Afatinib Tablets

What is this medication?

AFATINIB (a FA ti nib) treats lung cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): GILOTRIF

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

  • Eye disease
  • Heart disease
  • Kidney disease
  • Liver disease
  • Lung or breathing disease, such as asthma or COPD
  • Stomach or intestine problems
  • Vision problems or if you wear contact lenses
  • An unusual or allergic reaction to afatinib, other medications, foods, dyes, or preservatives
  • Pregnant or trying to get pregnant
  • Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is less than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

  • Amiodarone
  • Carbamazepine
  • Certain medications for fungal infections, such as ketoconazole, itraconazole
  • Cyclosporine A
  • Erythromycin
  • Grapefruit juice
  • Nelfinavir
  • Phenobarbital
  • Phenytoin
  • Quinidine
  • Rifampicin
  • Ritonavir
  • Saquinavir
  • St. John's wort
  • Tacrolimus
  • Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 2 weeks after the last dose. A reliable form of contraception is recommended while taking this medication and for 2 weeks after the last dose. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication and for 2 weeks after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Dry cough, shortness of breath or trouble breathing
  • Eye pain, redness, irritation, or discharge with blurry or decreased vision
  • Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
  • Redness, blistering, peeling, or loosening of the skin, including inside the mouth
  • Severe or prolonged diarrhea
  • Stomach pain that is severe, does not go away, or gets worse

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

  • Acne
  • Change in nail shape, thickness, or color
  • Diarrhea
  • Dry skin
  • Itching
  • Loss of appetite
  • Pain, redness, or swelling with sores inside the mouth or throat
  • Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

  • Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
  • If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

© 2024 Elsevier/Gold Standard (2023-04-11 00:00:00)


Additional Information From Chemocare.com About Afatinib

Self-Care Tips While Taking Afatinib:

  • While taking afatinib, drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • Wash your hands often and after taking each dose of afatinib.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
  • To help treat/prevent mouth sores while taking afatinib, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
  • Use an electric razor and a soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals while taking afatinib.
  • Eat foods that may help reduce diarrhea-see
  • Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
  • Managing Side Effects - Diarrhea
  • Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing. Afatinib may make you more sensitive to the sun and you may sunburn more easily.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while you are taking afatinib. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition while being treated with afatinib.
  • If you experience symptoms or side effects while being treated with afatinib, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4° F (38° C or higher, chills)
  • Shortness of breath, cough or trouble breathing
  • Chest pain or feeling that your hear is pounding or racing (palpitations)

The following symptoms require medical attention, but are not an emergency. Contact your doctor or health care provider within 24 hours of noticing any of the following:

  • Diarrhea (4-6 episodes in a 24-hour period).
  • Nausea (interferes with ability to eat and unrelieved with prescribed medication).
  • Vomiting (vomiting more than 4-5 times in a 24 hour period).
  • Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
  • Skin or the whites of your eyes turn yellow
  • Urine turns dark or brown (tea color)
  • Decreased appetite
  • Pain on the right side of your stomach
  • Bleed or bruise more easily than normal
  • Any skin or nail changes (rash, itching, severe dryness, blisters, nail infection, inflammation of the lips, etc.)
  • Cough with or without mucus
  • Mouth sores
  • Pain or burning with urination
  • Eye inflammation, watering, redness, pain, blurred vision, light sensitivity
  • Extreme fatigue (unable to carry on self-care activities)
  • Swelling of your ankles, feet or legs
  • Sudden weight gain

Always inform your doctor or health care provider if you experience any unusual symptoms.


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