Afatinib (Gilotrif®)

Afatinib is a kinase inhibitor. It works by targeting and blocking epidermal growth factor receptor (EGFR) tyrosine kinase. In some cancers, this receptor is overactive, causing cells to grow and divide too fast. By inhibiting EGFR, aftatinib prevents the uncontrolled growth of cells that contributes to tumor growth. Your oncology team will test your tumor for this abnormality, which must be present in order to receive the medication.

How To Take Afatinib

This medication comes in tablet form that you take by mouth once daily. Take this medication on an empty stomach, either 1 hour before or 2 hours after a meal. Take afatinib at around the same time every day. Take the tablet whole, do not cut, break, crush or chew.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose. If you take too much afatinib, call your care team or go to the emergency room right away.

Certain medications and supplements can interfere with how afatinib works, so be sure to tell your healthcare team about all medications, vitamins and supplements you are taking.

Tell your provider if you have a history of ulcers, diverticular disease, or cancer in your GI tract, as this medication can raise the risk of bowel perforation (a hole in the wall of the small intestine or colon).

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pouring the pills directly from their container into the cap, a small cup, or into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Certain cancer medications, including afatinib, are only available through specialty pharmacies. If you need to get this medication through a specialty pharmacy, your provider will help you start this process. Where you can fill your prescriptions may also be influenced by your pharmaceutical insurance coverage. Ask your health care provider or pharmacist for assistance in identifying where you can get this medication.

Insurance Information

This medication may be covered under your prescription drug plan. Depending on your diagnosis and fund availability, co-pay assistance from private foundations may be available. Patient assistance may be available to qualifying individuals, depending on your prescription drug coverage. Co-pay cards, which reduce the patent co-pay responsibility for eligible commercially (non-government sponsored) insured patients may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects of Aftatinib

There are a number of things you can do to manage the side effects of afatinib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Skin and Nail Changes

Afatinib has some unique nail and skin side effects that you may develop. Patients may develop a rash. While this rash may look like acne, it is not, and should not be treated with acne medications. The rash may appear red, swollen, crusty, dry and feel sore. You may also develop very dry skin, which may crack, become itchy, flaky, or scaly. The rash typically starts in the first week of treatment but can happen at any time during treatment. Tips for managing your skin include:

• Use a thick, alcohol-free emollient lotion or cream on your skin at least twice a day, including right after bathing.
• Avoid sun exposure, as it can worsen the rash or cause a severe burn. Use sunscreen with an SPF of 30 or higher and wear a hat and sunglasses to protect your head and face from the sun.
• Bathe/shower in cool or lukewarm (not hot) water and pat your skin dry.
• Use soaps, lotions and laundry detergents without alcohol, perfumes or dyes.
• Wear gloves to wash dishes or do housework or gardening.
• Drink plenty of water and try not to scratch or rub your skin.
• Notify your healthcare team if you develop a rash, as they can provide suggestions to manage the rash and/or prescribe a topical medication to apply to the rash or an oral medication.
• If you have peeling or blistering of the skin, call your healthcare team right away.

While receiving afatinib, you may develop an inflammation of the skin around the nail bed/cuticle areas of toes or fingers, which is called paronychia. It can appear red, swollen or pus filled. Nails may develop "ridges" in them or fall off. You may also develop cuts or cracks that look like small paper cuts in the skin on your toes, fingers or knuckles. These side effects may appear several months after starting treatment, but can last for many months after treatment stops.

• Follow the same recommendations for your skin (above).
• Don't bite your nails or cuticles or cut the cuticles.
• Keep your fingernails and toenails clean and dry.
• You may use nail polish, but do not wear fake nails.
• Tell your care team if any nails fall off or you develop any of these side effects or other skin changes.

Sun Sensitivity

This medication can make your skin more sensitive to the sun, which can lead to severe sunburn or rash. Sun sensitivity can last even after chemotherapy is completed. Avoid the sun between 10-2pm, when it is strongest. Wear sunscreen (at least SPF 30) every day; wear sunglasses, a hat, and long sleeves/pants to protect your skin and seek out shade whenever possible.

Diarrhea

Diarrhea can be a serious side effect that can lead to dehydration. Notify your care team if you develop diarrhea.

Your oncology team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole-grain bread, cereals, and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Mouth Sores

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. Notify your doctor or nurse if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon salt in an eight ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages and citrus juices.

Decreased Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your nurse about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products, and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce, or dressings. Use seasonings like basil, oregano, or rosemary to add flavor. Bacon, ham, and onion can add flavor to vegetables.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Less common but important side effects can include:

• Vision Changes: While receiving afatinib, you may develop irritation or damage to the cornea (clear part covers the eyeball) or changes in your eyesight. Notify your healthcare team if you develop any eye pain, swelling, redness or any vision changes, including blurriness and sensitivity to light.
• Liver Toxicity: This medication can cause liver toxicity, which your doctor may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown or pain in your abdomen, as these can be signs of liver toxicity.
• Lung Problems: Afatinib can cause lung problems, including interstitial lung disease. Call your provider right away if you have shortness of breath, cough , fever, or wheezing. If you are having difficulty breathing, call 911 or go to the neared emergency room.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 2 weeks after your last dose. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed during treatment and for 2 weeks after your final afatinib dose.