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This document outlines key safety information and warnings associated with the use of Venclexta (venetoclax). Please read carefully and discuss any concerns with your healthcare provider.

• Tumor Lysis Syndrome (TLS): Venclexta may cause TLS, a dangerous condition where cancer cells die rapidly, releasing substances into the blood that can lead to high uric acid and electrolyte imbalances. This may result in kidney damage and abnormal heart rhythms. TLS risk is heightened at the start of treatment and with dose increases. Patients with kidney issues, high tumor burden, enlarged spleen, circulating blasts, or elevated LDH levels are at greater risk.

• Low Blood Cell Counts: Venclexta can lower white and red blood cells and platelets, increasing the risk of anemia, bleeding, bruising, and infections. Regular blood count monitoring is essential. Report any signs of fever, illness, or unusual bleeding or bruising to your provider, as dosage adjustments may be necessary.

• Infections: The risk of serious infections, including pneumonia and sepsis, is increased with Venclexta use, which can be life-threatening if untreated. Immediate medical attention is required if symptoms such as fever, chills, fatigue, or cough occur.

• Vaccination Precautions: Avoid live vaccines before, during, and after Venclexta treatment unless approved by your healthcare provider, as they may cause infections in individuals with weakened immune systems. The effectiveness of vaccines may also be reduced.

• Pregnancy Warning: Animal studies suggest that Venclexta may harm an unborn child. Women who can become pregnant should use effective contraception during treatment and for one month after the last dose. Notify your provider immediately if you become pregnant during this period.

• Contraindications: Do not use Venclexta concurrently with strong CYP3A inhibitors during the initial and dose-escalation phases for CLL/SLL patients, as this increases the risk of TLS.

This information is crucial for safe and effective use of Venclexta. Always follow your healthcare provider’s instructions and report any adverse effects promptly.

When taking this medication, some common side effects may occur, though they are generally mild and manageable. These include diarrhea, nausea, vomiting, tiredness, and headaches. It’s advisable to eat small meals and rest adequately to help mitigate these symptoms. Additionally, some people might experience muscle and joint pain, swelling in limbs, stomach pain, rash, or constipation. If any of these persist or worsen, consulting a healthcare provider is recommended.

More serious side effects, although less common, should be taken seriously. These include easy bruising or bleeding, a low count of white or red blood cells, and low platelet count, which might increase the risk of infections. Symptoms such as fever, sore throat, or persistent cough could indicate an infection. In very rare cases, severe allergic reactions like rash, swelling, or trouble breathing might occur, requiring immediate medical attention.

Another serious condition associated with this medication is tumor lysis syndrome, which can result from the rapid destruction of cancer cells. Symptoms may include fever, chills, muscle weakness, and changes in urine color. It is crucial to stay hydrated and monitor for any signs of kidney problems.

If you notice symptoms such as low blood pressure, dizziness, or painful mouth sores, it is important to seek medical advice. Always communicate any unusual or severe side effects to a healthcare provider to ensure appropriate care and monitoring.