Other Medical Considerations (Donna) | VPRIV® (velaglucerase alfa) for injection

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VPRIV READY

DONNA — OTHER MEDICAL CONSIDERATIONS*

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

NAME: Donna

AGE: 36

AGE AT TYPE 1 GAUCHER DIAGNOSIS: 28

ETHNICITY: Ashkenazi Jewish

TREATMENT HISTORY: VPRIV,
8 years

SYMPTOMS AT BASELINE: Moderate thrombocytopenia, low hemoglobin¹

LAST CHECK-UP: Maintained improvements in hemoglobin level^2–4

FAMILY HISTORY: Brother with type 1 Gaucher disease

OTHER MEDICAL HISTORY: Anxiety and depression, treated with sertraline

Donna was diagnosed with type 1 Gaucher disease in her late 20s. Her doctor discussed the risks and benefits of treatment.

He then reviewed Donna’s entire medical history, including her use of sertraline, and decided to treat Donna with VPRIV.

Donna recently had her second child. Donna has now returned to work part-time and is balancing the new demands of her schedule.

Donna receives VPRIV at an infusion center near her office.² She recently started using the PreppedAhead™^† program so that her infusion is prepared ahead of arrival at the infusion center, giving her more time for her family and work.

consider

VPRIV has been evaluated during clinical trials in 73 adult patients (≥18 years)⁵
No drug–drug interactions have been observed with VPRIV, as per the Prescribing Information²
The PreppedAhead^TM program expedites infusion preparation

^†PreppedAhead is only available to eligible patients enrolled in OnePath®, and whose site of care is enrolled in the PreppedAhead program

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

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions, including anaphylaxis, have occurred. The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions.

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.

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

Hypersensitivity reactions, including anaphylaxis, have occurred. The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions.

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.

As with any intravenous protein product, hypersensitivity reactions are possible, therefore, appropriate medical support, including personnel adequately trained in cardiopulmonary resuscitative measures and access to emergency measures, should be readily available when VPRIV is administered. If anaphylactic or other acute reactions occur, immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment.

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. 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.

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.

Please click here for Full Prescribing Information.

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.

For assistance with medical inquiries about VPRIV, please contact Takeda at 1-877-TAKEDA-7 (1-877-825-3327), or email medinfous@takeda.com.