Osimertinib Oral tablet
What is this medicine?
Osimertinib (OH sim ER ti nib) is a chemotherapy drug. It targets a specific protein within cancer cells and stops the cancer cells from growing. This medicine is used to treat non-small cell lung cancer.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
history of irregular heartbeat
history of low levels of calcium, magnesium, or potassium in the blood
lung or breathing disease, like asthma
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
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.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This medicine may interact with the following medications:
antiviral medicines for HIV or AIDS, like ritonavir
certain antibiotics like telithromycin
certain medicines for fungal infections like ketoconazole and itraconazole
certain medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
other medicines that prolong the QT interval (cause an abnormal heart rhythm)
St. John's Wort
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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.
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
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 these to your doctor or health care professional if they continue or are bothersome.):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert