). Table 3 shows the dose modification guidelines for hematologic and nonhematologic toxicities. Table 3. Dosage Modifications for Hematologic and Nonhematologic Toxicities Hematologic and Nonhematologic Toxicities Recommended Action Persistent thrombocytopenia • If platelet count does not recover to greater than or equal to 100,000 mm3 within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue Mylotarg (do not administer MYLOTARG in the consolidation cycles).
Persistent neutropenia • If neutrophil count does not recover to greater than 500 mm3 within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue Mylotarg(do not administer Mylotarg in the consolidation cycles).
VOD/SOS • Discontinue Mylotarg (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Hepatotoxicity). MYLOTARG® (gemtuzumab ozogamicin for injection) – Product Monograph Page 8 of 44 Table 3. 5 × ULN prior to each dose. • Omit scheduled dose if delayed more than 2 days between sequential infusions.
Infusion related reactions • Interrupt the infusion and institute appropriate medical management based on the severity of symptoms. Patients should be monitored until signs and symptoms completely resolve and infusion may resume. • Permanently discontinue Mylotarg upon occurrence of a severe or life-threatening infusion reactions (see 7 WARNINGS AND PRECAUTIONS, General).
Other severe or life- threatening nonhematologic toxicities • Delay treatment with Mylotarg until recovery to a severity of no more than mild. • Consider omitting scheduled dose if delayed more than 2 days between sequential infusions.
Abbreviations:
ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; VOD=venoocclusive disease; ULN=upper limit of normal. 3 Reconstitution Parenteral Products: Use appropriate aseptic technique for the reconstitution and dilution procedures.
Mylotarg is light sensitive and should be protected from light during reconstitution, dilution, and administration. Reconstitution • Calculate the dose (mg) of Mylotarg required. • Prior to reconstitution, allow the vial to reach room temperature (below 25°C) for approximately 5 minutes.
5 mg). • Gently swirl the vial to aid dissolution. Do not shake. • Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution may contain small white to off-white, opaque to translucent, and amorphous to fiber-like particles.
• Mylotarg contains no bacteriostatic preservatives. • If the reconstituted solution cannot be used immediately, it may be stored in the original vial for up to 16 hours in a refrigerator (2°C-8°C) or up to 3 hours at room temperature (below 30°C).
Protect from light and do not freeze. Dilution • Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to patient body surface area. Withdraw this amount from the vial using a syringe.
5 mL overfill. 5 mL). Protect from light. Discard any unused reconstituted solution left in the vial. 9 mg must be prepared for administration by syringe. 234 mg/mL. Protect from light. 234 mg/mL. Protect from light. • Gently invert the infusion container to mix the diluted solution.
Do not shake. 9%) solution for injection, MYLOTARG solution should be infused immediately. If not used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2-8°C) and up to 6 hours at room temperature (below 30°C).
The allowed time at room temperature (below 30°C) includes the time required for preparation of the diluted solution, equilibration, if needed, and administration to the patient. The maximum time from preparation of the diluted solution through administration should not exceed 24 hours.
Protect from light and do not freeze. • It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, ethylene vinyl acetate (EVA) or polyolefin (polypropylene and/or polyethylene). Administration • Filtration of the diluted solution is required.
2 micron polyethersulphone (PES) filter must be used for infusion of Mylotarg. 2 micron polyethersulphone (PES) filter. • During the infusion, the intravenous bag or syringes need to be protected from light using a light (including ultraviolet light) blocking cover.
The infusion line does not need […]