Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized cake powder for reconstitution
- 4.5 mg/single-dose vial
Acute Myeloid Leukemia
Newly Diagnosed CD33-positive AML
- Indicated for newly diagnosed CD33-positive AML in adults
-
Combination regimen
- Induction cycle: 3 mg/m2 IV (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 gemtuzumab during second induction cycle
- Consolidation: 3 mg/m2 IV on Day 1 (up to one 4.5-mg vial) in combination with daunorubicin and cytarabine
-
Monotherapy
- Treatment course consists of 1 cycle of induction and up to 8 cycles of continuation therapy
- Induction: 6 mg/m2 IV on Day 1, and 3 mg/m2 on Day 8
- Continuation therapy: 2 mg/m2 IV on Day 1 q4weeks
Relapsed or Refractory CD33-positive AML
- Indicated for relapsed/refractory CD33-positive AML
- 3 mg/m2 on Days 1, 4, and 7 for 1 cycle
Dosing Modifications
Veno-occlusive disease (VOD): Discontinue treatment
Renal impairment
- Mild-moderate (CrCl: 30-89 mL/min): No dosage adjustment necessary
- Severe (CrCl: 15-29 mL/min): Safety and efficacy unknown
Hepatic impairment
- Mild (total bilirubin <1.5X ULN): No dosage adjustment necessary
- Moderate (total bilirubin >1.5-3x ULN) or severe (total bilirubin >3x ULN): Unknown
Total bilirubin >2x ULN, or AST and/or ALT >2.5x ULN
- Hold treatment until total bilirubin to ≤2x ULN and AST/ALT to ≤2.5x ULN prior to each dose
- Omit scheduled dose if delayed >2 days between sequential infusions
Infusion-related reactions
- Interrupt infusion and institute appropriate medical management
- Administer acetaminophen, diphenhydramine, and/or methylprednisolone, if needed
- Provide supportive care measures as needed
- Consider resuming the infusion at less than or half the rate at which the reaction occurred once symptoms resolve
- Repeat the procedure above in the event of recurrence of symptoms
- Permanently discontinue gemtuzumab if a severe infusion reaction occurs or for any life-threatening infusion reaction
Other severe/life-threatening nonhematologic toxicities
- Hold treatment until reaction severity is no more than mild
- Omit scheduled dose if delayed more than 2 days between sequential infusions
Combination therapy only
-
Persistent thrombocytopenia
- If platelet count does not recover to >100 Gi/L within14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue gemtuzumab
- Do not administer gemtuzumab in the consolidation cycle
-
Persistent neutropenia
- If neutrophil count does not recover to >0.5 Gi/L within14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue gemtuzumab
- Do not administer gemtuzumab in the consolidation cycle
Dosing Considerations
Use appropriate measures to prevent tumor lysis syndrome
Patients with hyperleukocytosis (leukocyte count ≥30 Gi/L): Cytoreduction is recommended prior to gemtuzumab administration
Monitor blood cell counts frequently through resolution of cytopenias
Monitor blood cell counts and chemistries <3X/week through recovery from treatment-related toxicities
Dosage Forms & Strengths
injection, lyophilized cake powder for reconstitution
- 4.5-mg/single-dose vial
Newly Diagnosed Acute Myeloid Leukemia
Indicated for newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients aged ≥1 month
<1 month: Safety and efficacy not established
≥1 month
- Body surface area (BSA) <0.6 m2: 0.1 mg/kg IV
- BSA ≥0.6 m2: 3 mg/m2 IV
- First induction cycle: Give once in combination with standard chemotherapy
- Second induction cycle: No gemtuzumab given
- First intensification cycle: No gemtuzumab given
- Second intensification cycle: Give once in combination with standard chemotherapy; consider risks and potential benefits before giving gemtuzumab
- Third intensification cycle: No gemtuzumab given
Relapse or refractory AML
Indicated for relapsed or refractory CD33-positive AML in adults and pediatric patients ≥2 years
3 mg/m2 (up to one 4.5-mg vial) on Days 1, 4, and 7 for 1 cycle
Dosing Modifications
Veno-occlusive disease (VOD): Discontinue treatment
Renal impairment
- Mild-moderate (CrCl: 30-89 mL/min): No dosage adjustment necessary
- Severe (CrCl: 15-29 mL/min): Safety and efficacy unknown
Hepatic impairment
- Mild (total bilirubin <1.5x ULN): No dosage adjustment necessary
- Moderate (total bilirubin >1.5-3x ULN) or severe (total bilirubin >3x ULN): Unknown
Combination therapy only
-
Persistent thrombocytopenia
- Platelet count should be at least 75 Gi/L before the next cycle (induction or intensification)
-
Persistent neutropenia
- Neutrophil count should be at least 1 Gi/L before the next cycle (induction or intensification)
Total bilirubin >2x ULN, or AST and/or ALT >2.5X ULN
- Hold treatment until total bilirubin improves to ≤2x ULN and AST/ALT to ≤2.5x ULN prior to each dose
- Omit scheduled dose if delayed >2 days between sequential infusions
Infusion-related reactions
- Interrupt infusion and institute appropriate medical management
- Administer acetaminophen, diphenhydramine, and/or methylprednisolone, if needed
- Provide supportive care measures as needed
- Consider resuming the infusion at less than or half the rate at which the reaction occurred once symptoms resolve
- Repeat the procedure above in the event of recurrence of symptoms
- Permanently discontinue gemtuzumab if a severe infusion reaction occurs or for any life-threatening infusion reaction
