Injection site reactions (ISRs) were the most frequently reported adverse event (98%). Few patients (4%) discontinued treatment because of ISRs. ISRs were generally seen within the first week of initiating FUZEON therapy. The average duration of an ISR was between 3 and 7 days in 41% of subjects, and more than
7 days in 24% of subjects. Reactions are often present at more than one injection site. Because of the frequency and duration of individual ISRs, 27% of subjects had 6 or more ongoing ISRs at any given time.
FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites.
Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Because FUZEON is a twice-daily injection and requires time to be properly mixed, patients may need to make adjustments to their lifestyle. However, in a survey of clinical trial patients, 85% assessed the injection process as easy, very easy or neutral and most patients found that the injection process did not limit their daily activities.
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For patients who may need a little extra support to become comfortable preparing and injecting FUZEON after receiving training from their healthcare provider, Nurse Connections™ can help. This program connects patients with an experienced FUZEON Nurse Educator who provides supplemental in-home education, self-injection training and follow-up support in addition to the healthcare provider's training. To learn more about Nurse Connections and how to refer your patients for additional support services,
click here.
FUZEON.com also features an Injection Tools and Tips section for patients, including a virtual
preparation and injection tutorial, a list of
preparation and injection tips and a variety of
support materials.
FUZEON comes packaged as a 30-day supply kit that contains the following:
- 60 vials of FUZEON powder
- 60 vials of sterile water for injection
- Reconstitution syringes (60 of each):
- 3 cc/mL Terumo® SurGuard2™ Safety Syringe: 23 gauge, 1 inch (25 mm) needle
- Injection syringes (60 of each):
- 1 cc/mL Terumo SurGuard2 Safety Syringe: 27 gauge, ½ inch (13 mm) needle
- Alcohol pads
About the Terumo SurGuard2 Safety Syringe:
- There are two different sized safety syringes, a 3 cc/mL (large) syringe and a 1 cc/mL (small) syringe
- There is a protective green cover that snaps into place over the needle after use, lowering the risk of needlestick injuries
Click here to read the full Prescribing Information for FUZEON.
Click here to read the Important Safety Information.