Osimertinib

DEA Class; Rx

Common Brand Names; Tasigna

• Antineoplastics, Tyrosine Kinase Inhibitor

Non-Small Cell Lung Cancer

Adjuvant therapy

• Indicated as adjuvant therapy after tumor resection for non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations

First-line treatment for metastatic NSCLC

• Indicated for first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations

Previously treated metastatic NSCLC

• Indicated for metastatic EGFR T790M mutation-positive NSCLC in patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

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• Adverse drug reactions listed are all grades of severity unless listed otherwise
• Lymphopenia (63%)
• Thrombocytopenia (46%)
• Anemia (43%)
• Diarrhea (41%)
• Rash (34%)
• Neutropenia (27%)
• Hypermagnesemia (27%)
• Hyponatremia (26%)
• Dry skin (23%)
• Nail toxicity (22%)
• Fatigue (22%)
• Hypoglycemia (20%)
• Eye disorders (18%)
• Decreased appetite (18%)
• Cough (17%)
• Nausea (16%)
• Stomatitis (15%)
• Constipation (14%)
• Pruritus (14%)
• Vomiting (11%)

nterstitial lung disease (ILD)/pneumonitis reported; permanently discontinue if diagnosed with ILD/pneumonitis; withhold therapy and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever); permanently discontinue therapy if ILD confirmed

May prolong QTc interval; conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval; permanently discontinue treatment in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

Cardiomyopathy (defined as cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction) occurred, some fatal; conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors; assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment; for symptomatic congestive heart failure, permanently discontinue therapy

Keratitis reported; promptly refer patients with signs and symptoms suggestive of keratitis (eg, eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, red eye) to an ophthalmologist

Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) reported; withhold therapy if SJS or EMM is suspected and permanently discontinue if confirmed

Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported; withhold therapy if cutaneous vasculitis suspected, evaluate for systemic involvement, and consider dermatology consultation; if no other etiology can be identified, consider permanent discontinuation of therapy based on severity

May cause fetal harm

No available data in pregnant women to inform the drug-associated risk

No data are available regarding the presence of nilotinib or its metabolites in human milk or its effects on a breastfed child or on milk production

Osimertinib

tablet

• 40mg
• 80mg