INDICATION
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 non-pharmacologic therapy and simple analgesics (e.g.,
acetaminophen).
Please see FULL PRESCRIBING INFORMATION.
CONTRAINDICATIONS
·
Do
not use EUFLEXXA to treat patients who have a known hypersensitivity to
hyaluronan preparations.
·
Do
not use EUFLEXXA to treat patients with knee joint infections, infections or
skin disease in the area of the injection site.
Please see FULL PRESCRIBING INFORMATION.
WARNINGS
·
Mixing of quaternary ammonium salts such as benzalkonium
chloride with hyaluronan solutions results in formation of a precipitate.
EUFLEXXA should
not be administered through a needle previously used with medical solutions containing
benzalkonium chloride. Do not use disinfectants for skin preparation that contain
quaternary ammonium salts.
·
Do not inject intravascularly because intravascular injection
may cause systemic adverse events.
Please see FULL PRESCRIBING INFORMATION.
PRECAUTIONS
GENERAL
·
Patients
having repeated exposure to EUFLEXXA have the potential for an immune response;
however, this has not been assessed in humans.
·
Safety
and effectiveness of injection in conjunction with other intra-articular injectables,
or into joints other than the knee has not been established.
·
Remove
any joint effusion before injecting.
·
Transient
pain or swelling of the injected joint may occur after intra-articular injection
with EUFLEXXA.
·
Do not
use after expiration date.
·
Protect
from light.
·
Do not
re-use — dispose of the syringe after use.
·
Do
not use if the blister package is opened or damaged.
Information for Patients
·
Provide
patients with a copy of the Patient Information prior to use.
·
Transient
pain and/or swelling of the injected joint may occur after intra-articular injection
of EUFLEXXA.
·
As with
any invasive joint procedure, it is recommended that the patient avoid any strenuous
activities or prolonged (i.e., more than 1 hour) weight-bearing activities such
as jogging or tennis within 48 hours following intra-articular injection.
·
The
safety of repeated treatment cycles of EUFLEXXA has been established up to 1 year.
Use in Specific Populations
·
Pregnancy:
The safety and effectiveness
of EUFLEXXA have not been established in pregnant women.
·
Nursing
Mothers: It is not known
if EUFLEXXA is excreted in human milk. The safety and effectiveness of EUFLEXXA
have not been established in lactating women.
·
Children:
The safety and effectiveness
of EUFLEXXA have not been demonstrated in children.
ADVERSE
REACTIONS
Adverse event information
regarding the use of EUFLEXXA as a treatment for pain in OA of the knee was available
from two sources; a 12 week multicenter clinical trial conducted in Germany, and
a 26 week multicenter clinical trial conducted in the US.
Reported Device-Related
Adverse Events
The most common adverse events related to
EUFLEXXA injections reported in the clinical studies are the following:
·
Arthralgia
·
Back
pain
·
Pain
in extremity
·
Musculoskeletal
pain
·
Joint
swelling
All adverse events
related to EUFLEXXA injections reported in Tables 1, 2, 3 and 4 in FULL
PRESCRIBING INFORMATION.
Potential Adverse
Events
The following adverse events are among those
that may occur in association with intra-articular injections
·
Arthralgia
·
Joint
swelling
·
Joint
effusion
·
Injection
site pain
·
Arthritis
Please
see FULL PRESCRIBING INFORMATION.
HOW
SUPPLIED
EUFLEXXA
is supplied in 2.25 mL nominal volume, disposable, pre-filled glass syringes
containing 2 mL of EUFLEXXA. Only the contents of the syringe are sterile.
EUFLEXXA is nonpyrogenic.
This
product is not made with natural rubber latex.
Product
Number: 55566-4100-1
3
disposable syringes per carton
STORAGE
INSTRUCTIONS
Do
not use EUFLEXXA if the package is open or damaged. Store in the original
package at 2º-25ºC (36º-77ºF). Protect
from light. Do not freeze.
CAUTION
Federal
law restricts this device to sale by or on the order of a physician.
DIRECTIONS
FOR USE
1.
Each
package of EUFLEXXA is manufactured using aseptic filling techniques. Do not
use if the blister package is opened or damaged.
2.
Remove
joint effusion, if present.
3.
Peel
off the blister Tyvek backing (The syringe should be used immediately after the
individual syringe blister is opened).
4.
While
holding the blister open side down, bend the blister and allow the syringe to fall
gently onto the clean surface. Alternatively, hold the blister open side up and
bend back the blister until the barrel’s luer end is exposed. Gripping the luer
end of the barrel, remove the syringe from the blister. Do not remove the syringe
from the plunger end.
5.
Remove
the tip cap from the syringe and attach an appropriately sized sterile needle, for
example 17 to 21 gauge.
Attention:
Do not apply pressure to the plunger rod while the needle is being affixed. Verify that the needle is properly locked to the
Luer Lock Adapter (LLA). Do not overtighten the LLA; this can lead to loosening
of the LLA from the barrel.
6.
Apply
gentle pressure to the plunger in order to expel air from the syringe needle and
to verify that the syringe is operating properly.
7.
The
syringe is ready for use.
8.
Inject
intra-articularly into the knee synovial capsule using strict aseptic injection
procedures. Inject the full syringe contents, 2 ml into one knee only. If treatment
is being administered to both knees, use a separate syringe for each knee. Discard
any unused EUFLEXXA.
9.
For
single use only. Do not resterilize.
10.
Store
at 2º-25ºC (36º-77ºF). Protect from light. Do not freeze. If refrigerated, remove
from refrigeration at least 20-30 minutes before use.
11.
A dose
of 2 ml is injected intra-articularly into the affected knee at weekly intervals
for three weeks, for a total of three injections.
EUFLEXXA® is a registered
trademark of Ferring B.V.
©2021 Ferring B.V. All rights reserved. US-EU-2100030
Please see FULL PRESCRIBING INFORMATION.
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.
Please see FULL PRESCRIBING INFORMATION.