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This information outlines crucial safety considerations for those prescribed Ofev (nintedanib). Please ensure you understand these warnings and discuss any questions or concerns with your healthcare provider.

• Serious Liver Issues: Ofev (nintedanib) has the potential to cause significant liver damage, possibly leading to liver failure or death. Symptoms typically appear within the first three months of treatment. Regular liver function tests are necessary before and during treatment. Be vigilant for signs such as jaundice, fatigue, poor appetite, nausea, abdominal pain, vomiting, confusion, slurred speech, mood changes, or personality shifts. Immediate medical intervention may be needed, and cessation of the medication could be required to prevent further liver damage.

• Gastrointestinal Perforation Risk: Ofev (nintedanib) can occasionally cause damage to the stomach or intestines, resulting in serious bleeding. Notify your healthcare provider if you have had recent abdominal surgery or existing gastrointestinal conditions. Immediate medical attention is required for sudden, severe abdominal pain or tenderness as these may indicate gastrointestinal perforation. Risks are elevated with recent stomach surgery, diverticular disease, and concurrent use of corticosteroids or NSAIDs.

• Pregnancy Warning: Ofev (nintedanib) poses significant risks to an unborn child, potentially causing severe harm or death. It should not be used during pregnancy. Females of childbearing potential should undergo pregnancy testing before and during treatment and use effective contraception before, during, and for at least three months after cessation of treatment.

• Bleeding Risk: This medication can increase the likelihood of severe bleeding, particularly if used alongside other drugs that elevate bleeding risk, such as anticoagulants, NSAIDs, or antiplatelets. If you have a predisposition to bleeding, treatment will only continue if the benefits outweigh the risks. Seek immediate medical assistance if you experience uncontrollable bleeding or symptoms such as dizziness or light-headedness.

• Blood Clot Risk: Although infrequent, Ofev (nintedanib) may heighten the risk of blood clots, leading to conditions like heart attacks, particularly in individuals with coronary artery disease. Inform your healthcare provider of all pre-existing conditions before commencing treatment. Call 911 if you experience symptoms indicative of a heart attack, such as chest pain, shortness of breath, or pain in the jaw, neck, or back.

• Kidney Concerns: The use of Ofev (nintedanib) may result in proteinuria, a condition where protein leaks from the blood into the urine, indicating potential kidney issues. Some patients see improvement after discontinuing the medication, while others continue to experience proteinuria. Your healthcare provider may pause treatment if proteinuria is suspected.

There are no specific contraindications noted for Ofev (nintedanib).

When taking this medication, you may experience some common side effects, which are often mild and manageable. These include diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, fatigue, headache, fever, back pain, dizziness, and elevated liver enzymes. It's important to stay hydrated if you experience diarrhea or vomiting, as these can be more severe. Additionally, this medication may cause high blood pressure, so regular monitoring is advised.

There are some less common side effects such as low thyroid hormone and hair loss. While these are not frequent, it's important to consult your healthcare provider if you notice them.

More serious side effects are rare but require immediate medical attention. These include symptoms of liver problems like yellowing of the skin or eyes, severe fatigue, or confusion. Signs of a heart attack, such as chest pain or shortness of breath, and symptoms of a stroke, like sudden vision problems or weakness on one side of the body, should also be addressed urgently. Other severe reactions can include blood clots, severe stomach or intestinal damage, and significant bleeding.

Lastly, although an allergic reaction to this medication is very rare, seek medical help immediately if you experience symptoms such as a rash, severe dizziness, or difficulty breathing. Always inform your healthcare provider of any new or worsening symptoms you may encounter while on this medication.