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The following is essential safety information regarding the use of Sprycel (dasatinib). Please review these warnings carefully and consult your healthcare provider if you have any questions or concerns.

• Low Blood Counts: Sprycel may lead to decreased levels of red blood cells, white blood cells, and platelets, resulting in fatigue, increased risk of bleeding, bruising, and infections. Regular blood count monitoring is necessary. Contact your healthcare provider if you experience fever, chills, or persistent bleeding and bruising, as you may need a dosage adjustment or cessation of the medication.

• Bleeding Risks: A small number of individuals in clinical studies experienced bleeding, occasionally severe or life-threatening. Notify your provider if you observe persistent bleeding, blood in urine, vomit, or stools. Caution is advised when using medications that increase bleeding risk, such as antiplatelets and blood thinners.

• Fluid Retention and Swelling: Sprycel can cause or exacerbate swelling in the limbs or fluid accumulation around the heart or lungs, leading to symptoms like shortness of breath, cough, weight gain, and poor appetite. Inform your healthcare provider if these symptoms occur, as a dosage adjustment or additional treatment may be required.

• Heart Issues: Rarely, Sprycel has been associated with serious heart conditions, including abnormal rhythms, heart attack, and pulmonary hypertension. These can occur anytime, even years after starting treatment. If you have a history of heart issues, your provider may monitor you more closely. Seek immediate medical attention if you faint, have a rapid heartbeat, chest pain, or breathing difficulties.

• Severe Skin Reactions: Although uncommon, serious skin reactions have been reported. Notify your provider immediately if you develop a rash, fever, or blisters.

• Tumor Lysis Syndrome (TLS): Rarely, TLS can occur when many cancer cells die rapidly, releasing contents that can damage the kidneys and disrupt heart rhythms. This is more likely in patients with a high tumor burden or previous kidney damage. Symptoms include reduced urination, dark urine, muscle cramps, or a racing heart. Inform your provider if these symptoms arise.

• Harm to Unborn Baby: Animal studies suggest Sprycel can harm an unborn baby or increase miscarriage risk. Effective birth control is recommended during treatment and for one month after the last dose. Inform your provider if you become pregnant.

• Growth and Development in Children: A small number of children experienced growth and developmental issues after prolonged use. These issues may resolve without stopping treatment. Pediatric patients should have their growth monitored regularly.

Always discuss potential risks and benefits with your healthcare provider to ensure the safe use of Sprycel.

When taking this medication, you may encounter some common side effects. These can include fluid retention or swelling, headaches, diarrhea, and tiredness. Additional common side effects are bleeding, trouble breathing, nausea, muscle, joint, or bone pain, rash, fever, and vomiting. Generally, these effects are mild, but if they persist or worsen, it's important to consult your healthcare provider for guidance.

There are other side effects that some individuals might experience, such as constipation, stomach pain, general pain, muscle spasms, infections, and itchy skin. Occasionally, users report fever, especially when accompanied by low white blood cell counts, known as febrile neutropenia. While these are less common, they should still be monitored and brought to your healthcare provider’s attention if they occur.

Serious side effects, although rare, require immediate medical attention. These include severe infections, characterized by repeated fevers, chills, cough, and severe diarrhea or vomiting, as well as painful or frequent urination. Serious bleeding can occur, evidenced by persistent bruising or bleeding, blood in the urine, vomiting blood, or black, tarry stools. Heart-related issues such as chest pain, a racing heart, shortness of breath, swelling in the legs or feet, sudden weight gain, fatigue, dizziness, or weakness on one side of the body also demand urgent care. Additionally, watch for signs of abnormal electrolyte levels or kidney problems, such as dark urine, reduced urination, pain in the lower back, muscle cramps or spasms, numbness, nausea, and vomiting.

Keep in mind that this medication may affect bone marrow function, leading to a decrease in red and white blood cells and platelets, which could result in anemia, increased infection risk, or easy bruising and bleeding. It's crucial to report any unusual tiredness, pale skin, persistent sore throat, fever, or chills to your healthcare provider promptly. Lastly, though rare, serious allergic reactions may happen, marked by rash, itching, swelling, severe dizziness, or trouble breathing, requiring immediate medical help.

When taking Sprycel (dasatinib), it's crucial to be aware of potential drug interactions. Some medications, such as blood thinners (e.g., warfarin, dabigatran), antiplatelet drugs (like clopidogrel), and NSAIDs (such as ibuprofen and naproxen), can increase bleeding risks when used with dasatinib. Aspirin may also elevate this risk. However, continue taking low-dose aspirin if your doctor prescribes it for heart attack or stroke prevention. Additionally, medicines that lower stomach acid, including antacids, H2 blockers (for example, famotidine, ranitidine), and proton pump inhibitors (such as omeprazole), may interact with dasatinib.

Dasatinib's effectiveness can be influenced by other drugs that affect its removal from the body, such as certain azole antifungals (itraconazole, ketoconazole), antibiotics like clarithromycin, and herbal supplements like St. John's wort. It is also important to note that dasatinib should not be used with specific medications, including Bepridil, Dronedarone, and several live vaccines, among others. In cases where co-administration is essential, your doctor might adjust dosages or the frequency of use. Always inform your healthcare provider about all medications and supplements you are taking to manage potential interactions effectively.