Other severe/life-threatening nonhematologic toxicities
- Hold treatment until reaction severity is no more than mild
- Omit scheduled dose if delayed more than 2 days between sequential infusions
Dosing Considerations
Use appropriate measures to prevent tumor lysis syndrome
Patients with hyperleukocytosis (leukocyte count ≥30 Gi/L): Cytoreduction is recommended prior to gemtuzumab administration
Monitor blood cell counts frequently through resolution of cytopenias
Monitor blood cell counts and chemistries <3X/week through recovery from treatment-related toxicities
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (24)
- amisulpride
amisulpride and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- axicabtagene ciloleucel
gemtuzumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bedaquiline
bedaquiline and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
gemtuzumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
gemtuzumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- desflurane
desflurane and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- efavirenz
efavirenz and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- encorafenib
encorafenib and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
gemtuzumab and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- glasdegib
gemtuzumab and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
gemtuzumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- isoflurane
isoflurane and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
- lefamulin
lefamulin and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
gemtuzumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- mobocertinib
mobocertinib and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- oxaliplatin
oxaliplatin and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of gemtuzumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- pitolisant
gemtuzumab and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- sevoflurane
sevoflurane and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- tisagenlecleucel
gemtuzumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (112)
- acalabrutinib
acalabrutinib, gemtuzumab. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- albuterol
albuterol and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- alfuzosin
alfuzosin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- amiodarone
amiodarone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- anagrelide
anagrelide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- apomorphine
apomorphine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- arformoterol
arformoterol and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- aripiprazole
aripiprazole and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- arsenic trioxide
arsenic trioxide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- artemether
artemether and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- artemether/lumefantrine
artemether/lumefantrine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- asenapine
asenapine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- atomoxetine
atomoxetine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- azithromycin
azithromycin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ceritinib
ceritinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- chloroquine
chloroquine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- chlorpromazine
chlorpromazine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- chlorpropamide
chlorpropamide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ciprofloxacin
ciprofloxacin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- citalopram
citalopram and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- clarithromycin
clarithromycin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- clofazimine
clofazimine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- clozapine
clozapine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- crizotinib
crizotinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- dasatinib
dasatinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- degarelix
degarelix and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- dengue vaccine
gemtuzumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- deutetrabenazine
deutetrabenazine and gemtuzumab both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.
- disopyramide
disopyramide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- dofetilide
dofetilide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- dolasetron
dolasetron and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- donepezil
donepezil and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- doxepin
doxepin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- droperidol
droperidol and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of gemtuzumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- eribulin
eribulin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- erythromycin base
erythromycin base and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- escitalopram
escitalopram increases toxicity of gemtuzumab by QTc interval. Use Caution/Monitor.
