ONUREG FILM-COATED TABLETS 200 MG [SIN16572P]

Product Info

ONUREG FILM-COATED TABLETS 200 MG

[SIN16572P]

1 INDICATIONS

ONUREG^TM (azacitidine film-coated tablets) is a nucleoside metabolic inhibitor indicated for:

• maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

Limitations of Use:

• ONUREG^TM is not interchangeable with, and should not be substituted with or for, azacitidine for injection. See DOSAGE AND ADMINISTRATION, Administration and WARNINGS AND PRECAUTIONS, General – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• The safety and effectiveness of ONUREG for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with ONUREG is not recommended outside of controlled trials. See WARNINGS AND PRECAUTIONS, General – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

1.1 Pediatrics

Pediatrics (< 18 years of age):
No data are available on administration of ONUREG^TM to pediatric or adolescent patients (< 18 years of age).

1.2 Geriatrics

Geriatrics (≥ 65 years of age): No dosage adjustment is required for ONUREG^TM based on age, see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4 DOSAGE AND ADMINISTRATION

4.1 Dosing Considerations

• No specific dose adjustments are recommended for elderly patients (≥ 65 years of age), see INDICATIONS.

• Administer an antiemetic 30 minutes prior to each dose of ONUREG for the first 2 cycles. Antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting.

• ONUREG^TM can be administered to patients with renal impairment without initial dose adjustment, see DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment and CLINICAL PHARMACOLOGY, Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Recommended Dose and Dosage Adjustment

Recommended Starting Dosage:

The recommended starting dose of ONUREG^TM is 300 mg orally once daily on Day 1 through Day 14 of repeated 28-day treatment cycles.

If the absolute neutrophil count (ANC) is less than 500/mcL on Day 1 of a cycle, do not administer ONUREG^TM. Delay the start of the cycle until the ANC is 500/mcL or more.

ONUREG^TM maintenance therapy should be initiated after achievement of a CR/CRi following completion of induction and consolidation therapy or following induction if consolidation therapy is not planned.

Dose Modifications During Treatment:

Dose Adjustment for Renal Impairment: No dose adjustment is required for patients with mild to moderate renal impairment.

ONUREG^TM can be administered to patients with severe renal impairment without initial dose adjustment. Monitor patients with severe renal impairment (creatinine clearance [CLcr] 15 to 29 mL/min calculated by Cockcroft-Gault formula) more frequently for adverse reactions and modify the ONUREG dosage for adverse reactions, see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Dose Adjustment for Hepatic Impairment: ONUREG^TM has not been studied in patients with pre-existing severe hepatic impairment (total bilirubin > 3 × ULN).

A recommended dosage of ONUREG^TM has not been established for patients with moderate hepatic impairment (total bilirubin > 1.5 to 3 × ULN).

No dose adjustment of ONUREG^TM is recommended for patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin 1 to 1.5 × ULN and any AST).

Dose Adjustment for Adverse Reactions: Dose modification guidelines for hematologic and non-hematologic adverse reactions are recommended based on clinical and laboratory findings if toxicities are judged related to ONUREG^TM (see Table 1).

Continuation and Discontinuation Recommendations:

ONUREG^TM, given Day 1 through Day 14 of repeated 28-day treatment cycles, is intended for continuous use. ONUREG^TM treatment should be continued until more than 15% blasts are observed in peripheral blood or bone marrow or until unacceptable toxicity occurs. Discontinue ONUREG^TM if more than 15% blasts are observed in either the peripheral blood or bone marrow or at the physician’s discretion.

4.3 Administration

ONUREG^TM can be taken with or without food. Do not split, crush, dissolve or chew ONUREG^TM tablets. Administer a dose at about the same time each day. Consider providing prophylactic anti-emetic therapy during ONUREG^TM treatment.

ONUREG^TM is not interchangeable with, and should not be substituted with or for, azacitidine for injection. Due to differences in exposure, the dose and schedule recommendations for ONUREG^TM are different from those for injectable azacitidine. Verify drug name, dose, and administration route. See INDICATIONS, Limitation of Use.

4.5 Missed Dose

If a dose of ONUREG^TM is missed, or not taken at the usual time, administer the dose as soon as possible on the same day, and return to the normal time of dose administration the following day. Do not take 2 doses on the same day. If a dose is vomited, do not take another dose on the same day, but return to the normal time of dose administration the following day.

2 CONTRAINDICATIONS

ONUREG^TM 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 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

ONUREG^TM is contraindicated in patients with advanced malignant hepatic tumors.