Inqovi

Inqovi is used to treat myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) in adults. Myelodysplastic syndromes are types of blood or bone marrow disorders. Your healthcare provider will determine if Inqovi can treat your type of MDS.

Inqovi (cedazuridine/decitabine) is also used in combination with venetoclax to treat newly diagnosed acute myeloid leukemia (AML) in adults who:

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

Inqovi is a combination once-daily tablet that contains cedazuridine and decitabine. Cedazuridine blocks the actions of cytidine deaminase (CDA), a gut and liver enzyme that would otherwise rapidly break down decitabine when it is taken orally. This allows adequate levels of decitabine to reach the bloodstream. Decitabine works by inhibiting an enzyme called DNA methyltransferase. This reduces abnormal DNA methylation in cancer cells, which may restore normal gene function controlling cell growth and differentiation, leading to cell death. Inqovi belongs to the drug class called combination nucleoside metabolic inhibitor/ cytidine deaminase inhibitor.

Inqovi (cedazuridine/decitabine) first received FDA approval on July 7, 2020. There is no generic.

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.

Before taking Inqovi, tell your healthcare provider about your medical conditions, including if you:

• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Inqovi is not approved for use by anyone younger than 18 years old.

Pregnancy

Inqovi can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• Females who can become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Inqovi Use effective birth control during treatment with Inqovi and for 6 months after the last dose of Inqovi.
• If you are a man, use effective birth control if your sex partner can get pregnant. Keep using birth control for at least 3 months after your last dose. Talk to your healthcare provider if you have questions about birth control options that are right for you.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

Fertility

Inqovi may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Breastfeeding

You should not breastfeed while using Inqovi and for at least 2 weeks after your last dose.

Important safety information and serious side effects

Inqovi may cause serious side effects, including:

• Low blood cell counts (myelosuppression). 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.
• Harm to an unborn baby. Inqovi can harm your unborn baby if you take it while you are pregnant. You should not be pregnant when starting Inqovi. See pregnancy information below.

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 the FDA at 1-800-FDA-1088.

Common side effects

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

• low white blood cell count (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.

To report suspected side effects, contact Taiho Oncology, Inc. at 1-844-878-2446 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dose of Inqovi for MDS or AML

• 1 tablet (containing 100 mg cedazuridine and 35 mg decitabine) orally once daily on Days 1 through 5 of each 28-day cycle.
• Take on an empty stomach.

Comments:

• Consider administering antiemetics before each dose to minimize nausea and vomiting.
• For MDS or CMML, Inqovi should be taken for a minimum of 4 cycles until disease progression or unacceptable toxicity occurs. A complete or partial response may take longer than 4 cycles.
• For AML, Inqovi should be taken until disease progression or unacceptable toxicity occurs. Match Day 1 of Inqovi dosing with Day 1 of venetoclax dosing for each 28-day cycle.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not eat for at least 2 hours before or after taking this medicine.

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.

Coadministration with other drugs broken down by cytidine deaminase (CDA), such as cytarabine, gemcitabine, or azacitidine, may increase their exposure and the risk of toxicity. Avoid combining Inqovi with these drugs.

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

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 out of the reach of children.

Active ingredients: cedazuridine and decitabine

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.

Inqovi (cedazuridine and decitabine) is manufactured by Taiho Pharmaceutical Co., Ltd., Japan, and distributed by Taiho Oncology, Inc., Princeton, NJ 08540, USA.