Osimertinib oral tablets

What is this medicine?

Osimertinib (OH sim ER ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

How should I use this medicine?

Take osimertinib tablets by mouth with a glass of water. You can take it with or without food. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. If swallowing is difficult, you can take the tablet by placing your dose in a container with 2 ounces of cool water only. Stir until the tablet is in small pieces. The tablet will not completely dissolve. Do not crush or chew. Drink the water and the tablet pieces right away. Then add 4 to 8 ounces of water to the same container and drink to make sure you take your full dose.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• red spots on the skin

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of increased potassium like muscle weakness; chest pain; or fast, irregular heartbeat

• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

• swelling of the legs or ankles

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• dry skin

• nail changes

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cisapride

• dronedarone

• pimozide

• thioridazine

This medicine may interact with the following medications:

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone

• rifampin

• rosuvastatin

• St. John's Wort

• sulfasalazine

• topotecan

What if I miss a dose?

If you miss a dose, do not make up for the missed dose. Take your next dose at your regular time. Do not take extra or double doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• lung or breathing disease, like asthma

• QT prolongation

• scarring or thickening of the lungs

• an unusual or allergic reaction to osimertinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Report any side effects. Continue your course of treatment unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for 6 weeks after the last dose. Males with female partners of reproductive potential should use effective contraception for 4 months after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. This medicine may interfere with the ability to have a child for both men and women. You should talk with your doctor or health care professional if you are concerned about your fertility. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after the last dose.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.