Lumizyme

Drug overview for LUMIZYME (alglucosidase alfa):

Generic name: ALGLUCOSIDASE ALFA (AL-gloo-KOE-si-dase AL-fa)
Drug class: Metabolic Disease Enzyme Replacement, Pompe Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents

Alglucosidase alfa is a biosynthetic (recombinant DNA origin) form of human acid alpha-glucosidase (GAA), an enzyme that catalyzes the hydrolysis of alpha-1,4- and alpha-1,6-glycosidic linkages of lysosomal glycogen.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for LUMIZYME (alglucosidase alfa) have been approved by the FDA:

Indications:
Lysosomal alpha-1,4-glucosidase deficiency

Professional Synonyms:
Acid maltase deficiency
Glycogen storage disease type 2
Glycogen storage disease type II
Glycogenosis type II
Pompe's disease

Dosing information for LUMIZYME
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
LUMIZYME 50 MG VIAL	Maintenance	Adults infuse 20 mg/kg over 4 hour(s) by intravenous route every 2 weeks at a rate of 1 mg/kg/hr for 30 minutes may increase to a max of 7 mg/kg/hr

Moderate List
Cardiopulmonary impairment
Chronic heart failure
Hypervolemia

The following adverse reaction information is available for LUMIZYME (alglucosidase alfa):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in at least 20% of patients receiving alglucosidase alfa in clinical trials include pyrexia, cough, decreased oxygen saturation, respiratory distress, respiratory failure, rhinorrhea, tachypnea, pneumonia, otitis media, upper respiratory tract infection, gastroenteritis, pharyngitis, ear infection, oral candidiasis, catheter-related infection, bronchiolitis, nasopharyngitis, diarrhea, vomiting, gastroesophageal reflux disease, constipation, rash, diaper dermatitis, urticaria, tachycardia, bradycardia, post-procedural pain, anemia, and flushing.

There are 32 severe adverse reactions.

More Frequent	Less Frequent
Anaphylaxis Angioedema Bronchospastic pulmonary disease Cyanosis Hypertension Hypoxia Infection Tachypnea Urticaria	Anemia Apnea Bradycardia Hypoventilation Seizure disorder Tachycardia Throat constriction

Rare/Very Rare
Acute respiratory failure Bacterial sepsis Cardiac arrest Cerebrovascular accident Dermal necrosis Dissection of aorta Dyspnea Glomerulonephritis Heart failure Hypersensitivity drug reaction Nephrotic syndrome Pharyngeal edema Pneumonia Pneumothorax Severe dyspnea Ventricular premature beats

There are 44 less severe adverse reactions.

More Frequent	Less Frequent
Agitation Chest pain Cough Diarrhea Dizziness Erythema Fatigue Fever Flushing Headache disorder Hypotension Malaise Myalgia Nausea Periorbital edema Pharyngitis Rhinitis Skin rash Upper abdominal pain Vomiting Wheezing	Back pain Constipation Gastroenteritis Hyperhidrosis Pallor Paresthesia Pruritus of skin Tremor

Rare/Very Rare
Acute abdominal pain Arthralgia Chills Conjunctivitis Drowsy Eye tearing Flu-like symptoms Livedo reticularis Muscle spasm Nervousness Pain Peripheral edema Proteinuria Skin inflammation Syncope

The following precautions are available for LUMIZYME (alglucosidase alfa):

Pediatric
Pregnant
Lactation
Geriatric

In 2 clinical trials, safety and efficacy of alglucosidase alfa have been evaluated in pediatric patients 1 month to 3.5 years of age at the time of the first infusion. Older pediatric patients (2-16 years of age) also have received alglucosidase alfa in open-label clinical trials; however, safety and efficacy of alglucosidase alfa have not been established in patients with juvenile-onset Pompe disease.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category B. (See Users Guide) See Pompe Disease Registry under Uses: Pompe Disease.

Not known whether alglucosidase alfa is distributed into milk. Since many drugs are distributed into milk, caution is advised if the drug is administered to nursing women. (See Pompe Disease Registry under Uses: Pompe Disease.)

Clinical studies of alglucosidase alfa did not include patients 65 years of age and older; it is not known whether geriatric patients respond differently than younger subjects.

Lysosomal alpha-1,4-glucosidase deficiency
E74.02	Pompe disease