A healthcare provider will give you this injection, usually for 7 days in a row every 4 weeks for at least 4 treatment cycles. If any Vidaza injection accidentally gets on your skin, wash it thoroughly with soap and warm water. Your treatment schedule may be different. Your doctor will determine how long to treat you with Vidaza.
Full Answer
How often should Vidaza be given?
Baseline patient and disease characteristics are summarized in Table 3; the 2 groups were similar. Vidaza was administered at a subcutaneous dose of 75 mg/m 2 daily for 7 days every 4 weeks. The dose was increased to 100 mg/m 2 if no beneficial effect was seen after 2 treatment cycles.
Is Vidaza available in sterile form?
The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of Vidaza contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.
What are the side effects of Vidaza in clinical trials?
Adverse Reactions in Clinical Trials. In Studies 1, 2 and 4 with subcutaneous administration of Vidaza, adverse reactions of neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, constipation, and injection site erythema/reaction tended to increase in incidence with higher doses of Vidaza.
Could stem cell therapies one day become a treatment for Disease?
Recent research reporting successful translation of stem cell therapies to patients have enriched the hope that such regenerative strategies may one day become a treatment for a wide range of vexing diseases (2). In fact, the past few years witnessed, a rather exponential advancement in clinical trials revolving around stem cell-based therapies.
How long can you stay on Vidaza?
We strongly recommend that patients be treated with azacitidine for a minimum of 6 months, and that in patients who achieve a documented response or stable disease (sd), treatment be continued until disease progression or unacceptable toxicity occurs.
What is the success rate of Vidaza?
Previous studies demonstrated that Vidaza alone contributed to 40% responses, of whom 20% achieved complete remission, in addition to a short response duration and an overall survival of six months for patients with TP53-mutated myelodysplastic syndromes and acute myeloid leukemia.
How long does Vidaza take to work?
VIDAZA is not a one-time treatment. Treatment cycles are given every 28 days for as long as your doctor recommends them. It may take several cycles (about 4 to 6 months) for your doctor to notice a difference. If you stop receiving treatment, your symptoms may return.
Can Vidaza cure AML?
The researchers concluded that treatment with Vidaza may provide an effective alternative therapeutic approach for elderly patients diagnosed with AML who are not candidates for standard induction therapy.
Does Vidaza lower platelets?
The following side effects are common (occurring in greater than 30%) for patients taking azacitadine: Low blood counts (low white blood cells, platelets, and red blood cells)
Can you go into remission with MDS?
Patients who get the higher-dose treatment are more likely to have their MDS go into remission, but they can also have more severe, even life-threatening side effects, so this treatment is typically given in the hospital. Still, this treatment may be an option for some patients with advanced MDS.
How long can you survive with myelodysplastic syndrome?
Survival statistics for MDSIPSS-R risk groupMedian survivalVery low8.8 yearsLow5.3 yearsIntermediate3 yearsHigh1.6 years1 more row•Jan 22, 2018
Do you lose hair with Vidaza?
Your hair may get thinner. But you are unlikely to lose all the hair from your head. Hair loss usually starts after your first or second treatment. It is almost always temporary, and your hair will usually grow back after treatment finishes.
What are the end stages of MDS?
MDS progresses over time in two ways. In most people with MDS, fewer and fewer healthy blood cells are produced or survive. This can lead to severe anemia (low RBCs), increased risk of infection (due to low WBCs) or risk of severe bleeding (due to low platelets).
How many chemo treatments needed for AML?
AML chemotherapy usually starts with 1 week of intense treatment. After this, the person may receive a 5-day treatment session every 4 weeks, with the cycle repeating three or four times. Doctors usually recommend a combination of chemotherapy medications rather than a single one.
Does AML come back after remission?
What is a relapse? AML relapse affects about 50% of all patients who achieved remission after initial treatment, and can occur several months to several years after treatment. However, every patient carries the risk of relapse, and the majority of relapses occur within two to three years of initial treatment.
How long do you live with acute myeloid leukemia?
The 5-year overall survival rate for AML is 29.5 percent , according to the National Cancer Institute (NCI). This means that an estimated 29.5 percent of people in America living with AML are still living 5 years after their diagnosis.
Before Taking This Medicine
You should not receive Vidaza if you are allergic to azacitidine or mannitol, or if you have: 1. advanced liver cancer.To make sure Vidaza is safe...
Vidaza Dosing Information
Usual Adult Dose of Vidaza for Myelodysplastic Syndrome:For use in the treatment of patients with the following myelodysplastic syndrome subtypes:...
What Should I Avoid While Using Vidaza?
Do not receive a "live" vaccine while using Vidaza, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR),...
What Other Drugs Will Affect Vidaza?
