Xuvan/Xuvan XL Special Precautions

General: The safety and effectiveness of the use of sodium hyaluronate solution in joints other than the knee have not been established.
The safety and effectiveness of the use of sodium hyaluronate solution concomitantly with other intra-articular injectables have not been established.
Strict aseptic administration technique must be followed to avoid infections in the injection site.
The safety and effectiveness of the use of Xuvan/Xuvan XL in severely inflamed knee joints have not been established.
The pre-filled syringe is intended for single use. Use the contents of the syringe immediately after its packaging is opened. Discard any unused Xuvan/Xuvan XL.
Opened or damaged packages of Xuvan/Xuvan XL should not be used. Always store in the original packaging (protected from light) at 30°C (86°F). DO NOT FREEZE.
Aspirate synovial effusion, if present, before each Xuvan/Xuvan XL injection.
Xuvan/Xuvan XL should be used with caution when there is evidence of lymphatic or venous stasis in that leg.
Xuvan: The effectiveness of a single treatment cycle of less than 3-5 injections has not been established.
Xuvan XL: Xuvan XL should be used with caution in diabetic patients and patients with chronic disorders.
Information for Patients: Transient pain, and/or swelling of the injected joint may occur after intra-articular injection of sodium hyaluronate solution.
As with any invasive joint procedure, it is recommended that the patient should avoid any strenuous activities or prolonged (i.e., more than 1 hour) weight-bearing activities such as jogging or playing tennis within 48 hours following the intra-articular injection. The patient should consult the attending physician regarding the appropriate time to resume such activities.
Xuvan: Provide patients with a copy of the Patient Information prior to use.
Xuvan XL: In some cases effusion may be considerable and can cause pronounced pain. Discuss with the physician if the swelling is extensive.
If the patient needs to repeat the dose, the second injection of Xuvan XL should be administered at least after 6 months.
Xuvan: Effects on ability to drive and use machines: Xuvan is not expected to affect the ability of the patient to operate machinery or drive a motor vehicle. However, it is recommended to watch for any signs of discomfort following the intra-articular administration.
Use in Pregnancy: Teratogenic Effects: The safety and effectiveness of sodium hyaluronate solution have not been established in pregnant women.
Use in Lactation: It is not known if sodium hyaluronate solution is excreted in human milk. The safety and effectiveness of sodium hyaluronate solution have not been established in lactating women.
Use in Children: The safety and effectiveness of sodium hyaluronate solution have not been demonstrated in children.
Xuvan XL: Use in Specific Populations: Pregnant women, Nursing mothers and Pediatric age group: The safety and effectiveness of Xuvan XL have not been established in pregnant women, lactating mothers and pediatric patients, defined as patients ≤ 21 years of age.