Inqovi

What is Inqovi?

• Inqovi is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor used to treat adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML).

What are the uses of this medicine?

• This medicine is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

How does this medicine work?

Decitabine stops cells from making DNA, which may help keep cancer cells from growing and may kill them. Cedazuridine prevents the breakdown of decitabine in the body, which may allow more cancer cells to be killed. Inqovi is a type of antimetabolite and a type of cytidine deaminase inhibitor.

Decitabine

• Decitabine is a nucleoside metabolic inhibitor that is believed to exert its effects after phosphorylation and direct incorporation into DNA and inhibition of DNA methyltransferase, causing hypomethylation of DNA and cellular differentiation and/or apoptosis.
• Decitabine inhibits DNA methylation in vitro, which is achieved at concentrations that do not cause major suppression of DNA synthesis.
• Decitabine-induced hypomethylation in cancer cells may restore normal function to genes that are critical for the control of cellular differentiation and proliferation.

Cedazuridine

• Cytidine deaminase (CDA) is an enzyme that catalyzes the degradation of cytidine, including the cytidine analog decitabine.
• High levels of CDA in the gastrointestinal tract and liver degrade decitabine and limit its oral bioavailability.
• Cedazuridine is a CDA inhibitor.
• Administration of cedazuridine with decitabine increases systemic exposure of decitabine.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

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

Administration

• 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. Do not eat for at least 2 hours before and 2 hours after taking Inqovi.
• Swallow Inqovi tablets whole. Do not cut, crush, or chew the tablet.
• 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 an additional dose. Take your next scheduled dose at your usual time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As tablets Tablets: 35 mg decitabine and 100 mg cedazuridine.

This medicine is available in fallowing brand namesː

• Inqovi

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

• fatigue
• constipation
• hemorrhage
• myalgia
• mucositis
• arthralgia
• nausea
• dyspnea
• diarrhea
• rash
• dizziness
• febrile neutropenia
• edema
• headache
• cough
• decreased appetite
• upper respiratory tract infection
• pneumonia
• transaminase increased
• leukocytes decreased
• platelet count decreased
• neutrophil count decreased
• hemoglobin decreased

What special precautions should I follow?

• Fatal and serious myelosuppression and infectious complications may occur. Obtain complete blood cell counts prior to initiation of Inqovi, prior to each cycle, and as clinically indicated to monitor for response and toxicity.
• Delay the next cycle and resume at the same or reduced dose as recommended.
• Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Inqovi can cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The safety and effectiveness of Inqovi have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store Inqovi at room temperature between 68°F and 77°F (20°C and 25°C).
• Do not store Inqovi outside of the original blisters.
• Talk to your healthcare provider about how to safely throw away (dispose of) Inqovi.
• Inqovi is a hazardous drug. Follow applicable special handling and disposal procedures.

• Dailymed label info on Inqovi
• FDA Inqovi

Inqovi Resources
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