Prescribing information

Summary of Prescribing Information

(Based on LPD version 4 LPDDAC042021)

Brand name of product: DACOPLICE®
Generic name of product: Dacomitinib tablets

Indication: Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. Presentation: Tablets 15 mg, 30 mg and 45 mg. Dosage: Recommended dosage is 45 mg orally once daily, with or without food. Method of Administration: Oral. Contraindications: None. Warnings and Precautions: 1. Interstitial Lung Disease (ILD)/pneumonitis, which could be fatal, has been reported in patients receiving Dacomitinib. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Dacomitinib and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue Dacomitinib if ILD is confirmed 2. Severe and fatal diarrhea occurred in patients treated with Dacomitinib. Withhold Dacomitinib for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume Dacomitinib at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea. 3. Rash and exfoliative skin reactions occurred in patients treated with Dacomitinib. Withhold Dacomitinib 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 Dacomitinib at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of Dacomitinib, 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. 4. Based on findings from animal studies and its mechanism of action, Dacomitinib can cause fetal 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 fetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose. The absence of EGFR signaling has been shown to result in embryolethality as well as post-natal death in animals. Advise pregnant women of the potential risk to the fetus. Use in Special population: Pregnancy: Advise pregnant women of the potential risk to a fetus Lactation: There is no information regarding the presence of Dacomitinib or its metabolites in human milk or their effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Dacomitinib, advise women not to breastfeed during treatment with Dacomitinib and for at least 17 days after the last dose. Females and Males of Reproductive Potential: Verify the pregnancy status of females of reproductive potential prior to initiating Dacomitinib. Advise females of reproductive potential to use effective contraception during treatment with Dacomitinib and for at least 17 days after the final dose. Pediatric Use: The safety and effectiveness of Dacomitinib in pediatrics have not been established. Geriatric Use: Exploratory analyses across this population suggest a higher incidence of Grade 3 and 4 adverse reactions (67% versus 56%, respectively), more frequent dose interruptions (53% versus 45%, respectively), and more frequent discontinuations (24% versus 10%, respectively) for adverse reactions in patients 65 years or older as compared to those younger than 65 years. Renal Impairment: No dose modification is recommended for patients with mild or moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min estimated by Cockcroft-Gault). The recommended dose of Dacomitinib has not been established for patients with severe renal impairment (CLcr <30 mL/min). Hepatic Impairment: No dose modification is recommended in patients with mild , moderate or severe hepatic impairment (Child-Pugh A, B or C). There is no data on effects on ability to drive and use machines. Adverse reactions (Very common and common): The most common (>20%) adverse reactions in patients treated with DACOMITINIB were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). Adverse Reactions of all grade occurring in ≥10% of Patients Receiving Dacomitinib were Diarrhea (87%), Stomatitis (45%),Nausea (19%), Constipation (13%), Mouth ulceration (12%), Rash (69%), Paronychia (64%), Dry skin (30%), Alopecia (23%), Pruritus (21%), Palmar-plantar Erythrodysesthesia syndrome (15%), Dermatitis (11%), Decreased appetite (31%), Decreased weight (26%), Cough (21%), Nasal mucosal disorder (19%), Dyspnea (13%), Upper respiratory tract infection (12%), Chest pain (10%), Conjunctivitis (19%), Pain in extremity (14%), Musculoskeletal pain (12%), Asthenia (13%), Insomnia (11%), Anemia (44%), Lymphopenia (42%), Hypoalbuminemia (44%), Increased ALT (40%), Hyperglycemia (36%), Increased AST (35%), Hypocalcemia (33%), Hypokalemia (29%), Hyponatremia (26%), Increased creatinine (24%), Increased alkaline phosphatase (22%), Hypomagnesemia (22%), Hyperbilirubinea (16%). Additional adverse reactions (All Grades) that were reported in <10% of patients who received DACOMITINIB include: fatigue (9%), skin fissures (9%), hypertrichosis (1.3%), skin exfoliation/exfoliative skin reactions (3.5%), vomiting (9%), dysgeusia (7%), interstitial lung disease (2.6%), keratitis (1.8%), dehydration (1.3%). Drug interactions: Concomitant use of Dacomitinib may increase the concentration of drugs that are CYP2D6 substrates. Avoid concomitant use of Dacomitinib with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities. Concomitant use of proton pump inhibitors (PPIs) with Dacomitinib should be avoided. As an alternative to PPIs, use locally-acting antacids or if using an histamine 2 (H2)-receptor antagonist. administer Dacomitinib at least 6 hours before or 10 hours after taking H2 receptor antagonists. Overdose: No data. Storage Condition: Store below 30°C. Keep out of reach of children. Pharmacokinetics: The maximum dacomitinib plasma concentration (Cmax) and AUC at steady state increased proportionally over the dose range of Dacomitinib 2 mg to 60 mg orally once daily (0.04 to 1.3 times the recommended dose) across dacomitinib studies in patients with cancer. At a dose of 45 mg orally once daily, the geometric mean [coefficient of variation (CV%)] 108 ng/mL (35%) and the AUCo-24h was 2213 ng•h/mL (35%) at steady state in a dose-finding clinical study conducted in patients with solid tumors. Steady state was achieved within 14 days following repeated dosing and the estimated geometric mean (CV%) accumulation ratio was 5.7 (28%) based on AUC. The mean absolute bioavailability of dacomitinib is 80% after oral administration. The median dacomitinib time to reach maximum concentration (Tmax) occurred at approximately 6.0 hours (range 2.0 to 24 hours) after a single oral dose of Dacomitinib 45 mg in patients with cancer. Following a single 45 mg oral dose of Dacomitinib in patients with cancer, the mean (CV%) plasma half-life of dacomitinib was 70 hours (21 %), and the geometric mean (CV%) apparent plasma clearance of dacomitinib was 24.9 L/h (36%). Pharmacodynamic: Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation).

Reference: LPD version 5, LPD version 4, LPDDAC042021
Date of this document: 18 August 2021.
Please refer to full prescribing information for more details.

®Trademark Proprietor: Pfizer Inc., USA, Licensed User: Pfizer Products India Private Limited, India.

Full Prescribing Information available on request
For the use only of Registered Medical Practitioners, or a Hospital or a Laboratory.

PP-DAC-IND-0093 22-07-2021


  1. 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.
  2. Mok TS, Cheng Y, Zhou X, et al. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021;81(2):257-266.
  3. Local Prescribing Document for DACOPLICE®. LPD Version 4. Pfizer India_LPDDAC042021.

Please click on Prescribing Information link to view safety and adverse events information of DACOPLICE®. For the use only of registered medical practitioner, or a hospital or a laboratory.

PP-DAC-IND-0093 22-07-2021