Osimertinib

Osimertinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• rash
• itching
• dry or cracking skin
• eczema
• nausea
• loss of appetite
• swelling or sores in the mouth
• back pain
• headache
• painful, watery, red, or dry eyes
• red, swollen eyelids
• nail changes including swelling, redness, pain, splitting, breaking, and separation or loss from the nailbed.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• fast, or pounding heartbeat
• new or worsening shortness of breath or difficulty breathing, or cough
• chest pain
• pain with deep breathing
• coughing up blood
• swelling of stomach, legs, ankles or feet
• sudden unexplained weight gain
• feeling dizzy, lightheaded, or faint
• fever
• extreme tiredness
• trouble speaking or understanding
• sudden severe headache
• paralysis or numbness in face, arm or leg
• sudden changes in vision sudden blurred or blackened vision, or seeing double
• warm, red, swollen, or tender leg
• swollen, painful neck

Osimertinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Osimertinib is a prescription medication used to treat non-small cell lung cancer. Osimertinib may be used when your non-small cell lung cancer has spread to other parts of the body and:

• has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, and
• you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working.

Your doctor will perform a test to make sure that osimertinib is right for you.

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Osimertinib is part of the drug class:

• Protein kinase inhibitors

Serious side effects have been reported with osimertinib. See the “Osimertinib Precautions” section.

Common side effects of osimertinib include the following:

• diarrhea
• rash
• dry skin
• changes in the nails (redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails)

This is not a complete list of osimertinib side effects. Ask your doctor or pharmacist for more information.

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

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

Before taking osimertinib, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to osimertinib or to any of its ingredients
• have lung or breathing problems
• have heart problems, including a condition called long QTc syndrome
• have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
• are pregnant or plan to become pregnant. Osimertinib can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with osimertinib or think you may be pregnant.
  • Females who are able to become pregnant should use an effective birth control during treatment with osimertinib and for 6 weeks after the final dose of osimertinib.
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with osimertinib and for 4 months after the final dose of osimertinib.
• are breastfeeding or plan to breastfeed. It is not known if osimertinib passes into your breast milk. Do not breastfeed during treatment with osimertinib and for 2 weeks after your final dose of osimertinib. Talk to your doctor about the best way to feed your baby during this time. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take osimertinib exactly as your doctor tells you to take it.

Your doctor may change your dose, temporarily stop, or permanently stop treatment with osimertinib if you have side effects.

Osimertinib is available in tablet form. It is typically taken once a day, with or without food.

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

If you cannot swallow osimertinib tablets whole:

• place your dose of osimertinib in a container that contains 2 ounces of water. Do not use carbonated water or any other liquids.
• stir the osimertinib tablet and water until the osimertinib tablet is in small pieces (the tablet will not completely dissolve). Do not crush or heat.
• drink the osimertinib and water mixture right away.
• add 4 to 8 ounces of water into the container and drink to make sure that you take your full dose of osimertinib. 

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 cancer medicines have been tried without success.

Osimertinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed to determine if this medicine can lengthen survival time.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

In the U.S.

• Tagrisso

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Take osimertinib exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

osimertinib should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take osimertinib with or without food.

If you have trouble swallowing the tablet:

• Dissolve it in 2 ounces of water. Do not use carbonated water or other liquids.
• Stir until the tablet is in small pieces. Do not crush or heat.
• Drink the liquid immediately or it may be given through a nasogastric tube.
• Add 4 to 8 ounces of water in the same container, and drink it immediately.

Dosing

The dose of osimertinib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of osimertinib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For lung cancer:
    • Adult—80 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of osimertinib, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Non-small cell lung cancer, metastatic: Treatment of metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an approved test, in patients who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

-Mild Hepatic Impairment (Total bilirubin less than upper limit of normal [ULN] and AST between 1 to 1.5 x ULN OR total bilirubin between 1 and 1.5 x ULN and any AST): No adjustment recommended.
-Moderate (Total bilirubin between 1.5 to 3 x ULN and any AST) or Severe Hepatic Impairment (Total bilirubin between 3 to 10 x ULN and any AST): Data not available; no recommended dose.