Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/767
| Predicate | Object |
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| rdf:type | |
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Mylotarg (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:dosage |
The recommended dose of Mylotarg is 9 mg/m, infused over a 2-hour period. Physicians should consider
leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral
white blood count to below 30,000/��L prior to administration
of Mylotarg. Appropriate measures (e.g. hydration and allopurinol)
must be taken to prevent hyperuricemia. Patients should receive the
following prophylactic medications one hour before Mylotarg administration:
diphenhydramine 50 mg po and acetaminophen 650-1000 mg po;
thereafter, two additional doses of acetaminophen 650-1000 mg po,
one every 4 hoursas needed. Vital signs should be monitored during
infusion and for four hours following infusion. The recommended treatment
course with Mylotarg is a total of 2 doses with 14 days between the
doses. Full recovery from hematologic toxicities is not a requirement
for administration of the second dose. Methylprednisolone
given prior to Mylotarg infusion may ameliorate infusion-related symptoms. Hepatic Insufficiency: Patients with hepatic impairment were not included in the clinical
studies. . Renal Insufficiency: Patients with renal impairment were not included in the clinical
studies.<br/>Instructions for Reconstitution: The drug product is light sensitive and must be protected
from direct and indirect sunlight and unshielded fluorescent light
during the preparation and administration of the infusion. All preparation should take place in a biologic safety
hood with shielded fluorescent light. Reconstitute the contents
of each vial with 5 mL Sterile Water for Injection, USP, using
sterile syringes. Gently swirl each vial. Each vial should be inspected
for complete dissolution of the drug. The final concentration of the
reconstituted drug solution is 1 mg/mL. See Table 11 for storage conditions for reconstituted product.<br/>Instructions for Dilution: Prepare an admixture corresponding to 9 mg/mdose of Mylotarg by injecting the reconstituted solution
into a 100 mL 0.9% sodium chloride injection solution in either a
polyvinyl chloride (PVC) or ethylene/polypropylene copolymer (non-PVC)
IV bag covered by an ultraviolet (UV) light protector. Mylotarg should
only be diluted with 0.9% sodium chloride solution. DO NOT DILUTE
WITH ANY OTHER ELECTROLYTE SOLUTIONS or 5% DEXTROSE or MIX WITH OTHER
DRUGS. See Table 11 for storage conditions
for diluted product. The drug solution in the
vial, transfer syringe, or the IV bag may appear hazy due to normal
light scattering from the protein.<br/>Administration: DO NOT ADMINISTER AS AN
INTRAVENOUS (IV) PUSH OR BOLUS Once
the reconstituted Mylotarg is diluted into the IV bag containing normal
saline, the resulting solution should be infused over a 2-hour period.
See Table 11 for infusion times.
Mylotarg may be given peripherally or through a central line. During
the infusion, only the IV bag needs to be protected from light. An
in-line, low protein binding filter must be used for the infusion
of Mylotarg. The following filter membranes are qualified: 0.22��m
or 1.2��m polyether sulfone (PES) (Supor);
1.2��m acrylic copolymer hydrophilic filter (Versapor); 0.8��m cellulose mixed ester (acetate and nitrate) membrane;
0.2��m cellulose acetate membrane. DO NOT CO���ADMINISTER
OTHER DRUGS THROUGH THE SAME INFUSION LINE. Premedication, consisting
of acetaminophen and diphenhydramine, should be given before each
infusion to reduce the incidence of a post-infusion symptom complex
(see ADVERSE REACTIONS,
Acute Infusion-Related Events).<br/>Stability and Storage:: Prior to Reconstitution: Mylotarg should be stored refrigerated 2��to 8��C (36��to 46��F) and protected from light. After Reconstitution: Follow the instructions
for reconstitution, dilution, and administration in the section above. See Table 11 below for reconstitution, dilution, and administration storage conditions
and time intervals. Instructions for Use,
Handling and for Disposal: Individuals who have contact
with anti-cancer drugs or work in areas where these drugs are used
may be exposed to these agents through direct contact with contaminated
objects.1 Potential health effects
may be reduced by adherence to institutional procedures, published
guidelines and local regulations for preparation, administration,
transportation and disposal of hazardous drugs. There is no general
agreement that all of the procedures recommended in the guidelines
are necessary or appropriate.2,3,4 Mylotarg should be inspected visually for
particulate matter and discoloration, once in the transfer syringe.