- ezogabine
ezogabine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- fingolimod
fingolimod and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- flecainide
flecainide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- fluconazole
fluconazole and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- fostemsavir
gemtuzumab and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemifloxacin
gemifloxacin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- gilteritinib
gilteritinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- goserelin
goserelin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- granisetron
granisetron and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- haloperidol
haloperidol and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- histrelin
histrelin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- hydroxyzine
hydroxyzine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ibutilide
ibutilide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- iloperidone
iloperidone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- indacaterol, inhaled
indacaterol, inhaled and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- inotuzumab
inotuzumab and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- itraconazole
itraconazole and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- lapatinib
lapatinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- lenvatinib
lenvatinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- leuprolide
leuprolide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- levofloxacin
levofloxacin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- lithium
lithium and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- lopinavir
lopinavir and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- lumefantrine
lumefantrine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- methadone
methadone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- mifepristone
mifepristone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- mirtazapine
mirtazapine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- moxifloxacin
moxifloxacin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- nilotinib
nilotinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, gemtuzumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- ofloxacin
ofloxacin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- olanzapine
olanzapine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- olaparib
gemtuzumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- ondansetron
ondansetron and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- osilodrostat
osilodrostat and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- oxaliplatin
oxaliplatin will increase the level or effect of gemtuzumab by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- paliperidone
paliperidone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- panobinostat
panobinostat and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- pasireotide
pasireotide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- pazopanib
pazopanib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- pentamidine
pentamidine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- perflutren
perflutren and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- pimavanserin
pimavanserin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- pimozide
pimozide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ponesimod
ponesimod and gemtuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- procainamide
procainamide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- propafenone
propafenone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- quetiapine
quetiapine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- quinidine
quinidine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ranolazine
ranolazine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ribociclib
ribociclib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- romidepsin
romidepsin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- saquinavir
saquinavir and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- selpercatinib
selpercatinib increases toxicity of gemtuzumab by QTc interval. Use Caution/Monitor.
- siponimod
siponimod and gemtuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sorafenib
sorafenib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- sotalol
sotalol and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- sunitinib
sunitinib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- telavancin
telavancin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- thioridazine
thioridazine and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- toremifene
toremifene and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- trastuzumab
trastuzumab, gemtuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, gemtuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trazodone
trazodone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- triptorelin
triptorelin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- vandetanib
vandetanib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- vemurafenib
vemurafenib and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- voclosporin
