osimertinib

What is the most important information I should know about osimertinib?

Osimertinib can cause serious side effects on your heart, lungs, skin, or eyes.

What is osimertinib?

Osimertinib is used to treat non-small cell lung cancer that is positive for an abnormal "EGFR" gene. You doctor will test you for this gene.

Osimertinib is sometimes given when the cancer has spread to other parts of the body (metastatic), or may come back after surgery.

Osimertinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking osimertinib?

Tell your doctor if you have ever had:

• lung or breathing problems;
• an electrolyte imbalance (such as high or low blood levels of sodium, calcium, potassium, or magnesium);
• eye problems; or
• heart problems, including long QT syndrome (in you or a family member).

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 weeks after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I take osimertinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Osimertinib is usually given once per day, with or without food.

To make swallowing easier, you may place the tablet in a glass with about 2 ounces of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Add 4 to 8 ounces more water to the glass, swirl gently and drink right away.

You may need medical tests to check your heart function.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking osimertinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of osimertinib?

• skin redness or purple spots that don't turn pale when pressed, and that still look red or bruised after 24 hours (may appear on your arms, legs, buttocks, or midsection);
• redness, rash, or blisters on the palms of your hands or the soles of your feet;
• new or worsening cough or trouble breathing;
• fast or pounding heartbeats;
• swelling in your lower legs, weight gain, feeling short of breath;
• a light-headed feeling, like you might pass out;
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet; or
• eye problems --vision changes, watery eyes, increased sensitivity to light, eye pain or redness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• low blood cell counts;
• muscle, bone, or joint pain;
• diarrhea;
• tiredness;
• cough, mouth sores;
• dry skin, rash; or
• redness, tenderness, pain, or other problems with your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect osimertinib?

Other drugs may affect osimertinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about osimertinib.