Inqovi (decitabine and cedazuridine)

Inqovi (decitabine and cedazuridine) is a prescription medicine used to treat adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). Your healthcare provider will determine if Inqovi can treat your type of MDS.

It is not known if Inqovi is safe or effective in children.

Inqovi may cause serious side effects, including:

• Low blood cell counts. Low blood counts (white blood cells, platelets, and red blood cells) are common with Inqovi but can also be serious and lead to infections that may be life-threatening. If your blood cell counts are too low, your healthcare provider may need to delay treatment with Inqovi, lower your dose of Inqovi, or in some cases give you a medicine to help treat low blood cell counts. Your healthcare provider may need to give you antibiotic medicines to prevent or treat infections or fever while your blood cell counts are low. Your healthcare provider will check your blood cell counts before you start treatment and regularly during treatment with Inqovi. Call your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with Inqovi:
  • fever
  • chills
  • body aches
  • bruising more easily than usual

The most common side effects of Inqovi include:

• low white blood cell count (leukopenia)
• low platelets in your blood (thrombocytopenia)
• low white blood cell count (neutropenia)
• low red blood cell count (anemia)
• tiredness
• constipation
• bleeding
• muscle pain
• pain or sores in your mouth or throat
• joint pain
• nausea
• shortness of breath
• diarrhea
• rash
• dizziness
• fever with low white blood cell count (febrile neutropenia)
• swelling of arms or legs
• headache
• cough
• decreased appetite
• upper respiratory tract infection
• pneumonia
• changes in liver function tests

Inqovi may affect fertility in men. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of Inqovi. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do NOT substitute Inqovi for an intravenous decitabine product within a cycle.

Consider administering antiemetics prior to each dose to minimize nausea and vomiting.

Recommended Dosage

The recommended dosage of Inqovi is 1 tablet (containing 35 mg decitabine and 100 mg cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle for a minimum of 4 cycles until disease progression or unacceptable toxicity. A complete or partial response may take longer than 4 cycles.

Instruct patients of the following:

• Take Inqovi at the same time each day.
• Swallow tablets whole. Do not cut, crush, or chew tablets.
• Do not consume food 2 hours before and 2 hours after each dose.
• Take one tablet a day for 5 days in each cycle. If the patient misses a dose within 12 hours of the time it is usually taken, instruct patients to take the missed dose as soon as possible and then to resume the 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 Inqovi administration but continue with the next schedule dose.

Inqovi is a hazardous drug. Follow applicable special handling and disposal procedures.

Monitoring And Dosage Modifications For Adverse Reactions

Hematologic Adverse Reactions

Obtain complete blood cell counts prior to initiating Inqovi and before each cycle. Delay the next cycle if absolute neutrophil count (ANC) is less than 1,000/µL and platelets are less than 50,000/µL in the absence of active disease. Monitor complete blood cell counts until ANC is 1,000/µL or greater and platelets are 50,000/µL or greater.

• If hematologic recovery occurs (ANC at least 1,000/μL and platelets at least 50,000/μL) within 2 weeks of achieving remission, continue Inqovi at the same dose.
• If hematologic recovery does not occur (ANC at least 1,000/μL and platelets at least 50,000/μL) within 2 weeks of achieving remission,
  • Delay Inqovi for up to 2 additional weeks AND
  • Resume at a reduced dose by administering Inqovi on Days 1 through 4. Consider further dose reductions in the order listed in Table 1 if myelosuppression persists after a dose reduction. Maintain or increase dose in subsequent cycles as clinically indicated.

Table 1: Recommended Inqovi Dose Reductions for Myelosuppression

Manage persistent severe neutropenia and febrile neutropenia with supportive treatment.

Non-Hematologic Adverse Reactions

Delay the next cycle for the following non-hematologic adverse reactions and resume at the same or reduced dose upon resolution:

• Serum creatinine 2 mg/dL or greater
• Serum bilirubin 2 times upper limit of normal (ULN) or greater
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 times ULN or greater
• Active or uncontrolled infection

Effects Of Inqovi On Other Drugs

Drugs Metabolized by Cytidine Deaminase

• Cedazuridine is an inhibitor of the cytidine deaminase (CDA) enzyme. Coadministration of Inqovi with drugs that are metabolized by CDA may result in increased systemic exposure with potential for increased toxicity of these drugs.
• Avoid coadministration of Inqovi with drugs that are metabolized by CDA.

• Based on findings from human data, animal studies, and its mechanism of action, Inqovi can cause fetal harm when administered to a pregnant woman.
• Inqovi are no data on the presence of cedazuridine, decitabine, or their metabolites in human milk or on their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Inqovi and for at least 2 weeks after the last dose.