Velaglucerase Alfa

Velaglucerase Alfa is a prescription medication indicated for long-term enzyme replacement therapy (ERT) for type 1 Gaucher disease.

• Velaglucerase Alfa is available under the following different brand names: VPRIV

Common side effects of Velaglucerase Alfa include:

• headache
• dizziness
• stomach pain
• back pain
• joint pain
• knee pain
• nausea
• fatigue
• weakness
• dizziness
• tiredness
• fever
• prolonged blood clotting time
• cold symptoms such as stuffy nose, sneezing, and sore throat

Serious side effects of Velaglucerase Alfa include:

• hives
• fever
• chest discomfort
• troubled breathing
• swelling of the face, lips, tongue, or throat

Rare side effects of Velaglucerase Alfa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 400 Units/vial

Gaucher disease type I

Adult dosage

• 60 Units/kg IV every other week
• Adjust dosage based on achievement and maintenance of each patient’s therapeutic goals

Pediatric dosage

• Children younger than 4 years: Safety and efficacy not established
• Children aged 4 years and older
• 60 Units/kg IV every other week
• Adjust dosage based on achievement and maintenance of each patient’s therapeutic goals

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Velaglucerase Alfa has no noted severe interactions with any other drugs
• Velaglucerase Alfa has no noted serious interactions with any other drugs
• Velaglucerase Alfa has no noted moderate interactions with any other drugs
• Velaglucerase Alfa has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed in the manufacturer's label

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Velaglucerase Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Velaglucerase Alfa?”

Cautions

• The most common adverse effect is 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 a 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

Pregnancy and Lactation

• Available data on use in pregnant women cannot definitively establish or exclude the absence of drug-associated risks during pregnancy
• No association was identified between use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • Women with type 1 Gaucher disease have an increased risk of spontaneous abortion, especially if disease symptoms are not treated and controlled preconception and during pregnancy
  • Pregnancy may exacerbate existing type 1 Gaucher disease symptoms or result in new disease manifestations; these manifestations may lead to adverse pregnancy outcomes including hepatosplenomegaly and thrombocytopenia
• Lactation
  • No data available on drug’s presence in human milk
  • Reported cases are insufficient to determine any effects on the breastfed infant or milk production
  • Endogenous beta-glucocerebrosidase is present in human milk