VIZIMPRO Tablets / Film-coated
Dacomitinib
45mg
Pfizer Europe MA EEIG
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | BELGIUM |
| Agent | Gulf Drug L.L.C. |
| Retail Price | 12891.50 AED |
Available as:
Indications
VIZIMPRO Tablets / Film-coated is used for:
Non-small Cell Lung Cancer
Adult Dose
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 PO qDay
Continue until disease progression or unacceptable toxicity occurs
Hepatic impairment
Mild or moderate (total bilirubin ?3x upper limit of normal [ULN] and any AST): No dosage adjustment necessary
Severe (total bilirubin 3-10x ULN and any AST): Recommended dose not established
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
Severe and fatal ILD/pneumonitis occurred; monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold treatment and promptly investigate for ILD in patients who present with worsening of respiratory symptoms, which may be indicative of ILD (eg, dyspnea, cough, fever); permanently discontinue treatment if ILD is confirmed
Severe and fatal diarrhea occurred; promptly initiate antidiarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea
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
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
VIZIMPRO 45mg Tablets / Film-coated manufactured by Pfizer Europe MA EEIG. Its generic name is Dacomitinib. VIZIMPRO is availble in United Arab Emirates.
Farmaco UAE drug index information on VIZIMPRO Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.