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The following information outlines important safety warnings for the use of erlotinib (Tarceva). It is crucial to understand these risks and consult your healthcare provider if you have any concerns or experience any symptoms described below.

• Severe Lung or Breathing Problems: In rare cases, erlotinib has been associated with a condition known as interstitial lung disease (ILD), which causes scarring of the lungs. Symptoms may appear from 5 days to 9 months after starting treatment. If you experience new or worsening breathing difficulties, chest pain, a dry cough, or fever, contact your healthcare provider immediately. Treatment may need to be paused or stopped to investigate these symptoms.

• Kidney or Liver Damage: This medication can occasionally lead to serious kidney issues. Regular laboratory tests will be conducted by your healthcare provider to monitor kidney function. If you notice changes in urination frequency or blood in your urine, notify your provider promptly. The risk is higher if you have a history of liver problems or are dehydrated.

• Gastrointestinal Perforation: Although extremely rare, there is a risk of tears in the stomach, intestines, or bowel, which can be life-threatening. This risk increases if you are also taking medications that affect blood vessel formation, corticosteroids, NSAIDs, or taxane chemotherapy. Seek immediate medical attention if you experience severe abdominal pain, fever, nausea, or vomiting.

• Severe Skin Problems: Erlotinib may cause skin issues such as pus-filled blisters, dry or cracking skin, nail changes, and excessive hair growth. Serious skin reactions or infections, though rare, can be life-threatening. Report any painful blisters, skin wounds, or peeling to your provider immediately, as these require urgent medical care.

• Stroke: There is a rare risk of blood clots in the brain, potentially leading to a stroke. Call emergency services if you experience severe headaches, sudden confusion, weakness on one side of your body, or difficulties with speech or movement.

• Eye Problems: Potential effects include reduced tear production, dry eyes, abnormal eyelash growth, and eye inflammation. Rarely, these may lead to severe complications. Report any eye pain or vision changes to your healthcare provider right away.

• Serious Bleeding Risk with Warfarin: Concurrent use of warfarin (Coumadin) and erlotinib increases the risk of bleeding. Regular blood tests will be conducted to ensure safe dosing. Seek immediate medical help if you observe signs of bleeding, such as blood in your urine or stool, or if bleeding from a wound does not stop.

• Risk to Unborn Baby: Animal studies suggest that erlotinib may harm an unborn baby or increase the risk of miscarriage. Women who can become pregnant should use effective contraception during treatment and for one month after the last dose. Inform your healthcare provider immediately if you become pregnant while taking this medication.

Please ensure you discuss any concerns or symptoms with your healthcare provider to ensure safe and effective use of erlotinib (Tarceva).

Common side effects:

• rash
• diarrhea
• loss of appetite
• extreme tiredness
• cough
• difficulty breathing
• nausea
• infection
• dry skin
• back pain
• chest pain
• itching
• changes in your nails
• joint or muscle pain
• eye inflammation

Less common but important to monitor:

• severe rash

Serious side effects:

• symptoms of a stroke (severe headaches, visual changes, sudden confusion)
• serious lung problems (extreme tiredness, dry cough)
• kidney issues (blood in the urine, painful urination)
• liver damage (dark urine, stomach pain, yellowing of the eyes or skin, loss of appetite)
• damage to the gut (intense stomach pain, fever, chills)
• severe skin reactions (painful blisters or sores)
• serious bleeding (unexplained bruising, throwing up blood)
• very serious allergic reaction (extensive rash, swelling of the face, tongue, or throat, severe dizziness, trouble breathing)

Interactions with high risk of serious adverse effects and should be avoided:

• omeprazole
• warfarin
• dabigatran
• Aspirin
• Acenocoumarol
• Amiodarone
• Boceprevir
• Indinavir
• Lopinavir
• Nelfinavir
• Ritonavir
• Saquinavir
• Telaprevir
• Itraconazole
• Ketoconazole
• Posaconazole
• Voriconazole
• Clarithromycin
• Telithromycin
• Carbamazepine
• Ciprofloxacin
• Enzalutamide
• Lumacaftor
• Mitotane
• Phenobarbital
• Phenytoin
• Rifabutin
• Rifampin
• Rifapentine
• St John's Wort

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• clopidogrel
• ibuprofen
• naproxen
• Cimetidine
• Famotidine
• Ranitidine