Leukemias, lymphomas, and other hematologic cancers:
Indications for INQOVI:
Myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the French-American-British subtypes and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Adult:
Not substitutable for an IV decitabine product within a cycle. May premedicate with antiemetics. Swallow whole. Take on empty stomach. 1 tab once daily on Days 1 through 5 of each 28-day cycle. Give for a minimum of 4 cycles until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children:
Not established.
Warnings/Precautions:
Risk of myelosuppression, infectious complications. Obtain CBCs at baseline, prior to each cycle, and as needed to monitor response and toxicity (see full labeling). Delay the next cycle if ANC <1000/microliter and platelets <50000/microliter in absence of active disease. Renal impairment (moderate): monitor; for severe or ESRD: not studied. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Pharmacologic Class:
Nucleoside analogue + cytidine deaminase inhibitor.
Interactions:
Avoid concomitant drugs metabolized by cytidine deaminase.
Adverse Reactions:
Fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased, lab abnormalities (decreased leukocytes, platelet count, neutrophil count, and hemoglobin); febrile neutropenia, pneumonia, sepsis.
Generic Availability:
NO
How Supplied:
Tabs—5 (blister card)
