Euflexxa injection

Call your doctor for instructions if you miss an appointment for your sodium hyaluronate injection.

Hyaluronic acid injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other treatments that did not work well.

Hyaluronic acid is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Applies to sodium hyaluronate: intra-articular solution

General

Most side effects are related to local reactions such as injection site pain, pain, swelling, effusion, or redness of the joint.

Increased risk, severity, or frequency of side effects does not appear to occur with retreatment of sodium hyaluronate (the active ingredient contained in Euflexxa) [Ref]

Local

Local side effects for sodium hyaluronate (the active ingredient contained in Euflexxa) in relation to placebo therapy have included injection site pain (23% vs 13%), joint pain and swelling (13% vs 13%), and local skin reactions consisting of ecchymosis and rash (14% vs 10%) and pruritus (7% vs 4%). Warmth and redness have also been reported.[Ref]

Injection site pain was listed as the reason for premature discontinuation of treatment in 4% (6/164) of the patients treated with sodium hyaluronate as compared to < 1% (1/164) of placebo-treated patients.

Patients with inflammatory arthritis may experience transient increases in inflammation of the injected knee following treatment.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions and allergic reactions.[Ref]

Hypersensitivity reactions have included 2 cases of anaphylactoid reactions and 3 cases of allergic reactions, which resolved upon discontinuation of sodium hyaluronate.[Ref]

Other

Other side effects have included fever and headache.[Ref]

Seven cases of fever were reported in one pivotal clinical study. Subsequently, 3 of these cases were reported to be associated with local reactions. No association to pyrogenic arthritis was found.[Ref]

Gastrointestinal

Gastrointestinal side effects for sodium hyaluronate (the active ingredient contained in Euflexxa) in relation to placebo therapy have included unspecified complaints (29% vs 36%).[Ref]

Non-specific gastrointestinal complaints were severe in both 4% of patients treated with sodium hyaluronate and 4% of patients treated with placebo.[Ref]

Cardiovascular

There has been one case report of hypotensive crisis or shock, which resolved and did not reoccur with repeated treatment.[Ref]

Cardiovascular side effects have included hypotensive crisis or shock.[Ref]

Musculoskeletal

Musculoskeletal side effects have included knee swelling/effusion and pseudosepsis.[Ref]

Pseudosepsis has been characterized as severe joint inflammation with pain and effusion occurring 24 to 72 hours after injection and it may be more likely to occur after the second or third injection or with repeated courses. Nonsteroidal anti-inflammatory drugs, intra-articular steroids, and/or arthrocentesis are often required to treat pseudosepsis.

In a pivotal clinical study 1.2% (2/164) patients treated with sodium hyaluronate vs. 1.8% (3/164) patients treated with placebo were reported to have a positive bacterial culture of effusion aspirated from the treated knee. Only 1 of the placebo-treated patients required hospitalization for presumptive treatment for septic arthritis. The remaining 4 patients did not show clinical or subsequent signs of infection.[Ref]

Some side effects of Euflexxa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Hyalgan(R): 2 mL by intra-articular injection into the knee once weekly for 5 weeks
Supartz(TM): 2.5 mL by intra-articular injection into the knee once weekly for 5 weeks

Data not available

Safety and effectiveness of repeat treatment cycles after the first 5 weeks have not been established.

Sodium hyaluronate has not been formally assigned to a pregnancy category by the FDA. Animal studies have failed to reveal evidence of fertility impairment or teratogenicity. There are no controlled data in human pregnancy. Sodium hyaluronate is only recommended for use during pregnancy if benefit outweighs risk.

There are no data on the excretion of sodium hyaluronate into human milk.