Giotrif

The recommended starting dose of Giotrif (Afatinib) is 40 mg taken by mouth, once daily.

Food reduces the amount of medication that is available for your body to use. Giotrif (Afatinib) should be taken at least 3 hours after eating or 1 hour before eating. It should not be crushed or chewed. Swallow the tablets whole with water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you vomit shortly after taking your dose of Giotrif (Afatinib), do not take another dose. Continue with your regular dosing schedule.

It is important that Giotrif (Afatinib) be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose (within 8 hours), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Giotrif (Afatinib) at room temperature, in its original package. Do not remove the tablet from its blister until you are ready to take it. Protect Giotrif (Afatinib) from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

20 mg
Each film-coated, white to slightly yellowish, round, biconvex, bevelled-edge tablet, debossed with the code "T20" on one side and with "BI" on the other, contains 20 mg of Giotrif (Afatinib) as Giotrif (Afatinib) dimaleate. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Film coating: hypromellose 2910, macrogol 400, polysorbate 80, talc, and titanium dioxide.

30 mg
Each film-coated, dark blue, round, biconvex, bevelled-edged tablet, debossed with the code "T30" on one side and with "BI" on the other contains 30 mg of Giotrif (Afatinib) as Giotrif (Afatinib) dimaleate. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Film coating: hypromellose 2910, macrogol 400, polysorbate 80, talc, titanium dioxide, and indigo carmine aluminium hydroxide.

40 mg
Each film-coated, light blue, round, biconvex, bevelled-edged tablet, debossed with the code "T40" on one side and with "BI" on the other contains 40 mg of Giotrif (Afatinib) as Giotrif (Afatinib) dimaleate. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Film coating: hypromellose 2910, macrogol 400, polysorbate 80, talc, titanium dioxide. and indigo carmine aluminium hydroxide.

Do not take Giotrif (Afatinib) if you are allergic to Giotrif (Afatinib), or any ingredients of the medication.

There may be an interaction between Giotrif (Afatinib) and any of the following:

• Amiodarone
• Apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Carbamazepine
• Carvedilol
• Cyclosporine
• Dronedarone
• Elagolix
• Flibanserin
• HIV protease inhibitors (e.g., atazanavir, indinavir, lopinavir, ritonavir, saquinavir)
• Lapatinib
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Phenobarbital
• Phenytoin
• Porfimer
• primidone
• Propafenone
• quinidine
• quinine
• rifampin
• St. John's wort
• Tacrolimus
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Giotrif (Afatinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Giotrif (Afatinib).

Corneal perforation: Rarely, Giotrif (Afatinib) has been linked to corneal perforation, a severe injury to the part of the eye that focuses light into the eye. If you experience persistent eye pain or changes in vision, contact your doctor as soon as possible.

Dehydration: Severe dehydration can occur with the use of Giotrif (Afatinib). This may be due to severe or persistent diarrhea, vomiting, or decreased fluid intake. Dehydration can lead to kidney failure, if it is severe enough. During treatment with Giotrif (Afatinib), you may be encouraged to drink extra water. Your doctor will do blood tests to check the function of your kidneys.

Diarrhea: Diarrhea is a common side effect of Giotrif (Afatinib). If severe enough, it can lead to dehydration and possibly kidney failure. If you experience diarrhea while taking Giotrif (Afatinib), it is important that it be treated quickly. Your doctor may give you medication to take at the first signs of diarrhea. If you experience diarrhea that does not go away with appropriate medication, contact your doctor immediately.

Galactose intolerance/glucose malabsorption: Giotrif (Afatinib) tablets are prepared with lactose. If you have a lactose or galactose intolerance, tell your doctor.

Gastrointestinal perforation: Rarely, Giotrif (Afatinib) can cause perforation (holes) in the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or black and tarry stools, contact your doctor immediately.

Heart problems: Giotrif (Afatinib) may reduce how well the heart is able to pump blood through the body. If you have a history of any heart problems, discuss with your doctor how Giotrif (Afatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Giotrif (Afatinib), and whether any special monitoring is needed. Difficulty breathing, unusual tiredness, and swelling of the feet, ankles or hands, may be symptoms of the heart not working efficiently. Contact your doctor as soon as possible if you experience any of these symptoms.

Interstitial lung disease (ILD): This is a rare but serious complication. People with other lung conditions (e.g., inflammation of the lung) have an increased risk of death from ILD. If you develop symptoms of ILD such as shortness of breath with cough or fever, seek immediate medical attention.

Kidney function: Kidney Disease or reduced kidney function may cause Giotrif (Afatinib) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Giotrif (Afatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Giotrif (Afatinib), and whether any special monitoring is needed. People with severely reduced kidney function should not take Giotrif (Afatinib).

Liver function: People taking Giotrif (Afatinib) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Giotrif (Afatinib). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Giotrif (Afatinib) or stop taking it altogether.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. People with severely reduced liver function should not take Giotrif (Afatinib).

Nail bed inflammation: Giotrif (Afatinib) may cause inflammation of the nail beds. This may appear as a painful, red, swollen area around the nails. Nails may look abnormally shaped, be detached, or have an unusual colour. It is important to take good care of your skin, keep your hands clean and dry, and avoid injury to your nails or finger tips. Avoid harsh chemicals such as soap, detergents and nail products.

Skin reactions: Severe skin reactions have been linked to Giotrif (Afatinib) use. Although rare, they are considered medical emergencies and require immediate medical attention.

If you experience skin blistering or peeling, a rash that covers a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort, seek medical attention immediately.

Pregnancy: There are no adequate studies of use of Giotrif (Afatinib) by pregnant women. Giotrif (Afatinib) should not be taken during pregnancy. If you are a woman who could become pregnant, use a reliable method of birth control (e.g., condoms, birth control pill) during treatment and for at least 2 weeks after treatment is finished. If you become pregnant while taking Giotrif (Afatinib), contact your doctor immediately.

Breast-feeding: It is not known if Giotrif (Afatinib) passes into breast milk. If you are a breast-feeding mother and are taking Giotrif (Afatinib), it may affect your baby. Due to the potential for serious harm to a baby if they are exposed to Giotrif (Afatinib), breast-feeding mothers are advised not use Giotrif (Afatinib).

Children: The safety and effectiveness of Giotrif (Afatinib) have not been established for children.

Seniors: People over the age of 65 may be at risk of a higher incidence of side effects, particularly diarrhea. Talk to your doctor if you have any concerns.