Osimertinib

Osimertinib is a prescription medication used to treat non-small cell lung cancer that has spread to other parts of the body. Osimertinib is specifically for those patients whose tumor has a certain abnormal epidermal growth factor (EGFR) gene(s) or whose previous treatment with EGFR-blocking therapy did not work or is no longer working. 

It belongs to a group of drugs called protein kinase inhibitors. These help by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

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

Common side effects of Osimertinib include diarrhea as well as skin and nail conditions. 

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(s), or
• you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine that did not work or 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 may be found in some form under the following brand names:

• Tagrisso

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.

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

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone. When taken together with osimertinib, these medications can increase the levels of osimertinib and cause more side effects or toxicity. 
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop). When taken together with osimertinib, these medications can decrease osimertinib levels in the body. 

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

Serious side effects have been reported with osimertinib including the following:

• lung problems. Osimertinib may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever.
• heart problems, including heart failure. Osimertinib may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking osimertinib and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded. 
• harm to your unborn baby. Osimertinib may cause fetal harm. Women are recommended to use effective contraception during treatment and for 6 weeks after the final dose. 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.
• eye problems. Tell your health care provider right away if you have any of the following symptoms of eye problems which may include vision changes, watery eyes, sensitivity to light, eye pain, eye redness. Your health care provider may refer you to see an eye specialist (ophthalmologist) if you get eye problems with this medication. 

Do not take osimertinib if you are allergic to osimertinib or any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of osimertinib, there are no specific foods that you must exclude from your diet when receiving this medication.

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
• have eye problems
• 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.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on data from animal studies and its mechanism of action, osimertinib can cause fetal harm when administered to a pregnant woman. There are no available data on osimertinib use in pregnant women. 

Women are recommended to use effective contraception during treatment and for 6 weeks after the final dose. 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. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if osimertinib crosses into human milk. Administration to rats during early lactation was associated with adverse events. 

Do not breastfeed during treatment with osimertinib and for 2 weeks after your final dose. Talk to your doctor about the best way to feed your baby during this time. 

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. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

If you take too much osimertinib, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store osimertinib at room temperature between 68°F to 77°F (20°C to 25°C).
• Safely throw away medicine that is out of date or that you no longer need.
• Keep osimertinib and all medicines out of the reach of children.