Consumer medicine information

Euflexxa

Sodium hyaluronate

BRAND INFORMATION

Brand name

Euflexxa

Active ingredient

Sodium hyaluronate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Euflexxa.

WHAT IS EUFLEXXA?

EUFLEXXA is a gel-like, elastic, sterile product containing natural, highly purified hyaluronan (hye-a-loo-ROE-nan), also known as sodium hyaluronate.

Hyaluronan is a substance found naturally in the body and is present in particularly high amounts in joint tissues and the synovial fluid (the fluid that fills the joints). Hyaluronan acts as a lubricant and shock absorber for the joints and allows the cartilage, the protective surfaces of your bones, to glide over each other smoothly. This helps the joints to work properly.

Osteoarthritis is a condition that involves the wearing down of cartilage and a reduction in the amount of hyaluronan in the joint fluid and tissues. In osteoarthritis, the quality of the hyaluronan in the joints may be reduced and there may not be enough hyaluronan to help the joints work properly.

WHAT IS EUFLEXXA USED FOR?

EUFLEXXA is used to relieve joint pain caused by osteoarthritis of the knee joint or other synovial joints. EUFLEXXA reduces pain in the affected joint by helping to lubricate the joint, allowing for greater joint mobility and flexibility.

WHAT OTHER TREATMENTS ARE AVAILABLE FOR OSTEOARTHRITIS?

If you have been diagnosed with osteoarthritis, there are several things you can do besides getting EUFLEXXA injections. These include:

Non-drug treatments:

  • avoiding activities that cause a lot of pain in your affected knee or other synovial joint
  • appropriate exercise
  • physical therapy
  • removal of excess fluid from the affected knee or other synovial joint

Drug therapy:

  • pain medications such as paracetamol and narcotics
  • drugs that reduce inflammation, such as nonsteroidal anti-inflammatory agents (NSAIDs) including aspirin, ibuprofen and naproxen
  • corticosteroids that are injected directly into the joint

ARE THERE ANY REASONS WHY YOU SHOULD NOT TAKE EUFLEXXA?

  • You should not take this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products
  • You should not have an injection into the affected knee joint or other synovial joint if you have a joint infection, skin diseases or infections around the injection site

THINGS YOU SHOULD KNOW ABOUT EUFLEXXA:

  • Always read the label
  • Your doctor will advise you whether EUFLEXXA is suitable for you and your condition
  • EUFLEXXA is a very highly purified product extracted from bacterial cells
  • EUFLEXXA is only for injection into the affected knee joint or other synovial joint, performed by a qualified doctor
  • Consult your doctor if you are allergic to hyaluronan products or any of the ingredients listed in "INGREDIENTS" below
  • After you receive the injection, you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time, i.e., more than one hour
  • The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established
  • EUFLEXXA has not been tested in pregnant women or women who are nursing. You should tell your doctor if you think you are pregnant or nursing a child.
  • The safety and effectiveness of EUFLEXXA have not been shown in children under 18 years of age.

POSSIBLE COMPLICATIONS:

Your doctor has weighed the risks of using this product against the benefits they expect it will have for you. Ask your doctor any questions you may have.

Tell your doctor if you notice any of the following after you are given EUFLEXXA:

  • Itching, redness, swelling at the injection site- Application of ice to the treated joint may help to relieve these symptoms. These symptoms are usually short-lived.
  • feeling sick (nausea)
  • feeling tired (fatigue)
  • tenderness
  • back pain
  • skin irritation
  • increased blood pressure
  • burning, itching, and/or tingling sensation

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people.

Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration (TGA) at www.tga.gov.au/reporting-problems.

HOW IS EUFLEXXA GIVEN?

Use only as directed. EUFLEXXA must be administered by doctor/qualified medical personnel.

EUFLEXXA comes in pre-filled syringes containing 2 mL of product. EUFLEXXA is given by injection directly into the affected knee joint or other synovial joint.

Your doctor will give you your injection of 1 to 2 mL EUFLEXXA (20 mg/ 2 mL) into your affected knee joint or other synovial joints once a week, for a total of three injections.

INGREDIENTS

Each 1 mL of EUFLEXXA contains:

  • Sodium hyaluronate 10 mg
  • Sodium chloride 8.5 mg
  • Disodium hydrogen phosphate dodecahydrate 0.56 mg
  • Sodium dihydrogen phosphate dehydrate 0.05 mg
  • Water for injections

HOW EUFLEXXA IS STORED

EUFLEXXA should be kept in the original packaging until it is time to use it. This helps protect it from light. Store EUFLEXXA in a refrigerator where the temperature stays between 2°C and 8°C. Do not freeze. Keep out of reach of children.

EUFLEXXA may be removed from the refrigerator and stored at room temperature (15°C - 25°C) for up to six (6) months within the product shelf-life.

