Afatinib, 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.
• If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. This medicine may cause other 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; chemotherapy

Generic and brand names: afatinib, oral; Gilotrif

What is this medicine used for?

This medicine is taken by mouth to treat non-small cell lung cancer.

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 (such as pulmonary fibrosis)
• Eye problems including dry eyes
• Heart problems
• Liver or kidney disease

Also, tell your healthcare provider if you wear contact lenses.

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. Do not become pregnant during treatment with this medicine and for at least 2 weeks after your last dose. Talk with your healthcare provider about effective birth control methods. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

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 of it or take it for longer than prescribed. Taking too much increases the risk of serious side effects. 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.

Take this medicine 1 hour before or 2 hours after a meal.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 12 hours of your next scheduled dose. In that case, skip the missed dose and take the next one as directed. 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 may include: severe diarrhea, nausea, vomiting, weakness, dizziness, headache, stomach pain.

What should I watch out for?

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

This medicine may cause or worsen diarrhea. If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

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).

Serious (Report these to your healthcare provider right away.): New or worsening shortness of breath; cough; chest pain; fever; eye pain, swelling, redness, or tearing; blurred vision or other vision changes; eye sensitivity to light; severe or continued diarrhea; severe nausea or vomiting; unusual bruising or bleeding; yellowing of your skin or eyes; light-colored bowel movements; dark urine; stomach pain; skin peeling or blistering; sudden weight gain; fast or pounding heartbeat; swelling in your ankles, feet, or legs; unusual tiredness or weakness; decreased or problems urinating.

Other: Acne; dry skin; runny nose; mouth sores; decreased appetite; mild rash; mild itching; nail redness, pain, or other nail problems.

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:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and rifampin (Rifadin)
• Antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and simeprevir (Olysio)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), doxorubicin (Doxil), ibrutinib (Imbruvica), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), vemurafenib (Zelboraf), and vinblastine
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Dexamethasone
• Dipyridamole (Persantine)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), reserpine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Live vaccines
• Mefloquine
• Nefazodone
• Progesterone
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• St. John’s wort

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

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 in the original container 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.