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Inqovi: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
100 mg, 35 mg
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Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Inqovi

What is INQOVI?

INQOVI 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.

  • in combination with venetoclax to treat adults with newly diagnosed acute myeloid leukemia (AML) who:

    • are 75 years of age or older, or
    • have other medical conditions that prevent the use of standard chemotherapy.

It is not known if INQOVI is safe and effective in children.

Before taking INQOVI, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems

  • are pregnant or plan to become pregnant. INQOVI can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will check to see if you are pregnant before you start treatment with INQOVI.
    • Use effective birth control (contraception) during treatment with INQOVI and for 6 months after the last dose of INQOVI. Talk to your healthcare provider if you have questions about birth control options.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with INQOVI.

    Males with female partners who are able to become pregnant:

    • Use effective birth control during treatment with INQOVI and for 3 months after the last dose of INQOVI. Talk to your healthcare provider if you have questions about birth control options.
  • are breastfeeding or plan to breastfeed. It is not known if INQOVI passes into breast milk. Do not breastfeed during treatment with INQOVI and for 2 weeks after the last dose of INQOVI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INQOVI may affect the way certain other medicines work and may cause side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take INQOVI?

  • Take INQOVI exactly as your healthcare provider tells you to.
  • Do not change your dose or stop taking INQOVI unless your healthcare provider tells you to.
  • Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking INQOVI if you get certain side effects.
  • Take INQOVI one time a day at about the same time each day.

  • Take INQOVI on an empty stomach at least 2 hours before or 2 hours after eating.

  • Swallow INQOVI tablets whole. Do not cut, crush, or chew the tablet.

  • If you take INQOVI in combination with venetoclax for AML:

    • take INQOVI at least 2 hours before or 2 hours after taking venetoclax. Do not take INQOVI and venetoclax at the same time.
    • read the venetoclax Medication Guide for additional information.
  • If you miss a dose of INQOVI take your dose as soon as possible if it is within 12 hours of your usual time. Then, continue taking INQOVI at your scheduled time. If you missed a dose by more than 12 hours, do not take additional doses to make up for the missed dose. Take your next scheduled dose on the following day at your usual time.
  • If you vomit after taking a dose of INQOVI, do not take another dose. Take your next scheduled dose at your usual time.
  • Your healthcare provider may prescribe medicine to reduce nausea and vomiting before each dose of INQOVI.

What are the possible side effects of INQOVI?

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. Tell your healthcare provider right away if you get any of the following signs and symptoms during treatment with INQOVI:
  • fever
  • chills
  • body aches
  • tiredness
  • bruising more easily than usual

The most common side effects of INQOVI in adults with MDS or CMML include:

  • low white blood cell counts (leukopenia, neutropenia)
  • low platelets in your blood (thrombocytopenia)
  • 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

The most common side effects of INQOVI in adults with AML in combination with venetoclax include:

  • low white blood cell counts (leukopenia, lymphocytopenia, neutropenia)
  • low platelets in your blood (thrombocytopenia)
  • fever with low white blood cell count (febrile neutropenia)
  • bleeding
  • low red blood cell count (anemia)
  • infection
  • diarrhea
  • tiredness
  • pain or sores in your mouth or throat
  • constipation
  • joint pain
  • decreased appetite
  • swelling of arms or legs
  • nausea
  • shortness of breath
  • sepsis
  • pneumonia
  • rash
  • changes in liver function tests
  • muscle pain
  • abnormal heart rhythm
  • stomach-area (abdomen) pain, dizziness or feeling lightheaded
  • decreased kidney function

INQOVI may affect fertility in men, which may affect your ability to have children. 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.

How should I store INQOVI?

  • Store INQOVI at room temperature between 68°F and 77°F (20°C and 25°C).
  • INQOVI comes in a blister card in a child-resistant carton.
  • Do not store INQOVI outside of the original blisters.
  • Talk to your healthcare provider about how to safely throw away (dispose of) INQOVI.

Keep INQOVI and all medicines out of the reach of children.

General information about the safe and effective use of INQOVI

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INQOVI for a condition for which it was not prescribed. Do not give INQOVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about INQOVI that is written for health professionals.

What are the ingredients in INQOVI?

Active ingredients: decitabine and cedazuridine

Inactive ingredients: lactose monohydrate, hypromellose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. The film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.

Manufactured for: Taiho Pharmaceutical Co., Ltd. Japan

Distributed by: Taiho Oncology, Inc., Princeton, NJ 08540 USA

INQOVI is a registered trademark of Taiho Pharmaceutical Co., Ltd.

For more information, go to www.INQOVI.com or call 1-888-878-2446.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 212576 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Inqovi

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Nucleoside Metabolic Inhibitor
Active ingredients Cedazuridine 100 mg, Decitabine 35 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) TAIHO ONCOLOGY
FDA approval NDA 212576New Drug Application (NDA) Approved July 7, 2020
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg, 35 mg – 5 in 1 blister pack / 1 in 1 carton NDC 64842-0727-9

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.