voclosporin, gemtuzumab. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- voriconazole
voriconazole and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- ziprasidone
ziprasidone and gemtuzumab both increase QTc interval. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10% (Newly diagnosed plus Daunorubicin and Cytarabine)
Hypophosphatemia, grade 3 or higher (64%)
Hypokalemia, grade 3 or higher (57%)
Infection, grade 3 or higher (47-55%)
Hyponatremia, grade 3 or higher (44%)
Prolonged thrombocytopenia (19-35%)
Hemorrhage, grade 3 or higher (5-18%)
AST increased, grade 3 or higher (14%)
Alkaline phosphatase increased, grade 3 or higher (13%)
>10% (Monotherapy for Relapsed)
Fever, all grades (79%)
Infection, all grades (42%)
Increased AST, all grades (40%)
Bleeding, all grades (23%)
Nausea and vomiting, all grades (21%)
Constipation, all grades (21%)
Mucositis, all grades (21%)
Headache, all grades (19%)
Increased ALT, all grades (16%)
Rash, all grades (16%)
Sepsis, grade 3 (32%)
Fever, grade 3 (16%)
Rash, grade 3 (11%)
1-10% (Newly diagnosed plus Daunorubicin and Cytarabine)
ALT increased, grade 3 or higher (10%)
Blood bilirubin increased, grade 3 or higher (8%)
Prolonged neutropenia (2-3%)
Veno-occlusive disease, grade 3 or higher (2%)
1-10% (Monotherapy for Relapsed)
Hyperbilirubinemia (7%)
Pneumonia, grade 3 (7%)
Bleeding, grade 3 (7%)
Mucositis, grade 3 (4%)
Pain, grade 3 (4%)
Diarrhea, grade 3 (2%)
Headaches, grade 3 (2%)
Tachycardia, grade 3 (2%)
Lung edema, grade 3 (2%)
Warnings
Black Box Warnings
Hepatotoxicity, including severe or fatal veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of gemtuzumab
In clinical trials, the risk of VOD was higher in adults who received higher gemtuzumab doses as monotherapy, in patients with moderate/severe hepatic impairment prior to treatment, in patients treated with gemtuzumab after HSCT, and in patients who underwent hematopoietic stem cell transplantation (HSCT), after treatment with gemtuzumab
Assess ALT, AST, total bilirubin, and alkaline phosphatase prior to each gemtuzumab dose
Monitor frequently for signs/symptoms of VOD (eg, elevations in ALT, AST, total bilirubin, hepatomegaly, rapid weight gain, ascites) after treatment; monitoring only total bilirubin may not identify all patients at risk of VOD
Patients who develop abnormal liver tests: More frequent monitoring of liver tests and clinical signs/symptoms of hepatotoxicity is recommended
Patients who proceed to HSCT: Monitor liver tests frequently during the post-HSCT period, as appropriate
Manage signs or symptoms of hepatic toxicity by dose interruption or discontinuation
In patients who experience VOD, discontinue treatment and treat according to standard medical practice
Contraindications
Hypersensitivity to the active substance in gemtuzumab or any of its components or to any of the excipients
Cautions
Hepatotoxicity, including severe or fatal VOD also known as SOS, has been reported; see Black Box Warnings
For patients being treated with gemtuzumab in combination with daunorubicin and cytarabine for newly diagnosed de novo AML, when cytogenetics testing results become available consider whether the potential benefit of continuing treatment outweighs the risks for the individual patient
Animal data report gemtuzumab may cause embryo-fetal harm when administered to pregnant women; see Pregnancy
Infusion-related reactions
- Life-threatening or fatal infusion related-reactions can occur during or within 24 hr following gemtuzumab infusion
- Premedicate prior to gemtuzumab infusion
- Monitor vital signs frequently during infusion
- Interrupt infusion immediately for patients who are suspected of infusion-related reaction, especially dyspnea, bronchospasm, or hypotension
- Monitor patients during and for ≥1 hr after infusion completed or until signs/symptoms completely resolve
- Discontinue gemtuzumab use in patients who develop signs or symptoms of anaphylaxis (eg, severe respiratory symptoms or clinically significant hypotension)
Hemorrhage
- Risk of fatal or life-threatening hemorrhage owing to prolonged thrombocytopenia
- Proportion of patients with persistent thrombocytopenia increased with progressive treatment phases and was higher in patients treated with combination therapy plus gemtuzumab than with chemotherapy alone
- Assess blood cell counts prior to each gemtuzumab dose; monitor frequently after treatment until resolution of cytopenias
- Monitor patients for signs/symptoms of bleeding during treatment; manage severe bleeding, hemorrhage, or persistent thrombocytopenia by treatment interruption or discontinuation and provide appropriate medical care
QT interval prolongation
- QT interval prolongation has been observed in patients treated with other drugs containing calicheamicin
- Obtain ECG and electrolytes before initiating drug and during treatment as needed in patients with history of or predisposition for QTc prolongation, who are taking drugs known to prolong QT interval, or with electrolyte disturbances
Pregnancy
Pregnancy
Based on animal data, gemtuzumab can cause embryo-fetal harm when administered to a pregnant woman
No available data on gemtuzumab use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
