Vizimpro Special Precautions

Assessment of EGFR mutation status: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Interstitial lung disease (ILD)/Pneumonitis: ILD/pneumonitis, which could be fatal, has been reported in patients receiving VIZIMPRO (see Adverse Reactions). Patients with a history of ILD have not been studied.
Careful assessment of all patients with an acute onset or unexplained worsening of pulmonary symptoms (e.g., dyspnoea, cough, fever) should be performed to exclude ILD/pneumonitis. Treatment with dacomitinib should be withheld pending investigation of these symptoms. If ILD/pneumonitis is confirmed, dacomitinib should be permanently discontinued and appropriate treatment instituted as necessary (see Dosage & Administration).
Diarrhoea: Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with VIZIMPRO (see Adverse Reactions). Diarrhoea may result in dehydration with or without renal impairment, which could be fatal if not adequately treated.
Proactive management of diarrhoea should start at the first sign of diarrhoea especially within the first 2 weeks of starting dacomitinib, including adequate hydration combined with anti-diarrhoeal medicinal products and continued until loose bowel movements cease for 12 hours. Anti-diarrhoeal medicinal products (e.g., loperamide) should be used and, if necessary, escalated to the highest recommended approved dose. Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib. Patients should maintain adequate oral hydration and patients who become dehydrated may require administration of intravenous fluids and electrolytes (see Dosage & Administration).
Skin-related adverse reactions: Rash, erythematous and exfoliative skin conditions have been reported in patients treated with VIZIMPRO (see Adverse Reactions).
For prevention of dry skin, initiate treatment with moisturizers, and upon development of rash, initiate treatment with topical antibiotics, emollients, and topical steroids. Start oral antibiotics and topical steroids in patients who develop exfoliative skin conditions. Consider adding broad spectrum oral or intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity. Rash, erythematous and exfoliative skin conditions may occur or worsen in areas exposed to the sun. Advise patients to use protective clothing and sunscreen before exposure to the sun. Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see Dosage & Administration).
Hepatotoxicity and transaminases increased: Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with VIZIMPRO (see Adverse Reactions). Among NSCLC patients treated with dacomitinib 45 mg daily, there have been isolated reports of hepatotoxicity in 4 (1.6%) patients. Across the dacomitinib program, hepatic failure led to a fatal outcome in 1 patient. Therefore, periodic liver function testing is recommended. In patients who develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted (see Dosage & Administration).
Medicinal products metabolised by cytochrome P450 (CYP)2D6: VIZIMPRO may increase exposure (or decrease exposure of active metabolites) of other medicinal products metabolised by CYP2D6. Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see Interactions).
Other forms of interactions: Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see Interactions).
Lactose: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Sodium: This medicinal product contains < 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".
Effects on ability to drive and use machines: VIZIMPRO has minor influence on the ability to drive and use machines. Patients experiencing fatigue or ocular adverse reactions while taking dacomitinib should exercise caution when driving or operating machinery.