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EUFLEXXA® [1% sodium hyaluronate] is indicated for the treatment of pain in osteoarthritis [OA] of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics [eg, acetaminophen].
EUFLEXXA is contraindicated in patients who have a known hypersensitivity to hyaluronate preparations or who have knee joint infections, infections, or skin disease in the area of the injection site.
EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use skin disinfectants for skin preparation that contain quaternary ammonium salts.
Do not inject intravascularly due to potential for systemic adverse events.
The safety and effectiveness of injection in conjunction with other intra-articular injectables, or into joints other than the knee have not been studied. Remove any joint effusion prior to injecting. Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
The most common adverse events related to EUFLEXXA injections reported in 12- and 26-week clinical studies were arthralgia, back pain, pain in extremity, musculoskeletal pain, and joint swelling. In an open-label extension of the 26-week clinical study with repeat series of injections, the most common adverse events related to EUFLEXXA at Week 52 were arthralgia and joint swelling.
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No reported adverse events of pseudosepsis in this trial.
A total of 160 patients received 478
injections of EUFLEXXA. There were 27
reported AEs considered
to be related to
EUFLEXXA injections: arthralgia, 11
(6.9%); back pain, 1 (0.63%); blood
pressure increase,
3 (1.88%); joint
effusion, 1 (0.63%); joint swelling, 3
(1.88%); nausea, 1 (0.63%); paresthesia, 2
(1.25%)
feeling of sickness from injection,
3 (1.88%); skin irritation, 1 (0.63%); and
tenderness in study knee,
1 (0.63%). Four
AEs were reported in the EUFLEXXA
group for which the relationship to
treatment was
considered to be
unknown: fatigue, 3 (1.88%) and nausea,
1 (0.63%).1
In the FLEXX trial, only acetaminophen
(up to 4 g daily) was permitted for rescue
analgesia; use was
quantified through pill
counts in both FLEXX and FLEXX
extension1,2
*Measured by a 100-mm VAS.
OA=osteoarthritis
No cases of pseudosepsis were reported
in the trial and extension.
*Preferred term with an incidence of >1 among
treatment groups
(safety population).
†TEAEs were reported for subjects who received
EUFLEXXA in both
the core and extension trials (219
of 433).
N=number of subjects in a given treatment group for
the population analyzed; n=number of
subjects
reporting at least 1 AE within
system organ
class/preferred term; (%)=percent of subjects based
on N. Note:
Related AEs are those with trial-device
relationship
classified
as “certain,” “probable,”
“possible,” or “unassessable.”
