VPRIV

VPRIV

velaglucerase alfa

Manufacturer:

Takeda

Distributor:

Zuellig Pharma

Marketer:

Takeda
Concise Prescribing Info
Contents
Velaglucerase alfa
Indications/Uses
Long-term enzyme replacement therapy (ERT) in patients w/ type 1 Gaucher disease.
Dosage/Direction for Use
IV infusion Administer as a 60-min IV infusion. Recommended dose: 60 u/kg administered every other wk. Dose adjustments can be made on an individual basis based on achievement & maintenance of therapeutic goals. Clinical studies have evaluated doses ranging from 15-60 u/kg every other wk.
Contraindications
Special Precautions
Discontinue immediately if anaphylactic or other acute reactions occur. Hypersensitivity reactions, including symptoms consistent w/ anaphylaxis. Infusion-related reactions. Pre-treatment w/ antihistamines &/or corticosteroids to prevent subsequent reactions. Recommended max daily intake of 2 g for adult. Perform test for presence of Ab in cases of severe infusion-related reactions. Women of childbearing potential. Pregnancy. Discontinue lactation during treatment or discontinue/abstain from use during lactation. Childn <4 yr.
Adverse Reactions
Headache, dizziness; abdominal pain/upper abdominal pain; bone & back pain, arthralgia; infusion-related reaction, asthenia/fatigue, pyrexia/increased body temp. Hypersensitivity reactions eg, allergic dermatitis & anaphylactic/anaphylactoid reactions; tachycardia; dyspnoea; HTN, hypotension, flushing; nausea; rash, urticaria, pruritus; chest discomfort; prolonged aPTT, neutralizing Ab +ve.
MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AB10 - velaglucerase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
VPRIV powd for soln for infusion 400 U
Packing/Price
20 mL x 1's
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