Geriatric Patient (John) | VPRIV® (velaglucerase alfa) for injection

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VPRIV READY

JOHN — GERIATRIC PATIENT*

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

NAME: John

AGE: 68

AGE AT TYPE 1 GAUCHER DIAGNOSIS: 55

ETHNICITY: Hispanic

TREATMENT HISTORY: VPRIV, 13 years

SYMPTOMS AT BASELINE: Moderately enlarged spleen, mildly low platelet count, moderately low hemoglobin¹

LAST CHECK-UP: Maintained improvements in spleen volume, hemoglobin level, and platelet count^2–4

OTHER MEDICAL HISTORY: Heart condition and high blood pressure, currently treated with verapamil

John was diagnosed with type 1 Gaucher disease at the age of 55.

John and his physician discussed treatment options, and they decided together that VPRIV was right for him. Throughout the years, John has continued to receive his VPRIV infusions once every other week.² John used to have his infusions at a treatment center but then decided to receive them at home, where he is more comfortable. When John retired, he wanted to travel abroad with his family. As he informed his physician in advance, they were able to devise a plan with suitable arrangements that supported his therapeutic needs while he was traveling.

In recent years, John has been diagnosed with a heart condition and high blood pressure, for which he needs prescription medication. Despite these new medications, John’s doctor advised that he was able to continue to receive his VPRIV treatment, as VPRIV does not have any associated drug–drug interactions listed on the Prescribing Information.²

consider

VPRIV has been evaluated during clinical trials in 56 older patients (≥65 years, including 10 patients ≥75 years)²
No drug–drug interactions or contraindications are listed with VPRIV, as per the Prescribing Information²

CLICK ON EACH PATIENT BELOW TO READ THEIR STORY^†:

LIBBY Pediatric
Patient MATEO College
Student ALISON Patient Preference NATASHA Pregnant Patient DONNA Other Medical Considerations MICHAEL Delayed
Diagnosis

JOHN Geriatric
Patient

^†These are hypothetical patient profiles intended to represent patients with type 1 Gaucher disease

LOOKING TO START YOUR PATIENTS ON VPRIV? Complete a VPRIV Start Form via the portal or download
one and fill it in with your patients. Please contact
Takeda Patient Support at 1-866-888-0660 with any questions.

VPRIV Start Form Portal

LOOKING TO START YOUR PATIENTS ON VPRIV? Complete a VPRIV Start Form via the portal or download one and fill it in with your patients.
Please contact Takeda Patient Support at 1-866-888-0660 with any questions.

VPRIV Start Form Portal

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

INDICATION

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

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including VPRIV. VPRIV-treated patients have had these reactions occur in clinical studies and postmarketing experience.

Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. 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 treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time. Additional hypersensitivity reactions of chest discomfort, dyspnea, pruritus and vomiting have been reported in post-marketing experience. In some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation.

Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures including access to cardiopulmonary resuscitation equipment.

Management of hypersensitivity reactions should be based on severity of the reaction, such as slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. In cases where patients have exhibited symptoms of hypersensitivity to velaglucerase alfa or excipients in the drug product or to other enzyme replacement therapy, pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.

The most common adverse reactions during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated partial thromboplastin time (aPTT), fatigue/asthenia, and pyrexia. In clinical studies, the overall frequency of adverse events was generally higher in the population naïve to enzyme replacement therapy (ERT) than in the population switched from imiglucerase to VPRIV.

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. Adverse reactions more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, prolonged aPTT, and pyrexia. The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions.

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 (2%) enzyme treatment-naïve patients treated with VPRIV developed IgG class antibodies (neutralizing in an in vitro assay). One additional patient developed IgG antibodies to VPRIV during an extension study. It is unknown if the presence of IgG antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

To report SUSPECTED ADVERSE REACTIONS, contact Medical Information at 1-866-888-0660, option 2 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information, including Boxed WARNING for Risk of Anaphylaxis.

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