• Treatment of various myelodysplastic syndromes (MDS).

Contraindicated in:

• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Moderate renal impairment (↑ risk for adverse reactions)
• Severe renal impairment or end-stage renal disease (safety not established).
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: arrhythmias, edema, hypotension.

Derm: rash.

Endo: hyperglycemia, hypoglycemia.

F and E: hypocalcemia, hyponatremia.

GI: ↑ liver enzymes, abdominal pain, constipation, diarrhea, hypoalbuminemia, mucositis, nausea, vomiting.

GU: renal impairment, ↓ fertility (males).

Hemat: anemia, bleeding, neutropenia, thrombocytopenia.

Metab: ↓ appetite, ↓ weight.

MS: arthralgia, myalgia.

Neuro: dizziness, falls, headache, insomnia, peripheral neuropathy.

Resp: cough, dyspnea.

Misc: fatigue, fever, infection.

Drug-Drug:

• None reported.

• Tablets: decitabine 35 mg/cedazuridine 100 mg;

Do not substitute IV decitabine for decitabine/cedazuridine.

• PO (Adults): One tablet (decitabine 35 mg/cedazuridine 100 mg) once daily on Days 1–5 of each 28–day cycle; continue for a minimum of four cycles until disease progression or unacceptable toxicity.

Inqovi

• Decitabine: inhibits DNA methyltransferase, causing apoptosis; has more effect on rapidly replicating cells. Cedazuridine: acts as a cytidine deaminase inhibitor, preventing the degradation of decitabine in the GI tract and liver; leads to an increase in systemic exposure of decitabine.

• Decreased progression of disease and improved rate of conversion from bring transfusion dependent to independent of red blood cell and platelet transfusions.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: Cedazuridine increases the oral bioavailability of decitabine.

Distribution: Widely distributed to extravascular tissues.

Metabolism/Excretion: Decitabine: degraded by cytidine deaminase and undergoes physicochemical degradation; Cedazuridine: undergoes physicochemical degradation; 27% excreted unchanged in feces, 21% excreted unchanged in urine.

Half-life: Decitabine: 1.5 hr; Cedazuridine: 6.7 hr.

(plasma concentrations)

• Instruct patient to take medication as directed once daily for 5 days in each cycle. Take missed doses as soon as possible within 12 hrs of the time it is usually taken, and then to resume normal daily dosing schedule. Extend the dosing period by one day for every missed dose to complete 5 daily doses for each cycle. Do not take an additional dose if vomiting occurs after administration but continue with next scheduled dose. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional promptly is signs and symptoms of low blood cell counts (fever, chills, body aches, bruising more easily than usual) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.
• Rep: May cause fetal harm. Advise females or reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for at least 2 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. May impair fertility in males.

de-SYE-ta-been/SED-az-URE-i-deen