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy. Avoid use of PPIs with dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

              • risperidone

                dacomitinib will increase the level or effect of risperidone by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • ritonavir

                dacomitinib will increase the level or effect of ritonavir by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • sertraline

                dacomitinib will increase the level or effect of sertraline by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • tamoxifen

                dacomitinib will increase the level or effect of tamoxifen by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • tamsulosin

                dacomitinib will increase the level or effect of tamsulosin by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • thioridazine

                dacomitinib will increase the level or effect of thioridazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • timolol

                dacomitinib will increase the level or effect of timolol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • timolol ophthalmic

                dacomitinib will increase the level or effect of timolol ophthalmic by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • tolterodine

                dacomitinib will increase the level or effect of tolterodine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • tramadol

                dacomitinib will increase the level or effect of tramadol by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • trimipramine

                dacomitinib will increase the level or effect of trimipramine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • valbenazine

                dacomitinib will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • venlafaxine

                dacomitinib will increase the level or effect of venlafaxine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              • vortioxetine

                dacomitinib will increase the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

              Monitor Closely (5)

              • dengue vaccine

                dacomitinib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • deutetrabenazine

                dacomitinib will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

              • oliceridine

                dacomitinib will increase the level or effect of oliceridine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. If concomitant use is necessary, may require less frequent oliceridine dosing. Closely monitor for respiratory depression and sedation and titrate subsequent doses accordingly. If inhibitor is discontinued, consider increase oliceridine dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.

              • pitolisant

                dacomitinib will increase the level or effect of pitolisant by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. If coadministered with strong CYP2D6 inhibitors, initiate pitolisant at 8.9 mg/day and increase after 7 days to maximum of 17.8 mg/day. For patients currently taking pitolisant, reduce pitolisant dose by half upon initiating strong CYP2D6 inhibitors.

              • siponimod

                siponimod and dacomitinib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              Minor (0)

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                Adverse Effects

                >10% (All Grades)

                Diarrhea (87%)

                Rash (69%)

                Paronychia (64%)

                Stomatitis (45%)

                Anemia (44%)

                Hypoalbuminemia (44%)

                Lymphopenia (42%)

                Increased ALT (40%)

                Hyperglycemia (36%)

                Increased AST (35%)

                Hypocalcemia (33%)

                Decreased appetite (31%)

                Dry skin (30%)

                Hypokalemia (29%)

                Decreased weight (26%)

                Hyponatremia (26%)

                Increased creatinine (24%)

                Alopecia (23%)

                Increased alkaline phosphatase (22%)

                Hypomagnesemia (22%)

                Pruritus (21%)

                Cough (21%)

                Nasal mucosal disorder (19%)

                Conjunctivitis (19%)

                Nausea (19%)

                Hyperbilirubinemia (16%)

                Palmar-plantar erythrodysesthesia syndrome (15%)

                Pain in extremity (14%)

                Dyspnea (13%)

                Constipation (13%)

                Asthenia (13%)

                Mouth ulceration (12%)

                Musculoskeletal pain (12%)

                Upper respiratory tract infection (12%)

                Dermatitis (11%)

                Insomnia (11%)

                1-10% (All Grades)

                Chest pain (10%)

                Fatigue (9%)

                Vomiting (9%)

                Skin fissures (9%)

                Dysgeusia (7%)

                Skin exfoliation/exfoliative skin reactions (3.5%)

                Interstitial lung disease (2.6%)

                Keratitis (1.8%)

                Hypertrichosis (1.3%)

                Dehydration (1.3%)

                1-10% (Grade 3 or 4)

                Hypokalemia (7%)

                Lymphopenia (6%)

                Decreased appetite (3.1%)

                Hyponatremia (2.9%)

                Decreased weight (2.2%)

                Dyspnea (2.2%)

                Asthenia (2.2%)

                Upper respiratory tract infection (1.3%)

                Dry skin (1.8%)

                Dermatitis (1.8%)

                Increased ALT (1.4%)

                Hypocalcemia (1.4%)

                Hyperglycemia (1%)

                <1% (Grade 3 or 4)

