Osimertinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat non-small cell lung cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: osimertinib, oral; Tagrisso

What is this medicine used for?

This medicine is taken by mouth to treat a certain kind of non-small cell lung cancer that has spread to other parts of the body and that is linked to an abnormal EGFR gene. It is used when other cancer medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Any other lung disease
• Heart disease or heart failure
• Liver or kidney disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with the levels of calcium, magnesium, potassium, or sodium in your blood

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 6 weeks after you finish treatment. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine and for at least 2 weeks after you finish treatment.

Males: Use an effective birth control method while you are taking this medicine and for 4 months after stopping it. Talk with your healthcare provider about effective birth control.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Take it once a day at the same time each day. If you have trouble swallowing the tablets, you can stir the tablet in 2 ounces of plain (not carbonated) water until it is in small pieces (the tablet will not completely dissolve). Do not crush the tablet or use hot water. Drink the mixture right away, then add another 4 to 8 ounces of water to the container, and drink it to make sure you get your full dose.

What if I miss a dose?

If you miss a dose, skip that dose and take the next regular dose. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause life-threatening lung problems. Tell your healthcare provider right away if you have any new or worsening lung symptoms, such as trouble breathing, shortness of breath, cough, or fever.

This medicine may cause life-threatening heart problems. Your healthcare provider may check your heart function before you start treatment and regularly during treatment with this medicine. Call your healthcare provider right away if you feel like your heart is pounding or racing, feel lightheaded, or if you have shortness of breath or swelling of your ankles and feet.

You need to have blood tests and checkups regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy or cause vision problems. Do not drive or operate machinery unless you are fully alert and can see clearly.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): New or worsening shortness of breath; chest pain; fast, slow, or irregular heartbeat; severe dizziness or fainting; unexplained cough, sore throat, or fever; unusual tiredness or weakness; pain, warmth, redness, or swelling in your leg; eye pain or vision problems; swelling in your hands, ankles, or feet; unusual mood changes or confusion.

Other: Mild rash, diarrhea, constipation, mild nausea, decreased appetite, mild dizziness, headache, back pain, dry skin, changes in your nails.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, diazepam (Valium), and midazolam (Versed)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethosuximide (Zarontin), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Apomorphine (Apokyn)
• Bladder control medicines such as darifenacin (Enablex), solifenacin (VESIcare), and tolterodine (Detrol)
• Bromocriptine (Cycloset, Parlodel)
• Buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), tamoxifen, topotecan (Hycamtin), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Diabetes medicines such as linagliptin (Tradjenta), nateglinide (Starlix), repaglinide (Prandin), and saxagliptin (Onglyza)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Fingolimod (Gilenya)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dronedarone (Multaq), felodipine, flecainide, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), rivaroxaban (Xarelto), and ticagrelor (Brilinta)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer) and macitentan (Opsumit)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone, methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Roflumilast (Daliresp)
• Sleeping pills such as flurazepam, triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil), benzphetamine (Regimex), and modafinil (Provigil)
• Sulfasalazine (Azulfidine)
• Tetrabenazine (Xenazine)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.