Delay subsequent Decitabine for injection treatment for any the following nonhematologic toxicities and do not restart until toxicities resolve: Serum creatinine greater than or equal to 2 mg/dL Alanine transaminase (ALT), total bilirubin greater than or equal to 2 times upper limit of normal (ULN) Active or uncontrolled infection
Full Answer
What are the indications and use cases for decitabine?
Indications and Usage for Decitabine. Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts,...
What is the final concentration of decitabine for injection?
Upon reconstitution, the final concentration of the reconstituted Decitabine for Injection solution is 5 mg/mL. You must dilute the reconstituted solution with 0.9% Sodium Chloride Injection or 5% Dextrose Injection prior to administration.
What is the pathophysiology of decitabine deamination?
One of the pathways of elimination of decitabine appears to be deamination by cytidine deaminase found principally in the liver but also in granulocytes, intestinal epithelium and whole blood.
How is decitabine administered in a single arm MDS study?
In a single-arm MDS study (N=99) Decitabine was dosed at 20 mg/m 2 intravenous, infused over one hour daily for 5 consecutive days of a 4-week cycle. Table 2 presents all adverse reactions occurring in at least 5% of patients.
What does decitabine treat?
Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Decitabine is in a class of medications called hypomethylation agents.
What are the side effects of decitabine?
What are some other side effects of this drug?Hair loss.Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.Heartburn.Feeling dizzy, tired, or weak.Mouth irritation or mouth sores.Trouble sleeping.Headache.Itching.More items...•
Can decitabine cause neutropenia?
The most common adverse effects included myelosuppression (neutropenia, thrombocytopenia, and anemia), pyrexia, fatigue, nausea, cough, petechiae, diarrhea, and constipation (Table 3). Febrile neutropenia occurred in 28% of patients who received decitabine.
How does decitabine work in MDS?
Decitabine (Dacogen) In some MDS patients, using one of these drugs can improve blood counts (sometimes enough so that blood transfusions aren't needed), improve quality of life, lower the chance of getting leukemia, and even help a person live longer.
What is the mechanism of decitabine treatment for sickle cell disease?
In SCD subjects at risk of early death, non-cytotoxic DNMT1 depletion using a metronomic (frequent but intermittent) regimen of the nucleoside analogue decitabine directly antagonizes a mechanism of gamma-globin repression, and produces sustained, clinically significant HbF elevations.
Is decitabine a vesicant or irritant?
Frequently asked questions about Dacogen Products Dacogen Injection is not a vesicant and is not known to cause severe local tissue damage upon extravasation (leaking of injected Dacogen Injection into the surrounding tissues from the site of administration) when injected.
When do you hold decitabine?
Hold decitabine therapy until hepatotoxicity resolves in patients who develop hepatic impairment (i.e., ALT level or total bilirubin level 2-times the upper limit of normal or greater). The use of decitabine in patients with renal disease has not been studied.
How effective is decitabine?
Decitabine-CAG combination regimen showed favorable response rates (CR 64.7% and ORR 82.4%) and low treatment-related adverse effects (induction mortality 4.4%). A significantly longer median OS in patients with response (16 months) was observed.
Does decitabine need a central line?
Other Comments. Administration advice: -Once prepared, the final product should be given as a continuous IV infusion over one hour; a central venous catheter is not required. -Premedication for prevention of nausea and vomiting is not typically required, but may be administered if necessary.
How is decitabine administered?
Dacogen is administered at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks. Patients may be premedicated with standard anti-emetic therapy.
Is decitabine a chemotherapy?
DECITABINE (dee SYE ta been) is a chemotherapy drug. This medicine reduces the growth of cancer cells. It is used to treat adults with myelodysplastic syndromes.
How long does it take decitabine to work?
How long does it take for patients to respond to treatment? In the clinical study, the median time for patients to achieve some level of remission for either CR or CRh was 2 months (with a range of 0.8 to 4.2 months).
How long does it take for a patient to recover from a previous treatment with decitabine?
If hematologic recovery from a previous Decitabine for Injection treatment cycle requires more than 6 weeks, delay the next cycle of Decitabine for Injection therapy and reduce Decitabine for Injection dose temporarily by following this algorithm:
How many patients were randomized to Decitabine?
