Mylotarg

MYLOTARG- gemtuzumab ozogamicin injection, powder, lyophilized, for solution
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

WARNING: HEPATOTOXICITY

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. (5.1 and 6.1)

1 INDICATIONS AND USAGE

1.1 Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML)

MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.

1.2 Relapsed or Refractory CD33-positive AML

MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.

2 DOSAGE AND ADMINISTRATION

2.1 Premedication and Special Considerations

  • Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to MYLOTARG dosing and 1 mg/kg methylprednisolone or an equivalent dose of an alternative corticosteroid within 30 minutes prior to infusion of MYLOTARG.
  • Premedicate pediatric patients 1 month and older with acetaminophen 15 mg/kg (maximum of 650 mg) and diphenhydramine 1 mg/kg (maximum of 50 mg) 1 hour prior to MYLOTARG dosing, and 1 mg/kg methylprednisolone orally or intravenously within 30 minutes prior to infusion of MYLOTARG; additional doses of acetaminophen and diphenhydramine may be administered every 4 hours after the initial pretreatment dose. Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction, such as fever, chills, hypotension, or dyspnea during the infusion or within 4 hours afterwards [see Warnings and Precautions (5.2)].
  • Use appropriate measures to prevent tumor lysis syndrome.
  • For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of MYLOTARG.

2.2 Recommended Dosage

Newly-Diagnosed De Novo CD33-positive AML (Combination Regimen)

Adults

The recommended dose of MYLOTARG in adults is 3 mg/m2. A treatment course including MYLOTARG in combination therapy for adults with newly-diagnosed de novo CD33-positive AML consists of 1 induction cycle and 2 consolidation cycles [see Clinical Studies (14.1)].

For the induction cycle, the recommended dose of MYLOTARG is 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine. For patients requiring a second induction cycle, do NOT administer MYLOTARG during the second induction cycle.

For the consolidation cycles, the recommended dose of MYLOTARG is 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine.

Pediatric Patients 1 Month and Older

The recommended dose of MYLOTARG in pediatric patients 1 month and older is:

  • 3 mg/m2 for patients with body surface area (BSA) greater than or equal to 0.6 m2
  • 0.1 mg/kg for patients with BSA less than 0.6 m2

For Induction 1, MYLOTARG is given once in combination with standard chemotherapy. No MYLOTARG is given in the second induction cycle [see Clinical Studies (14.1)].

No MYLOTARG is given in the first or third intensification cycles. For Intensification 2, MYLOTARG is given once in combination with standard chemotherapy. Consider the risks and potential benefits before giving MYLOTARG during Intensification 2 [see Adverse Reactions (6.1)].

Newly-Diagnosed CD33-positive AML (Single-agent Regimen)

A treatment course of MYLOTARG as a single agent for adults with newly-diagnosed CD33-positive AML consists of 1 cycle of induction and up to 8 cycles of continuation therapy [see Clinical Studies (14.1)].

For the induction cycle, the recommended dose of MYLOTARG is 6 mg/m2 (not limited to one 4.5 mg vial) as a single agent on Day 1, and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8.

For continuation, the recommended dose of MYLOTARG is 2 mg/m2 (not limited to one 4.5 mg vial) as a single agent on Day 1 every 4 weeks.

Relapsed or Refractory CD33-positive AML (Single-agent Regimen)

The recommended dose of MYLOTARG as a single agent for treatment for adults and pediatric patients 2 years and older with relapsed or refractory CD33-positive AML is 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7. Treatment in the relapsed or refractory setting consists of a single course of MYLOTARG [see Clinical Studies (14.2)].

2.3 Dosage Modifications for Toxicities

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. Management of some adverse reactions [see Warnings and Precautions (5) , Adverse Reactions (6)] may require dose interruptions or permanent discontinuation of MYLOTARG. Table 1 shows the dose modification guidelines for hematologic and nonhematologic toxicities.

Table 1. Dosage Modifications for Hematologic and Nonhematologic Toxicities
Hematologic and Nonhematologic Toxicities Recommended Action
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; VOD=veno-occlusive disease; ULN=upper limit of normal.
For patients receiving MYLOTARG in combination therapy
Persistent thrombocytopenia
  • Adults: If platelet count does not recover to greater than or equal to 100 Gi/L 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).
  • Pediatrics: Patients should have a platelet count of 75 Gi/L before the next cycle (induction or intensification).
Persistent neutropenia
  • Adults: If neutrophil count does not recover to greater than 0.5 Gi/L 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).
  • Pediatrics: Patients should have a neutrophil count of 1 Gi/L before the next cycle (induction or intensification).
For all patients receiving MYLOTARG (Monotherapy or in Combination)
VOD
Total bilirubin greater than 2 × ULN, or AST and/or ALT greater than 2.5 × ULN
  • Delay treatment with MYLOTARG until recovery of total bilirubin to less than or equal to 2 × ULN and AST and ALT to less than or equal to 2.5 × 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.
  • Administer acetaminophen, diphenhydramine and/or methylprednisolone, if needed [see Dosage and Administration (2.1)]
  • Provide supportive care measures as needed.
  • For mild, moderate or severe infusion-related reactions, once symptoms resolve, consider resuming the infusion at no more than half the rate at which the reaction occurred. Repeat the procedure above in the event of recurrence of symptoms.
  • Permanently discontinue MYLOTARG upon occurrence of a severe infusion reaction or for any life-threatening infusion reaction [see Warnings and Precautions (5.2)].
Other severe or life-threatening non-hematologic toxicities
  • Delay treatment with MYLOTARG until recovery to a severity of no more than mild.
  • Omit scheduled dose if delayed more than 2 days between sequential infusions.

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