Reviews Mylotarg


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Mylotarg Drug Description
Mylotarg®
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit www.wyeth.com
or call our medical communications department toll-free at 1-800-934-5556.

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.
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 patients with 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/µL prior to administration of Mylotarg. (See
WARNINGS.)
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 patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION



What are the possible side effects of gemtuzumab (Mylotarg)?

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
difficulty breathing, shortness of breath,...
Read All Potential Side Effects for Mylotarg »




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.Last reviewed on RxList: 6/24/2008




Mylotarg Drug Description
Mylotarg®
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit www.wyeth.com
or call our medical communications department toll-free at 1-800-934-5556.

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.
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 patients with 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/µL prior to administration of Mylotarg. (See
WARNINGS.)
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 patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION



What are the possible side effects of gemtuzumab (Mylotarg)?

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
difficulty breathing, shortness of breath,...
Read All Potential Side Effects for Mylotarg »




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.Last reviewed on RxList: 6/24/2008




Mylotarg Drug Description
Mylotarg®
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit www.wyeth.com
or call our medical communications department toll-free at 1-800-934-5556.

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.
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 patients with 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/µL prior to administration of Mylotarg. (See
WARNINGS.)
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 patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION



What are the possible side effects of gemtuzumab (Mylotarg)?

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
difficulty breathing, shortness of breath,...
Read All Potential Side Effects for Mylotarg »




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.Last reviewed on RxList: 6/24/2008




Mylotarg Drug Description
Mylotarg®
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit www.wyeth.com
or call our medical communications department toll-free at 1-800-934-5556.

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.
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 patients with 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/µL prior to administration of Mylotarg. (See
WARNINGS.)
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 patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION



What are the possible side effects of gemtuzumab (Mylotarg)?

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
difficulty breathing, shortness of breath,...
Read All Potential Side Effects for Mylotarg »




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.Last reviewed on RxList: 6/24/2008




Mylotarg Drug Description
Mylotarg®
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit www.wyeth.com
or call our medical communications department toll-free at 1-800-934-5556.

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.
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 patients with 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/µL prior to administration of Mylotarg. (See
WARNINGS.)
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 patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION



What are the possible side effects of gemtuzumab (Mylotarg)?

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
difficulty breathing, shortness of breath,...
Read All Potential Side Effects for Mylotarg »




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.Last reviewed on RxList: 6/24/2008





Other reviews about Mylotarg on wordpress

The Clinic
  by cataldo11
Sitting at the clinic now.  What is the clinic?  It is the "state of the art" out-patient clinic for the Blood and Marrow Group of GA, Patrick's oncologist.  […]


FDA MedWatch - Mylotarg (gemtuzumab ozogamicin): Market Withdrawal-Drug failed to demonstrate clinical benefit to patients enrolled in trials
  by irbtipoftheweek
ISSUE: FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to […]


Gemtuzumab Ozogamicin [Mylotarg]: Market Withdrawal
  by thassodotcom
June 21, 2010 -  FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate […]


Pfizer Withdraws Mylotarg Drug After Deaths, No Proven Benefit
  by healthcare and consumer research pro
THE FDA GOT THIS APPROVAL WRONG Pfizer Inc. will withdraw its blood cancer drug Mylotarg after 10 years on the U.S. market because studies didn’t prove it works […]


Mylotarg removed from market --Expensive targeted agent didn't improve survival
  by medicynic
This drug was approved in 2000 through the FDA's expedited release program. For what it's worth, it was not approved for use in Europe because of several studies […]


Cancer Drug Kills Four Times More than No Treatment at All
  by Grace
Posted By Dr. Mercola | July 06 2010 Drugmaker Pfizer is pulling Mylotarg, a decade-old leukemia medicine, off the U.S. market after a study found a higher death rate and no […]


FDA: Pfizer leukemia drug increased fatality rates
  by primewords
By James R Owens Pfizer Inc. is at it again. Remember last year they were fined $2.3 billion in a health care fraud case for illegally promoting uses of […]


Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You
  by The Global Realm
Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You By Martha Rosenberg AlterNet July 10, 2010 The drug company Pfizer is best known for Lipitor, a drug that […]


Pfizer: The Drug Giant That Makes Money from Drugs That Can Kill You
  by Suzan
From Alternet By Martha Rosenberg, AlterNet Posted on July 10, 2010, Printed on July 11, 2010 http://www.alternet.org/story/147467/ The drug company Pfizer is best known for Lipitor, a drug that brings […]


Medicine by Averages
  by Beth
Reason Pharm discusses the problem of practicing medicine by averages...though the same arguments are also relevant for restricting care by comparative effectiveness, or practice protocols, or any number […]



Other reviews about Mylotarg on web:

Learn about the prescription medication Mylotarg (Gemtuzumab Ozogamicin for Injection), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Mylotarg (Gemtuzumab Ozogamicin for Injection) Drug Information ...


Gemtuzumab ozogamicin (marketed by Wyeth as Mylotarg) is a monoclonal antibody used to treat acute myelogenous leukemia. It is a monoclonal antibody to CD33 linked to a cytotoxic agent ... Gemtuzumab ozogamicin - Wikipedia, the free encyclopedia


All about Mylotarg. View complete and up to date Mylotarg information - part of the Drugs.com trusted medication database. Mylotarg Facts and Comparisons at Drugs.com


Accurate, FDA approved Mylotarg information for healthcare professionals and patients - brought to you by Drugs.com. Mylotarg Official FDA information, side effects and uses.


To report an adverse event or to speak to a member of Pfizer Medical Information, please call 1.800.438.1985 Health Care Professionals Log In


Mylotarg is the trade name for Gemtuzumab Ozogamicin. Mylotarg is a monoclonal antibody. Mylotarg, Gemtuzumab Ozogamicin - Chemotherapy Drugs, Chemo Drug ...


Consumer information and patient comments on perscription drugs ... We currently have info on 350 drugs Users have posted 4369 comments Mylotarg - The Internet Drug Database


Consumer information about the medication GEMTUZUMAB OZOGAMICIN - INJECTABLE (Mylotarg), includes side effects, drug interactions, recommended dosages, and storage information. GEMTUZUMAB OZOGAMICIN - INJECTABLE (Mylotarg) side effects ...


1 Mylotarg ® (gemtuzumab ozogamicin for Injection) for intravenous use only Rx only WARNINGS Mylotarg should be administered under the supervision of physicians experienced in the ... Mylotarg® (gemtuzumab ozogamicin for Injection) for intravenous ...


What is Mylotarg (Gemtuzumab)? Gemtuzumab is a cancer medication. Gemtuzumab interferes with the growth of cancer cells and slows their growth and spread in the body. Mylotarg - Drugs & Treatments - Revolution Health





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Paxil-CR Drug Description PAXIL CR® (paroxetine hydrochloride) Controlled-Release Tablets Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality)...
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Reviews Hydroxocobalamin for Injection

Cyanokit Drug Description Cyanokit® (hydroxocobalamin) for Injection 5 g for Intravenous Infusion DRUG DESCRIPTION What are the possible side effects of hydroxocobalamin (Cyanokit)? Get emergency medical help if you have any...
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Reviews Cortisporin Cream

Cortisporin Cream Drug Description CORTISPORIN® Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate) Cream, USP DRUG DESCRIPTION CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream,...
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Reviews Synthetic conjugated estrogens

Cenestin Drug Description Cenestin® (synthetic conjugated estrogens, A) Tablets ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,...
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