Inqovi

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Inqovi Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Decitabine 35mg, cedazuridine 100mg; tabs.

    Pharmacological Class

    Nucleoside analogue + cytidine deaminase inhibitor.

    How Supplied

    Tabs—5 (blister card)

    How Supplied

    Inqovi tablets are oval-shaped, film-coated, red, and debossed with H35 on one side.

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Dispense medication in the original packaging.

    Manufacturer

    Taiho Oncology

    Generic Availability

    NO

    Inqovi Indications

    Indications

    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.

    Inqovi Dosage and Administration

    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.

    Inqovi Contraindications

    Not Applicable

    Inqovi Boxed Warnings

    Not Applicable

    Inqovi Warnings/Precautions

    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; 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).

    Pregnancy Considerations

    Can cause fetal harm; advise pregnant women of the potential risk to the fetus. Verify pregnancy status prior to initiating Inqovi.

    Nursing Mother Considerations

    Women should not breastfeed during treatment and for 2 weeks after the last dose as there is a potential for serious adverse reactions in the breastfed child.

    Pediatric Considerations

    The safety and effectiveness of Inqovi have not been established in pediatric patients.

    Geriatric Considerations

    In clinical trials, 75% of participants were 65 years and older, while 36% were 75 years and older. No overall differences were observed between older patients and younger patients.

    Renal Impairment Considerations

    Monitor patients with moderate renal impairment (CrCl 30-59mL/min) frequently for adverse reactions. 

    Severe renal impairment or end-stage renal disease (CrCl<15mL/min): Not studied.

    Other Considerations for Specific Populations

    Females of reproductive potential: Use effective contraception during treatment and for 6 months after the last dose.

    Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after the last dose.

    May impair male fertility.

    Inqovi Pharmacokinetics

    Metabolism

    Decitabine: Primarily by cytidine deaminase and by physicochemical degradation

    Cedazuridine: Conversion to epimer by physicochemical degradation

    Elimination

    Decitabine: Half-life 1.5 hours

    Cedazuridine: Half-life: 6.7 hours; 46% excreted in urine, 51% excreted in feces

    Inqovi Interactions

    Interactions

    Avoid concomitant drugs metabolized by cytidine deaminase.

    Inqovi Adverse Reactions

    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.

    Inqovi Clinical Trials

    Clinical Trials

    Study ASTX727-01-B (ClinicalTrials.gov Identifier: NCT02103478)

    The open-label, randomized, 2-cycle, 2-sequence crossover study included 80 adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). Patients were randomly assigned to receive Inqovi orally in cycle 1 and decitabine 20mg/m2  intravenously in cycle 2 or the reverse sequence. Both Inqovi and IV decitabine were administered once daily on days 1 through 5 of the 28-day cycle. Starting with cycle 3, all patients received Inqovi orally once daily on days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.

    The median follow-up time was 24 months (range, 12-28.8 months) and the median duration of treatment was 6.6 months (range, <0.1-27.9). Results showed that 18% (95% CI, 10-28) of patients had a complete response (CR) with a median duration of CR of 8.7 months (95% CI, 1.1-18.2). The median time to CR was 4.8 months (95% CI, 1.7-10).  

    Among patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline (n=41), 49% became transfusion independent during any consecutive 56-day post baseline period. Among patients who were independent of transfusions at baseline (n=39), 64% remained transfusion-independent during any consecutive 56-day post baseline period.

     

    Study ASTX727-02 (ClinicalTrials.gov Identifier: (NCT03306264)

    The open-label, randomized, 2-cycle, 2-sequence crossover study that included 133 adult patients with MDS or CMML. Patients were randomly assigned to receive Inqovi orally in cycle 1 and decitabine 20mg/m2  intravenously in cycle 2 or the reverse sequence. Both Inqovi and IV decitabine were administered once daily on days 1 through 5 of the 28-day cycle. Starting with cycle 3, all patients received Inqovi orally once daily on days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.

    The median follow-up time was 12.6 months (range, 9.3-20.5) and median duration of  treatment was 8.2 months (range, 0.2-19.7). Results showed that 21% (95% CI, 15-29) of patients had a CR with a median duration of CR of 7.5 months (95% CI, 1.6-17.5). The median time to CR was 4.3 months (95% CI, 2.1-15.2).  

    Among patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline (n=57), 53% became transfusion independent during any consecutive 56-day post baseline period. Among patients who were independent of transfusions at baseline (n=76), 63% remained transfusion-independent during any consecutive 56-day post baseline period.

    Inqovi Note

    Not Applicable

    Inqovi Patient Counseling

    Patient Counseling

    Take medication at the same time each day on an empty stomach. Avoid eating for at least 2 hours before and 2 hours after taking Inqovi.

    Risk of myelosuppression: Report symptoms of fever, infection, anemia or bleeding. Lab monitoring is necessary.

    Risk of embryo-fetal toxicity: Use effective contraception during treatment and for 6 months after the last dose. For males with female partners: Use effective contraception during treatment and for 3 months after the last dose.

    Breastfeeding is not recommended for 2 weeks after the last dose.

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