A randomized open-label, multicenter, controlled trial evaluated 170 adult patients with myelodysplastic syndromes (MDS) meeting French-American-British (FAB) classification criteria and International Prognostic Scoring System (IPSS) High-Risk, Intermediate-2 and Intermediate-1 prognostic scores. Eighty-nine patients were randomized to Decitabine for Injection therapy plus supportive care (only 83 received Decitabine for Injection), and 81 to Supportive Care (SC) alone. Patients with Acute Myeloid Leukemia (AML) were not intended to be included. Of the 170 patients included in the study, independent review (adjudicated diagnosis) found that 12 patients (9 in the Decitabine for Injection arm and 3 in the SC arm) had the diagnosis of AML at baseline. Baseline demographics and other patient characteristics in the Intent-to-Treat (ITT) population were similar between the 2 groups, as shown in Table 4.
How long does it take for decitabine to go away?
Recovery requiring more than 6, but less than 8 weeks: delay Decitabine for Injection dosing for up to 2 weeks and reduce the dose temporarily to 11 mg/m 2 every 8 hours (33 mg/m 2 /day, 99 mg/m 2 /cycle) upon restarting therapy.
What is decitabine used for?
Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
How much sodium chloride is used in decitabine?
If Decitabine for Injection is intended to be administered within 15 minutes from the time of preparation, dilute the reconstituted solution with room temperature (20°C to 25°C) 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 0.1 mg/mL to 1 mg/mL. Discard unused portion.
What are the abnormalities of a 39 year old woman who was exposed to decitabine?
These abnormalities included holoprosencephaly, absence of nasal bone, mid-facial deformity, cleft lip and palate, polydactyly and rocker-bottom feet. The pregnancy was terminated.
What is the chemical name of decitabine?
Decitabine is a fine, white to almost white powder with the molecular formula of C 8 H 12 N 4 O 4 and a molecular weight of 228.21. Its chemical name is 4-amino-1- (2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2 (1 H )-one and it has the following structural formula:
What is decitabine used for?
Decitabine is a cancer medicine that is used to treat myelodysplastic syndromes (certain types of blood or bone marrow cancer). Decitabine may also be used for purposes not listed in this medication guide.
What are the side effects of decitabine?
Decitabine side effects. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: fever, chills, sore throat; mouth sores, red or swollen gums, skin sores;
Does decitabine affect the immune system?
Decitabine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, or unusual bleeding or bruising.
Can you use decitabine while pregnant?
If you are a woman, do not use decitabine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose. If you are a man, use effective birth control if your sex partner is able to get pregnant.
Can decitabine cause pregnancy?
This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because de citabine can harm an unborn baby.
Can decitabine cause liver disease?
liver disease. You may need to have a negative pregnancy test before starting this treatment. Decitabine can harm an unborn baby or cause birth defects if the mother or the father is using decitabine. If you are a woman, do not use decitabine if you are pregnant.
Is decitabine cytotoxic?
Decitabine is a cytotoxic drug and caution should be exercised when handling and preparing decitabine for injection 1 . Aseptically reconstitute decitabine for injection with room temperature (20°C to 25°C) 10 mL of Sterile Water for. Injection, USP.
Is decitabine soluble in water?
Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for Injection is a white to almost white sterile lyophilized solid friable lumps or powder supplied in a clear glass vial.
How long after symptom onset can you give alteplase?
When alteplase is given within 2 hours after symptom onset, the death rate for MI has been shown to be 5.4%, compared with 9.4% if given 4 to 6 hours after symptom onset. ASA may be given at the first sign of MI; it is not necessary to wait for cardiac enzyme results.
What is P2Y12 ADP?
A P2Y12 ADP receptor antagonist is used as secondary prevention. This patient should not begin taking ASA unless her risk factors change, or until she is 65 years old. A patient who is taking clopidogrel [Plavix] calls the nurse to report black, tarry stools and coffee-ground emesis. The nurse will tell the patient to:
Can heparin cause tachycardia?
Heparin overdose may cause hemorrhage, which can be characterized by low blood pressure, tachycardia, and lumbar pain. Protamine sulfate should be given, and the heparin should be discontinued. An aPTT may be drawn later to monitor the effectiveness of protamine sulfate.
Can you swallow dabigatran without food?
