Azacitidine
آزاسیتیدین
🎗️ Antineoplastic And Immunomodulating AgentsHypomethylating agent
Market / country: 🇺🇸 USA
Vidaza (US)
🧮 Dose calculator
Myelodysplastic syndrome (MDS) · Regimen source: FDA Vidaza · 2.2FDA Vidaza · 2.3
- • Only under an oncologist in an equipped centre. Calculator = label mg/m² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal/hepatic function rest with the oncology team. FDA Vidaza · 2.2
- • May increase to 100 mg/m² after 2 cycles without benefit or toxicity (other than nausea). At least 4–6 cycles. Not interchangeable with oral azacitidine. FDA Vidaza · 2.3FDA Vidaza · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Advanced malignant hepatic tumours. FDA Vidaza · 4.1
- ⛔ Hypersensitivity to azacitidine or mannitol. FDA Vidaza · 4.2
Warnings
- • Anaemia, neutropenia and thrombocytopenia; hepatotoxicity with severe hepatic impairment; renal toxicity; tumour lysis syndrome; embryo-fetal toxicity. FDA Vidaza · 5
Formulations
- 100 mg vial (25 mg/mL after reconstitution for SC) — powder for injection 🇺🇸 USA FDA Vidaza · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Vidaza · 8.1
“Risk Summary Based on its mechanism of action and findings in animals, VIDAZA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )].”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Vidaza · 8.2
“… s [see Nonclinical Toxicology ( 13.1 )] and the potential for serious adverse reactions in nursing infants from VIDAZA, advise patients not to breastfeed during treatment with VIDAZA and for 1 week after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Vidaza · 8.4
“The safety and effectiveness of VIDAZA have been established in pediatric patients with newly diagnosed JMML aged 1 month and older and the information on this use is discussed throughout the labeling.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Vidaza · 8.5
“Monitor renal function in these patients [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.4 )].”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Vidaza · 8.3
“Contraception Females Advise pregnant women of the potential risk to a fetus.”
🔗 Reference links
- FDA (approval record)NDA050794
- DailyMed (FDA label)FDA Vidaza
- MedlinePlus (NIH)AzacitidineAzacitidine Injection
- WHO ATC/DDDL01BC07
- Darooyab (Iran)Azacitidine
🇮🇷 Registered in Iran Darooyab · G-949/Azacitidine
Dosage forms with Iranian generic codes, per Darooyab.
- 09486 · AZACITIDINE 100MG AMP · آمپول آزاسیتیدین ۱۰۰ میلیگرم
- 15946 · AZACITIDINE 25MG AMP · آمپول آزاسیتیدین ۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Vidaza · 3FDA Vidaza · 2.2FDA Vidaza · 2.3FDA Vidaza · 2.1FDA Vidaza · 4.1FDA Vidaza · 4.2FDA Vidaza · 5FDA Vidaza · 8.1FDA Vidaza · 8.2FDA Vidaza · 8.4FDA Vidaza · 8.5FDA Vidaza · 8.3FDA Vidaza · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-949/Azacitidine
- Clinical review⚠ Unverified