Vizimpro Generic Name & Formulations
Legal Class
Rx
General Description
Dacomitinib 15mg, 30mg, 45mg; tabs.
Pharmacological Class
Kinase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Vizimpro Indications
Indications
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.
Vizimpro Dosage and Administration
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.
Vizimpro Contraindications
Not Applicable
Vizimpro Boxed Warnings
Not Applicable
Vizimpro Warnings/Precautions
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 renal impairment: not established. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥17 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥17 days after the last dose).
Vizimpro Pharmacokinetics
See Literature
Vizimpro Interactions
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).
Vizimpro Adverse Reactions
Adverse Reactions
Diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, pruritus; ILD, dermatologic reactions.
Vizimpro Clinical Trials
See Literature
Vizimpro Note
Not Applicable
Vizimpro Patient Counseling
See Literature
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