Vpriv

Drug overview for VPRIV (velaglucerase alfa):

Generic name: VELAGLUCERASE ALFA (VEL-a-GLOO-ser-ase Al-fa)
Drug class: Metabolic Disease Enzyme Replacement, Gaucher's Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents

Velaglucerase alfa is a biosynthetic (gene activation technology origin) form of human beta-glucocerebrosidase (glucosylceramidase), a lysosomal enzyme that catalyzes the hydrolysis of glucocerebroside into glucose and ceramide.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for VPRIV (velaglucerase 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 VPRIV
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VPRIV 400 UNITS VIAL	Maintenance	Adults infuse 15 unit/kg over 60 minute(s) by intravenous route every 2 weeks

Moderate List
No disease contraindications

The following adverse reaction information is available for VPRIV (velaglucerase alfa):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in 10% or more of patients receiving velaglucerase alfa include hypersensitivity reactions, headache, dizziness, pyrexia, abdominal pain, back pain, joint pain, asthenia/fatigue, and prolonged activated partial thromboplastin time (aPTT).

There are 7 severe adverse reactions.

More Frequent	Less Frequent
Hypersensitivity drug reaction	Urticaria

Rare/Very Rare
Anaphylaxis Dyspnea Hypertension Hypotension Vomiting

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Arthralgia Back pain Dizziness Fatigue Fever General weakness Headache disorder Nausea Prolonged activated partial thromboplastin time	Bone pain Skin rash Tachycardia

Rare/Very Rare
Chest discomfort Flushing Pruritus of skin

The following precautions are available for VPRIV (velaglucerase alfa):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of velaglucerase alfa have not been established in children younger than 4 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category B. (See Users Guide.) There are no adequate and well-controlled studies of velaglucerase alfa in pregnant women; the drug should be used during pregnancy only if clearly needed. Animal studies suggest no evidence of fetal harm.

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

Clinical response and adverse effects in geriatric patients appear to be similar to those of younger adults; in general, dosage should be selected with caution and the presence of any comorbid conditions should be considered in geriatric patients.