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Azacitidine

Azacitidine is a brand of Azacitidine.

Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic sy.

Checked against the official label · Updated

Prescription medicine Intravenous

Azacitidine: quick answers

Used for
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia…
Usual adult dose
Adults The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days.
Children
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Oct 2024). Your prescription and pharmacist come first.

How to use Azacitidine

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). …

How to take it and how often
  • Do not substitute azacitidine for injection for oral azacitidine
  • The indications and dosing regimen for azacitidine for injection differ from that of oral azacitidine
  • MDS: The recommended starting dosage for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for injection75 mg/m 2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion
  • See full prescribing information for schedule for subsequent cycles
  • Premedicate for nausea and vomiting
  • Continue treatment as long as the patient continues to benefit
  • Monitor all patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate
  • Important Administration Information Do not substitute azacitidine for injection for oral azacitidine
  • The indications and dosing regimen for azacitidine for injection differ from that of oral azacitidine [see Warnings and Precautions ] First Treatment Cycle for Adults The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days
  • Premedicate patients for nausea and vomiting
  • Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose
  • Subsequent Treatment Cycles for Adults Repeat cycles every 4 weeks. …
Strengths it comes in

Azacitidine for injection is supplied as lyophilized powder in 100 mg single-dose vials Lyophilized powder in 100 mg single-dose vials ( 3 ).

Children
  • Safety and effectiveness of azacitidine for injection
  • In pediatric patients with MDS have not been established
  • Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection)
  • However, due to Celgene Corporation's marketing exclusivity rights, this drug product is not labeled with that information
Older adults

Of the total number of patients in Studies 1, 2 and 3, 62% were 65 years and older and 21% were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition, there were no relevant differences in the frequency of adverse reactions observed in patients 65 years and older compared to younger patients. …

While you are taking it
  • Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment Instruct patients to inform their physician about any underlying liver disease [see Warnings and Precautions ]
  • Renal Toxicity Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions ]
  • Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions and Use in Specific Populations ]
  • Advise females of reproductive potential to use effective contraception during treatment with azacitidine for injection and for 6 months after the last dose. …
Talk to a doctor first if
  • Advanced Malignant Hepatic Tumors
  • Hypersensitivity to Azacitidine or Mannitol
  • Advanced Malignant Hepatic Tumors Azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions ]
  • Hypersensitivity to Azacitidine or Mannitol Azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol
Warnings

Risks of Substitution with Other Azacitidine Products: Do not substitute azacitidine for injection for oral azacitidine ( 2.1 , 5.1 ). Anemia, Neutropenia and Thrombocytopenia: Monitor complete blood counts (CBC) frequently ( 5.2 ). Hepatotoxicity: Patients with severe preexisting hepatic impairment are at higher risk for toxicity ( 5.3 ). Renal Toxicity: Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys ( 5.4 ). Tumor Lysis Syndrome: Azacitidine for injection may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate ( 5.5 ). …

Possible side effects

The following adverse reactions are described in other labelingsections: Anemia, Neutropenia and Thrombocytopenia [see Warnings and Precautions ( 5.2 )] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see Warnings and Precautions ( 5.3 )] Renal Toxicity [see Warnings and Precautions ( 5.4 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (>30%) in adult patients with MDS by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no data on the use of azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended human daily dose (see Data). …

If you take too much

One case of overdose with azacitidine for injection was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m 2 , almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day. In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for azacitidine for injection overdosage.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-10-30.

Same medicine, other brands

Products with Azacitidine as the active ingredient. Names differ between countries.

Check your pack of Azacitidine

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Azacitidine

What is in Azacitidine?

Azacitidine contains Azacitidine. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.

What is Azacitidine used for?

Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transfo (From the official U.S. FDA label.)

How do I take Azacitidine?

Follow your prescription or the leaflet in your pack. The official label says: Do not substitute azacitidine for injection for oral azacitidine. The indications and dosing regimen for azacitidine for injection differ from that of oral azacitidine ( 2.1 , 5.1 ). MDS: The recommended starting dosage for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for injection75 mg/m 2 daily for 7 days to be administe…

Do I need a prescription for Azacitidine?

Usually yes. Azacitidine is a prescription medicine in most countries. Rules differ by country.

What brands contain Azacitidine?

Azacitidine is sold under names such as Onureg, Vidaza. Brand names differ between countries.

What are the side effects of Azacitidine?

The official label lists: The following adverse reactions are described in other labelingsections: Anemia, Neutropenia and Thrombocytopenia [see Warnings and Precautions ( 5.2 )] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see Warnings and Precautions ( 5.3 )] Renal Toxicity [see Warnings and Precautions ( 5.4 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.5 )] Mos… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Azacitidine?

Safety and effectiveness of azacitidine for injection in pediatric patients with MDS have not been established. Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection). However, due to Celgene Corporation's marketing exclusivity rights, this drug product is not labeled with that information. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Azacitidine when pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no data on the use of azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended… Ask your doctor or midwife first.

What happens if I take too much Azacitidine?

One case of overdose with azacitidine for injection was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m 2 , almost 4 times the recommended starting dose. The events resolved without sequelae, an… Get medical help right away.

How can I check that my Azacitidine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.