osimertinib (Tagrisso)

Brand Names: Tagrisso

Generic Name: osimertinib

• What is osimertinib (Tagrisso)?
• What are the possible side effects of osimertinib (Tagrisso)?
• What is the most important information I should know about osimertinib (Tagrisso)?
• What should I discuss with my healthcare provider before taking osimertinib (Tagrisso)?
• How should I take osimertinib (Tagrisso)?
• What happens if I miss a dose (Tagrisso)?
• What happens if I overdose (Tagrisso)?
• What should I avoid while taking osimertinib (Tagrisso)?
• What other drugs will affect osimertinib (Tagrisso)?
• Where can I get more information (Tagrisso)?

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

Osimertinib is used to treat a certain type of non-small cell lung cancer. Osimertinib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Osimertinib is usually given after other treatments have failed.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath even with mild exertion;
• fast or pounding heartbeats;
• a light-headed feeling, like you might pass out;
• swelling, rapid weight gain;
• new or worsening lung symptoms--sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath; 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:

• mouth sores, loss of appetite;
• diarrhea;
• feeling tired;
• dry skin, rash; or
• tenderness, discoloration, infection, 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, or vision.

Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, a cough, fever, shortness of breath, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed.

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

Tell your doctor if you have ever had:

• a breathing disorder;
• an electrolyte imbalance (such as high or low levels of calcium, potassium, or magnesium in your blood);
• eye problems; or
• 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, do not use osimertinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 weeks after your last dose.
• If you are a man, use effective 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 while either the mother or the father is using osimertinib.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because osimertinib can harm an unborn baby.

You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

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.

You may take osimertinib with or without food.

To make swallowing easier, you may place the tablet in a glass with about 4 tablespoons 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 frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Osimertinib is usually given until your body no longer responds to the medication.

Store at room temperature away from moisture and heat.

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 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.

Many drugs can affect osimertinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about osimertinib.

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