Azacitidine

multilineage dysplasia, induction chemotherapy, Anemia, Refractory + 11 more

Treatment

4 FDA approvals

20 Active Studies for Azacitidine

What is Azacitidine

Azacitidine

The Generic name of this drug

Treatment Summary

Azacytidine is a medication used to treat cancer by blocking the action of an enzyme involved in DNA methylation. It is also used as an antimetabolite of cytidine, which is incorporated into RNA. Azacytidine is an antineoplastic drug, meaning that it is used to stop the growth of cancer cells.

Vidaza

is the brand name

image of different drug pills on a surface

Azacitidine Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Vidaza

Azacitidine

2004

34

Approved as Treatment by the FDA

Azacitidine, commonly known as Vidaza, is approved by the FDA for 4 uses like multilineage dysplasia and Leukemia, Myeloid, Acute .

multilineage dysplasia

Leukemia, Myeloid, Acute

Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia

Effectiveness

How Azacitidine Affects Patients

Azacitidine works by decreasing the methylation of DNA, which can restore normal function to genes that are important for cell growth and differentiation. It also causes the death of cells that are no longer responding to normal growth control mechanisms. After it is taken up by cells, it is converted into different forms that disrupt nuclear and cytoplasmic RNA metabolism and inhibit protein synthesis, as well as stop DNA synthesis. Azacitidine is most effective when cells are in the S-phase of the cell cycle.

How Azacitidine works in the body

Azacitidine helps fight cancer by blocking DNA from being made. At low doses, it prevents DNA from being methylated, which is necessary for it to be made. At high doses, it gets incorporated into both DNA and RNA, stopping the cells from being able to produce the proteins needed for cell growth and survival, eventually leading to cell death.

When to interrupt dosage

The measure of Azacitidine is contingent upon the diagnosed malady, including induction chemotherapy, 20-30% blasts and Anemia. The dosage is dependent on the technique of delivery (e.g. Subcutaneous or Tablet - Oral) detailed in the table below.

Condition

Dosage

Administration

Acute Myeloid Leukemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Complete Remission

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

multilineage dysplasia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Leukemia, Myeloid, Acute

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Blood Transfusion

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

induction chemotherapy

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Complete Blood Count

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia, Refractory

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Chronic Myelomonocytic Leukemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Malignant Neoplasms

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

neutropenia and/or thrombocytopenia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Anemia

100.0 mg, , 10.0 mg/mL, 100.0 mg/mL, 1.0 mg/mg, 200.0 mg, 25.0 mg/mL, 300.0 mg

, Subcutaneous, Powder, for suspension - Subcutaneous, Powder, for suspension, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous; Subcutaneous, Intravenous; Subcutaneous, Injection, powder, lyophilized, for solution - Subcutaneous, Injection, powder, lyophilized, for suspension, Injection, powder, lyophilized, for suspension - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Oral, Tablet, Tablet - Oral

Warnings

Azacitidine Contraindications

Condition

Risk Level

Notes

Liver Neoplasms

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Azacitidine may interact with Pulse Frequency

There are 20 known major drug interactions with Azacitidine.

Common Azacitidine Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Abatacept.

Abetimus

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Azacitidine is combined with Acteoside.

Azacitidine Toxicity & Overdose Risk

A patient experienced diarrhea, nausea, and vomiting after taking a large dose of azacitidine. This was almost 4 times the recommended starting dose and the equivalent of 290 mg/m2.

image of a doctor in a lab doing drug, clinical research

Azacitidine Novel Uses: Which Conditions Have a Clinical Trial Featuring Azacitidine?

367 active studies are currently being conducted to determine the efficacy of Azacitidine in treating Chronic Myelomonocytic Leukemia, Blood Transfusion and multilineage dysplasia.

