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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
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.3
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:
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
DACOPLICE® is a second-generation EGFR TKI
Learn more
First-line use of DACOPLICE® was studied in a Phase III, head-to-head trial with gefitinib
Review efficacy profile
ARCHER 1050 study reported the most common adverse events in patients
Review safety profile
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For more details on, Who is a Registered Medical Practitioner*, please visit
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
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PP-UNP-IND-0012 July 2022