Treatment FAQ

a patient receiving decitabine must have treatment delayed for which of the following?

by Marty Littel Sr. Published 3 years ago Updated 2 years ago

• 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/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy. • Recovery requiring more than 8, but less than 10 weeks: Perform bone marrow aspirate to assess for disease progression.

Full Answer

What is the overall response rate to decitabine?

If necessary, a two week delay before the next cycle of decitabine was permitted to allow count recovery. For grade 4 neutropenia lasting more than two weeks or grade 4 thrombocytopenia lasting more than one week after decitabine therapy, one day of treatment was deleted from the subsequent cycle.

How is decitabine administered?

Aug 16, 2018 · A patient receiving decitabine must have treatment delayed for which of the following? a: ANC 1,200 neutrophils/mcL: b: Aspartate aminotransferase 6 U/L: c: Serum creatinine 2.5 mg/dL: d: Direct bilirubin 0.3 mg/dL: Question 20.

What are the most common causes of decitabine discontinuation?

Which patient would the nurse need to assess first if the patient is receiving mannitol? A. A 67-year-old patient with type 1 diabetes mellitus B. A 21-year-old patient with a head injury C. A 47-year-old patient with anuria D. A 55-year-old patient receiving cisplatin to treat ovarian cancer

What are the benefits of decitabine?

A. "Do not chew or crush extended-release forms of medication." B. "Take the medication with food if gastrointestinal distress occurs." C. "If a dose is missed, the missed dose should be taken along with the next dose that is due to be taken." D. "Take the medications with an antacid if gastrointestinal distress occurs."

When do you hold decitabine?

In patients who have an active or uncontrolled infection, hold decitabine therapy until the infection resolves. Start growth factor and/or anti-infective therapy as clinically indicated. The use of decitabine in patients with hepatic disease has not been studied.

How decitabine can have an antitumor effect?

Dual modes of action of decitabine

At high doses its cytotoxic activity is due to covalent trapping the enzyme DNA methyltransferase into DNA. At lower doses its antitumor effect is likely due to its ability to inhibit DNA hypermethylation and to reactivate tumor suppressor genes.

What is the purpose of decitabine?

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.

How does decitabine work in MDS?

People with MDS may have problems such as infections, anemia, and easy bleeding/bruising. Decitabine is a chemotherapy drug. It is believed to work by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

What is azacitidine used to treat?

Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome subtypes, including refractory anemia or chronic leukemia. Azacitidine belongs to the group of medicines called metabolites. It interferes with the growth of cancer cells, which are eventually destroyed.Feb 1, 2022

What is the difference between azacitidine and decitabine?

Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs.Jan 8, 2020

How is decitabine administered?

2.1 Recommended Starting Dosage

Administer DACOGEN at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/µL and platelets at least 50,000/µL) for a minimum of 4 cycles. .

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.

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.

How long does decitabine take 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).

What is the best treatment for MDS?

A bone marrow transplant, also known as a stem cell transplant, is the only treatment option that offers the potential of a cure for myelodysplastic syndromes.Mar 30, 2021

How is MDS treated in the elderly?

There are many options for the management of MDS, but the only potentially curative treatment is allogenic hematopoietic stem cell transplantation (allo-HSCT), which is often not an option because of advanced age or comorbidities at diagnosis or lack of a human leukocyte antigen-identical donor.Mar 9, 2011

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:

Does decitabine cause bone loss?

Decitabine inhibits proliferation and increases apoptosis of neural progenitor cells of the fetal CNS and induces palatal clefting in the developing murine fetus. Studies in mice have also shown that decitabine administration during osteoblastogenesis (day 10 of gestation) induces bone loss in offspring.

How long does it take to recover from a previous cycle of Dacogen?

If hematologic recovery from a previous Dacogen treatment cycle requires more than 6 weeks, delay the next cycle of Dacogen therapy and reduce Dacogen dose temporarily by following this algorithm:

Is dacogen cytotoxic?

Dacogen is a cytotoxic drug. Follow special handling and disposal procedures. 1. Aseptically reconstitute Dacogen with room temperature (20°C to 25°C) 10 mL of Sterile Water for Injection, USP. Upon reconstitution, the final concentration of the reconstituted Dacogen solution is 5 mg/mL.