Additionally, the diluted admixture solution should be inspected visually
for particulate matter and discoloration. Mylotarg is light sensitive
and must be protected from direct and indirect sunlight and unshielded
fluorescent light during the preparation and administration of the
infusion (using an ultraviolet [UV] protective bag over the IV bag
during infusion). All preparation should take place in a biologic
safety hood with shielded fluorescent light. Vials are for single
use. Aseptic technique must be strictly observed throughout the handling
of Mylotarg since no bacteriostatic agent or preservative is present.
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| dailymed-instance:descripti... |
Mylotarg (gemtuzumab ozogamicin
for Injection) is a chemotherapy agent composed of a recombinant humanized
IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic,
calicheamicin, isolated from fermentation of a bacterium, Micromonospora echinospora subsp. calichensis. The antibody portion of
Mylotarg binds specifically to the CD33 antigen, a sialic acid-dependent
adhesion protein found on the surface of leukemic blasts and immature
normal cells of myelomonocytic lineage, but not on normal hematopoietic
stem cells. The
anti-CD33 hP67.6 antibody is produced by mammalian cell suspension
culture using a myeloma NS0 cell line and is purified under conditions
which remove or inactivate viruses. Three separate and independent
steps in the hP67.6 antibody purification process achieves retrovirus
inactivation and removal. These include low pH treatment, DEAE-Sepharose
chromatography, and viral filtration. Mylotarg contains amino acid
sequences of which approximately 98.3% are of human origin. The constant
region and framework regions contain human sequences while the complementarity-determining
regions are derived from a murine antibody (p67.6) that binds CD33.
This antibody is linked to N-acetyl-gamma calicheamicin via a bifunctional
linker. Gemtuzumab ozogamicin has approximately 50% of the antibody
loaded with 4-6 moles calicheamicin per mole of antibody. The remaining
50% of the antibody is not linked to the calicheamicin derivative.
Gemtuzumab ozogamicin has a molecular weight of 151 to 153 kDa. Mylotarg is a sterile, white, preservative-free lyophilized
powder containing 5 mg of drug conjugate (protein equivalent)
in an amber vial. The drug product is light sensitive and must be
protected from direct and indirect sunlight and unshielded fluorescent
light during the preparation and administration of the infusion. The
inactive ingredients are: dextran 40; sucrose; sodium chloride; monobasic
and dibasic sodium phosphate.
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| dailymed-instance:clinicalP... |
General: Gemtuzumab ozogamicin binds to the CD33 antigen.
This antigen is expressed on the surface of leukemic blasts in more
than 80% of patients with acute myeloid leukemia (AML). CD33 is also
expressed on normal and leukemic myeloid colony-forming cells, including
leukemic clonogenic precursors, but it is not expressed on pluripotent
hematopoietic stem cells or on nonhematopoietic cells. Mechanism of Action: Mylotarg is directed against the CD33 antigen expressed by hematopoietic
cells. Binding of the anti-CD33 antibody portion of Mylotarg with
the CD33 antigen results in the formation of a complex that is internalized.
Upon internalization, the calicheamicin derivative is released inside
the lysosomes of the myeloid cell. The released calicheamicin derivative
binds to DNA in the minor groove resulting in DNA double strand breaks
and cell death. Gemtuzumab ozogamicin is cytotoxic
to the CD33 positive HL-60 human leukemia cell line. Gemtuzumab ozogamicin
produces significant inhibition of colony formation in cultures of
adult leukemic bone marrow cells. The cytotoxic effect on normal myeloid
precursors leads to substantial myelosuppression, but this is reversible
because pluripotent hematopoietic stem cells are spared. In preclinical
animal studies, gemtuzumab ozogamicin demonstrates antitumor effects
in the HL-60 human promyelocytic leukemia xenograft tumor in athymic
mice.<br/>Human Pharmacokinetics: After administration of the first recommended 9 mg/mdose of gemtuzumab ozogamicin, given as a 2 hour infusion,
the elimination half lives of total and unconjugated calicheamicin
were about 41 and 143 hours, respectively. After the second 9 mg/mdose, the half life of total calicheamicin was increased
to about 64 hours and the area under the concentration-time curve
(AUC) was about twice that in the first dose period. The AUC for the
unconjugated calicheamicin increased 30% after the second dose. Age,
gender, body surface area (BSA), and weight did not affect the pharmacokinetics
of Mylotarg. Patients, especially patients
previously treated with HSCT, have an underlying risk of VOD. The
AUC of total calicheamicin was correlated with additional risk of
hepatomegaly and the risk of veno-occlusive disease (VOD). There is
no evidence that reducing Mylotarg dose will reduce the underlying
risk of VOD. Metabolic studies indicate hydrolytic release of the
calicheamicin derivative from gemtuzumab ozogamicin. Many metabolites
of this derivative were found after in
vitro incubation of gemtuzumab ozogamicin in human liver
microsomes and cytosol, and in HL-60 promyelocytic leukemia cells.
