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MYLOTARG is a brand name for Gemtuzumab Ozogamicin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mylotarg (gemtuzumab ozogamicin for injection) is indicated for: • Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia 1.1 Pediatrics Pediatrics (< 18 years of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Mylotarg (gemtuzumab ozogamicin for injection) should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available.
• Mylotarg should be used only in patients eligible to receive intensive induction chemotherapy. • Premedication with a corticosteroid, antihistamine, and acetaminophen is recommended 1 hour prior to Mylotarg dosing to help ameliorate infusion related symptoms (see 7 WARNINGS AND PRECAUTIONS).
• Appropriate measures to help prevent the development of tumor lysis-related hyperuricemia such as hydration, administration of antihyperuricemic or other agents for treatment of hyperuricemia must be taken (see 7 WARNINGS AND PRECAUTIONS).
• For patients with hyperleukocytosis (leukocyte count >30,000/mm3), cytoreduction is recommended prior to administration of Mylotarg (see Table 2). • Mylotarg must be reconstituted and diluted before administration. 3 Reconstitution.
2 Recommended Dose and Dosage Adjustment A treatment course including Mylotarg in combination therapy for adults with newly-diagnosed de novo CD33-positive acute myeloid leukemia (AML) consists of 1 induction cycle and 2 consolidation cycles.
5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with daunorubicin (DNR), 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and cytarabine (AraC) 200 mg/m2/day by continuous infusion on Day 1 to Day 7.
For patients requiring a second induction cycle, do NOT administer Mylotarg during the second induction cycle. Only DNR and AraC should be administered during the second induction cycle, at the following recommended dosing: DNR 35 mg/m2/day on Days 1 and 2, and AraC 1 g/m2 every 12 hours, on Day 1 to Day 3.
5 mg vial on Day 1) are recommended. Table 1 shows dosing regimens for Mylotarg in combination with chemotherapy. Table 1. 5 mg vial) on Days 1,4, and 7 60 mg/m2/day on Days 1-3 200 mg/m2/day on Days 1-7 Second induction (if required) Do NOT administer Mylotarg during the second induction cycle.
5 mg vial) on Day 1 60 mg/m2/day on Days 1-2 1 g/m2/every 12 hours from Days 1-4 a. See Table 2 and Table 3 for dose modification information. b. For patients experiencing a complete remission following induction. c. See Table 3 for dose modification information.
). 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.
, 01/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 3 Reconstitution ................................................................................................... 4 Administration...................................................................................................
5 Missed Dose ...................................................................................................... 9 5 OVERDOSAGE ...........................................................................................................
• Mylotarg (gemtuzumab ozogamicin for injection) 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5-times ULN. 5-times ULN prior to each dose. 3 Pharmacokinetics).
Renal Impairment:
No adjustment to dose of Mylotarg is required in patients with mild to moderate renal impairment. 3 Pharmacokinetics). Schedule modification for hyperleukocytosis MYLOTARG® (gemtuzumab ozogamicin for injection) – Product Monograph Page 7 of 44 In patients with hyperleukocytic (leukocyte count >30,000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea, or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of Mylotarg(see 7 WARNINGS AND PRECAUTIONS, General).
If AraC is used for leukoreduction with or without hydroxyurea in patients with previously untreated, de novo hyperleukocytic AML receiving Mylotarg in combination therapy, apply the following modified schedule (Table 2): Table 2. 5 mg vial) on Days 3, 6, and 9 60 mg/m2/day on Days 3-5 200 mg/m2/day on Days 1-7 Day 1 (as per standard medical practice) a.
See Table 3 for additional dose modification information. Dose modification for adverse drug reactions Monitor blood counts frequently through resolution of cytopenias. Monitor blood counts and chemistries at least three times per week through recovery from treatment-related toxicities.
Dose modification of Mylotarg is […]
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 […]
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ..........................................................................................
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
4 Geriatrics ................................................................................................... 14 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions ..................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...................................................................................................... 5 Post-Market Adverse Reactions........................................................................
23 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview.............................................................................. 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
25 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action.................................................................................. 2 Pharmacodynamics ....................................................................................
3 Pharmacokinetics ....................................................................................... 26 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
29 PART II: SCIENTIFIC INFORMATION ...................................................................................... 30 13 PHARMACEUTICAL INFORMATION............................................................................ 30 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 31 15 MICROBIOLOGY ........................................................................................................ 35 16 NON-CLINICAL TOXICOLOGY .....................................................................................
35 PATIENT MEDICATION INFORMATION ................................................................................. 38 MYLOTARG® (gemtuzumab ozogamicin for injection) – Product Monograph Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Mylotarg (gemtuzumab ozogamicin for injection) is indicated for: • Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients […]