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The following information outlines critical safety warnings and precautions for the use of Gilotrif (afatinib). It is essential to read these warnings carefully and consult your healthcare provider if you have any concerns or questions.

• Diarrhea: Most patients taking Gilotrif (afatinib) experience diarrhea, usually within the first 6 weeks of treatment. This can sometimes lead to severe dehydration and electrolyte imbalance. Inform your healthcare provider immediately if diarrhea occurs, as it may require medical intervention. Your provider might advise pausing the medication or adjusting the dose. Anti-diarrheal medications like loperamide (Imodium A-D) may be recommended until symptoms resolve for a minimum of 12 hours. This condition can also affect kidney function.

• Skin Reactions: Common skin reactions include rashes, itching, and acne-like eruptions. In rare cases, severe reactions such as blisters, skin peeling, and hand-foot syndrome may occur. Contact your healthcare provider if you notice any skin changes. They may suggest stopping the medication temporarily or permanently, depending on the severity.

• Lung Problems: Gilotrif (afatinib) can, though rarely, cause serious lung conditions like interstitial lung disease (ILD). If you experience new or worsening respiratory symptoms such as a dry cough, difficulty breathing, or fever, inform your provider immediately. You may need to discontinue the medication if ILD is diagnosed.

• Liver Problems: Elevation of liver enzymes and potential liver damage are possible. Regular blood testing is necessary to monitor liver function. Inform your provider if you experience symptoms such as fatigue, loss of appetite, nausea, vomiting, dark urine, abdominal pain, easy bruising, or jaundice, as these may indicate liver issues.

• Tearing of the Stomach or Intestines: Although rare, Gilotrif (afatinib) can cause tears in the stomach or intestines, especially if taken with certain medications like NSAIDs or corticosteroids. Older adults and those with stomach ulcers or inflammatory bowel conditions are at higher risk. Severe abdominal pain should be reported immediately, and treatment may need to be stopped.

• Eye Problems: Some patients have experienced corneal redness and swelling, leading to increased light sensitivity, watery eyes, blurred vision, and eye pain. Those with severe dry eyes, corneal issues, or who wear contact lenses should exercise caution. Report any eye-related symptoms to your healthcare provider.

• Harm to Unborn Baby: While Gilotrif (afatinib) has not been studied extensively in human pregnancies, animal studies suggest potential harm to unborn babies and pregnant mothers. Women who can become pregnant should use effective birth control during treatment and for at least 2 weeks after the last dose. Notify your provider immediately if you become pregnant while taking this medication.

No specific contraindications are provided for Gilotrif (afatinib); however, the above warnings and precautions are crucial to ensure safe use of the medication.

When taking this medication, you may experience some common side effects, which are usually mild. These include diarrhea, which is quite prevalent, alongside rash or acne-like skin bumps, and painful sores in the mouth or throat. Some users may notice nail infections, elevated liver enzyme levels, reduced kidney function, and low white blood cell counts. Other possible effects are dry skin, low potassium levels, loss of appetite, nausea, and itchy skin. If these symptoms persist or become bothersome, it’s advisable to consult your healthcare provider.

Additionally, some individuals might encounter weight loss, nosebleeds, bladder infections, vomiting, cracked or swollen lips, fever, runny nose, and pink eye. If these effects occur and are severe, informing your healthcare provider is essential.

There are rare but serious side effects that necessitate immediate medical attention. These include severe skin reactions characterized by painful rashes, blisters, or peeling skin, and lung issues such as coughing, fever, difficulty breathing, or chest pain. Serious liver problems might manifest as unusual tiredness, persistent nausea or vomiting, dark urine, stomach pain, easy bruising, or yellowing of the eyes or skin. A tear in the stomach or intestines could show as fever, chills, severe stomach pain, bloating, or vomiting. Severe diarrhea also requires urgent medical care. If you experience any of these serious symptoms, seek medical help without delay.