Metabolic studies characterizing the possible isozymes involved in
the metabolic pathway of Mylotarg have not been performed.
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Mylotarg is contraindicated in patients with a known
hypersensitivity to gemtuzumab ozogamicin or any of its components:
anti-CD33 antibody (hP67.6), calicheamicin derivatives, or inactive
ingredients.
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| dailymed-instance:supply |
Mylotarg (gemtuzumab ozogamicin
for Injection) is supplied as a single-vial package with an amber
glass vial containing 5 mg of Mylotarg lyophilized powder. Single-unit
5 mg package: each vial contains 5 mg of Mylotarg. NDC 0008-4510-01. United States Patent Numbers: 5,079,233; 5,606,040; 5,712,374;
5,714,586; 5,739,116; 5,767,285; 5,770,710; 5,773,001; 5,877,296.
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| dailymed-instance:genericDr... | |
| dailymed-instance:boxedWarn... |
WARNINGS: Mylotarg should be administered under the supervision
of physicians experienced in the treatment of acute leukemia and in
facilities equipped to monitor and treat leukemia patients. There are no controlled trials demonstrating efficacy
and safety using Mylotarg in combination with other chemotherapeutic
agents. Therefore, Mylotarg should only be used as single agent chemotherapy
and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when Mylotarg is used at
recommended doses.<br/>HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION
REACTIONS, PULMONARY EVENTS: Mylotarg administration can result in severe hypersensitivity
reactions (including anaphylaxis), and other infusion-related reactions
which may include severe pulmonary events. Infrequently, hypersensitivity
reactions and pulmonary events have been fatal. In most cases, infusion-related
symptoms occurred during the infusion or within 24 hours of administration
of Mylotarg and resolved. Mylotarg infusion should be interrupted
for patients experiencing dyspnea or clinically significant hypotension.
Patients should be monitored until signs and symptoms completely resolve.
Discontinuation of Mylotarg treatment should be strongly considered
for patients who develop anaphylaxis, pulmonary edema, or acute respiratory
distress syndrome. Since patientswith high peripheral blast counts
may be at greater risk for pulmonary events and tumor lysis syndrome,
physicians should consider leukoreduction with hydroxyurea or leukapheresis
to reduce the peripheral white count to below 30,000/��L prior
to administration of Mylotarg.<br/>HEPATOTOXICITY:: Hepatotoxicity, including severe hepatic veno-occlusive
disease (VOD), has been reported in association with the use of Mylotarg
as a single agent, as part of a combination chemotherapy regimen,
and in patients without a history of liver disease or hematopoietic
stem cell transplant (HSCT). Patients who receive Mylotarg either
before or after HSCT, patients with underlying hepatic disease or
abnormal liver function, and patients receiving Mylotarg in combinations
with other chemotherapy are at increased risk for developing VOD,
including severe VOD. Death from liver failure and from VOD has been
reported in patients who received Mylotarg. Physicians should monitor
their patients carefully for symptoms of hepatotoxicity, particularly
VOD. These symptoms can include: rapid weight gain, right upper quadrant
pain, hepatomegaly, ascites, elevations in bilirubin and/or liver
enzymes. However, careful monitoring may not identify all patientsat risk or prevent the complications of hepatotoxicity.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:possibleD... |
diseasome-diseases:1173,
diseasome-diseases:1693,
diseasome-diseases:1694,
diseasome-diseases:1696,
diseasome-diseases:181,
diseasome-diseases:2789,
diseasome-diseases:3004,
diseasome-diseases:3020,
diseasome-diseases:3365,
diseasome-diseases:4136,
diseasome-diseases:602,
diseasome-diseases:698,
diseasome-diseases:701,
diseasome-diseases:833
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| dailymed-instance:precautio... |
DO NOT ADMINISTER AS AN
INTRAVENOUS PUSH OR BOLUS<br/>General: Treatment by Experienced
Physicians: Mylotarg should be administered under the supervision
of physicians experienced in the treatment of acute leukemia and in
facilities equipped to monitor and treat leukemia patients. Laboratory Monitoring: Electrolytes, tests of hepatic function, complete blood counts (CBCs)
and platelet counts should be monitored during Mylotarg therapy. Drug Interactions: There have been no formal drug-interaction studies performed with
Mylotarg. The potential for drug-drug interaction with drugs affected
by cytochrome P450 enzymes may not be ruled out. Laboratory Test Interactions: Mylotarg is not known to interfere with any routine diagnostic tests. Carcinogenesis, Mutagenesis,
Impairment of Fertility: No long-term studies in animals
have been performed to evaluate the carcinogenic potential of Mylotarg.