Other drugs may interact with azacitidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your...
How often do you get azacitidine?
If azacitidine is scheduled to be given for 7 days each cycle and you need weekends off, you may receive days 1 - 5 of azacitidine on Monday-Friday, skip Saturday and Sunday, then resume treatment on Monday and Tuesday, on days 6 and 7. Azacitidine is repeated every 28 days. This is known as one cycle.
How many people discontinue Azacitidine?
Side effects sometimes have percentage ranges [example 38 – 45%] because they differed between in clinical studies: On average, 3 - 9% of patients discontinue azacitidine due to unacceptable side effects.
Why is azacitidine given?
Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, decrease the risk of bleeding, and to prevent MyeloDysplastic Syndrome (MDS) from transforming to acute leukemia. Azacitidine is not commonly given with the goal of cure.
How long does it take for blood transfusions to improve?
On average, it takes 3 - 4 cycles (= 3 - 4 months) to see an improvement in the White Blood Cell count, Red Blood Cell count/Hemoglobin, or Platelet count
Can anti-cancer drugs be reduced?
Prognosis. Certain anti-cancer medications can be reduced without affecting the overall chances of getting rid of the cancer. Your doctor or clinical pharmacist may be able to answer this question for you based upon the specific cancer and treatment. Sometimes dose reductions are made due to side effects.
Does Medicare preauthorize Vidaza?
Medicare and Medicaid patients (Patients 65 years or older): The clinic providing treatment will likely pre-authorize medications and immune therapies such as Azacitidine (Vidaza®) and are the best source to help you understand drug cost.
Can I give I.V. over time?
Sometimes intravenous (I.V.) medications are given over a pre-specified period of time, depending upon the medication and cancer type. Tell your doctor what your work schedule looks like and the type of work you do so that you can decide together on a treatment that makes the most sense for you.
How long does it take to administer Vidaza?
Vidaza solution is administered intravenously. Administer the total dose over a period of 10 - 40 minutes. The administration must be completed within 1 hour of reconstitution of the Vidaza vial.
What is a vidaza?
Vidaza is a pyrimidine nucleoside analog of cytidine. Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine.
What is the primary route of elimination of azacitidine?
Published studies indicate that urinary excretion is the primary route of elimination of azacitidine and its metabolites. Following intravenous administration of radioactive azacitidine to 5 cancer patients, the cumulative urinary excretion was 85% of the radioactive dose.
Is Vidaza compatible with Hespan?
Vidaza is incompatible with 5% Dextrose solutions, Hespan, or solutions that contain bicarbonate. These solutions have the potential to increase the rate of degradation of Vidaza and should therefore be avoided.
Is Vidaza cytotoxic?
Vidaza is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1. The Vidaza vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [see How Supplied/Storage and Handling ( 16 )]. Do not save any unused portions for later administration.
Can Vidaza cause fetal harm?
Based on the mechanism of action and findings in animals, Vidaza can cause fetal harm when administered to a pregnant woman. Azacitidine administered to pregnant rats via a single intraperitoneal (IP) dose approximating 8% of the recommended human daily dose caused fetal death and anomalies [see Use in Specific Populations ( 8.1 )].
Can you overdose on Vidaza?
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 Vidaza overdosage.
What is a vidaza?
Azacitidine (Vidaza) Azacitidine is a cancer treatment and is also called by its brand name, Vidaza. It is a treatment for people who can’t have high dose treatment with a stem cell transplant for the following conditions: chronic myelomonocytic leukaemia (CMML) acute myeloid leukaemia (AML) myelodysplastic syndrome.
How long does azacitidine last?
You can also have it every day, for 5 days. Then have 2 days off and have azacitidine again for 2 days at the start of the next week.
How does azacitidine work?
How it works. Azacitidine is a type of drug called a hypomethylating agent. It works by switching off a protein called DNA methyltransferase. This switches on genes that stop the cancer cells growing and dividing. This reduces the number of abnormal blood cells and helps to control cell growth.
How long can you stay off live shots?
Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.
What is the generic name for Vidaza?
Azacitadine is the generic name for the trade name drugs Vidaza or Onureg. In some cases, health care professionals may use trade name or the generic name when referring to the drug.
How is azacitadine given?
How Azacitadine Is Given. As a once daily subcutaneous (under the skin) injection or as an IV (intravenous) injection. As a tablet taken by mouth. Additional instructions for tablet formulation. Do not split, crush or chew tablets. Take a dose about the same time each day.
What are some examples of medications that destroy cancer cells?
Examples of medications that destroy cancer cells include cytotoxic chemotherapy, targeted therapy, immunotherapy, and antibody-drug conjugates.
What are the cells that are most affected by chemo?
