Vizimpro

Vizimpro Dosage/Direction for Use

dacomitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
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.
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 Dosage Modifications for Acid-Reducing Agents under Dosage & Administration and Pharmacology under Actions].
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 2. Dosage modifications for specific adverse reactions are provided in Table 3. (See Tables 2 and 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

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 a histamine 2 (H2)-receptor antagonist, administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2- receptor antagonist [see Effect of Other Drugs on VIZIMPRO under Interactions and Pharmacology under Actions].
Use in Specific 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 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 under Actions].
Elderly population: No starting dose adjustment of Vizimpro in elderly (≥ 65 years of age) patients is required.
Paediatric population: The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been established. No data are available.
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