Gemtuzumab ozogamicin was clastogenic in the mouse in vivo micronucleus test. This positive
result is consistent with the known ability of calicheamicin to cause
double-stranded breaks in DNA. Gemtuzumab ozogamicin adversely affected
male, but not female, fertility in rats. Following daily administration
of gemtuzumab ozogamicin to male rats for 28 days at doses of 0.02 to 0.16 mg/kg/day
(approximately 0.01 to 0.11 times the human dose ona mg/mbasis) gemtuzumab ozogamicin caused: decreased fertility rates,
epididymal sperm counts, and sperm motility; increased incidence of
sperm abnormalities; and microscopic evidence of decreased spermatogonia
and spermatocyte count. These findings did not resolve following a
9-week recovery period. Pregnancy Category D: See WARNINGS section. Nursing Mothers: It is not known if Mylotarg is excreted in human milk. Because many
drugs, including immunoglobulins, are excreted in human milk, and
because of the potential for serious adverse reactions in nursing
infants from Mylotarg, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance
of the drug to the mother. Pediatric Use: The safety and effectiveness of Mylotarg in pediatric patients have
not been established. Use in Patients with Renal
Impairment: Patients with renal impairment were not studied.
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| dailymed-instance:overdosag... |
No cases of overdose with Mylotarg were reported
in clinical experience. Single doses higher than 9 mg/min adults were not tested. When a single dose of Mylotarg was administered
to animals, mortality was observed in rats at the dose of 2 mg/kg
(approximately 1.3-times the recommended human dose on a mg/mbasis), and in male monkeys at the dose of 4.5 mg/kg
(approximately 6-times the recommended human dose on a mg/mbasis). Signs and Symptoms: Signs of overdose with Mylotarg are unknown. Recommended Treatment: General supportive measures should be followed in case of overdose.
Blood pressure and blood counts should be carefully monitored. Gemtuzumab
ozogamicin is not dialyzable.
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| dailymed-instance:genericMe... |
gemtuzumab ozogamicin
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| dailymed-instance:fullName |
Mylotarg (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
Mylotarg has been administered to 277 patients with
relapsed AML at 9 mg/m. Mylotarg was generally given
as two intravenous infusions separated by 14 days. Acute Infusion-Related
Events (Table 3) Fever and chills were commonly reported despite
prophylactic treatment with acetaminophen and antihistamines . Generally, these symptoms occurred at the end of the 2
hour infusion and resolved after 2 to 4 hours with supportive therapy
including acetaminophen, diphenhydramine, and intravenous fluids.