The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.
Does chemotherapy stop the cell cycle?
Cancer cells no longer have normal checks and balances in the cell cycle process which leads to uncontrolled cell growth and division. Chemotherapy stops the cell cycle which leads to cell death.
Does azacitadine inhibit DNA methylation?
An increase in DNA methylation can lead to decreased activity of specific genes that suppress cancer cell division and growth. Azacitadine interferes and prevents methylation of DNA, thus, preventing uncontrolled growth of cancer cells.
Can you take 2 meds of a syringe at the same time?
If a dose is missed, take the dose as soon as possible on the same day. Resume the normal schedule the following day. Do NOT take 2 dos es on the same day. If a dose is vomited, do not take another dose on the same day. Resume the normal schedule the following day.
What is the FDA's response to stem cell products?
When stem cell products are used in unapproved ways— or when they are processed in ways that are more than minimally manipulated, which relates to the nature and degree of processing—the FDA may take (and has already taken) a variety of administrative and judicial actions, including criminal enforcement, depending on the violations involved.
What are stem cells?
Sometimes called the body’s “master cells,” stem cells are the cells that develop into blood, brain, bones, and all of the body’s organs. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases. But the U.S. Food and Drug Administration is concerned ...
What is the FDA approved product?
About FDA-approved Products Derived from Stem Cells. The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders that affect the body system ...
Where do stem cells come from?
The FDA has the authority to regulate stem cell products in the United States. Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system. Electron micrograph of stem cells, color-enhanced for visual clarity.
Do investigational products have to go through a FDA review?
With limited exceptions, investigational products must also go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies.
Is stem cell treatment illegal?
Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so ...
Can stem cells be unsafe?
Please try again later. Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases. But unproven stem cell treatments can be unsafe—so get all of the facts if you’re considering any treatment.
Indications and Usage For Vidaza
Vidaza Dosage and Administration
- 2.1 Important Administration Information
Do not substitute Vidaza for oral azacitidine. The indications and dosing regimen for Vidaza differ from that of oral azacitidine [see Warnings and Precautions (5.1)] - 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/m2subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemi…
Contraindications
- Advanced Malignant Hepatic Tumors
Vidaza is contraindicated in patients with advanced malignant hepatic tumors [see Warnings and Precautions (5.3)]. - Hypersensitivity to Azacitidine or Mannitol
Vidaza is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol.
Warnings and Precautions
- 5.1 Risks of Substitution with Other Azacitidine Products
Due to substantial differences in the pharmacokinetic parameters [see Clinical Pharmacology (12.3)], the recommended dose and schedule for Vidaza are different from those of oral azacitidine products. Treatment of patients using Vidaza at the recommended dosage of oral az… - Anemia, Neutropenia and Thrombocytopenia
Vidaza causes anemia, neutropenia and thrombocytopenia in adult patients with MDS and in pediatric patients with JMML. Monitor complete blood counts frequently for response and/or toxicity, at a minimum, prior to each dosing cycle. In adult patients with MDS, after administratio…
Adverse Reactions
- The following adverse reactions are described in other labeling sections: o 1. Anemia, Neutropenia and Thrombocytopenia [see Warnings and Precautions (5.2)] o 1. Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [see Warnings and Precautions (5.3)] o 1. Renal Toxicity [see Warnings and Precautions (5.4)] o 1. Tumor Lysis Syndrome [see Warnings a…
Use in Specific Populations
- Pregnancy
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)]. There are no data on the use of azacitidine in pregnant women. Azacitidine was teratogenic and caused embr… - Lactation
Risk Summary There is no information regarding the presence of azacitidine in human milk, the effects of Vidaza on the breastfed infant, or the effects of Vidaza on milk production. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown f…
Overdosage
- One case of overdose with Vidaza was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m2, 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 sho…
Vidaza Description
- Vidaza (azacitidine for injection) contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows: The empirical formula is C8H12N4O5.The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ket…
Vidaza - Clinical Pharmacology
- Mechanism of Action
Vidaza is a pyrimidine nucleoside analog of cytidine. Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of D… - Pharmacodynamics
In pediatric patients with JMML post azacitidine treatment (75 mg/m2or 2.5 mg/kg), reductions in genome-wide DNA methylation (global DNA methylation scores) were attained in bone marrow granulocytes during the first treatment cycle, confirming the DNA-hypomethylating activity of az…
Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment of Fertility
The potential carcinogenicity of azacitidine was evaluated in mice and rats. Azacitidine induced tumors of the hematopoietic system in female mice at 2.2 mg/kg (6.6 mg/m2, approximately 8% the recommended human daily dose on a mg/m2 basis) administered IP three times per week fo…