What are the most common causes of Dacogen discontinuation?

Fatal and serious myelosuppression occurs in Dacogen-treated patients. Myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of Dacogen dose reduction, delay, and discontinuation. Neutropenia of any grade occurred in 90% of Dacogen-treated patients with grade 3 or 4 occurring in 87% of patients. Grade 3 or 4 febrile neutropenia occurred in 23% of patients. Thrombocytopenia of any grade occurred in 89% of patients with grade 3 or 4 occurring in 85% of patients. Anemia of any grade occurred in 82% of patients. Perform complete blood count with platelets at baseline, prior to each cycle, and as needed to monitor response and toxicity. Manage toxicity using dose-delay, dose-reduction, growth factors, and anti-infective therapies as needed [see Dosage and Administration (2.2)]. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS.

Can dacogen cause fetal harm?

Based on findings from human data, animal studies and its mechanism of action, Dacogen 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 adverse developmental outcomes including embryo-fetal lethality and malformations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception while receiving Dacogen and for 6 months following the last dose. Advise males with female partners of reproductive potential to use effective contraception while receiving treatment with Dacogen and for 3 months following the last dose [see Use in Specific Populations (8.1, 8.3) ].

Is dacogen an antidote?

There is no known antidote for overdosage with Dacogen. Higher doses are associated with increased myelosuppression including prolonged neutropenia and thrombocytopenia. Standard supportive measures should be taken in the event of an overdose.

How long does adenosine last?

Adenosine has an extremely short half-life of less than 10 seconds; its onset occurs within 1 minute; and it must be given as a fast IV push injection. In addition, a very brief episode of asystole may occur after administration. A 62-year-old man is to receive lidocaine as treatment for a symptomatic dysrhythmia.

Can antiarrhythmics cause bradycardia?

Apical pulse and blood pressure. Antiarrhythmic drugs can cause both hypotension and bradycardia; therefore it is important to assess blood pressure and apical pulse before administration. Peripheral pulses are not as reliable as the apical pulse assessment.

What class is amiodarone?

The nurse is reviewing the classes of antidysrhythmic drugs. Amiodarone is classified on the Vaughan Williams classification as a class III drug, which means it works by. A. blocking slow calcium channels. B. prolonging action potential duration. C. blocking sodium channels and affecting phase.

Is amiodarone a class 3 drug?

The nurse is reviewing the classes of antidysrhythmic drugs. Amiodarone is classified on the Vaughan Williams classification as a class III drug, which means it works by.

Indications and Usage For Dacogen

Dacogen 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. Dacogen Regimen Options Three Day Regimen Administer Dacoge…
  • Dosage Modifications for Adverse Reactions
    Hematologic Toxicity If hematologic recovery from a previous Dacogen treatment cycle requires more than 6 weeks, delay the next cycle of Dacogen therapy and reduce Dacogen dose temporarily by following this algorithm: 1. Recovery requiring more than 6, but less than 8 weeks…
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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
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Warnings and Precautions

  • Myelosuppression
    Fatal and serious myelosuppression occurs in Dacogen-treated patients. Myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of Dacogen dose reduction, delay, and discontinuation. Neutropenia of any grade occurred in 90% of Dacogen-tre…
  • Embryo-Fetal Toxicity
    Based on findings from human data, animal studies and its mechanism of action, Dacogen 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…
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Adverse Reactions

  • The following clinically significant adverse reactions are described elsewhere in the labeling: 1. Myelosuppression [see Warnings and Precautions (5.1)]
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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…
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Use in Specific Populations

  • Pregnancy
    Risk Summary Based on findings from human data, animal studies, and the mechanism of action, Dacogen can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. Limited published data on Dacogen us…
  • 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 Dacogen in a breastfed child, advise women not to breastfeed w…
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Overdosage

  • There is no known antidote for overdosage with Dacogen. Higher doses are associated with increased myelosuppression including prolonged neutropenia and thrombocytopenia. Standard supportive measures should be taken in the event of an overdose.
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Dacogen 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…
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Dacogen - 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.
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