DUROLANE 60MG 3ML ALL JOINT PFS 1`S

DUROLANE contains a stabilised form of hyaluronic acid (HA) using Non-Animal Stabilised Hyaluronic Acid (NASHA) technology. Hyaluronic acid is a naturally occurring glycosaminoglycan found in high concentrations in healthy joint synovial fluid, where it provides lubrication and shock absorption. In osteoarthritis, HA concentration and molecular weight decrease, impairing joint mechanics and pain sensitisation.

DUROLANE is indicated for the symptomatic treatment of pain in osteoarthritis of any joint (knee, hip, shoulder, ankle), where joint fluid analysis confirms osteoarthritis and conservative measures (physiotherapy, analgesics, weight management) have been insufficient.

The NASHA technology cross-links hyaluronic acid to extend its residence time in the joint to several months. A single injection of DUROLANE has been shown in clinical trials to provide sustained pain relief for 6 months or longer in many patients with knee osteoarthritis.

DUROLANE is administered as a single intra-articular injection (Inject 60 mg (3 mL) once), by a qualified healthcare professional trained in intra-articular injection technique. It must never be self-administered.

Injection Procedure

•       The injection site should be cleaned with an antiseptic.

•       Local anaesthetic may be used at the injection site.

•       If joint effusion is present, it should be aspirated before injecting DUROLANE.

•       Inject the entire 3 mL content of the pre-filled syringe into the joint space under sterile conditions.

Post-injection

•       Patients should avoid strenuous activities (jogging, heavy lifting, prolonged standing) for 48 hours after injection.

•       Mild discomfort and swelling immediately after injection is common and usually resolve within 24–48 hours.

•       If required, repeat injection may be considered after 6 months. Do not inject more frequently than every 6 months.

Very Common Side Effects

•       Injection site reactions: pain, swelling, warmth, effusion (joint fluid accumulation) — typically mild and transient, resolving within a few days.

Common Side Effects

•       Joint stiffness or increased pain in the first 48 hours post-injection (known as post-injection flare).

•       Bruising at the injection site.

Uncommon but Important Side Effects

•       Pseudo-septic arthritis reaction (acute local inflammatory response) — distinguished from true septic arthritis by absence of fever and negative joint fluid culture. Treat with NSAIDs.

•       Allergic reaction to hyaluronic acid or avian-derived components (rare with NASHA technology — produced by bacterial fermentation, not from avian sources).

Seek Immediate Medical Attention If:

•       Severe joint pain, joint swelling, redness, fever, or discharge at the injection site — could indicate septic arthritis (joint infection), a rare but serious complication.

Septic Arthritis Risk

Although rare, intra-articular injection carries a risk of introducing infection. Strict aseptic technique is mandatory. Any post-injection fever, severe pain increase, or purulent joint fluid should be treated as suspected septic arthritis until proven otherwise. Joint aspiration for culture is required.

Inflammatory Arthropathies

DUROLANE is not indicated for rheumatoid arthritis or other inflammatory arthropathies. Viscosupplementation should only be used in osteoarthritis. Ensure inflammatory arthritis is excluded or in remission before injection.

Pregnancy and Breastfeeding

The safety of intra-articular hyaluronic acid during pregnancy and lactation has not been established. Use is not recommended during pregnancy unless clearly necessary.

No significant systemic drug interactions are known for intra-articular hyaluronic acid, given its localised action and minimal systemic absorption.

•       Do not mix DUROLANE with other medicines in the same syringe.

•       If concurrent intra-articular corticosteroid injection is planned, this should be performed as a separate procedure on a different visit — mixing may degrade the hyaluronic acid.

•       Quaternary ammonium compounds (used as disinfectants): avoid contact with DUROLANE as they may cause precipitation.

•       Store in a refrigerator at 2–8 degrees Celsius. Do not freeze.

•       Keep in the original packaging to protect from light.

•       Allow the pre-filled syringe to reach room temperature before injection (remove from refrigerator 20–30 minutes before use) for patient comfort.

•       Do not use if the solution is cloudy, discoloured, or contains particles.

•       Single-use only — discard any unused portion.

•       Keep out of reach of children.

DUROLANE is a medical device/pharmaceutical product in Kenya, requiring a prescription from a registered medical practitioner.

Patient Selection

Best results are seen in: Kellgren-Lawrence grade I–III osteoarthritis (moderate disease); patients with predominantly mechanical/activity-related joint pain; patients with adequate joint space (not bone-on-bone). Evidence is strongest for knee OA. For the hip and shoulder, ultrasound-guided injection is recommended.

Compared to Corticosteroid Injections

Intra-articular corticosteroids provide faster relief (onset within days) but shorter duration (typically 4–12 weeks). DUROLANE has a slower onset but longer duration of effect (up to 6 months). Consider corticosteroids for acute pain relief, viscosupplementation for sustained management.

How long will the pain relief from DUROLANE last?

Clinical studies show that pain relief from a single DUROLANE injection can last 6 months or longer in many patients. Individual response varies depending on disease severity, activity level, and patient factors. The effect tends to be longer-lasting than standard hyaluronic acid products that require 3–5 injections.

How many injections will I need?

DUROLANE is designed as a single-injection treatment per treatment course, unlike older viscosupplementation products that required multiple weekly injections. If your symptoms return, your doctor may recommend a repeat injection after 6 months.

Is DUROLANE suitable for all types of arthritis?

DUROLANE is specifically indicated for osteoarthritis (wear-and-tear arthritis). It is not suitable for inflammatory arthritis such as rheumatoid arthritis, gout, or psoriatic arthritis. If there is any doubt about the type of arthritis, further investigations (blood tests, joint fluid analysis) should be performed first.