Decitabine and Cedazuridine Tablets (INQOVI) is an innovative oral fixed-dose combination product, composed of decitabine (a nucleoside metabolism inhibitor) and cedazuridine (a cytidine deaminase inhibitor). First approved by the U.S. FDA in 2020, this medication provides a convenient treatment option for patients with myelodysplastic syndromes (MDS).

Indications for Decitabine and Cedazuridine Tablets (INQOVI)

Primary Indications

Decitabine and Cedazuridine Tablets are indicated for the treatment of myelodysplastic syndromes (MDS) in adult patients, including those who have received prior treatment and treatment-naive patients, as well as primary and secondary MDS.

Specific Indication Classifications

Refractory anemia.

Refractory anemia with ring sideroblasts.

Refractory anemia with excess blasts.

Chronic myelomonocytic leukemia (CMML).

Specifications and Properties of Decitabine and Cedazuridine Tablets (INQOVI)

Active Ingredients

Each tablet contains 35 mg of decitabine and 100 mg of cedazuridine.

Dosage Form

Biconvex, oval-shaped film-coated tablets

Red in appearance

Imprinted with "H35" on one side.

Physical Properties

Decitabine: A white to off-white solid with the molecular formula C₈H₁₂N₄O₄ and a molecular weight of 228.21 Daltons.

Cedazuridine: A white to off-white solid with the molecular formula C₉H₁₄F₂N₂O₅ and a molecular weight of 268.21 Daltons.

Excipient Ingredients

Tablet core: Lactose monohydrate, hypromellose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.

Film coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide.

Storage Methods for Decitabine and Cedazuridine Tablets (INQOVI)

Temperature Requirements

Standard storage temperature: 20°C to 25°C (68°F to 77°F).

Brief exposure to an environment of 15°C to 30°C (59°F to 86°F) is permitted.

Packaging Requirements

Must be distributed and used in the original packaging.

The original packaging is a child-resistant blister pack.

Each carton typically contains one blister card with 5 tablets.

Special Precautions

Decitabine and Cedazuridine Tablets are classified as hazardous drugs and must be handled and disposed of in accordance with special pharmaceutical handling and disposal procedures.

Avoid storage in locations with significant temperature and humidity fluctuations, such as bathrooms and kitchens.

Keep out of the reach and sight of children.

Expired or unused medications should be professionally disposed of in compliance with hazardous drug disposal regulations.