Composition
Tab: Osimertinib 80 mg
Indications & Dosage
Non-small cell lung cancer (initiated by a specialist): Adult: 80 mg once daily, for dose adjustment and details (consult product literature).
Contraindications
Congenital long QT syndrome
Precautions
Severe or end-stage renal impairment, avoid in severe hepatic impairment; monitor LFTs, Elderly (more frequent dose adjustments may be required), history of interstitial lung disease; monitor patients with pulmonary symptoms and consider dose reduction, radiation pneumonitis requiring steroid treatment, history or susceptibility to QT-interval prolongation (consider dose reduction if QTc interval is more than 500 milliseconds), pre-existing cardiac disease or electrolyte disturbances; monitor ECG and electrolytes periodically, use of effective, non-hormonal, contraception during and for 2 months after treatment in women, and 4 months after treatment in men is required.
Interactions
Aliskiren, Antacids, Antiarrhythmics, Antiepileptics, Antifungals, azoles, non-sedating antihistamines, Aprepitant, Calcium channel blockers, ciclosporin, Cobicistat, colchicine, Coumarins (warfarin), Crizotinib, dabigatran, digoxin, edoxaban, Enzalutamide, ergotamine, everolimus, H2 receptor antagonists, HIV-protease inhibitors, Idelalisib, Imatinib, Lapatinib, loperamide, Macrolides, Netupitant, Nilotinib, NSAIDs, Opioids, pimozide, Proton pump inhibitors, Ranolazine, Rifampicin, sirolimus. St Johns Wort, sulfonylureas (glimepiride). Tacrolimus,Taxanes, topotecan.
Pregnancy
Avoid unless essential
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Diarrhoea, eyelid pruritus, increased risk of infection, nail discolouration, nail disorders, respiratory disorders, skin reactions, stomatitis, cutaneous vasculitis, eye disorders, eye inflammation, QT interval prolongation, thrombocytopenia. Rare: Stevens-Johnson syndrome, decreased leucocytes, neutropenia.