Vizimpro Dosage/Direction for Use

Treatment with VIZIMPRO should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
EGFR mutation status should be established prior to initiation of dacomitinib therapy (see Precautions).
Posology: The recommended dose of VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.
Patients should be encouraged to take their dose at approximately the same time each day. If the patient vomits or misses a dose, an additional dose should not be taken and the next prescribed dose should be taken at the usual time the next day.
Dose modifications: Dose modifications may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose of VIZIMPRO should be reduced as described in Table 2. Dose modification and management guidelines for specific adverse reactions are provided in Table 3 (see Precautions and Adverse Reactions). (See Tables 2 and 3.)

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Special populations: Hepatic impairment: No starting dose adjustments are required when administering VIZIMPRO to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Dacomitinib has not been studied in patients with severe (Child-Pugh class C) hepatic impairment. Treatment in this population is not recommended (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No starting dose adjustments are required when administering VIZIMPRO to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥30 mL/min). Limited data are available in patients with severe renal impairment (CrCl <30 mL/min). No data are available in patients requiring haemodialysis. Thus no dosing recommendations can be made for either patient population (see Pharmacology: Pharmacokinetics under Actions).
Elderly population: No starting dose adjustment of VIZIMPRO in elderly (≥65 years of age) patients is required (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of VIZIMPRO in the paediatric population (<18 years of age) have not been established. No data are available.
Method of administration: VIZIMPRO is for oral use. The tablets should be swallowed with water and can be taken with or without meals.