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This document outlines essential safety and warning information associated with the use of Azacitidine (Vidaza). It is crucial to understand these details to manage potential risks effectively. Always consult your healthcare provider if you have any questions or concerns.

• Low Blood Cell Counts: Azacitidine (Vidaza) may reduce your white blood cells, red blood cells, and platelets, increasing the risk of bleeding and infections. Regular blood count monitoring before each treatment cycle is essential. Contact your healthcare provider immediately if you experience a fever of 100.4°F or higher, feel unwell, or notice unusual bruising or bleeding. Dosage adjustments or discontinuation may be necessary.

• Liver Damage: Azacitidine (Vidaza) can cause severe liver damage, especially in individuals with pre-existing liver conditions or those with high tumor burden. Regular liver function tests are required before each treatment cycle. Symptoms of liver issues include fatigue, appetite loss, nausea, vomiting, dark urine, abdominal pain, easy bruising or bleeding, and yellowing of the skin or eyes. Inform your provider if you experience any of these symptoms.

• Kidney Damage: There is a risk of serious kidney problems with Azacitidine (Vidaza). Kidney health will be monitored through lab tests before each treatment cycle. Report any changes in urination frequency or blood in your urine to your healthcare provider promptly.

• Tumor Lysis Syndrome (TLS): Azacitidine (Vidaza) may trigger TLS, a condition where dying cancer cells release substances into the bloodstream, leading to high levels of uric acid and electrolytes. This can result in kidney damage and abnormal heart rhythms. Monitoring is necessary to mitigate these risks.

• Pregnancy Risks: Azacitidine (Vidaza) can harm an unborn baby, according to animal studies. Women should use birth control during and for at least six months after treatment, while men should do so for at least three months post-treatment. Notify your provider immediately if pregnancy occurs during this period.

Contraindications: Azacitidine (Vidaza) should not be used if you have advanced cancerous liver tumors or a severe allergy to mannitol. If you have these conditions, discuss alternative treatments with your healthcare provider.

Common side effects:

• Redness at the injection site
• Pain at the injection site
• Bruising at the injection site
• Tiredness
• Diarrhea
• Dizziness
• Trouble sleeping
• Constipation
• Nausea
• Vomiting
• Dry skin
• Headache
• Loss of appetite
• Fever
• Injection site warmth

Less common but important to monitor:

• Low red blood cells (anemia)
• Low platelets (increased bruising)
• Low white blood cells (increased infection risk)
• Persistent sore throat
• Chills

Serious side effects:

• Easy bleeding or bruising
• Chest pain
• Muscle or joint pain
• Irregular heartbeat
• Mental changes like anxiety
• Severe allergic reactions (rash, itching, swelling, severe dizziness, difficulty breathing)
• Liver damage (dark urine, yellowing of the skin or eyes)
• Kidney damage (changes in urination)
• Tumor lysis syndrome (muscle spasms, weakness, flank pain)

When taking azacitidine, it's important to be aware of potential interactions with other medications and substances. Azacitidine can interact with various drugs, leading to increased risks of infections, bone marrow suppression, or reduced effectiveness of treatments.

Medications That May Increase Infection Risk:

Combining azacitidine with certain immunosuppressive drugs can heighten the risk of serious infections. For instance, using azacitidine alongside baricitinib or upadacitinib may elevate this risk. It's crucial to monitor for signs of infection, such as fever, chills, or sore throat, and report them to your healthcare provider promptly.

Drugs That Can Worsen Bone Marrow Suppression:

Some medications, when taken with azacitidine, can further suppress bone marrow function, leading to conditions like neutropenia (low white blood cell count). For example, combining azacitidine with Clozapine may increase the risk of neutropenia. Regular blood tests are essential to monitor blood cell counts during treatment.

Vaccines and Azacitidine:

Live vaccines, such as the measles, mumps, and rubella (MMR) vaccine, should generally be avoided during azacitidine treatment due to the potential for reduced vaccine efficacy and increased risk of infection. It's advisable to complete any necessary vaccinations at least two weeks before starting azacitidine therapy.

Other Considerations:

Azacitidine is primarily excreted by the kidneys. Patients with severe kidney disease should use azacitidine with caution, as the drug may accumulate in the body, increasing the risk of side effects. Regular monitoring of kidney function is recommended.

Additionally, azacitidine can cause liver toxicity, especially in patients with pre-existing liver conditions. It's important to monitor liver function tests during treatment.

Always inform your healthcare provider about all medications, supplements, and vaccines you are taking or planning to take. This ensures that potential interactions are identified and managed appropriately, optimizing the safety and effectiveness of your azacitidine treatment.