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Start With Proven First-line Efficacy1-3
 

Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.3

Dose Modifications

DACOPLICE® dose modifications: Diarrhoea3


Severe and fatal diarrhea occurred in patients treated with DACOPLICE®. Diarrhea occurred in 86% of the 394 DACOPLICE®-treated patients; Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal.
 

Recommendations include3:

  • Patients should contact their healthcare provider at the first sign of diarrhoea

  • Patient may require intravenous hydration and/or anti-diarrhoeal medication to manage diarrhoea

DACOPLICE® dose modifications: Dermatological effects3

  • Rash and exfoliative skin reactions occurred in patients treated with DACOPLICE®3

  • The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure3

Recommendations include3: 


Advise patients to initiate the use of moisturizers and to minimise sun exposure with protective clothing and the use of sunscreen at the time of the initiation of DACOPLICE®. Advise patients to contact their healthcare provider immediately to report new or worsening rash, erythematous and exfoliative reaction.3

 

DACOPLICE® dose modifications: ILD/pneumonitis3
 

Severe and fatal ILD/pneumonitis occurred in patients treated with DACOPLICE® and occurred
in 0.5% of the 394 DACOPLICE®-treated patients; 0.3% of cases were fatal.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold DACOPLICE®
and promptly investigate for ILD in patients who present with worsening of respiratory
symptoms which may be indicative of ILD (e.g. dyspnoea, cough and fever). Permanently
discontinue DACOPLICE® if ILD is confirmed.

  

  

ILD, interstitial lung disease.

  

References:

Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-1466.Mok TS, Cheng Y, Zhou X, et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non-small-cell lung cancer and EGFR-activating mutations. J Clin Oncol. 2018;36(22):2244-2250.Dacoplice. Local product document. Pfizer; 2021. Version LPDDAC042021.

     

Please click the Prescribing Information link to view the safety and adverse events information of DACOPLICE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

     

PP-DAC-IND-0147 June 2022

Dosing & Therapy Management
Mechanism of Action

DACOPLICE® is a second-generation EGFR TKI​​​​

Learn more


Clinical Efficacy

First-line use of DACOPLICE® was studied in a Phase III, head-to-head trial with gefitinib

Review efficacy profile


Safety Profile

ARCHER 1050 study reported the most common adverse events in patients

Review safety profile

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