Reviews Lumizyme


No reviews yet.

Lumizyme Drug Description
LUMIZYME
(alglucosidase alfa) for Injection, for Intravenous Use

WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune
mediated reactions have been observed in some patients during LUMIZYME™ infusions.
Therefore, appropriate medical support should be readily available when LUMIZYME
is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease
patients less than 8 years of age, LUMIZYME is available only through a restricted
distribution program called the LUMIZYME ACE ProgramSM. Only prescribers and
healthcare facilities enrolled in the program may prescribe, dispense or administer
LUMIZYME. LUMIZYME may be administered only to patients who are enrolled in
and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME
ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase
(GAA), encoded by the most predominant of nine observed haplotypes of this gene.
LUMIZYME is produced by recombinant DNA technology in a Chinese hamster ovary
cell line. The LUMIZYME manufacturing process differs from that for MYOZYME,
resulting in differences in some product attributes. Alglucosidase alfa degrades
glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic
linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons
for the polypeptide chain, and a total mass of approximately 109,000 daltons,
including carbohydrates. Alglucosidase alfa has a specific activity of 3 to
5 Units/mg (one unit is defined as that amount of activity that results in the
hydrolysis of 1 micromole of synthetic substrate per minute under specified
assay conditions). LUMIZYME is intended for intravenous infusion. It is supplied
as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for
reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial
contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80,
9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic
monohydrate. Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase
alfa. LUMIZYME does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010




Lumizyme Drug Description
LUMIZYME
(alglucosidase alfa) for Injection, for Intravenous Use

WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune
mediated reactions have been observed in some patients during LUMIZYME™ infusions.
Therefore, appropriate medical support should be readily available when LUMIZYME
is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease
patients less than 8 years of age, LUMIZYME is available only through a restricted
distribution program called the LUMIZYME ACE ProgramSM. Only prescribers and
healthcare facilities enrolled in the program may prescribe, dispense or administer
LUMIZYME. LUMIZYME may be administered only to patients who are enrolled in
and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME
ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase
(GAA), encoded by the most predominant of nine observed haplotypes of this gene.
LUMIZYME is produced by recombinant DNA technology in a Chinese hamster ovary
cell line. The LUMIZYME manufacturing process differs from that for MYOZYME,
resulting in differences in some product attributes. Alglucosidase alfa degrades
glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic
linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons
for the polypeptide chain, and a total mass of approximately 109,000 daltons,
including carbohydrates. Alglucosidase alfa has a specific activity of 3 to
5 Units/mg (one unit is defined as that amount of activity that results in the
hydrolysis of 1 micromole of synthetic substrate per minute under specified
assay conditions). LUMIZYME is intended for intravenous infusion. It is supplied
as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for
reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial
contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80,
9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic
monohydrate. Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase
alfa. LUMIZYME does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010




Lumizyme Drug Description
LUMIZYME
(alglucosidase alfa) for Injection, for Intravenous Use

WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune
mediated reactions have been observed in some patients during LUMIZYME™ infusions.
Therefore, appropriate medical support should be readily available when LUMIZYME
is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease
patients less than 8 years of age, LUMIZYME is available only through a restricted
distribution program called the LUMIZYME ACE ProgramSM. Only prescribers and
healthcare facilities enrolled in the program may prescribe, dispense or administer
LUMIZYME. LUMIZYME may be administered only to patients who are enrolled in
and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME
ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase
(GAA), encoded by the most predominant of nine observed haplotypes of this gene.
LUMIZYME is produced by recombinant DNA technology in a Chinese hamster ovary
cell line. The LUMIZYME manufacturing process differs from that for MYOZYME,
resulting in differences in some product attributes. Alglucosidase alfa degrades
glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic
linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons
for the polypeptide chain, and a total mass of approximately 109,000 daltons,
including carbohydrates. Alglucosidase alfa has a specific activity of 3 to
5 Units/mg (one unit is defined as that amount of activity that results in the
hydrolysis of 1 micromole of synthetic substrate per minute under specified
assay conditions). LUMIZYME is intended for intravenous infusion. It is supplied
as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for
reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial
contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80,
9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic
monohydrate. Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase
alfa. LUMIZYME does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010




Lumizyme Drug Description
LUMIZYME
(alglucosidase alfa) for Injection, for Intravenous Use

WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune
mediated reactions have been observed in some patients during LUMIZYME™ infusions.
Therefore, appropriate medical support should be readily available when LUMIZYME
is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease
patients less than 8 years of age, LUMIZYME is available only through a restricted
distribution program called the LUMIZYME ACE ProgramSM. Only prescribers and
healthcare facilities enrolled in the program may prescribe, dispense or administer
LUMIZYME. LUMIZYME may be administered only to patients who are enrolled in
and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME
ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase
(GAA), encoded by the most predominant of nine observed haplotypes of this gene.
LUMIZYME is produced by recombinant DNA technology in a Chinese hamster ovary
cell line. The LUMIZYME manufacturing process differs from that for MYOZYME,
resulting in differences in some product attributes. Alglucosidase alfa degrades
glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic
linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons
for the polypeptide chain, and a total mass of approximately 109,000 daltons,
including carbohydrates. Alglucosidase alfa has a specific activity of 3 to
5 Units/mg (one unit is defined as that amount of activity that results in the
hydrolysis of 1 micromole of synthetic substrate per minute under specified
assay conditions). LUMIZYME is intended for intravenous infusion. It is supplied
as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for
reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial
contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80,
9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic
monohydrate. Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase
alfa. LUMIZYME does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010




Lumizyme Drug Description
LUMIZYME
(alglucosidase alfa) for Injection, for Intravenous Use

WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune
mediated reactions have been observed in some patients during LUMIZYME™ infusions.
Therefore, appropriate medical support should be readily available when LUMIZYME
is administered [see WARNINGS AND PRECAUTIONS].
Because of the potential risk of rapid disease progression in Pompe disease
patients less than 8 years of age, LUMIZYME is available only through a restricted
distribution program called the LUMIZYME ACE ProgramSM. Only prescribers and
healthcare facilities enrolled in the program may prescribe, dispense or administer
LUMIZYME. LUMIZYME may be administered only to patients who are enrolled in
and meet all the conditions of the LUMIZYME ACE Program. To enroll in the LUMIZYME
ACE Program call 1-800-745-4447 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION
LUMIZYME (alglucosidase alfa) consists of the human enzyme acid α-glucosidase
(GAA), encoded by the most predominant of nine observed haplotypes of this gene.
LUMIZYME is produced by recombinant DNA technology in a Chinese hamster ovary
cell line. The LUMIZYME manufacturing process differs from that for MYOZYME,
resulting in differences in some product attributes. Alglucosidase alfa degrades
glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6 glycosidic
linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons
for the polypeptide chain, and a total mass of approximately 109,000 daltons,
including carbohydrates. Alglucosidase alfa has a specific activity of 3 to
5 Units/mg (one unit is defined as that amount of activity that results in the
hydrolysis of 1 micromole of synthetic substrate per minute under specified
assay conditions). LUMIZYME is intended for intravenous infusion. It is supplied
as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for
reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial
contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80,
9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic
monohydrate. Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase
alfa. LUMIZYME does not contain preservatives; each vial is for single use only.
Last reviewed on RxList: 6/18/2010





Other reviews about Lumizyme on wordpress

Biotech Trader Alerts (DNDN, DNA, GENZ, PDLI)
  by 247wallst
We are seeing unusual trading activity so far this morning in shares of Dendreon Corp. (NASDAQ: DNDN), Genentech, Inc. (NYSE: DNA), Genzyme Corp. (NASDAQ: GENZ), and PDL BioPharma, […]


Genzyme Shows Biotech Drugs Are Tough to Reproduce
  by bloghealthblog
Genzyme’s shares were off some 7% today in the wake of the company’s continued troubles getting FDA approval to expand production of its own biotech drug. The […]


replicating biology not so generic
  by Jeffrey Seguritan
"The Administration will accelerate access to make affordable generic biologic drugs available through the establishment of a workable regulatory, scientific, and legal pathway for generic versions of biologic […]


Pompe Research
  by Auntie Mysh
Research is continuing in many different directions: Improved ERT, Gene therapy and pharmacological chaperones. Studies are underway to investigate the performance of Myozyme over the long-term and also […]


Lumizyme Approved for Non-Infantile Pompe Disease
  by nalonsospc
TUESDAY, May 25 (HealthDay News) -- Lumizyme (alglucosidase alfa) has been approved by the U.S. Food and Drug Administration to treat late-onset Pompe disease, a genetic disorder that […]


