The overall safety profile of FUZEON is based on 2120 subjects who received at least 1 dose of FUZEON during various clinical trials. This includes 2051 adults, 658 of whom received the recommended dose for greater than 48 weeks, and 52 pediatric subjects. Assessment of treatment-emergent adverse events is based on the pooled data from the two Phase 3 studies T20-301 and T20-302.
Injection site reactions (ISRs) are the most commonly reported adverse event (98%); few patients (4%) discontinued treatment because of them. Excluding ISRs, the events most frequently reported in patients receiving FUZEON plus a background regimen were diarrhea (38 per 100 patient-years, or 32%), nausea (27 per 100 patient-years, or 23%) and fatigue (24 per 100 patient-years or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without FUZEON: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).
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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.
For most subjects, the severity of signs and symptoms of ISRs did not change during 48 weeks of treatment.
Pain/Discomfort: 96% of patients felt some degree of pain or discomfort at some point in the studies. 11% of patients had severe pain that required analgesics or limited their usual activities.
Induration: 90% of patients had some degree of hardening of the skin; of those, 82% had areas that were less than 50 mm in diameter.
Erythema: 91% of patients noticed redness at the injection site; of those, 90% had areas less than 85 mm in diameter.
Nodules and Cysts: 80% of patients had nodules or cysts. Nodules and cysts varied in size; 77% were less than 3 cm in diameter.
Pruritus: Itching at the injection site was experienced by 65% of patients; of those, 97% did not seek treatment or only needed to use over-the-counter topical creams.
Ecchymosis: 52% of patients experienced bruising at the injection site; of those, 98% had bruising that was less than 5 cm in diameter.
Infection: The incidence of infection at the injection site (including abscess and cellulitis) was 1.7%.
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.
An increased rate of bacterial pneumonia was observed in patients treated with FUZEON in the
Phase 3 clinical trials compared to the control arm. It is unclear if the increased incidence of
pneumonia is related to FUZEON use. However, because of this finding, patients with HIV infection
should be carefully monitored for signs and symptoms of pneumonia, especially if they have underlying
conditions that may predispose them to pneumonia. Risk factors for pneumonia included low initial
CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have occurred in <1% of patients studied and have included combinations of rash, fever, nausea and vomiting, chills, rigors, hypotension and/or elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barré syndrome.
Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue FUZEON treatment and should seek medical evaluation immediately. Therapy with FUZEON should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to FUZEON have not been identified.
Excluding ISRs, the events most frequently reported in patients receiving FUZEON plus a background regimen were diarrhea (38 per 100 patient-years, or 32%); nausea (27 per 100 patient-years, or 23%); and fatigue (24 per 100 patient-years, or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without FUZEON: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).
The table below shows the treatment-emergent laboratory abnormalities that occurred in at least 2 subjects per 100 patient-years and more frequently in those receiving FUZEON plus a background regimen (than a background regimen alone) from studies T20-301 and T20-302.
Click here to read the full Prescribing Information for FUZEON.