Inqovi (decitabine and cedazuridine)

What is Inqovi (decitabine and cedazuridine) for?

Inqovi (decitabine and cedazuridine) is a medication used for the treatment of adults 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.

It is available in vial form each containing 35 mg decitabine and 100 mg cedazuridine.¹

How does Inqovi (decitabine and cedazuridine) work?

In healthy cells, tumor suppressor genes slow down cell division and make sure growth and proliferation occurs normally. When the tumor suppressor gene function is disrupted, leading to uncontrolled growth and division, and ultimately to cancer.²

Decitabine has two functions. It ‘hypomethylates’, switches off, tumor suppressor genes, causing restoration of their function, and thereby help them regain control over cell division.¹

Additionally, decitabine also functions as an antimetabolite. This means that it looks very similar to substances that are used by the cell for regular growth and division. When taken up by cells, these antimetabolites will have a cytotoxic effect, leading to death of rapidly dividing cells. Because normal cells do not proliferate often, they are relatively insensitive to decitabine’s effect.²

Cedazuridine is a cytidine deaminase (CDA) inhibitor. CDA is a type of protein that breaks down substances, including decitabine, making them less available for the body to use. By administering decitabine together with cedazuridine, the efficiency of decitabine will be increased.^1,3

Where has Inqovi (decitabine and cedazuridine) been approved?

Inqovi (decitabine and cedazuridine) was approved for the treatment of adult patients with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) by:

• The Food and Drug Administration (FDA), USA on July 7, 2020.⁴

Inqovi (decitabine and cedazuridine) was granted Priority Review and Orphan Drug designation by the FDA, which is intended for the safe and effective treatment of rare diseases.⁴

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Inqovi (decitabine and cedazuridine) taken?

The standard dosage is:¹

• 35 mg decitabine and 100 mg cedazuridine.

One Inqovi (decitabine and cedazuridine) tablet is taken orally once daily for 5 consecutive days 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.

When hematologic adverse events (i.e. too low complete blood cell count) occur, the next cycle should be delayed. If hematologic recovery occurs within 2 weeks, continue Inqovi administration at the same dose. If not, delay the next cycle for an additional 2 weeks, and resume the next cycle at reduced dose (see official prescribing information).¹

Complete information about Inqovi (decitabine and cedazuridine) dosage and administration can be found in the official prescribing information listed in our references section.¹

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known adverse reactions or side effects of Inqovi (decitabine and cedazuridine)?

Common adverse reactions

The most common adverse reactions (≥20% of patients) listed in the prescribing information include:¹

• Low white blood cell count (leukopenia)
• Low blood platelets (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

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:¹

• Febrile neutropenia
• Pneumonia
• Sepsis

Use in a specific population

Inqovi (decitabine and cedazuridine) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.¹

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

References

1. Full prescribing information [FDA]: Inqovi (decitabine and cedazuridine) [PDF]
Astex Pharmaceuticals, July 2020

2. Types of Chemotherapy Agents and Regimens - Antimetabolites
Chemoth, last checked July 22, 2020

3. Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets
Astex Pharmaceuticals press release, July 2020

4. FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
FDA press release, July 7 2020