MANUFACTURED BY:

Bio-Technology General (Israel) Ltd.
Be’er Tuvia Industrial Zone,
Kiryat Malachi, 8310402, Israel.

AUSTRALIAN SPONSOR

Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street PYMBLE NSW 2073

EUFLEXXA and FERRING are registered trademarks of Ferring B.V.

DATE OF PREPARATION

06 February 2020

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Euflexxa

Active ingredient

Sodium hyaluronate

Schedule

Unscheduled

 

Name of the medicine

1% Sodium hyaluronate.

Excipients.

Each 1 mL of Euflexxa contains: sodium chloride 8.5 mg, disodium hydrogen phosphate dodecahydrate 0.56 mg, sodium dihydrogen phosphate dehydrate 0.05 mg, water for injections q.s.

Description

Each 1 mL of Euflexxa contains: sodium hyaluronate 10 mg, sodium chloride 8.5 mg, disodium hydrogen phosphate dodecahydrate 0.56 mg, sodium dihydrogen phosphate dehydrate 0.05 mg, water for injections q.s.
Euflexxa is a viscoelastic, sterile solution of highly purified, high molecular weight (2.4-3.6 million daltons) sodium hyaluronate in phosphate buffered saline. Euflexxa is a highly purified physiological product. It is a polysaccharide consisting of a repeating disaccharide of N-acetylglucosamine and sodium glucuronate, linked by alternating β-1,3 and β-1,4 glycosidic bonds.
Hyaluronate can be found in synovial fluid, in the vitreous and aqueous humor of the eye, in skin and in the umbilical cord. The contents of the Euflexxa syringe are sterile (aseptic filling) and the external surface of the blister packed syringe is sterilised by ethylene oxide sterilisation.

Indications

Euflexxa is indicated for the treatment of pain caused by osteoarthritis of the knee joint or other synovial joints. Euflexxa aids in lubrication of the joint, allows for greater mobility and flexibility of the treated joint, and reduces pain in the affected joint.

Contraindications

Do not use Euflexxa to treat patients who have a known hypersensitivity to hyaluronate preparations or patients with joint infection, infections in the injection site area or skin diseases.

Precautions

Euflexxa is to be administered only by qualified medical personnel. Remove any joint effusion before injection.
The efficacy and tolerance of an injection in conjunction with other intra-articular treatments have not been established.
Euflexxa has not been tested on pregnant women, lactating women and children under 18 years.
Since Euflexxa is a substance purified from bacterial cells, the presence of exceedingly minute quantities of impurities cannot be totally excluded. The physician should be aware of potential risks associated with the injection of biological substances.
Protect from light. Do not use after expiry date. Do not inject intravascularly. Do not re-use; dispose of the syringe after use. Do not use if the blister package or the syringe is opened or damaged.

Interactions

None currently known.

Adverse Effects

In clinical trials, the most common events were arthralgia and joint swelling.
Other events experienced were effusion, nausea, fatigue, nonspecified tenderness, back pain, paraesthesia, skin irritation and nonspecified hypertension. Associated symptoms such as itching, redness, swelling and pain may occur at the injection site. Application of ice to the treated joint may relieve these symptoms. These symptoms generally decrease within a short period.
Any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration (TGA) at www.tga.gov.au/reporting-problems.

Dosage and Administration

Euflexxa is intended for injection into the synovial space. Usually a dose of 1 mL or 2 mL is injected into the affected joint at weekly intervals for a total of three injections. For the best effect, all three injections must be administered.
Bring the Euflexxa syringe to room temperature before use. Use aseptic technique when handling the syringe and administering the injection. See the Instructions for use section for details of preparing the syringe for use. If the patient presents with effusion, the effusion should be removed before Euflexxa is injected into the joint. Inject the contents of the syringe into the joint being treated. Discard any unused Euflexxa. Each Euflexxa syringe is intended for single use only. The syringe should be used immediately after the individual syringe blister is opened. If treatment is being administered to more than one joint, use a separate syringe for each joint.
For patients who respond to treatment, the effect of treatment lasts for at least twenty six weeks.
Do not use Euflexxa if the package or the syringe is opened or has been tampered with or damaged.

Incompatibilities.

Mixing of quaternary ammonium salts such as benzalkonium chloride with sodium hyaluronate 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.

Presentation

Euflexxa is supplied in 2.25 mL nominal volume, disposable, pre-filled glass syringes containing 2 mL of Euflexxa. Available in a box of 3 syringes. The contents of the syringe are sterile and non-pyrogenic.

Storage

Shelf life.

3 years.
Store in a cold dark place (2°C-8°C). Do not freeze. May be removed from refrigeration within the product shelf life and stored at room temperature (15°C-25°C) for up to six (6) months.

Poison Schedule

Unscheduled.