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 may also be used for purposes not listed in this medication guide.
Osimertinib side effects
Get emergency medical help if you have signs of an allergic reaction (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).
Osimertinib may cause serious side effects. 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 side effects of osimertinib may include:
low blood cell counts;
muscle, bone, or joint pain;
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.
Osimertinib can cause serious side effects on your heart, lungs, skin, or eyes.
Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, fever, cough, trouble breathing, skin blistering or peeling, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed or short of breath.
Before taking this medicine
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 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 this medicine, and for at least 2 weeks after your last dose.
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.
Store at room temperature away from moisture and heat.
Osimertinib dosing information
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
-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
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?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking osimertinib?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect osimertinib?
Osimertinib 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.
Frequently asked questions
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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