Tagrisso is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

Tagrisso is sometimes given when the cancer has spread to other parts of the body (metastatic) or to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery.

Tagrisso is also used when your lung cancer has spread to other parts of the body and you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine that did not work or is no longer working.

Tagrisso may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever.

Tagrisso may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking this medicine and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.

Take Tagrisso exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Tagrisso 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.

Store Tagrisso:at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day
Duration of therapy:
-Adjuvant setting: Until disease progression, unacceptable toxicity, or for up to 3 years
Metastatic lung cancer: Until disease progression or unacceptable toxicity

Uses:
-As adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
-For treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

You should not use Tagrisso if you are allergic to osimertinib.

To make sure Tagrisso is safe for you, 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).

Osimertinib can harm an unborn baby if the mother or the father is using this medicine.

• 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.

Do not breastfeed while using Tagrisso, and for at least 2 weeks after your last dose.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction to Tagrisso (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• 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 Tagrisso 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.

Tagrisso can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

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