VPRIV 400 Units powder for solution for infusion
velaglucerase alfa
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet (see section 4).
1. What VPRIV is and what it is used for
2. What you need to know before you use VPRIV
3. How to use VPRIV
4. Possible side effects
5. How to store VPRIV
6. Contents of the pack and other information
VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this material causes the signs and symptoms found in Gaucher disease.
VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
- if you are allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor before VPRIV is used
- If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects). These are called infusion-related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache.
- Apart from symptoms of hypersensitivity reactions, infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, blurry vision, or vomiting.
If you experience any of the symptoms, you must tell your doctor immediately. - You may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, antipyretics, and corticosteroids.
Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Do not use in children under the age of 4 years because there is no experience of using the medicine in this age group.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth. Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
It is not known whether VPRIV can pass into breast milk. If you are breast-feeding or considering breast-feeding, you should talk to your doctor before this medicine is used. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop using VPRIV, considering the benefit of breast-feeding to the baby and the benefit of VPRIV to the mother.
VPRIV has no or negligible influence on your ability to drive or use machines.
This medicine contains 12.15 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 0.484 mg of polysorbate 20 in each vial which is equivalent to 0.11 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any known allergies.
This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease, who will also determine the dose that you should receive.
It is given by a doctor or nurse by intravenous infusion. While remaining under the doctor’s supervision, VPRIV can be self-administered (by you or your caregiver) after appropriate training by the doctor and/or nurse. Self-administration should occur in the presence of a responsible adult.
The recommended dose is 60 Units/kg given every other week.
If you are currently being treated for Gaucher disease with another ERT and your doctor wants to change you to VPRIV, you can initially receive VPRIV at the same dose and frequency you had been receiving the other ERT.
Use in children and adolescents
VPRIV may be given to children and adolescents (4 to 17 years of age) at the same dose and frequency as in adults.
Use in elderly
VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.
Response to treatment
Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.
VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to intravenous infusion.
After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
For self-administration, the dose and rate of infusion given should not be changed without the agreement of the treating doctor.
If you believe you have used more VPRIV than you should, please contact your doctor.
If you believe you have used less VPRIV than you should, please contact your doctor.
If you have missed an infusion of VPRIV, please contact your doctor.
If you stop using VPRIV, please contact your doctor. Your symptoms may return if you stop the treatment. If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Commonly (may affect up to 1 in 10 people), patients experienced a severe allergic reaction, with difficulty breathing, chest discomfort (chest tightness), feeling sick (nausea), swelling of the face, lips, tongue or throat (anaphylactic/anaphylactoid reactions), common is also an allergic skin reaction such as hives, severe rash or itching. If any of these happen tell your doctor immediately.
Most side effects, including the allergic reactions, occurred during the infusion or shortly after. These are called infusion-related reactions.
- If the reaction is severe, in the clinic your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
- In case of home administration, if a serious infusion-related reaction occurs, including anaphylaxis, immediately stop the infusion, immediately seek emergency support and contact your doctor.
- If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment.
- Your doctor or nurse may decide to continue to administer VPRIV even if you experience any infusion-related reaction. Your condition will be closely monitored.
Other infusion-related reactions that occurred very commonly (may affect more than 1 in 10 people) include headache, dizziness, fever/body temperature increased, back pain, joint pain and tiredness, as well as high blood pressure (commonly reported), blurry vision, and vomiting (uncommonly reported).
If any of these happen tell your doctor immediately.
Other side effects include:
Very common side effects (may affect more than 1 in 10 people) are:
- bone pain
- weakness/loss of strength
- stomach ache
Common side effects (may affect up to 1 in 10 people) are:
- lengthening of the time it takes for a cut to stop bleeding may lead to easy/spontaneous bleeding/easy bruising
- skin flushing
- rapid heart beat
- developing antibodies to VPRIV (see section 2)
- decreased blood pressure
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Reconstituted and diluted solution for infusion:
Use immediately. Do not exceed 24 hours at 2 °C to 8 °C.
Do not use if the solution is discoloured or if foreign particles are present.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
- The active substance is velaglucerase alfa.
Each vial contains 400 Units of velaglucerase alfa.
After reconstitution, one ml of solution contains 100 Units of velaglucerase alfa. - The other ingredients are sucrose, sodium citrate dihydrate (E331), citric acid monohydrate (E330) and polysorbate 20 (E432) (see section 2 “VPRIV contains sodium” and “VPRIV contains polysorbate 20”).
20 ml glass vial containing a white to off-white powder for solution for infusion.
Packs of 1, 5 or 25 vials.
Not all pack sizes may be marketed.
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
This leaflet was last revised in 07/2026.
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