- Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) – Investigational use for pediatric patients
- Investigational use for newly-diagnosed High Risk Acute Lymphoblastic Leukemia (ALL)
- Supplied as a white to off-white powder in a single-use amber glass vial containing 0.9 mg/vial
- Store unreconstituted vials in refrigerator (2-8 C). Protect from light. Do not shake.
- Prior to reconstitution, allow drug vial to reach room temperature for 15 minutes
- Reconstitute vial with 4 mL Sterile Water for Injection to get 0.25 mg/mL. Only 3.6 mL can be withdrawn per vial (0.9 mg) Swirl gently - do not shake and avoid foaming.
- Allow reconstituted vial to settle for 1 minute to eliminate bubbles. Solution should be clear, colourless, and particle-free. Protect from light and store at refrigeration if not used immediately. Discard reconstituted vial after 4 hours.
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Inotuzumab should be protected from light during preparation and administration using an amber bag. Foil should also cover the syringe barrel if the reconstituted solution is not transferred immediately into the IV bag.
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Dilution: Reconstituted inotuzumab ozogamicin should be further diluted in 0.9% Sodium Chloride Injection (Normal Saline) prior to IV infusion. The final concentrations for administration are as follows:
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Syringe: 0.025 mg/mL to 0.1 mg/mL
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50 mL exact volume IV Bag: 0.01 mg/mL to 0.1 mg/mL
- For IV bag, make an exact volume 0.9% Sodium chloride in an empty PVC or polyolefin bag. Add the dose of inotuzumab ozogamicin. Gently mix and avoid vigorous shaking.
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Diluted solution can be stored up to 4 hours at room temperature (including administration time) or up to 8 hours (total) with refrigeration. Diluted solution may be stored in the fridge for a maximum of 6 hours, to allow solution to equilibrate at room temperature for approximately 1 hour prior to 1 hour administration. The prepared IV bag must be used within 8 hours of initial product reconstitution.
- The IV line can be exposed to light for approximately 1 hour for infusion. If lines are primed in advance or infusion runs longer than 1 hour, lines must be protected from light.
- Solutions Compatible: 0.9% NaCl
- Additives/Above Cassette Compatible: Do not mix with other drugs or IV solutions
- Y-site Compatible: Do not run with other drugs
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES Usual dilution: Syringe: 0.025mg/mL to 0.1mg/mL 50mL exact volume IV bag: 0.01 mg/mL to 0.1mg/mL - lines with or without an in-line filter are acceptable - use microbore tubing for infusions of 25 mL or less Infusion time: 60 minutes |
| IV Continuous Infusion | NO |
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Cycle 1: 0.8 mg/m2 on day 1, and 0.5 mg/m2 on days 8 and 15 (cycle length 21-28 days)
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Subsequent cycles (cycles 2-6) given every 3 - 4 weeks: 0.5-0.8 mg/m2/dose on day 1, then 0.5 mg/m2 on days 8 and 15
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Investigational Dosing (AALL1732): 0.5 mg/m2 on days 1, 8 and 15
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Minimum 6 days between inotuzumab doses
- Common/Occasional:
- Hepatic: elevation of liver enzymes and bilirubin, sinusoidal obstruction syndrome (a.k.a. veno-occlusive disease)
- GI: nausea, vomiting, abdominal pain, constipation, diarrhea, anorexia, increased amylase, lipase.
- CNS: headache, paresthesia
- Hematologic: thrombocytopenia, neutropenia, lymphopenia
- Respiratory: dyspnea, epistaxis, upper respiratory tract infection, pneumonia.
- Fatigue, asthenia, Chills, Peripheral edema
- Rare:
- Infusion-related reactions: fever, chills, hypotension. If an infusion-related reaction occurs, stop the infusion and contact physician for appropriate treatment (e.g., corticosteroids, epinephrine, bronchodilators, oxygen). Depending on the reaction and its severity, could consider starting again the infusion, but at a reduced rate.
- Cardiovascular: QTc interval prolongation
- Extravasation potential: none
- Considered low emetogenic potential
- Inotuzuamb ozogamicin Product Monograph. Pfizer Canada, Version: 15 March2018
- Inotuzuamb ozogamicin Pharmacy Manual. AALL1732. Version 5. Date: 04/22/2021