Osimertinib Oral Tablet (OSIMERTINIB - ORAL)

Instructions

Do not break or crush the tablets before dissolving in water.

The tablet may be dissolved in a small amount of water (about 1 teaspoon or just enough to cover the tablet). Stir and drink the mixture as soon as the tablet is dissolved.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

This medicine may cause blurry vision or increased sensitivity to light. Avoid driving at night.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Please tell your doctor if you have moderate to severe diarrhea while on this medicine. Do not treat the diarrhea with over-the-counter diarrhea medicine.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 6 weeks after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use a condom during sexual activity while taking this medicine and for 4 months after stopping to prevent pregnancy.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• back pain
• diarrhea
• lack of energy and tiredness
• headaches
• mouth sores or irritation
• nausea
• dry skin

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• shallow, irregular breathing
• chest pain
• confusion
• coughing
• severe, watery or bloody diarrhea
• drowsiness or sedation
• swelling of the legs, feet, and hands
• pain in the eye
• fainting
• fever
• fast, irregular, or slow heartbeat
• itching
• sudden leg pain, swelling, warmth or redness
• sensitivity to light
• mood changes
• seizures
• shortness of breath
• unusual or unexplained tiredness or weakness
• blurring or changes of vision
• severe or persistent vomiting
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.