Opportunity Knocks: Turning Around 3 Large Biotechs (AMGN, BIIB, GENZ)
  by Administrator
Biotech is the land of promise for emerging players.  It is also the land of stagnation for well established and sturdy giants.  Amgen, Inc. (NASDAQ: AMGN), Biogen Idec […]


The First Lumizyme Infusion
  by purplelv93
June 16, 2010. Today I had my 7th infusion. What made this infusion different is that it was the first official Lumizyme infusion since Genzyme received their FDA […]


Can Genzyme finally turning the corner?
  by Jeffrey Clark
[vodpod id=ExternalVideo.950288&w=425&h=350&fv=] In what has been described as a humbled tone, Genzyme CEO Henri Termeer assured investors at this week’s meeting that the company would do everything possible […]


The Suite Life
  by purplelv93
  On Monday, I received my Lumizyme infusion at the new site Genzyme arranged in Orlando. This site is technically closer to where I am than the University of […]


"Extraordinary Measures" - A Movie about Pompe's Disease
  by biochemistryquestions
  Extraordinary Measures is a 2010 film about parents trying to save their children affected by Pompe Disease, A Glycogen Storage Disease produced by mutations on a gen that […]



Other reviews about Lumizyme on web:

Lumizyme (alglucosidase alfa) is a new drug in development for the treatment of Pompe disease. Lumizyme information includes news, clinical trial results and side effects. Genzyme Receives Complete Response Letter from FDA on Lumizyme ...


Now approved for the treatment of late-onset Pompe disease. On May 24, 2010 the Food and Drug Administration granted marketing approval for Lumizyme™ (alglucosidase alfa). Lumizyme.com | Homepage


Lumizyme (alglucosidase alfa) is a new drug in development for the treatment of Pompe disease. Lumizyme information includes news, clinical trial results and side effects. Genzyme Submits All Information Requested by FDA for Lumizyme


Alglucosidase alfa (Lumizyme, Myozyme, Genzyme) is an enzyme replacement therapy (ERT) orphan drug for treatment of Pompe disease (Glycogen storage disease type II), a rare ... Alglucosidase alfa - Wikipedia, the free encyclopedia


Genzyme will launch the same biologic under two different names in the US after the FDA decided the drug produced at 2000L was considerably different to the 160L version. Myozyme becomes Lumizyme after biologics scale-up


Learn about the prescription medication Lumizyme (Alglucosidase Alfa), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling. Lumizyme (Alglucosidase Alfa) Drug Information: Uses, Side Effects ...


NEW YORK (Reuters) - U.S. regulators have declined to approve Genzyme Corp's new Lumizyme treatment for Pompe disease, a setback the drugmaker said could delay its approval for six ... Genzyme's Lumizyme faces delay after FDA rejection | Reuters


Tuesday, March 3, 2009. FDA rejects Genzyme’s Lumizyme By Mass High Tech staff FDA rejects Genzyme’s Lumizyme - Mass High Tech Business News


Lumizyme ACE Program. Lumizyme is available only through a restricted distribution program called the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program. Lumizyme.com | Lumizyme ACE Program


Genzyme released its Q3/09 financial results last week, with non-GAAP earnings coming up short of both mine and the markets expectations. Non-GAAP earnings were reported at $0 ... Genzyme: Focusing on Lumizyme Approval -- Seeking Alpha





Featured Reviews

Reviews Onglyza

Onglyza Drug Description ONGLYZA (saxagliptin) Tablets DRUG DESCRIPTION Saxagliptin is an orally-active inhibitor of the DPP4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]de...
Read More  |  Review This
Reviews Armour Thyroid

Armour Thyroid Drug Description Armour® Thyroid (thyroid) Tablets, USP DRUG DESCRIPTION What are the possible side effects of thyroid (Armour Thyroid, Westhroid)? If you experience any of the following uncommon but serious...
Read More  |  Review This
Reviews Saxagliptin Tablets

Onglyza Drug Description ONGLYZA (saxagliptin) Tablets DRUG DESCRIPTION Saxagliptin is an orally-active inhibitor of the DPP4 enzyme. Saxagliptin monohydrate is described chemically as (1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxytricyclo[3.3.1.13,7]de...
Read More  |  Review This
Reviews Enalaprilat Injection

Enalaprilat Injection Drug Description ENALAPRILAT Injection USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy...
Read More  |  Review This
Reviews Protriptyline Hydrochloride Tablet

Vivactil Drug Description VIVACTIL (protriptyline hydrochloride) Tablet, Film Coated Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in...
Read More  |  Review This
Recent News
59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....