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Dosing with INQOVI
INQOVI is THE ONLY oral HMA for MDS, including CMML, that
patients can take from the convenience of home1
Oral dosing
Tablet shown is not actual size. Actual tablet size is 7.94 mm x 14.29 mm.
- 1 tablet, once a day for 5 days per 28-day cycle
- Fixed-dose combination tablet containing decitabine (35 mg) and cedazuridine (100 mg)
- It is important to remind patients that response to INQOVI® tablets may not be immediate. Premature discontinuation can limit therapeutic benefits that would otherwise have been reached
- A complete or partial response may take longer than 4 cycles
28-day dosing cycle
Important dosing reminders
- Avoid eating for 2 hours before and 2 hours after taking INQOVI
- Swallow tablet whole—do not cut, crush, or chew
- Consider antiemetics before each dose to minimize nausea and vomiting
- Do NOT substitute INQOVI for an IV decitabine product within a cycle
- Take at the same time each day
Storage and handling
- Store in original packaging at room temperature at 20°C-25°C (68°F-77°F); excursions permitted from 15°C-30°C (59°F-86°F)
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 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.
What to do if a dose of INQOVI is missed
What to do if a dose of INQOVI is missed
If vomiting occurs following dosing:
- No additional dose should be taken that day
- Continue with next scheduled dose
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