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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

Dosage

Dosing recommendations3
 

The recommended starting dose of DACOPLICE® is 45 mg taken orally once daily, until disease progression or until unacceptable toxicity occurs. Dose modification may be required based on individual safety and tolerability3

  


DACOPLICE® is available in tablet form in 3 dose strengths (45 mg, 30 mg and 15 mg)3

  

Recommended dose modifications for DACOPLICE® adverse reactions3,*

  


Tablets are not actual size.

Dosing guidance3


DACOPLICE® can be taken with or without food3

If a 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 day3

Avoid the concomitant use of PPIs while taking DACOPLICE®. As an alternative to PPIs, use locally-acting antacids or if using an H2-receptor antagonist, administer DACOPLICE® at least 6 hours before or 10 hours after taking an H2-receptor antagonist3

  

Special warnings and precautions for use3:

  

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. 
ILD/Pneumonitis: 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.
Diarrhoea: Severe and fatal diarrhoea occurred in patients treated with DACOPLICE®. Diarrhoea occurred in 86% of the 394 DACOPLICE®-treated patients; Grade 3 or 4 diarrhoea was reported in 11% of patients and 0.3% of cases were fatal. Withhold DACOPLICE® for Grade 2 or greater diarrhoea until recovery to less than or equal to Grade 1 severity, then resume DACOPLICE® at the same or a reduced dose depending on the severity of diarrhoea [see Sections 4.2. Posology and method of administration and 4.8. Clinical trial experience]. Promptly initiate anti-diarrhoeal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhoea.
Skin-related adverse reactions: Rash and exfoliative skin reactions occurred in patients treated with DACOPLICE®. Rash occurred in 78% of the 394 DACOPLICE®-treated patients; Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold DACOPLICE® for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume DACOPLICE® at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. Posology and method of administration and clinical trial experience]. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of DACOPLICE®, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.
Embryo-foetal Toxicity: Based on findings from animal studies and its mechanism of action, DACOPLICE® can cause foetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced foetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose. The absence of EGFR sign align has been shown to result in embryo lethality as well as post-natal death in animals. Advise pregnant women of the potential risk to the foetus. Advise females of reproductive potential to use effective contraception during treatment with DACOPLICE® and for at least 17 days after the final dose.


*Dose reductions occurred in 66% of patients treated with DACOPLICE®.1
For further details about interactions, warnings and precautions and management of other adverse reactions, please see the DACOPLICE® prescribing information.
 
EGFR, epidermal growth factor receptor; H2, histamine receptor 2; ILD, interstitial lung disease; NSCLC, non-small cell lung cancer; PPI, proton pump inhibitor.

 

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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