Condition

Clinical Trials

Trial Phases

Acute Myeloid Leukemia

267 Actively Recruiting

Phase 2, Phase 3, Phase 1, Phase 4, Not Applicable, Early Phase 1

Complete Remission

0 Actively Recruiting

Chronic Myelomonocytic Leukemia

54 Actively Recruiting

Phase 1, Phase 2, Phase 3, Early Phase 1

Anemia, Refractory

0 Actively Recruiting

Blood Transfusion

0 Actively Recruiting

induction chemotherapy

0 Actively Recruiting

Complete Blood Count

0 Actively Recruiting

Anemia

0 Actively Recruiting

Anemia

0 Actively Recruiting

neutropenia and/or thrombocytopenia

0 Actively Recruiting

Leukemia, Myeloid, Acute

0 Actively Recruiting

Malignant Neoplasms

0 Actively Recruiting

Anemia

0 Actively Recruiting

multilineage dysplasia

0 Actively Recruiting

Azacitidine Reviews: What are patients saying about Azacitidine?

4

Patient Review

5/5/2017

Azacitidine for Bone Marrow Disorders Occurring Before Leukemia

This treatment was really effective. My hemoglobin count went from 6.2 to 17 after six treatments.

3.3

Patient Review

1/27/2010

Azacitidine for Bone Marrow Disorders Occurring Before Leukemia

I developed large lumps under my skin and felt itchiness and pain on my left side. The injection was inserted in the fatty tissue above my belly button.

1.7

Patient Review

7/19/2016

Azacitidine for Bone Marrow Disorders Occurring Before Leukemia

My mother was given this treatment three times and had terrible side effects each time, eventually leading to her death from renal failure caused by extreme diarrhea.

1.3

Patient Review

8/25/2013

Azacitidine for Bone Marrow Disorders Occurring Before Leukemia

I have MDS. This treatment didn't work for me, so the medical model says I'm out of options.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about azacitidine

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What class of drug is azacitidine?

"Azacitidine is a cancer medication that works by killing abnormal cells in the bone marrow, as well as by helping the bone marrow to produce normal blood cells."

Answered by AI

Is azacitidine a chemotherapy?

"Azacitadine is a chemotherapy drug that works by killing cancer cells. It is classified as an antimetabolite and a demethylating agent."

Answered by AI

What is the drug azacitidine used for?

"Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome (bone marrow problem) subtypes, including refractory anemia or chronic leukemia. This medicine is also used to treat juvenile myelomonocytic leukemia (JMML)."

Answered by AI

How long can you take azacitidine?

"We recommend that patients be treated with azacitidine for a minimum of 6 months, and that in patients who achieve a response or stable disease, treatment be continued until disease progression or unacceptable toxicity occurs."

Answered by AI

Clinical Trials for Azacitidine

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Levofloxacin for Blood Cancers

18+
All Sexes
Winnipeg, Canada

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life-changing blood cancers. Patients with MDS and AML commonly experience complications related to infection, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of levofloxacin (antibiotic) in MDS and AML patients to safely reduce the risk of infection. In this study 50% of patients will be randomized (like a flip of a coin) to receive levofloxacin and the other 50% will receive usual care (control). The primary objective of the trial is to demonstrate the feasibility of a pragmatic pilot trial necessary to inform our planned phase 3 trial. Additionally, the investigators will monitor both groups of patients to see if the investigators improve the risk and/or severity of infection. Levofloxacin is commonly used in other clinical settings but has not been studied in patients with MDS or AML receiving outpatient chemotherapy (ie, chemotherapy that can be given from clinic, rather than a hospital).

Phase 2
Waitlist Available

CancerCare Manitoba

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ThINKK Immunotherapy for Cancer

2 - 12
All Sexes
Toronto, Canada

A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse. ThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.

Phase 1
Waitlist Available

The Hospital for Sick Children (+1 Sites)

Michel Duval, MD

ExCellThera inc.

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Ropeginterferon Alfa-2b for Chronic Myelomonocytic Leukemia

18+
All Sexes
Los Angeles, CA

This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes and chronic myelomonocytic leukemia. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects.

Phase 2
Waitlist Available

UCLA / Jonsson Comprehensive Cancer Center

Wanxing Chai-Ho, MD

PharmaEssentia

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