BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/VIAL

WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDING LLC (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Jul 17, 2019
Approval ID: f16257673be70500
Company: WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDING LLC (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: f16257673be70500
Drug Name: BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/VIAL
Product Name: BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/VIAL
Approval Number: SIN15747P
Approval Date: 2019-07-17
Registrant: PFIZER PRIVATE LIMITED
Licence Holder: PFIZER PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: POWDER, FOR SOLUTION
Dosage: 4.2. Posology and method of administration For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count ≤10,000/mm3 is recommended prior to the first dose. Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients should be observed during and for at least 1 hour after the end of the infusion for symptoms of infusion related reactions (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Posology Administer inotuzumab ozogamicin in 3- to 4-week cycles. For patients proceeding to a hematopoietic stem cell transplant (HSCT), the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles. A third cycle should be considered for those patients who do not achieve a complete remission (CR) or a complete remission with incomplete hematologic recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For patients not proceeding to HSCT, a maximum of 6 cycles may be administered. Any patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment. Table 1 shows the recommended dosing regimens. For the first cycle, the recommended total dose of inotuzumab ozogamicin for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2). Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a CR or CRi, and/or to allow recovery from toxicity. For subsequent cycles, the recommended total dose of inotuzumab ozogamicin is 1.5 mg/m2 per cycle, administered as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR or CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR or CRi. Subsequent cycles are 4 weeks in duration. <img src="/TGIF/Besponsa-Table1_241023.png" alt="Besponsa Dosage Table 1" /> Dose modifications Dose modification of inotuzumab ozogamicin may be required based on individual safety and tolerability (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Management of some adverse drug reactions may require dosing interruptions and/or dose reductions, or permanent discontinuation of inotuzumab ozogamicin (see Sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If the dose is reduced due to inotuzumab ozogamicin-related toxicity, the dose must not be re-escalated. Table 2 and Table 3 show the dose modification guidelines for hematologic and nonhematologic toxicities, respectively. Inotuzumab ozogamicin doses within a treatment cycle (i.e., Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for nonhematologic toxicities. <img src="/TGIF/Besponsa-Table2_241023.png" alt="Besponsa Dosage Table 2" /> <img src="/TGIF/Besponsa-Table3_241023.png" alt="Besponsa Dosage Table 3" /> Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity. <img src="/TGIF/Besponsa-Table4_241023.png" alt="Besponsa Dosage Table 4" /> Special populations Elderly patients No adjustment to the starting dose is required based on age (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Increased age may be associated with an increased risk of venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS) after HSCT (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 × ULN (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is limited safety information available in patients with total bilirubin >1.5 × ULN and AST/ALT >2.5 × ULN prior to dosing. Interrupt dosing until recovery of total bilirubin to ≤1.5 × ULN and AST/ALT to ≤2.5 × ULN prior to each dose unless due to Gilbert’s syndrome or hemolysis. Permanently discontinue treatment if total bilirubin does not recover to ≤1.5 × ULN or AST/ALT does not recover to ≤2.5 × ULN (see Table 3 and Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No adjustment to the starting dose is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CLcr] 60–89 mL/min, 30–59 mL/min, or 15–29 mL/min, respectively) (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and efficacy of inotuzumab ozogamicin have not been studied in patients with end-stage renal disease. Pediatric population The safety and efficacy of inotuzumab ozogamicin in the pediatric population (<18 years) have not been established. Currently available data are described in Sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information but no recommendation on a posology can be made. Method of administration Inotuzumab ozogamicin is for intravenous use. The infusion must be administered over 1 hour. Do not administer inotuzumab ozogamicin as an intravenous push or bolus. Inotuzumab ozogamicin must be reconstituted and diluted before administration. For instructions on reconstitution and dilution of inotuzumab ozogamicin before administration, see Section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Route Of Administration: INTRAVENOUS
Indication Info: 4.1. Therapeutic indications Inotuzumab ozogamicin is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Contraindications: 4.3. Contraindications <ul class="dash"> <li>Hypersensitivity to inotuzumab ozogamicin or to any of the excipients.</li> <li>Patients who have ongoing VOD/SOS.</li> <li>Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis).</li> </ul>
Atc Code: L01XC26
Atc Item Name: xl 01 xc 26
Pharma Manufacturer Name: PFIZER PRIVATE LIMITED

Active Ingredients

Inotuzumab Ozogamicin

1mg/vial

Inotuzumab Ozogamicin

1mg/vial

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jul 17, 2019

Approval ID

f16257673be70500

Type

Therapeutic

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