Osimertinib requires medical supervision because it can affect the lungs, heart, eyes and bone marrow and can interact with other medicines.
Interstitial lung disease and pneumonitis
Interstitial lung disease/pneumonitis is a major safety concern. Patients with new or worsening respiratory symptoms require prompt clinical evaluation. The U.S. label includes specific interruption and discontinuation rules for confirmed drug-related lung toxicity.
QTc interval prolongation
Osimertinib can prolong the QTc interval. The risk may be greater in patients with relevant cardiac conditions or electrolyte abnormalities. The label provides management recommendations based on QT findings.
Cardiomyopathy
Cardiomyopathy and reductions in left ventricular ejection fraction can occur. The U.S. label recommends cardiac monitoring in specified patients and requires more intensive assessment when osimertinib is combined with chemotherapy.
Keratitis and eye toxicity
Patients developing signs of keratitis or significant eye symptoms should receive appropriate ophthalmic assessment.
Aplastic anemia
Aplastic anemia is a rare but serious risk. The U.S. prescribing information includes specific instructions for suspected and confirmed cases.
Severe skin reactions
Serious cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis are addressed in the label.
Drug interactions
Strong CYP3A4 inducers can substantially lower osimertinib exposure. St. John’s wort should not be used with Tagrisso according to the EMA product information.
Pregnancy and lactation
Osimertinib can cause fetal harm. Current U.S. labeling advises against breastfeeding during treatment and for the specified period after the final dose.