Osimertinib

Osimertinib is used to treat non-small cell lung cancer that has an abnormal "EGFR" gene. Your 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 return after surgery.

Osimertinib may also be used for reasons not mentioned in this medication guide.

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

Osimertinib is usually taken once a day, with or without food.

To make it easier to swallow, you can put the tablet in a glass with about 2 ounces of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Then add 4 to 8 ounces more water to the glass, swirl gently, and drink it right away.

You may need medical tests to check your heart function.

Store at room temperature, away from moisture and heat.

Osimertinib can lead to serious side effects affecting your heart, lungs, skin, or eyes.

Contact your doctor immediately if you experience fast or pounding heartbeats, swelling in your lower legs, fever, cough, difficulty breathing, skin blistering or peeling, changes in vision, eye pain, increased sensitivity to light, or if you feel light-headed or short of breath.

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

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 osimertinib.

• 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 can 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 happen 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 this medicine, and for at least 2 weeks after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Osimertinib may cause serious side effects. Call your doctor right away if you have:

• skin redness or purple spots that do not 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 faint;
• 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 stopped if you have certain side effects.

Common side effects of osimertinib 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 issues 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.

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 yearsMetastatic lung cancer: Until disease progression or unacceptable toxicityUses: -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

Skip the missed dose and take your next dose at the regular time. Do not take two doses at the same 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, drinks, or activities.

Osimertinib can lead to a serious heart issue. Your risk might increase if you are also taking specific other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other medications may impact osimertinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.

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