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ALGLUCOSIDASE ALFA
Overview
What is Myozyme?
MYOZYME (alglucosidase alfa), a lysosomal glycogen-specific enzyme, consists of the human enzyme acid
α-glucosidase (GAA), encoded by the most predominant of nine
observed haplotypes of this gene. MYOZYME is produced by
recombinant DNA technology in a Chinese hamster ovary cell
line. The MYOZYME manufacturing process differs from that for LUMIZYME, 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 110 kilo Daltons, including carbohydrates.
Alglucosidase alfa has a specific activity of 3 to 5 U/mg (one unit is
defined as that amount of activity that results in the hydrolysis of 1
µmole of synthetic substrate per minute under the specified
assay conditions). MYOZYME 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 5.0 mg/mL alglucosidase alfa.
MYOZYME does not contain preservatives; each vial is for single use
only.
What does Myozyme look like?
What are the available doses of Myozyme?
MYOZYME is supplied as a sterile, nonpyrogenic, white to
off-white, lyophilized cake or powder for reconstitution with Sterile
Water for Injection, USP to yield a concentration of 5 mg/mL; and then
further diluted with 0.9% Sodium Chloride for Injection, USP for
intravenous infusion.
Single-use vials are available in 50 mg dosage only.
What should I talk to my health care provider before I take Myozyme?
How should I use Myozyme?
MYOZYME (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated
for use in patients with Pompe disease (GAA deficiency). MYOZYME has been shown to improve ventilator-free survival in patients
with infantile-onset Pompe disease as compared to an untreated
historical control, whereas use of MYOZYME in patients with other forms
of Pompe disease has not been adequately studied to assure safety and
efficacy
.
The recommended dosage regimen of MYOZYME is 20 mg/kg
body weight administered every 2 weeks as an intravenous
infusion.
What interacts with Myozyme?
Sorry No Records found
What are the warnings of Myozyme?
Sorry No Records found
What are the precautions of Myozyme?
Sorry No Records found
What are the side effects of Myozyme?
Sorry No records found
What should I look out for while using Myozyme?
None.
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Warnings and Precautions (5.1)
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Warnings
and Precautions (5.3)
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What might happen if I take too much Myozyme?
There have been no reports of overdose with MYOZYME. In
clinical trials, patients received doses up to 40 mg/kg of body
weight.
How should I store and handle Myozyme?
Sorry No Records found
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pompe disease (glycogen storage disease type II, GSD II,
glycogenosis type II, acid maltase deficiency) is an inherited
disorder of glycogen metabolism caused by the absence or marked
deficiency of the lysosomal enzyme GAA.
MYOZYME provides an exogenous source of GAA.
Binding to mannose-6-phosphate receptors on the cell surface has
been shown to occur via carbohydrate groups on the GAA molecule,
after which it is internalized and transported into lysosomes,
where it undergoes proteolytic cleavage that results in
increased enzymatic activity. It then exerts enzymatic
activity in cleaving glycogen.
Non-Clinical Toxicology
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Warnings and Precautions (5.1)
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Warnings and Precautions (5.3)
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Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and furosemide tablets may reduce the natriuretic and antihypertensive effects of furosemide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. The intake of furosemide and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of furosemide concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of furosemide. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of furosemide, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide.
Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAlDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
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Anaphylaxis and severe allergic reactions have been reported in some patients during and up to three hours after MYOZYME infusion, some of which were IgE-mediated. Some of the reactions were life-threatening and included: anaphylactic shock, cardiac arrest, respiratory distress, hypotension, bradycardia, hypoxia, bronchospasm, throat tightness, dyspnea, angioedema, and urticaria. Interventions have included: cardiopulmonary resuscitation, mechanical ventilatory support, oxygen supplementation, intravenous (IV) fluids, hospitalization, treatment with inhaled beta-adrenergic agonists, epinephrine, and IV corticosteroids .
In clinical trials and postmarketing safety experience with MYOZYME, approximately 1% of patients developed anaphylactic shock and/or cardiac arrest during MYOZYME infusion that required life-support measures. In clinical trials and expanded access programs with MYOZYME, approximately 14% of patients treated with MYOZYME have developed allergic reactions that involved at least 2 of 3 body systems, cutaneous, respiratory or cardiovascular systems. These events included: Cardiovascular: hypotension, cyanosis, hypertension, tachycardia, ventricular extrasystoles, bradycardia, pallor, flushing, nodal rhythm, peripheral coldness; Respiratory: tachypnea, wheezing/bronchospasm, rales, throat tightness, hypoxia, dyspnea, cough, respiratory tract irritation, decreased oxygen saturation; Cutaneous: angioedema, urticaria, rash, erythema, periorbital edema, pruritus, hyperhidrosis, cold sweat, livedo reticularis .
If anaphylactic or other severe allergic reactions occur, immediate discontinuation of the administration of MYOZYME should be considered, and appropriate medical treatment should be initiated. Because of the potential for severe allergic reactions, appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available when MYOZYME is administered.
The risks and benefits of re-administering MYOZYME following an anaphylactic or severe allergic reaction should be considered. Some patients have been rechallenged and have continued to receive MYOZYME under close clinical supervision. Extreme care should be exercised, with appropriate resuscitation measures available, if the decision is made to re-administer the product .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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