Dacocent 45 Tablet
Dacomitinib
45 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 10's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 300.00 AED |
Indications
Dacocent 45 Tablet is used for:
Non-small Cell Lung Cancer
Adult Dose
Oral
Non-small Cell Lung Cancer
Indicated for first-line treatment of patients with metastatic non-small lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test
45 mg once daily
Continue until disease progression or unacceptable toxicity occurs
Child Dose
Renal Dose
Renal impairment
Mild or moderate (CrCl 30-89 mL/min estimated by Cockcroft-Gault equation): No dosage adjustment necessary
Severe (CrCl <30 mL/min): Recommended dose not established
Administration
Administer with or without food at the same time each day
Contra Indications
Precautions
Interstitial Lung Disease (ILD): Permanently discontinue Dacomitinib if ILD is confirmed.
Diarrhea: Withhold and reduce the dose of Dacomitinib based on the severity.
Dermatologic Adverse Reactions: Withhold and reduce the dose of Dacomitinib based on the severity.
Embryo-Fetal Toxicity: Dacomitinib can cause fetal harm. Advise females of reproductive potential to use effective contraception
MONITORING PARAMETERS
Monitor liver function periodically—interrupt treatment if severe changes in liver function occur.
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to a pregnant woman
There are no available data on use in pregnant women
Verify pregnancy status of females of reproductive potential prior to initiating treatment
Advise females of reproductive potential to use effective contraception during treatment and for at least 17 days after final dose
Animal data
In animal reproduction studies, oral administration of dacomitinib to pregnant rats during organogenesis period resulted in an increased incidence of postimplantation loss and reduced fetal body weight at doses resulting in similar exposures seen at the 45-mg human dose
Absence of EGFR signaling resulted in embryo lethality as well as postnatal death in animals
Advise pregnant women of the potential risk to a fetus
Lactation
There is no information regarding presence of dacomitinib or its metabolites in human milk or their effects on breastfed infants or on milk production
Because of potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for at least 17 days after last dose
Interactions
Proton Pump Inhibitors (PPIs): Avoid use with Dacomitinib; use locally acting antacids or H2-receptor antagonist; administer Dacomitinib at least 6 hours before or 10 hours after H2 receptor antagonist.
CYP2D6 Substrates: Avoid concomitant use with Dacomitinib, where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.
Adverse Effects
Side effects of Dacomitinib :
>10% (All Grades)
Diarrhea (87%)
Rash (69%)
Paronychia (64%)
Stomatitis (45%)
Anemia (44%)
Hypoalbuminemia (44%)
Lymphopenia (42%)
Increased ALT (40%)
Hyperglycemia (36%)
Increased AST (35%)
Hypocalcemia (33%)
Decreased appetite (31%)
Dry skin (30%)
Hypokalemia (29%)
Decreased weight (26%)
Hyponatremia (26%)
Increased creatinine (24%)
Alopecia (23%)
Increased alkaline phosphatase (22%)
Hypomagnesemia (22%)
Pruritus (21%)
Cough (21%)
Nasal mucosal disorder (19%)
Conjunctivitis (19%)
Nausea (19%)
Hyperbilirubinemia (16%)
Palmar-plantar erythrodysesthesia syndrome (15%)
Pain in extremity (14%)
Dyspnea (13%)
Constipation (13%)
Asthenia (13%)
Mouth ulceration (12%)
Musculoskeletal pain (12%)
Upper respiratory tract infection (12%)
Dermatitis (11%)
Insomnia (11%)
Mechanism of Action
Irreversible kinase inhibitor 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)
Also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 in vitro at clinically relevant concentrations
Demonstrates dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing SC implanted human tumor xenografts driven by HER family targets including mutated EGFR; also, exhibits antitumor activity in orally dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications
Note
Dacocent 45 45 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Dacomitinib. Dacocent 45 is availble in Bangladesh.
Farmaco BD drug index information on Dacocent 45 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.