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This document outlines crucial safety information regarding the use of Imbruvica (ibrutinib). It is essential for patients and healthcare providers to be aware of potential risks and take necessary precautions. Please read the following points carefully and consult your healthcare provider if you have any questions or concerns.

• Bleeding Risks: Imbruvica may lead to bleeding complications, ranging from minor bruising and red spots on the skin to severe brain and stomach hemorrhages. The risk increases if you are taking antiplatelet drugs or blood thinners, or if you have recently undergone surgery. Inform your healthcare provider if you are scheduled for any surgical procedures as they may advise you to pause the medication temporarily. Seek immediate medical attention if you notice blood in your vomit, urine, or stool, or if you experience a sudden, severe headache.

• Infection Risks: There is a possibility of serious and sometimes fatal infections occurring while taking Imbruvica. To mitigate this risk, practice good hygiene by washing your hands frequently with soap and warm water. Report any signs of infection, such as fever or chills, to your healthcare provider. Preventative medications might be prescribed if your infection risk is high.

• Cardiac Concerns: Although rare, Imbruvica can cause serious heart issues, including irregular heartbeats and heart failure. Share your complete medical history with your provider, especially if you have a history of heart conditions. Immediate consultation with a healthcare provider is recommended if you experience fainting, rapid heartbeat, lightheadedness, chest pain, or sudden shortness of breath.

• Hypertension: Approximately 20% of patients in clinical trials experienced high blood pressure while on Imbruvica. It is important to attend regular clinic visits to monitor your blood pressure. Your healthcare provider may prescribe medications to manage increased blood pressure.

• Cancer Risk: There is a potential for Imbruvica to increase the risk of developing other cancers, most often non-melanoma skin cancer. Use protective clothing and sunscreen when exposed to sunlight to lower this risk.

• Tumor Lysis Syndrome: This rare but serious condition can occur, especially if you have a high number of cancer cells, dehydration, or kidney damage. Symptoms such as dark urine, rapid heartbeat, muscle cramps, numbness, nausea, or vomiting may appear within the first week of treatment. Immediate medical intervention is necessary to prevent severe complications.

There are no specific contraindications listed for Imbruvica. Always follow your healthcare provider's instructions and report any unusual symptoms or side effects immediately.

When taking this medication, some individuals experience common side effects, typically mild in nature. These can include fatigue, bone or muscle pain, diarrhea, bruising, rash, upper respiratory tract infections, high blood pressure, joint pain, nausea, headache, and low blood cell counts. Other frequently reported symptoms are cough, fever, mouth sores, muscle spasms, body swelling, stomach pain, constipation, dizziness, vomiting, and skin infections. If these effects persist or worsen, it's advisable to consult a healthcare provider.

In some cases, patients may encounter other side effects such as indigestion, sinus swelling, urinary tract infections, weakness, low potassium levels, fast heart rate, trouble sleeping, bronchitis, flu, sore throat, poor appetite, and blurry vision. While these are less common, any severe occurrences should prompt immediate consultation with a healthcare provider.

Serious side effects, although rare, require urgent medical attention. These include symptoms of serious bleeding like blood in vomit or stool, severe infections, heart problems, new or worsening high blood pressure, and significantly low blood cell counts. Additionally, new skin cancers or changes in moles, along with symptoms of tumor lysis syndrome such as dark urine, muscle cramps, or numbness, are critical and need immediate medical intervention.

Furthermore, this medication could potentially affect your liver, manifesting as prolonged nausea, vomiting, loss of appetite, abdominal pain, yellowing of the skin or eyes, and dark urine. Serious allergic reactions, though uncommon, may present as rash, severe dizziness, or difficulty breathing and require prompt medical care. Always monitor your health and report any unusual symptoms to your healthcare provider for guidance.

Certain medications can interact with this drug, potentially leading to increased risks of bleeding or altered drug effectiveness. Drugs that can cause bleeding or bruising, such as antiplatelet medications like clopidogrel, NSAIDs like ibuprofen and naproxen, and anticoagulants like warfarin and dabigatran, should be used with caution when taking this drug. Aspirin may also heighten the risk of bleeding; however, if your healthcare provider has prescribed low-dose aspirin (typically 81-162 milligrams daily) to lower the risk of heart attack or stroke, continue its use unless advised otherwise by your doctor.

Additionally, certain medications can influence how ibrutinib is eliminated from the body, which can impact its effectiveness. This includes azole antifungals like itraconazole and ketoconazole, nefazodone, St. John's wort, macrolide antibiotics such as erythromycin and clarithromycin, rifamycins like rifampin and rifabutin, ritonavir, and some seizure medications like carbamazepine and phenytoin. Consult with your healthcare provider or pharmacist for more detailed information.