Elelyso

Drug overview for ELELYSO (taliglucerase alfa):

Generic name: TALIGLUCERASE ALFA (TAL-i-GLOO-ser-ase AL-fa)
Drug class: Metabolic Disease Enzyme Replacement, Gaucher's Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents

Taliglucerase alfa is a biosynthetic (recombinant DNA origin) form of human glucocerebrosidase, a lysosomal enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.

No enhanced Uses information available for this drug.

DRUG IMAGES

ELELYSO 200 UNITS VIAL

The following indications for ELELYSO (taliglucerase alfa) have been approved by the FDA:

Indications:
Gaucher's disease

Professional Synonyms:
Cerebroside lipidosis
Familial splenic anemia
Type 1 Gaucher disease

Dosing information for ELELYSO
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ELELYSO 200 UNITS VIAL	Maintenance	Adults infuse 60 unit/kg over 60-120 minute(s) by intravenous route every 2 weeks

Moderate List
No disease contraindications

The following adverse reaction information is available for ELELYSO (taliglucerase alfa):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in 10% or more of patients receiving taliglucerase alfa include infusion reactions, upper respiratory tract infection or nasopharyngitis, pharyngitis or throat infection, headache, arthralgia, influenza, urinary tract infection or pyelonephritis, back pain, and pain in extremities.

There are 3 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Hypotension

There are 19 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Arthralgia Back pain Dizziness Flushing Headache disorder Hypersensitivity drug reaction Nausea Pain in extremities Pruritus of skin Urticaria Vomiting	Chest pain Diarrhea Erythema Fatigue Skin rash

Rare/Very Rare
Chest tightness Wheezing

The following precautions are available for ELELYSO (taliglucerase alfa):

Pediatric
Pregnant
Lactation
Geriatric

Use of taliglucerase alfa in pediatric patients 4 years of age or older is supported principally by adequate and well-controlled studies of the drug in adults. In general, adverse effects are similar between adults and pediatric patients with the exception of vomiting, which has been reported with higher frequency in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

There is insufficient experience with taliglucerase alfa in pregnant women; animal studies have not suggested any evidence of adverse embryofetal effects.

It is not known whether taliglucerase alfa is distributed into milk. The known benefits of breast-feeding should be considered along with the woman's clinical need for taliglucerase alfa and any potential adverse effects of the drug or disease on the infant.

Clinical studies of taliglucerase alfa did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. In clinical studies, only 8 patients 65 years of age and older received taliglucerase alfa.