VPRIV® (velaglucerase alfa) for injection is a prescription medication indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

FITTING VPRIV INTO YOUR LIFE

Living with GD1 sometimes means factoring in some extra planning and thinking ahead, and might mean you need some extra support an guidance as you journey through life.

The people in these hypothetical patient profiles have experienced growing up and living with GD1, navigating through various stages that you might be facing in your own life. Their experiences might help you navigate your own, similar circumstances.

BACK TO ALL PROFILES
LIBBY – STARTING SCHOOL

MATEO – GOING TO COLLEGE

ALISON – TREATMENT CHOICE NATASHA – PREGNANCY DONNA – TAKING OTHER MEDICATION MICHAEL – FINDING SUPPORT JOHN – RETIREMENT AND TRAVELING
Male VPRIV Patient

*Patient profiles for illustrative purposes only and do not depict actual patients

Male VPRIV Patient

MATEO
– GOING TO COLLEGE

Female VPRIV Patient
ALISON
– TREATMENT CHOICE
Female VPRIV Patient
NATASHA
– PREGNANCY
Female VPRIV Patient
DONNA
– TAKING OTHER MEDICATION
Male VPRIV Patient
MICHAEL
– FINDING SUPPORT
Older Male VPRIV Patient
JOHN
– RETIREMENT AND TRAVELLING
Pediatric Female VPRIV Patient
LIBBY
– STARTING SCHOOL

*Patient profiles for illustrative purposes only and do not depict actual patients

KEY TOPICS

  • Initiating Treatment
  • Home Infusions
  • Setting up Infusions in a New Area
  • Multidisciplinary Team

MATEO’S STORY*

Mateo was diagnosed with GD1 at age 15 after several symptoms, including fatigue and easy bruising, led to his referral to a hematologist and a medical geneticist. Because of his symptoms, it was decided he should initiate treatment, and after discussing the risks and benefits with his doctor, he and his parents decided on VPRIV. A doctor suggested they make use of QuickStart, which allowed him to initiate treatment quickly.

After six months of receiving infusions in a hospital, Mateo made the switch to home infusions. This gave him some time back, and meant his parents didn’t have to drive him to and from the hospital every two weeks.

When he was 18, Mateo applied to a college out of state. He was excited, but had some questions about how to set up his infusion schedule in a new area. As part of Takeda Patient Support, a Patient Support Specialist helped him to complete this process, and to find a local pharmacy that could supply his VPRIV treatments. Together, they created an infusion schedule that would work around his classes, and he was mindful to let them know when he would be travelling home for the holidays.

As part of his multidisciplinary team (which includes his infusion nurse, primary care physician, and physiotherapist) his therapist helped him to alleviate his concerns about moving away, and to develop a plan on how to explain GD1 to his new friends. Two years into college, Mateo is well settled into his studies and his busy schedule.

important safety information <

Life-threatening hypersensitivity reactions, including anaphylaxis may occur with VPRIV treatment. This reaction may occur early in treatment or after many doses. Seek immediate help if you experience wheezing, shortness of breath, trouble breathing, itching, hives, rapid heartbeat, swelling of the tongue or throat.

important safety information <

Life-threatening hypersensitivity reactions, including anaphylaxis may occur with VPRIV treatment. This reaction may occur early in treatment or after many doses. Seek immediate help if you experience wheezing, shortness of breath, trouble breathing, itching, hives, rapid heartbeat, swelling of the tongue or throat. VPRIV should be administered under the supervision of a healthcare professional. Appropriate medical support should be available when VPRIV is administered.

Hypersensitivity reactions were the most commonly observed side effects in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, low blood pressure, high blood pressure, nausea, tiredness/weakness, and fever. Hypersensitivity reactions in the clinical trials include any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis. Generally the reactions were mild and, in patients not previously treated, occurred mostly during the first 6 months of treatment and tended to occur less frequently with time. After the drug was approved, additional hypersensitivity reactions of chest discomfort, difficulty breathing, itching and vomiting have been reported. In some cases, vomiting can be serious and require hospitalization and/or stopping the medication.

If anaphylactic or other acute reactions occur, seek immediate medical care. Your healthcare provider will immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment. A hypersensitivity reaction should be treated based on the severity of the reaction. Your healthcare provider may manage a reaction by slowing the infusion rate or treating with medicine such as antihistamines, fever-reducing agents and/or corticosteroids or possibly stopping the medication and then restarting with a longer infusion time. For patients who have had symptoms of hypersensitivity reaction to enzyme replacement therapy, the doctor may consider treating the patient with antihistamines and/or corticosteroids before an infusion to help prevent such a reaction from happening.

The most commonly reported side effects during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, increased time it takes for blood to clot, tiredness/weakness, and fever. In clinical studies, the overall frequency of side effects was generally higher in the patients not previously treated with ERT than in the patients who switched from imiglucerase to VPRIV.

Talk to your doctor if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

The safety and efficacy profiles were similar in pediatric (ages 4 to 17) and adult patients. The safety of VPRIV has not been established in patients under 4 years of age. Side effects more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, increased time it takes for blood to clot, and fever.

The side effect profile in elderly patients was generally similar to that seen in pediatric and other adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering other existing medical conditions.

As with all therapeutic proteins, there is a potential for developing antibodies to VPRIV. In clinical studies, 1 of 54 (2%) patients who had not previously been treated with ERT, who were then treated with VPRIV, developed antibodies. One additional patient developed antibodies to VPRIV during an extension study. It is unknown if having antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

For additional safety information, please click here for Full Prescribing Information including WARNING for Risk of Anaphylaxis, and discuss with your doctor
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, contact Takeda at 1-877-TAKEDA-7 (1-877-825-3327), or by email at medinfous@takeda.com