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velaglucerase alfa (Rx)Brand and Other Names:VPRIV

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection

  • 400 unit/vial
more...

Gaucher Disease Type I

60 Unit/kg IV q2week; infuse over 1 hr

Administration

Adjust dose according to individualize patient requirements

Clinical trials have evaluated dosage range between 15-60 mg q2week

Switching from imiglucerase: Begin treatment with velaglucerase with same dose of imiglucerase the patient was taking

May pretreat with corticosteroids and/or antihistamines to decrease risk of infusion-related reactions

Dosage Forms & Strengths

lyophilized powder for injection

  • 400 unit/vial
more...

Gaucher Disease Type I

<4 years: Safety/efficacy not established

≥4 years: As adults; 60 Unit/kg IV q2week; infuse over 1 hr

Administration

Adjust dose according to individualize patient requirements

Clinical trials have evaluated dosage range between 15-60 mg q2week

Switching from imiglucerase: Begin treatment with velaglucerase with same dose of imiglucerase the patient was taking

May pretreat with corticosteroids and/or antihistamines to decrease risk of infusion-related reactions

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Adverse Effects

>10%

Fatigue (13%)

Dizziness (8-22%)

Abdominal pain (15-19%)

Headache (30-35%)

Upper respiratory tract infections (30-32%)

Prolonged aPPT (5-11%)

1-10%

Flushing (>2%)

Tachycardia (>2%)

Hypertension/hypotension (>2%)

Urticaria (>2%)

Rash (>2%)

Postmarketing reports

Chest discomfort

Dyspnea

Pruritus

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Warnings

Contraindications

None listed in the manufacturer's label

Cautions

The most common adverse effect are infusion-related reactions; body temperature may increase when hypersensitivity reactions occur

Consider slowing infusion rate, treatment with antihistamines, antipyretics and/or corticosteroids, and/or stopping treatment if hypersensitivity reaction occurs during infusion; consider pre-treatment with antihistamines and/or corticosteroids in patients with prior reactions

Most reactions are mild and occur within the first 6 months; pretreatment or symptomatic treatment with corticosteroids, antihistamines, or antipyretics may help manage the reactions

Ensure that personnel administering product are adequately trained in cardiopulmonary resuscitative measures, and have ready access to emergency medical services

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
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Pharmacology

Mechanism of Action

Hydrolytic lysosomal glucocerebroside-specific enzyme plays a role in the hydrolysis of glucocerebroside to glucose and ceramide thereby preventing the accumulation of glucocerebroside in macrophages, which is responsible for the signs and symptoms of Gauche'r disease

Pharmacokinetics

Half-Life: 11-12 min

Vd: 82-108 mL/kg

Clearance:  6.72-7.56 mL/min/kg

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Administration

IV Compatibilities

Solution: 0.9% NaCl

Y-site: Do no infuse with other drugs in same infusion tubing

IV Preparation

Vial Reconstitution

  • Reconstitute vial with sterile water for injection
  • Determine the number of vials to be reconstituted based on the individual patient’s weight and the prescribed dose
  • Inject 4.3 mL of Sterile Water for Injection, USP into a vial containing VPRIV lyophilized powder
  • Mix gently. DO NOT SHAKE. The reconstituted VPRIV solution will have a 100 Units/mL concentration (400 Units VPRIV in 4 mL of solution)
  • If additional vials are needed, repeat steps above

Upon reconstitution, mix vial gently; DO NOT SHAKE

Inspect reconstituted vial; should be clear to slightly opalescent and colorless

Do not use if solution is discolored or foreign particulate matter present

IV infusion: Withdraw calculated volume and further dilute in 100 mL of 0.9% NaCl; mix gently and DO NOT SHAKE

IV Administration

Diluted solution should be administered using an in-line low protein-binding 0.2 micron filter

Administer IV injection via volumetric infusion pump over 1 hr

Storage

Contains no preservatives

Once reconstituted, use immediately

If immediate use not possible, reconstituted or diluted product may be stored refrigerated for up to 24 hr; do not freeze and protect from light

Store unreconstituted vials refrigerated (2-8 degrees C; 36-46 degrees F), do not freeze and protected from light

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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