INQOVI

What it is

INQOVI is a film-coated tablet containing 35 mg of decitabine and 100 mg of cedazuridine. INQOVI is a cytotoxic drug. This medicinal product is subject to additional monitoring in Australia.

Approved indications —

Myelodysplastic syndromes (MDS) intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups — Chronic myelomonocytic leukaemia (CMML)

Dosing overview

The recommended dose of INQOVI is 1 tablet containing 35 mg of decitabine and 100 mg of cedazuridine taken orally once daily on Days 1 through 5 of each 28-day cycle for a minimum of 4 cycles. Best response may take longer than 4 cycles, and treatment should continue as long as the patient continues to benefit. INQOVI tablets should be taken with water on an empty stomach, at approximately the same time each day, and food should not be consumed two hours before and two hours after taking INQOVI. Agents that increase gastric pH should not be taken within 4 hours of INQOVI administration.

Key safety warnings

**Myelosuppression.** Fatal and serious myelosuppression may occur with INQOVI. New or worsening thrombocytopenia occurred in 82 per cent of patients (with Grade 3 or 4 in 76 per cent), neutropenia in 73 per cent (with Grade 3 or 4 in 71 per cent), anaemia in 71 per cent (with Grade 3 or 4 in 55 per cent), and febrile neutropenia in 33 per cent (with Grade 3 or 4 in 32 per cent). Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily indicate progression of underlying MDS. Complete blood cell counts should be obtained prior to initiation of INQOVI and prior to each cycle, and as clinically indicated to monitor response and toxicity. **Infections.** Fatal and serious infectious complications may occur with INQOVI. Pneumonia occurred in 21 per cent of patients (with Grade 3 or 4 in 15 per cent), sepsis in 14 per cent (with Grade 3 or 4 in 11 per cent), with fatal pneumonia in 1 per cent, fatal sepsis in 1 per cent, and fatal septic shock in 1 per cent. **Haemorrhage.** Serious bleeding-related treatment-emergent adverse events have been reported with INQOVI due to severe thrombocytopenia. Gastrointestinal haemorrhage was reported in 6.7 per cent (including Grade ≥3 in 2.4 per cent) and intracranial haemorrhage in 1.9 per cent (including Grade ≥3 in 1.4 per cent). **Pregnancy.** Based on its mechanism of action and findings in animals, INQOVI can cause fetal harm when administered to a pregnant woman, as decitabine alters DNA synthesis and is expected to result in adverse reproductive effects. Advise women of childbearing potential to avoid becoming pregnant while taking INQOVI and for 6 months following the last dose.

Contraindications

INQOVI is contraindicated in pregnancy. INQOVI is also contraindicated in patients with hypersensitivity to the active substances, decitabine or cedazuridine, or to any of the excipients.

PBS listing

No PBS listing information is available in the source documents.

Regulatory history

INQOVI 35/100 was first listed on the Australian Register of Therapeutic Goods on 22 December 2021.