Patients should be taught to swallow capsules of dabigatran intact; absorption may be increased as much as 75%, increasing the risk of bleeding, if the capsules are crushed, chewed, or opened. Dabigatran may be taken with or without food. The risk of bleeding is not less than that of warfarin.
When to use ASA for myocardial infarction?
ASA is used for primary prevention of myocardial infarction (MI) in men and in women older than 65 years. Aspirin for primary prevention may be used in women ages 55 to 79 years when the potential benefit of a reduction in MI outweighs the potential harm of increased GI hemorrhage. This patient has no previous history of MI, ...
Can carbamazepine be increased?
The warfarin dose should be increased if the patient begins taking carbamazepine. Decreasing the dose of carbamazepine is not indicated.
Is dabigatran a pill organizer?
Dabigatran is unstable when exposed to moisture, so using a pill organizer is not recommended. A postoperative patient will begin anticoagulant therapy with rivaroxaban [Xarelto] after knee replacement surgery. The nurse performs a history and learns that the patient is taking erythromycin.
Why are drugs studied?
Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.
Is a syringe a substitute for medical advice?
It is not a substitute for medical advice. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. Please see your health care professional for more information about your specific medical condition and the use of this drug.
Is decitabine safe for cancer?
Use in Cancer. Decitabine is approved to treat adults with: Myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). Decitabine is also being studied in the treatment of other conditions and types of cancer. Decitabine is also available in a tablet form. For more information, see the Drug Information Summary ...
Indications and Usage For Decitabine
Decitabine Dosage and Administration
- Recommended Dosage
Pre-Medications and Baseline Testing 1. Consider pre-medicating for nausea with antiemetics. 2. Conduct baseline laboratory testing: complete blood count (CBC) with platelets, serum hepatic panel, and serum creatinine. Decitabine for Injection Regimen Options Three Day Regimen Admi… - Dosage Modifications for Adverse Reactions
Hematologic Toxicity If hematologic recovery from a previous Decitabine for injection treatment cycle requires more than 6 weeks, delay the next cycle of Decitabine for injection therapy and reduce Decitabine for injection dose temporarily by following this algorithm: 1. Recovery requirin…
Dosage Forms and Strengths
- For Injection: 50 mg of Decitabine as a sterile, white to almost white lyophilized powder in a single-dose vial for reconstitution.
Warnings and Precautions
- Myelosuppression
Fatal and serious myelosuppression occurs in Decitabine-treated patients. Myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of Decitabine dose reduction, delay, and discontinuation. Neutropenia of any grade occurred in 90% of Decitabine-tr… - Embryo-Fetal Toxicity
Based on findings from human data, animal studies and its mechanism of action, Decitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. In preclinical studies in mice and rats, Decitabine caused advers…
Adverse Reactions
- The following clinically significant adverse reactions are described elsewhere in the labeling: 1. Myelosuppression [see Warnings and Precautions (5.1)]
Drug Interactions
- Drug interaction studies with Decitabine have not been conducted. In vitro studies in human liver microsomes suggest that Decitabine is unlikely to inhibit or induce cytochrome P450 enzymes. In vitro metabolism studies have suggested that Decitabine is not a substrate for human liver cytochrome P450 enzymes. As plasma protein binding of Decitabine is negligible (<1%), interacti…
Use in Specific Populations
- Pregnancy
Risk Summary Based on findings from human data, animal studies, and the mechanism of action, Decitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. Limited published data on Decitabine u… - Lactation
Risk Summary There are no data on the presence of Decitabine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions from Decitabine in a breastfed child, advise women not to breastfeed …
Overdosage
- There is no known antidote for overdosage with Decitabine. Higher doses are associated with increased myelosuppression including prolonged neutropenia and thrombocytopenia. Standard supportive measures should be taken in the event of an overdose.
Decitabine Description
- Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one and it has the following structural formula: Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50…
Decitabine - Clinical Pharmacology
- Mechanism of Action
Decitabine is believed to exert its antineoplastic effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation or apoptosis. Decitabine inhibits DNA methylation in vitro, which is ac… - Pharmacodynamics
Decitabine has been shown to induce hypomethylation both in vitro and in vivo. However, there have been no studies of Decitabine-induced hypomethylation and pharmacokinetic parameters.