VIZIMPRO Film-coated tablet Ref.[7605] Active ingredients: Dacomitinib

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 section 4.4).

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 1. Dose modification and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and 4.8).

Table 1. Recommended dose modifications for Vizimpro adverse reactions:

Table 2. Dose modification and management for Vizimpro adverse reactions:

Interstitial lung disease (ILD/Pneumonitis):

• Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
• Permanently discontinue dacomitinib if ILD/Pneumonitis is confirmed.

Diarrhoea:

• For Grade 1 diarrhoea, no dose modification is required. Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea. Encourage adequate oral fluid intake during diarrhoea.
• For Grade 2 diarrhoea, if not improved to Grade ≤1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib. Upon recovery to Grade ≤1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level.
• For Grade ≥3 diarrhoea, withhold dacomitinib. Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate. Upon recovery to Grade ≤1, resume dacomitinib with a reduction of 1 dose level.

Skin-related adverse reactions:

• For Grade 1 rash or erythematous skin conditions, no dose modification is required. Initiate treatment (e.g., antibiotics, topical steroids, and emollients).
• For Grade 1 exfoliative skin conditions, no dose modification is required. Initiate treatment (e.g., oral antibiotics and topical steroids).
• For Grade 2 rash, erythematous or exfoliative skin conditions, no dose modification is required. Initiate treatment or provide additional treatment (e.g., oral antibiotics and topical steroids).
• If Grade 2 rash, erythematous or exfoliative skin conditions persist for 72 hours despite treatment, withhold dacomitinib. Upon recovery to Grade ≤1, resume dacomitinib at the same dose level or consider a reduction of 1 dose level.
• For Grade ≥3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib. Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids). Upon recovery to Grade ≤1, resume dacomitinib with a reduction of 1 dose level.

Other:

• For Grade 1 or 2 toxicity, no dose modification is required.
• For Grade ≥3 toxicity, withhold dacomitinib until symptoms resolve to Grade ≤2. Upon recovery, resume dacomitinib with a reduction of 1 dose level.

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 section 5.2).

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 section 5.2).

Elderly population

No starting dose adjustment of Vizimpro in elderly (≥65 years of age) patients is required (see section 5.2).

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.

The adverse reactions observed at doses greater than 45 mg once daily were primarily gastrointestinal, dermatological, and constitutional (e.g., fatigue, malaise, and weight loss).

There is no known antidote for dacomitinib. The treatment of dacomitinib overdose should consist of symptomatic treatment and general supportive measures.

Shelf life: 5 years.

This medicinal product does not require any special storage conditions.

Aluminium/aluminium blister containing 10 film-coated tablets. Each pack contains 30 film-coated tablets.

Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.