These events all occurred on the same day as gemtuzumab ozogamicin
infusion. Fewer infusion-related events were observed after the second
dose. Methylprednisolone given prior to Mylotarg infusion may ameliorate
infusion-related symptoms. Antibody Formation: Antibodies to gemtuzumab ozogamicin were not detected in any of
the 277 patients, including the 20 patients who received more than
1 course of study drug, in the Phase 2 clinical studies. Two patients
in a Phase 1 study developed antibody titers against the calicheamicin/calicheamicin-linker
portion of gemtuzumab ozogamicin after three doses. One patient experienced
transient fever, hypotension and dyspnea; the other patient had no
clinicalsymptoms. No patient developed antibody responses to the
hP67.6 antibody portion of Mylotarg. Myelosuppression: Severe myelosuppression is the major toxicity associated with Mylotarg. Neutropenia: During
the treatment phase, 267/272 (98%) patients experienced Grade 3 or
Grade 4 neutropenia. For all patients, the median times to ANC
recovery at 500/��L for the CR and CRp patients were 40.0 and
43.0 days, respectively. Anemia, Thrombocytopenia: During the treatment phase, 143/276 (52%) patients experienced
Grade 3 or Grade 4 anemia and 272/276 (99%) patients experienced Grade
3 or Grade 4 thrombocytopenia. A summary of the platelet recovery
for responding patients is provided in Table
4. Infection: During
the treatment phase, 84/277 (30%) patients experienced Grade 3 or
Grade 4 infections, including opportunistic infections. The most frequent
Grade 3 or Grade 4 infection-related treatment-emergent adverse events
(TEAEs) were sepsis (17%), pneumonia (8%), shock (4%), infection (3%),
stomatitis (2%), and herpes simplex (2%). Bleeding: During
the treatment phase, 36/277 (13%) patients experienced Grade 3 or
Grade 4 bleeding. The most common bleeding events for all patients
were epistaxis (3%), cerebral hemorrhage (2%), intracranial hemorrhage
(1%), melena (1%), petechiae (1%), hematuria (1%), and disseminated
intravascular coagulation (1%). A greater proportion
of NR patients (15%) experienced NCI grade 3 or 4 bleeding events
compared with OR patients (7%). Among CR patients, 1 grade 3 bleeding
event, epistaxis, was experienced. Bleeding events occurred in 1/35
CR patients and 4/36 CRp patients. Transfusions: During the treatment phase, more transfusions were required in the
NR and CRp patients compared with the CRs (Table
5): Mucositis: A
total of 69/277 (25%) patients were reported to have a TEAE consistent
with oral mucositis or stomatitis. During the treatment phase, 9/277
(3%) patients experienced Grade 3 or 4 stomatitis/mucositis after
the first dose. Hepatotoxicity: In clinical studies, 80/274 (29%) patients experienced Grade 3 or
Grade 4 hyperbilirubinemia. 26/274 (9%) of patients experienced Grade
3 or Grade 4 abnormalities in levels of ALT, and 49/274 (18%) patients
experienced Grade 3 or Grade 4 abnormalities in levels of AST. One
patient died with liver failure in the setting of tumor lysis syndrome
and multisystem organ failure 22 days after treatment. Another patient
died after an episode of persistent jaundice and hepatosplenomegaly
156 days after treatment. Ascites, an event that can be associated
with liver damage, was observed in 8 patients. Abnormalities
of liverfunction were often transient and reversible. Skin: Pruritus
was reported in 18/277 (6%) patients, while rash occurred in
51/277 (18%) patients. Cutaneous herpes simplex was reported
in 59/277 (21%) patients. No patient experienced alopecia.<br/>Early Mortality in Clinical Studies: The overall mortality rate within 28 days of
last dose was 16% (44/277). The mortality rate was 14% (17/120)
for patients who were<60 years old, and 17% (27/157)
for patients who were���60 years old. Retreatment Events: Twenty (20) patients received additional courses of Mylotarg in
the studies. One (1) patient received a total of 4 courses of
treatment. Dose Relationship for Adverse
Events: Dose-relationship data were generated from a small
dose-escalation study. The most common clinical adverse event observed
in this study was an infusion-related symptom complex of fever and
chills. In general, the severity of fever, but not chills, increased
as the dose level increased. Only one dose level of Mylotarg was studied
in the Phase 2 clinical trials in relapsed AML. Treatment-Emergent Adverse
Events (TEAE): TEAEs (Grades 1-4) that occurred in���10% of the patients regardless of causality are listed in Table 7. TEAEs of NCI grade 3 or 4 severity that occurred
in part I of studies with an incidence of���10% in
at least 1 age subgroup, are presented in Table
8. There were considered to be no clinically important
differences in TEAEs between patients<60 years of age
and those patients���60. There
were considered to be no clinically important differences in TEAEs
between female and male patients.<br/>Other Clinical Experience:: In postmarketing experience and other clinical trials,
additional cases of VOD have been reported, some in association with
the use of other chemotherapeutic agents, underlying hepatic disease/abnormal
liver function, or a history of prior or subsequent HSCT. Renal failure,
renal failure secondary to TLS, renal impairment, hypersensitivity
reactions (including bradycardia), anaphylaxis, pulmonary events,
pulmonary hemorrhage, gastrointestinal hemorrhage, Budd Chiari Syndrome,
portal vein thrombosis, and neutropenic sepsis have alsobeen reported
in association with the use of Mylotarg. . Observational Study: A prospective postmarketing
registry study is being conducted to assess the safety of Mylotarg
under conditions of routine clinical practice. The primary objectives
is to estimate the incidence of hepatic veno-occlusive disease (VOD)
among patients treated with Mylotarg. In an interim analysis of 225
patients, SAEs are presented according to an���events of special
interest���(ESI) classification comprised of hepatic (including
VOD), renal, infusion-related, pulmonary, and hypersensitivity events
(Table 10). There were 816 SAEs reported in 197/225 patients (87.6% of all patients).
