Azacitidine

Azacitidine is a prescription medication used to treat the symptoms of Rheumatoid Arthritis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of Interleukin-1 Receptor Antagonist.

• Azacitidine is available under the following different brand names: Vidaza, Onureg

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 100mg/single-dose vial (Vidaza, generic)

Tablet

• 200mg (Onureg)
• 300mg (Onureg)

Myelodysplastic Syndromes

Adult dosage

• Each cycle is 4 weeks
• 75 mg/m2 IV or SC every day for 7 days; repeat cycle every 4 weeks
• May increased to 100 mg/m2 if no benefit is observed after 2 treatment cycles and if no toxicity other than nausea and vomiting
• Treat for a minimum of 4-6 cycles

Acute Myeloid Leukemia

Adult and pediatric dosage

• Each cycle is 28 days
• 300 mg orally every day on Days 1-14

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Azacitidine include:

• injection site reactions (redness, pain, bruising, irritation),
• tiredness,
• weakness,
• diarrhea,
• headache,
• dizziness,
• anxiety,
• trouble sleeping (insomnia),
• constipation,
• stomach pain,
• nausea and vomiting (may be severe),
• loss of appetite,
• joint or muscle pain, or
• cold symptoms such as stuffy nose, sneezing, or sore throat.

Serious side effects of the Azacitidine include:

• easy bleeding or bruising,
• chest pain,
• muscle cramps,
• irregular heartbeat,
• swollen ankles or feet,
• mental/mood changes (e.g., anxiety, depression),
• changes in the amount of urine,
• dark urine, or
• yellowing eyes or skin.

Rare side effects of the Azacitidine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Azacitidine has no noted severe interactions with any other drugs.
• Azacitidine has no noted serious interactions with any other drugs.
• Azacitidine has no noted moderate interactions with any other drugs.
• Azacitidine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• IV or SC
  • Advanced malignant hepatic tumors
  • Hypersensitivity to azacitidine or mannitol
• Oral
  • Hypersensitivity to azacitidine or its components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Anakinra?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Anakinra?”

Cautions

• Do not substitute oral azacitidine for IV or SC azacitidine
• May cause anemia, neutropenia, and thrombocytopenia; monitor CBC frequently for response and/or toxicity, at a minimum, before each dosing cycle; provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs
• Fetal harm may occur when administered to pregnant females
• Oral  azacitidine
  • Safety and effectiveness for MDS have not been established
  • Not recommended for MDS patients outside of controlled trials
• IV or SC azacitidine
  • Fatal or serious tumor lysis syndrome may occur despite concomitant use of allopurinol; assess baseline risk and monitor and treat appropriately
  • Hepatic toxicity
  • Exercise caution in patients with liver disease due to the increased risk of hepatotoxicity in patients with severe pre-existing hepatic impairment
  • Patients with extensive tumor burden due to metastatic disease reported experiencing progressive hepatic coma and death during treatment, especially in such patients with baseline albumin less than 30 g/L; monitor liver chemistries prior to initiation of therapy and with each cycle
  • Safety and effectiveness in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials
• Renal toxicity
  • Renal toxicity ranging from elevated serum creatinine to renal failure and death was reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non MDS conditions
  • Renal tubular acidosis, defined as a fall in serum bicarbonate to less than 20 mEq/L in association with alkaline urine and hypokalemia (serum potassium below 3 mEq/L) reported in patients with CML treated with azacitidine and etoposide; monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle
  • Patients with renal impairment may be at increased risk of renal toxicity; closely monitor if treated
  • If unexplained reductions in serum bicarbonate below 20 mEq/L or elevations of BUN or serum creatinine occur, reduce or hold the dose

Pregnancy and Lactation

• Based on its mechanism of action and animal studies, fetal harm may occur when administered to pregnant females
• No data available on use in pregnant females to evaluate for drug-associated risks
• Verify pregnancy status of females of reproductive potential before initiating treatment
• Contraception
  • IV or SC
    • Females of reproductive potential: Avoid pregnancy during treatment
    • Males with female sexual partners of reproductive potential: Avoid pregnancy and use effective contraception during treatment
  • Oral
    • Females of reproductive potential: Use effective contraception during treatment and for at least 6 months after the last dose
    • Males with female sexual partners of reproductive potential: Use effective contraception during treatment and for at least 3 months after the last dose
• Infertility
  • Oral
    • Based on animal data, male and female fertility may be impaired
  • Lactation
    • There is no information regarding the presence of azacitidine in human milk, the effects of therapy on the breastfed infants, or the effects of therapy on milk production
    • IV or SC: Advise patients not to breastfeed during therapy
    • PO: Advise patients not to breastfeed during therapy and for 1 week after the last dose