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Azacitidine is available in 100 mg single-dose vials.

Azacitidine is a type of chemotherapy that is used to treat:

• Certain types of myelodysplastic syndromes (MDS)
• Juvenile myelomonocytic leukemia (JMML)

Azacitidine is a chemotherapy medication called a hypomethylating agent. The main way it fights blood cancers is by allowing these immature blood cells to grow up properly into healthy “adult” blood cells. Sometimes, this also leads to cell death of the immature blood cells.

Your provider will calculate your dose of Azacitidine using your body surface area (BSA, in units of m2), which takes into account your body weight and height.

MDS

• AZA is injected into the veins or under the skin daily for the first 7 days of a 28-day cycle. It’s recommended that this is repeated for at least 4 to 6 cycles
• The typical dose of Azacitidine during the first treatment cycle is 75 mg/m2 daily. You’ll repeat this cycle as long as you continue to benefit from treatment and don’t have intolerable side effects. If needed, your provider might raise your dose after 2 treatment cycles

JMML

• Azacitidine is injected into the veins daily for the first 7 days of a 28-day cycle. This treatment is typically repeated through 3 to 6 cycles
• Children aged 1 month to less than 1 year (or weighing less than 10 kg): The typical dose is 2.5 mg/kg daily

Children aged 1 year and older (and weighing 10 kg or more):

• The typical dose is 75 mg/m2 daily

Your dose of Azacitidine might be different depending on your response to treatment or if you experience certain side effects.

Azacitidine is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Advanced Malignant Hepatic Tumors
• Hypersensitivity to Azacitidine or Mannitol

Common side effects of Azacitidine:

• Nausea
• Low red blood cells
• Low platelets
• Vomiting
• Fever
• Constipation
• Low white blood cells
• Injection site redness or warmth
• Diarrhea
• Bruising
• Trouble breathing
• Small red skin spots
• Injection site pain
• Joint pain
• Headache

Serious side effects are rare with Azacitidine. Contact your healthcare provider immediately if you experience any of the following.

• Liver damage: tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, easy bruising or bleeding, or yellowing of the eyes or skin
• Kidney damage: blood in urine, changes in urination (more or less)
• High uric acid and electrolyte imbalances: dark urine, not urinating as much as usual, pain on either side of the lower back, racing heart, muscle cramps or spasms, numbness, nausea, vomiting
• Serious bleeding: unusual bleeding, easy bruising, blood in urine or stool, confusion, vision changes
• Serious infections: fevers, chills, sweating, trouble breathing

There are no major drug interactions listed for Azacitidine. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.

Various FDA-approved generic manufacturers

Based on its mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment with Azacitidine and for 6 months after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment with Azacitidine and for 3 months after the last dose. Report known or suspected pregnancy to your physicians immediately

• Vidaza