Of the SAEs, 159 were also ESIs reported in 64 (28.4%) patients. The
percentage of patients experiencing a serious ESI was 9.8% (hepatic),
6.7% (renal), 8.0% (infusion-related), and 12.9% (pulmonary). Among
the 816 SAEs, 225 (27.6%) were fatal events (multiple concurrent fatal
events could be reportedfor a patient) reported in 134 (59.6%) patients.
Using the ESI classification, there were 30 fatal ESIs reported in
19 (8.4%) patients. In this registry, the incidence
of VOD based on an independent review is 10.2% (23/225). Among patients
with HSCT before or after Mylotarg infusion the incidence of VOD was
14.9% (10/67 patients). For patients without HSCT the VOD incidence
was 8.2% (12/146 patients). HSCT status was not reported in 8.3%
(19/225) of patients.
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| dailymed-instance:warning |
Mylotarg should be administered under the supervision
of physicians experienced in the treatment of acute leukemia and in
facilities equipped to monitor and treat leukemia patients. There are no controlled trials demonstrating efficacy
and safety using Mylotarg in combination with other chemotherapeutic
agents. Therefore, Mylotarg should only be used as single agent chemotherapy
and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when Mylotarg is used at
recommended doses.<br/>HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION
REACTIONS, PULMONARY EVENTS: Mylotarg administration can result in severe hypersensitivity
reactions (including anaphylaxis), and other infusion-related reactions
which may include severe pulmonary events. Infrequently, hypersensitivity
reactions and pulmonary events have been fatal. In most cases, infusion-related
symptoms occurred during the infusion or within 24 hours of administration
of Mylotarg and resolved. Mylotarg infusion should be interrupted
for patients experiencing dyspnea or clinically significant hypotension.
Patients should be monitored until signs and symptoms completely resolve.
Discontinuation of Mylotarg treatment should be strongly considered
for patients who develop anaphylaxis, pulmonary edema, or acute respiratory
distress syndrome. Since patientswith high peripheral blast counts
may be at greater risk for pulmonary events and tumor lysis syndrome,
physicians should consider leukoreduction with hydroxyurea or leukapheresis
to reduce the peripheral white count to below 30,000/��L prior
to administration of Mylotarg.<br/>HEPATOTOXICITY:: Hepatotoxicity, including severe hepatic veno-occlusive
disease (VOD), has been reported in association with the use of Mylotarg
as a single agent, as part of a combination chemotherapy regimen,
and in patients without a history of liver disease or hematopoietic
stem cell transplant (HSCT). Patients who receive Mylotarg either
before or after HSCT, patients with underlying hepatic disease or
abnormal liver function, and patients receiving Mylotarg in combinations
with other chemotherapy are at increased risk for developing VOD,
including severe VOD. Death from liver failure and from VOD has been
reported in patients who received Mylotarg. Physicians should monitor
their patients carefully for symptoms of hepatotoxicity, particularly
VOD. These symptoms can include: rapid weight gain, right upper quadrant
pain, hepatomegaly, ascites, elevations in bilirubin and/or liver
enzymes. However, careful monitoring may not identify all patientsat risk or prevent the complications of hepatotoxicity.
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| dailymed-instance:indicatio... |
Mylotarg is indicated for the treatment of patients
with CD33 positive acute myeloid leukemia in first relapse who are
60 years of age or older and who are not considered candidates for
other cytotoxic chemotherapy. The safety and efficacy of Mylotarg
in patients with poor performance status and organ dysfunction has
not been established. The effectiveness of
Mylotarg is based on OR rates . There are
no controlled trials demonstrating a clinical benefit, such as improvement
in disease-related symptoms or increased survival, compared to any
other treatment.
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| dailymed-instance:name |
Mylotarg
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