In rat embryo-fetal development studies, gemtuzumab ozogamicin caused embryofetal toxicity at maternal systemic exposures that ≥0.4 times the exposure in patients at the maximum recommended dose, based on AUC
For patients who are pregnant, or become pregnant during treatment, advise the patient of the potential risk to a fetus
Verify the pregnancy status of females of reproductive potential prior to initiating treatment
Gemtuzumab may impair fertility in male or females of reproductive potential
Contraception
- Advise females of reproductive potential to avoid becoming pregnant while receiving gemtuzumab
- Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after last dose
- Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after last dose
Lactation
No data on the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production
Owing to potential for adverse reactions in breastfed infants, women should not breastfeed during treatment and for at least 1 month after the final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
CD33-directed antibody-drug conjugate (ADC); the antibody portion (hP67.6) recognizes human CD33 antigen and the small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker
Nonclinical data suggest that the anticancer activity results from ADC binding to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker
Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death
Absorption
Peak plasma concentration: 3 mg/mL (first dose); 3.6 mg/mL (second dose)
Distribution
Protein bound: 97% (N-acetyl gamma calicheamicin dimethyl hydrazide)
Vd: ~21.4 L (hP67.6 antibody)
Metabolism
N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolized, primarily via nonenzymatic reduction of the disulfide moiety
Elimination
Half-life (hP67.6 antibody): 62 hr (first dose); 90 hr (second dose)
Clearance (hP67.6 antibody): 0.35 L/hr (first dose); 0.15 L/hr (second dose)
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Cytotoxic drug; follow applicable special handling and disposal procedures
Reconstitution
- Calculate dose in mg and determine number of vials required
- Allow vials to reach ambient temperature for ~5 minutes
- Reconstitute each vial with 5 mL sterile water for injection to obtain a concentration of 1 mg/mL
- Do not shake; gently swirl vial to aid dissolution
- Inspect reconstituted solution for particulates and discoloration
- Reconstituted solution may contain small white to off-white, opaque-to-translucent, and amorphous to fiber like particles
- Contains no bacteriostatic preservatives
- Use solution immediately to further dilute or refrigerate (see Storage)
Further dilution required
- 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(s) using a syringe; discard unused reconstituted solution
- Remove a volume of 0.9% NaCl from the prefilled bag equal to the volume of product (mL) calculated above
- Add reconstituted solution to infusion container with 0.9% NaCl to make a total volume of 50 mL or 100 mL, depending on dose
- Do not shake; gently invert infusion container to mix diluted solution
Premedication
Children and adolescents
- Premediate 1 hr before with acetaminophen and diphenhydramine, then 30 min before with methylprednisolone
- Acetaminophen 15 mg/kg (not to exceed 650 mg/dose) PO AND
- Diphenhydramine 1 mg/kg (not to exceed 50 mg/dose) PO/IV AND
- Methylprednisolone 1 mg/kg PO/IV
- Additional doses of acetaminophen and diphenhydramine may be administered q4hr after the initial pretreatment dose
- Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction (eg, fever, chills, hypotension, or dyspnea) during the infusion or within 4 hr afterwards
Adults
- Premediate 1 hr before with acetaminophen and diphenhydramine, then 30 min before with methylprednisolone
- Acetaminophen 650 mg PO AND
- Diphenhydramine 50 mg PO/IV AND
- Methylprednisolone 1 mg/kg IV or an equivalent dose of an alternative corticosteroid
- Additional doses of acetaminophen and diphenhydramine may be administered q4hr after the initial pretreatment dose
- Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction (eg, fever, chills, hypotension, or dyspnea) during the infusion or within 4 hr afterwards
IV Administration
- Must use an in-line 0.2 micron polyethersulfone (PES) filter for infusion
- Protect IV bag from light using a light-blocking cover during infusion; the infusion line does not need to be protected from light
- Infuse diluted solution IV over 2 hr
- Do not mix or infuse gemtuzumab with other medicinal products
- Cytotoxic drug; follow applicable special handling and disposal procedures
Storage
Protect from light
Do not freeze
Unopened vials
- Refrigerate at 2-8°C (36-46°F) store in the original carton
Reconstituted solution
- Refrigerate at 2-8°C (36-46°F) for up to 1 hr
Diluted solution
- Store at room temperature 15-25°C (59-77°F) for up to 6 hr; the 6-hr timeframe includes the 2-hr infusion time and 1 hr, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature
- Refrigerate at 2-8°C (36-46°F) for up to 12 hr, which includes up to 1 hr in the vial following reconstitution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Mylotarg intravenous - | 4.5 mg (1 mg/mL initial conc) vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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- View the formulary and any restrictions for each plan.
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