Osimertinib (oh-sim-ER-ti-nib)

Treats non-small cell lung cancer. Also prevents non-small cell lung cancer from coming back in patients whose tumor has been removed by surgery.

Brand Name(s):

Tagrisso

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• If you cannot swallow the tablet:
  • Put it in a glass with 2 ounces (60 milliliters [mL]) of water. Do not use carbonated water or other liquids.
  • Stir until the tablet is in small pieces, and drink the mixture right away.
  • Add 4 to 8 ounces (120 to 240 mL) of water to the same glass, and drink it to make sure you get the full dose.
  • The tablet may also be given using a nasogastric tube. Dissolve it in 15 mL of non-carbonated water, then add another 15 mL of water to transfer any medicine to the syringe.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose, and then go back to your regular schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how osimertinib works. Tell your doctor if you are using fexofenadine, itraconazole, rifampin, rosuvastatin, or medicine that may cause heart rhythm problems.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Women should use effective birth control during treatment and for at least 6 weeks after the last dose. Men should use effective birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed while you are taking this medicine and for at least 2 weeks after your last dose.
• Tell your doctor if you have heart disease, heart failure, heart rhythm problems (including QT prolongation), or a history of eye problems or other lung disease or breathing problems.
• This medicine may cause the following problems:
  • Interstitial lung disease or pneumonitis
  • Heart rhythm changes
  • Heart problems, including heart failure
  • Eye problems, including keratitis
  • Serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis
  • Cutaneous vasculitis (swelling of the blood vessels in the skin)
  • Aplastic anemia (blood problem)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Blurred vision, eye pain
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Large hives, bruising
• Lightheadedness, dizziness, fainting
• Purple spots or redness of the skin on the lower arms, lower legs, or buttocks
• Swelling in your hands, ankles, or feet
• Tiredness, trouble breathing, chest pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Muscle pain
• Rash, dry skin, changes in your nails
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088