Gilotrif

Generic Name: afatinib (Oral route)

a-FA-ti-nib

Commonly used brand name(s)

In the U.S.

  • Gilotrif

Available Dosage Forms:

  • Tablet

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Gilotrif

Afatinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer or NSCLC that has certain types of abnormal epidermal growth factor receptor (EGFR) genes in patients who have not received any treatments for cancer that has already spread to other parts of the body.

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is available only with your doctor's prescription.

Before Using Gilotrif

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of afatinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of afatinib in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Amiodarone
  • Azithromycin
  • Bosutinib
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Cyclosporine
  • Diltiazem
  • Dronedarone
  • Erythromycin
  • Felodipine
  • Fosphenytoin
  • Itraconazole
  • Ketoconazole
  • Lomitapide
  • Lopinavir
  • Nelfinavir
  • Nilotinib
  • Phenytoin
  • Primidone
  • Quercetin
  • Quinidine
  • Ranolazine
  • Rifampin
  • Ritonavir
  • Saquinavir
  • Simeprevir
  • St John's Wort
  • Tacrolimus
  • Telaprevir
  • Ticagrelor
  • Tipranavir
  • Tocophersolan
  • Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Eye problems (eg, keratitis, ulcerative keratitis, severe dry eyes), history of or
  • Heart disease or
  • Kidney disease or
  • Liver disease or
  • Lung disease (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.

Proper Use of Gilotrif

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

Take this medicine 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.

This medicine 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 this medicine on an empty stomach at least 1 hour before or 2 hours after a meal.

Dosing

The dose of this medicine 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 this medicine. 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 this medicine, 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 this medicine 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.

Precautions While Using Gilotrif

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 2 weeks after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if diarrhea occurs while taking this medicine. You may need medicines to help manage or prevent the diarrhea.

Skin reactions (eg, acne, rash, or skin redness) may occur while you are using this medicine. Check with your doctor right away if you develop severe skin reactions, such as blistering or peeling of the skin, or severe rash. Also, avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are using this medicine.

Check with your doctor right away if you start having breathing problems, shortness of breath, a cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if you have vision changes, such as blurred vision, difficulty reading, or eye pain, irritation, or swelling, during or after treatment. Your doctor may want you to have your eyes checked by an eye doctor. Also, tell your doctor if you wear contact lenses.

Check with your doctor right away if you have trouble breathing, cough, fast or uneven heartbeat, rapid weight gain, swelling of your ankles or legs, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Gilotrif Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bloody or cloudy urine
  • burning, dry, or itching eyes
  • diarrhea
  • difficult, burning, or painful urination
  • discharge or excessive tearing
  • fever
  • frequent urge to urinate
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • tingling of the hands and feet
  • ulceration of the skin
Less common
  • Cough
  • difficult breathing
  • shortness of breath

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Abdominal or stomach pain
  • dizziness
  • headache
  • lack or loss of strength
  • nausea
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Blemishes on the skin
  • canker sores
  • chapped, red, or swollen lips
  • decreased appetite
  • decreased weight
  • dry skin
  • itching skin
  • loosening of the fingernails
  • nosebleeds
  • pimples
  • rash
  • redness or soreness around the fingernails
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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