                Alopecia

                Pruritus

                Palmar-plantar erythrodysesthesia syndrome

                Musculoskeletal pain

                Insomnia

                Anemia

                Increased alkaline phosphatase

                Hypomagnesemia

                Hyperbilirubinemia

                Increased AST

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                Warnings

                Contraindications

                None

                Cautions

                Severe and fatal ILD/pneumonitis occurred; monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold treatment and promptly investigate for ILD in patients who present with worsening of respiratory symptoms, which may be indicative of ILD (eg, dyspnea, cough, fever); permanently discontinue treatment if ILD is confirmed

                Severe and fatal diarrhea occurred; promptly initiate antidiarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea

                Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to a pregnant woman (see Pregnancy)

                Dermatologic adverse reactions

                • Rash and exfoliative skin reactions occurred; incidence and severity of rash and exfoliative skin reactions may increase with sun exposure
                • At time of initiation of treatment, initiate use of moisturizers and appropriate measures to limit sun exposure
                • Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids
                • Initiate oral antibiotics for Grade ≥2 severe dermatologic adverse reactions

                Drug interactions overview

                • Dacomitinib inhibits UGT1A1, P-gp, BCRP, and organic cation transporter (OCT)1
                • Dacomitinib is a P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) substrate
                • Concomitant use of acid-reducing agents
                  • Avoid use with proton pump inhibitors (PPIs)
                  • As an alternative to PPIs, use locally acting antacids, or, if using a histamine 2 (H2)-receptor antagonist, administer dacomitinib at least 6 hr before or 10 hr after taking an H2-receptor antagonist
                  • Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy
                • Effect of dacomitinib on CYP2D6 substrates
                  • Concomitant use of dacomitinib increases concentration of CYP2D6 substrates, which may increase the risk of toxicities of these drugs
                  • Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities
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                Pregnancy

                Pregnancy

                Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to a pregnant woman

                There are no available data on use in pregnant women

                Verify pregnancy status of females of reproductive potential prior to initiating treatment

                Advise females of reproductive potential to use effective contraception during treatment and for at least 17 days after final dose

                Animal data

                • In animal reproduction studies, oral administration of dacomitinib to pregnant rats during organogenesis period resulted in an increased incidence of postimplantation loss and reduced fetal body weight at doses resulting in similar exposures seen at the 45-mg human dose
                • Absence of EGFR signaling resulted in embryo lethality as well as postnatal death in animals
                • Advise pregnant women of the potential risk to a fetus

                Lactation

                There is no information regarding presence of dacomitinib or its metabolites in human milk or their effects on breastfed infants or on milk production

                Because of potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for at least 17 days after last dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Irreversible kinase inhibitor of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR-activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation)

                Also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 in vitro at clinically relevant concentrations

                Demonstrates dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing SC implanted human tumor xenografts driven by HER family targets including mutated EGFR; also, exhibits antitumor activity in orally dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications

                Absorption

                Peak plasma concentration: 108 ng/mL

                Peak plasma time (single 45-mg dose): 6 hr

                AUC: 2213 ng·hr/mL

                Time to steady-state: 14 days

                Bioavailability: 80%

                Effect of food

                • Administration with a high-fat, high-calorie meal (~800-1000 calories with 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively) had no clinically meaningful effect on dacomitinib pharmacokinetics

                Distribution

                Vd (steady-state): 1889 L

                Protein binding: 98%

                Metabolism

                Hepatic metabolism is main route of clearance, with oxidation and glutathione conjugation as the major pathways

                Following oral administration of a single 45-mg dose of [14C] dacomitinib, the most abundant circulating metabolite was O-desmethyl dacomitinib, which had similar in vitro pharmacologic activity as dacomitinib

                Elimination

                Half-life (single 45-mg dose): 70 hr

                Clearance (single 45-mg dose): 24.9 L/hr

                Excretion: Feces 79% (20% unchanged); urine 3% (<1% unchanged)

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                Administration

                Oral Administration

                Administer with or without food at the same time each day

                If patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with next scheduled dose

                Storage

                Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

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                Images

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.