Daconib 45 mg

Daconib 45 mg | INDICATIONS AND USES

Dacomitinib is 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 as detected by an FDA-approved test.

Daconib 45 mg | PHARMACOLOGY

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). In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations. Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR. Dacomitinib also exhibited antitumor activity in orally-dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications.

Daconib 45 mg | DOSAGE & ADMINISTRATION

The recommended dosage of Dacomitinib is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs. Dacomitinib can be taken with or without food. Take Dacomitinib the same time each day. If the patient vomits or misses a dose, do not take an additional dose or make up a missed dose but continue with the next scheduled dose. First dose reduction Dose Level-30 mg Dose (Once Daily) Second dose reduction Dose Level-15 mg Dose.

Daconib 45 mg | DRUG 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 antagonistCYP2D6 Substrates: Avoid concomitant use with DACOMITINIB where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities

Daconib 45 mg | SIDE EFFECTS

Most common adverse reactions (incidence >20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

Daconib 45 mg | USE DURING PREGNANCY AND LACTATION

Dacomitinib can cause fetal harm when administered to a pregnant woman. 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.

Daconib 45 mg | PRECAUTIONS & WARNINGS

Interstitial Lung Disease (ILD): Permanently discontinue Dacomitinib if ILD is confirmedDiarrhea: Withhold and reduce the dose of DACOMITINIB based on the severityDermatologic Adverse Reactions: Withhold and reduce the dose of DACOMITINIB based on the severityEmbryo-Fetal Toxicity: Dacomitinib can cause fetal harm. Advise females of reproductive potential to use effective contraception.

Daconib 45 mg | USE IN SPECIAL POPULATIONS

Pediatric Use: The safety and effectiveness of Dacomitinib in pediatrics have not been established.Renal Impairment: No dosage modification is recommended for patients with mild or moderate renal impairment (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)

Daconib 45 mg | THERAPEUTIC CLASS

Cytotoxic Chemotherapy

Daconib 45 mg | STORAGE CONDITIONS

Do not store above 30⁰C. Keep away from light and out of the reach of children.