Key Takeaways:
- Inqovi is the first orally administered hypomethylating agent approved by the US Food and Drug Administration.
- Inqovi is a fixed-dose combination (FDC) of the hypomethylating agent decitabine and the cytidine deaminase inhibitor cedazuridine, which prevents degradation of decitabine in the gastrointestinal tract and liver and enables its absorption via oral dosing.
- Approval is based on the ASCERTAIN phase 3 trial and other supporting studies that compared systemic exposure to decitabine from oral Inqovi with exposure from IV decitabine and assessed the safety and efficacy of Inqovi.
- Inqovi delivers an option for intermediate and high-risk MDS and CMML patients to potentially reduce the number of office visits and to take their medicine from the convenience and comfort of their homes.
Overview of Inqovi:
Inqovi is approved for adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary myelodysplastic syndromes (MDS) with the following French-AmericanBritish subtypes (refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1/2, and high-risk International Prognostic Scoring System groups.
Dosage and Administration:
The recommended dosage is 1 tablet (containing 35 mg decitabine and 100 mg cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle for at least four cycles until there is evidence of disease progression or the emergence of unacceptable toxicity. A complete or partial response may take longer than 4 cycles. Clinicians must advise patients to take the pills at the same time each day and to swallow them completely without chewing or crushing.
Patients must take the tablets on an empty stomach, which indicates no food for 2 hours before and 2 hours after each dose. The use of antiemetics may minimize vomiting and nausea before each dose.
Potential Side Effects:
The most common side effects with incidence ≥ 20% are decreased appetite, fatigue, constipation, rash, dyspnea, diarrhea, hemorrhage, myalgia, mucositis, arthralgia, nausea, dizziness, febrile neutropenia, pneumonia, edema, headache, upper respiratory tract infection, cough, and transaminase increase.
Warnings and Precautions:
- Myelosuppression (anemia, thrombocytopenia, neutropenia, and febrile neutropenia) is the most frequent cause of decitabine/cedazuridine dose reduction or interruption. Patients in the first and second treatment cycles may feel neutropenia and myelosuppression more frequently.
- Patients on treatment with this drug may experience serious and fatal infectious complications of pneumonia and sepsis. Pharmacists must counsel patients to report any signs or symptoms of an infection to their healthcare provider promptly throughout treatment.
- Inqovi can cause fetal harm when administered to pregnant women. Pharmacists must counsel women of reproductive potential to use effective contraception during therapy and for 6 months after the last dose.
- Males with female partners of reproductive age/potential must be counseled to use effective contraception during treatment and for three months after the final dose. Women should avoid breastfeeding during therapy and for at least two weeks after the last dose.
- Healthcare providers must verify pregnancy status in females of reproductive age before starting therapy. The FDC medicine may impair fertility in males. Never substitute intravenous decitabine products for oral decitabine within a cycle.
How and Where to Buy Inqovi:
Inqovi (decitabine and cedazuridine) is a prescription drug that can be ordered from the Indian Pharma Network (IPN) if the drug has not been approved or is not available in your country. Inquire and we will help you calculate the total price to buy Inqovi tablets online and have them delivered to your place. From your end, we’ll need a prescription from your treating doctor. In some countries, we might also ask for an import license. Our Patient Support team will help you throughout the process.
References:
https://www.inqovi.com/
https://www.inqovi.com/considering-inqovi-for-MDS
https://www.inqovi.com/hcp/inqovi-efficacy-and-safety
