EUFLEXXA® [1% sodium hyaluronate] by Ferring Pharmaceuticals


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Indication

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

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

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

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.

 

 

Please see FULL PRESCRIBING INFORMATION.

Adverse Reactions

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 & Storage Instructions

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.

 

 

Please see FULL PRESCRIBING INFORMATION.

Directions for Use

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.

 

 

Please see FULL PRESCRIBING INFORMATION.

EUFLEXXA® is a registered trademark of Ferring B.V.
©2021 Ferring B.V. All rights reserved. US-EU-2100030

Please see FULL PRESCRIBING INFORMATION.

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION.


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 nonpharmacologic therapy and simple analgesics [eg, acetaminophen].

IMPORTANT SAFETY INFORMATION

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.