【Drug Name】

Name: Osimertinib Tablets

Product Name:OYSIENDX

【Specification】

80mg

【Indications】

OYSIENDX is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC)

that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

• to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or

• as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or

• when your lung cancer has spread to other parts of the body (metastatic) and you have had

previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no

longer working.

Your healthcare provider will perform a test to make sure that OYSIENDX is right for you.

It is not known if OYSIENDX is safe and effective in children.

【Recommended Dosage】

How should I take OYSIENDX?

• Take OYSIENDX exactly as your healthcare provider tells you to take it.

• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OYSIENDX if you have side effects.

• Take OYSIENDX 1 time each day.

• You can take OYSIENDX with or without food.

• If you miss a dose of OYSIENDX, do not make up for the missed dose. Take your next dose at your regular time.

• If you cannot swallow OYSIENDX tablets whole:

o place your dose of OYSIENDX in a container that contains 60 mL (2 ounces) of water. Do not use carbonated water or any other liquids.

o stir the OYSIENDX tablet and water until the OYSIENDX tablet is in small pieces (the tablet will not completely dissolve). Do not crush, heat, or use ultrasound to prepare the mixture.

o drink the OYSIENDX and water mixture right away.

o add 120 mL to 240 mL (4 to 8 ounces) of water into the container and drink to make sure that you take your full dose of OYSIENDX.  

【Side Effects】

OYSIENDX may cause serious side effects, including:

• See “What is the most important information I should know about OYSIENDX?”

• Severe blistering or peeling of skin – seek medical attention right away if you develop these symptoms.

• Target lesions, which are skin reactions that look like rings – seek medical attention right away

if you develop these symptoms.

The most common side effects of OYSIENDX are:

• low white blood cell counts

• low platelet counts

• diarrhea

• muscle, bone, or joint pain

• changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail

• low red blood cell counts (anemia)

• rash

• dry skin

• mouth sores

• tiredness

• cough

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OYSIENDX. For more information, ask your healthcare

provider or pharmacist.

Call your doctor for medical advice about side effects.

【Storage】

• Store at or below 86°F (30°C).

• Safely throw away medicine that is out of date or that you no longer need.

Keep all medicines out of reach of children.