INQOVI

1 Dosing Considerations Inqovi must be prescribed under the supervision of a qualified physician experienced in the use of chemotherapeutic agents. Important Administration Information • Do NOT substitute Inqovi for an intravenous decitabine product within a cycle.

• Consider premedication with standard antiemetic therapy prior to each dose to minimize nausea and vomiting (See 8 ADVERSE REACTIONS). • Obtain complete blood cell counts 1-4 days prior to initiating Inqovi, before each subsequent cycle and as clinically indicated to monitor response and toxicity.

• Obtain liver chemistries and serum creatinine prior to initiation of treatment and repeat if liver/renal toxicities are suspected. • Delay treatment at the discretion of the treating physician if patients experience hematological or non-hematological adverse reactions.

Modify dosage in the presence of hematological and non-hematological toxicities. These adjustments can only occur after cycle 2. (See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment). • Agents that increase gastric pH should not be taken within 4 hours of Inqovi administration (See 9 DRUG INTERACTIONS).

2 Recommended Dose and Dosage Adjustment Recommended Dose The recommended dose of Inqovi is 1 tablet containing (35 mg of decitabine and 100 mg of cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.

A complete or partial response may take longer than 4 cycles. Continue treatment until disease progression or unacceptable toxicity. Repeat cycles every 28-days. Do not modify the recommended dose for the first 2 cycles. Delay or reduce the dose per cycle following hematologic and non-hematologic toxicities.

Dosage Adjustment Hematologic Adverse Reactions Refer to Table 1 for dose delay and dose resumption criteria for hematologic toxicities (See 7 WARNINGS AND PRECAUTIONS; 8 ADVERSE REACTIONS). 0 x 109/L and platelets at least 50 x 109/L) within 2 weeks of the last Inqovi treatment cycle, continue Inqovi at the same dosage.

0 x 109/L and platelets at least 50 x 109/L) within 2 weeks of the last Inqovi treatment cycle • Delay Inqovi for up to 2 additional weeks AND • Resume at a reduced dosage by administering Inqovi on Days 1 through 4 only. Consider further dosage reductions in the order listed in Table 2 if myelosuppression persists after a dosage reduction.

). • Obtain complete blood cell counts 1-4 days prior to initiating Inqovi, before each subsequent cycle and as clinically indicated to monitor response and toxicity. • Obtain liver chemistries and serum creatinine prior to initiation of treatment and repeat if liver/renal toxicities are suspected.

• Delay treatment at the discretion of the treating physician if patients experience hematological or non-hematological adverse reactions. Modify dosage in the presence of hematological and non-hematological toxicities. These adjustments can only occur after cycle 2.

(See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment). • Agents that increase gastric pH should not be taken within 4 hours of Inqovi administration (See

, Hematologic • Potential for fetal harm (See 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). 1 Dosing Considerations Inqovi must be prescribed under the supervision of a qualified physician experienced in the use of chemotherapeutic agents.

Important Administration Information • Do NOT substitute Inqovi for an intravenous decitabine product within a cycle. • Consider premedication with standard antiemetic therapy prior to each dose to minimize nausea and vomiting (See

Inqovi is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.