Afatinib

Name: Afatinib

Afatinib Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using afatinib and call your doctor at once if you have:

  • severe skin reaction that causes blistering and peeling;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • eye problems--eye pain or redness, blurred vision, watery eyes, feeling like something is in your eye, increased sensitivity to light;
  • heart problems--pounding heartbeats or fluttering in your chest, shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • lung problems--fever, chest pain, dry cough, wheezing.

Common side effects may include:

  • mild diarrhea for 1 day or less;
  • nausea, vomiting, loss of appetite;
  • mouth sores;
  • acne, dry skin, mild itching or skin rash; or
  • redness, pain, swelling, or other signs of infection around your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Afatinib Interactions

Avoid exposure to sunlight or tanning beds. Afatinib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with afatinib, especially:

  • St. John's wort; or
  • an antibiotic--erythromycin, rifampin; antifungal medicine--itraconazole, ketoconazole; HIV or AIDS medicine--nelfinavir, ritonavir, saquinavir; heart or blood pressure medication--amiodarone, quinidine, verapamil; medicine to prevent organ transplant rejection--cyclosporine, tacrolimus; seizure medication--carbamazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with afatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Afatinib Dosage

Before you start treatment, your doctor may perform tests to make sure afatinib is the best treatment for your type of lung cancer.

Afatinib is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take afatinib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Afatinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given medications to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking afatinib. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

Call your doctor if you are sick with severe diarrhea, or diarrhea lasting longer than 2 days. You may need to stop taking afatinib for a short time.

While using afatinib, you may need frequent blood tests.

Store the tablets in their original container at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Throw away any afatinib tablets not used before the expiration date on the medicine label.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

Why is this medication prescribed?

Afatinib is used to treat certain types of non-small cell lung cancer that has spread to nearby tissues or to other parts of the body. Afatinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

How should this medicine be used?

Afatinib comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after eating a meal or snack. Take afatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take afatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may temporarily or permanently stop your treatment or decrease the dose if you experience serious side effects of afatinib. Talk to your doctor about how you are feeling during your treatment.

Continue to take afatinib even if you feel well. Do not stop taking afatinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking afatinib,

  • tell your doctor and pharmacist if you are allergic to afatinib, any other medications, or any of the ingredients in afatinib tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); cyclosporine (Gengraf, Neoral, Sandimmune); erythromycin (E.E.S., Erythrocin, others); certain medications for human immunodeficiency virus (HIV) such as nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin); quinidine (in Nuedexta); rifampin (Rimactane, Rifadin, in Rifater); tacrolimus (Prograf); and verapamil (Calan, Covera, Isoptin, Verelan). Many other medications may also interact with afatinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you are of Asian descent or have or have ever had lung or breathing problems (other than lung cancer); eye problems, including dry eyes; heart problems; liver or kidney disease; or any other medical condition. Also, tell your doctor if you wear contact lenses.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking afatinib and for at least 2 weeks after your treatment. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking afatinib, call your doctor immediately. Afatinib may harm the fetus.
  • tell your doctor if you are breast-feeding. You should not breast-feed while you are taking afatinib.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Afatinib may make your skin sensitive to sunlight. Exposure to sunlight increases the risk that you will develop a rash or acne during your treatment with afatinib.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • nausea
  • vomiting
  • weakness
  • dizziness
  • headache
  • stomach pain

Afatinib Brand Names

Afatinib may be found in some form under the following brand names:

  • Gilotrif

  • Giotrif

Inform MD

Before you take afatinib, tell your doctor if you: 

  • have kidney or liver problems
  • have lung or breathing problems other than lung cancer 
  • have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses. 
  • have heart problems 
  • have any other medical conditions 
  • are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

Proper Use of afatinib

Medicines used to treat cancer are very strong and can have many side effects. Before receiving afatinib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take afatinib exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

afatinib comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Take afatinib on an empty stomach at least 1 hour before or 2 hours after a meal.

Dosing

The dose of afatinib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of afatinib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For metastatic non-small cell lung cancer:
      • Adults—40 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of afatinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take afatinib if it has been more than 12 hours since you missed your last dose. Do not take 2 doses at the same time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Brand Names U.S.

  • Gilotrif

Use Labeled Indications

Non-small cell lung cancer, metastatic, EGFR mutation-positive: First-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an approved test.

Limitations of use: Safety and efficacy have not been established in patients whose tumors express EGFR mutations other than exon 19 deletion or exon 21 (L858R) substitution.

Non-small cell lung cancer, metastatic squamous: Treatment of previously treated metastatic squamous cell NSCLC which has progressed following platinum-based chemotherapy.

Dosing Hepatic Impairment

Preexisting mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment is necessary.

Preexisting severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); closely monitor and adjust dose if necessary.

Hepatotoxicity during treatment: Withhold therapy for ≥ grade 3 hepatic dysfunction. Upon improvement to baseline or ≤ grade 1, resume therapy at 10 mg per day less than previous dose. Permanently discontinue for severe afatinib-induced hepatic impairment.

Storage

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Dispense in original bottle; protect from high humidity and light.

Patient Handout

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Usual Adult Dose for Non-Small Cell Lung Cancer

40 mg orally once a day

Duration of therapy: Until disease progression or no longer tolerated by patient.

Comments: Administer at least 1 hour before or 2 hours after a meal

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