Osimertinib

Indications & Dose:

Adjuvant treatment of early stage NSCLC 

80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.  

Metastatic NSCLC: 

80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.  

Contraindications:

None. 

Side Effects:

Cautions:

Precautions:

- Interstitial Lung Disease (ILD)/Pneumonitis, Permanently discontinue in patients diagnosed with ILD/Pneumonitis.  

- QTc Interval Prolongation, Monitor electrocardiograms and electrolytes in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Withhold then restart at a reduced dose or permanently discontinue . 

- Cardiomyopathy:  Conduct cardiac monitoring, including left ventricular ejection fraction (LVEF) assessment in patients with cardiac risk factors.  

- Keratitis, Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist for evaluation. 

- Erythema Multiforme and Stevens-Johnson Syndrome: Withhold if erythema multiforme major (EMM) or Stevens Johnson syndrome (SJS) is suspected and permanently discontinue if confirmed. 

- Cutaneous Vasculitis, Withhold  if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent

discontinuation based on severity. 

- Embryo Fetal Toxicity, can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with and for 6 weeks after final dose. Advise males to use effective contraception for 4 months, after the last dose of .  

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Most common adverse reactions, including laboratory abnormalities were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue and cough. 

Patient And Carer Advice: