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Dosing with INQOVI
Straightforward oral dosing schedule1
- 1 tablet, once a day for 5 days per 28-day cycle
- After 5 days of treatment, patients do not need to take INQOVI tablets for the next 23 days
28-day dosing cycle
Fixed-dose combination tablet containing decitabine (35 mg) and cedazuridine (100 mg)
Tablet shown is not actual size. Actual tablet size is 7.94 mm x 14.29 mm.
Important dosing reminders
- Tablets should be taken on an empty stomach, at least 2 hours before or 2 hours after a meal
- Tablets must be swallowed whole—not cut, crushed, or chewed
- Consider administering antiemetics prior to each dose to minimize nausea and vomiting
- Do NOT substitute INQOVI for an IV decitabine product within a cycle
- Patients should take INQOVI at the same time each day
- Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate
CMML=chronic myelomonocytic leukemia; IV=intravenous; HMA=hypomethylating agent; MDS=myelodysplastic syndromes.
Storage and handling with INQOVI
- Store INQOVI tablets in original packaging at room temperature at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F)
Easy-to-use blister pack
DosePak is 7.35 in x 2.45 in.
Monitoring and dosing modifications1
Monitoring
In patients who received INQOVI:
- 41% had dose interruptions due to an adverse reaction
- 19% had dose reductions due to an adverse reaction
The most frequent cause of dose reduction or interruption was myelosuppression (thrombocytopenia, neutropenia, anemia, and febrile neutropenia).
Monitor response
- Obtain complete blood cell counts prior to initiating INQOVI and before each cycle
- Manage toxicity using dose delay, dose modification, growth factors, and anti-infective therapies for treatment or prophylaxis as needed
When to delay or reduce the dose
Delay the next cycle if absolute neutrophil count (ANC) is <1000/μL and platelets are <50,000/μL in the absence of active disease. Monitor complete blood cell counts until ANC is ≥1000/μL and platelets are ≥50,000/μL.
If hematologic recovery does not occur within 2 weeks of achieving remission:
Delay
- For up to 2 additional weeks
Reduce
- Resume at a reduced dose by administering INQOVI on days 1 through 4
- Consider further dose reductions if myelosuppression persists after first dose reduction
Maintain or increase dose
- In subsequent cycles as clinically indicated
Delay the next cycle for these nonhematologic adverse reactions and resume at the same or reduced dose once resolved:
- Serum creatinine ≥2 mg/dL
- Serum bilirubin ≥2× upper limit of normal (ULN)
- Aspartate aminotransferase or alanine aminotransferase ≥2× ULN
- Active or uncontrolled infection
Recommended dose reductions for myelosuppression*
1st dose reduction
Dosage:
2nd dose reduction
Dosage:
3rd dose reduction
Dosage:
- Manage persistent severe neutropenia and febrile neutropenia with supportive treatment
*Myelosuppression includes thrombocytopenia, neutropenia, anemia, and febrile neutropenia.
If vomiting occurs following dosing:
- No additional dose should be taken that day
- Continue with next scheduled dose
What to do if a dose of INQOVI is missed
What to do if a dose of INQOVI is missed
Within 12 hours of the time it is usually taken:
- Take the missed dose as soon as possible and resume the normal daily dosing schedule
- Extend the dosing period by 1 day for every missed dose to complete 5 daily doses for each cycle