Simerta® may cause serious side effects including:
- Lung problems. Osimertinib may cause Interstitial Lung Disease/Pneumonitis that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Patients may experience new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms.
- Heart problems, including heart failure. Osimertinib may cause heart problems that may lead to death. Osimertinib may cause heart rate-corrected QT (QTc) interval prolongation and cardiomyopathy (defined as cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction). Symptoms of a heart problem may include: feeling like the heart is pounding or racing, shortness of breath, swelling of ankles and feet, dizziness, lightheadedness, and syncope. Patients’ heart function should be checked before starting Simerta® and during treatment as needed. In patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc, electrocardiograms and electrolytes should be monitored. Advise patients to report these symptoms and to inform their physician about the use of any heart or blood pressure medications.
- Eye problems (Keratitis). Patients treated with Osimertinib may experience eye problems. Symptoms suggestive of keratitis may include: watery eyes (lacrimation), eye inflammation, light sensitivity, eye pain, eye redness, blurred vision or vision changes. If patients get eye problems with Simerta®, the healthcare provider will send them to see an eye specialist (ophthalmologist).
- Skin problems. Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) have been reported in patients receiving Osimertinib. Advise patients to contact their healthcare provider immediately if they experience developing target lesions (skin reactions that look like rings), severe blistering or peeling of the skin.
- Inflammation of the blood vessels in skin (Cutaneous Vasculitis). Cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving Osimertinib. Signs and symptoms that may be indicative of cutaneous vasculitis include: purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on lower arms, lower legs, or buttocks or large hives on the main part of body (trunk) that do not go away within 24 hours and look bruised.
Call your healthcare provider right away if you have aforementioned symptoms.
The most common side effects
The most common side effects in people who take Osimertinib include:
- Low white blood cell counts
- Low platelet counts
- Muscle, bone, or joint pain
- Changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
- Dry skin
- Mouth sores
- Low red blood cell counts (anemia)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.