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Hyaluronate and Derivatives

Pronunciation

(hye al yoor ON ate & dah RIV ah tives)

Index Terms

  • Hyaluronan
  • Hyaluronate Sodium
  • Hyaluronic Acid
  • Hylan G-F 20
  • Hylan Polymers
  • Sodium Hyaluronate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, topical [sodium hyaluronate]:

Bionect: 0.2% (25 g)

Foam, topical [sodium hyaluronate]:

Bionect: 0.2% (113.4 g)

Gel, topical [sodium hyaluronate]:

Bionect: 0.2% (30 g, 60 g)

HyGel: 2.5% (10 g)

Hylase Wound: 2.5% (75 g [DSC])

Injection, gel, intra-articular [cross-linked hyaluronate]:

Gel-One: 10 mg/mL (3 mL) [derived from or manufactured using an avian source]

Injection, gel, intradermal [hyaluronic acid]:

Juvederm Ultra: 24 mg/mL (0.4 mL, 0.8 mL) [derived from or manufactured from bacterial source]

Juvederm Ultra Plus: 24 mg/mL (0.4 mL, 0.8 mL) [derived from or manufactured from bacterial source]

Juvederm Ultra Plus XC: Hyaluronic acid 24 mg/mL and lidocaine 0.3% (0.4 mL, 0.8 mL) [derived from or manufactured from bacterial source]

Juvederm Ultra XC: Hyaluronic acid 24 mg/mL and lidocaine 0.3% (0.4 mL, 0.8 mL) [derived from or manufactured from bacterial source]

Perlane-L: Hyaluronic acid 20 mg/mL and lidocaine 0.3% (1 mL [DSC], 2 mL [DSC]) [derived from or manufactured from bacterial source]

Restylane-L: Hyaluronic acid 20 mg/mL and lidocaine 0.3% (0.5 mL, 1 mL, 2 mL) [derived from or manufactured from bacterial source]

Restylane Lyft: Hyaluronic acid 20 mg/mL and lidocaine 0.3% [derived from or manufactured from bacterial source]

Restylane Silk: Hyaluronic acid 20 mg/mL and lidocaine 0.3% [derived from or manufactured from bacterial source]

Injection, gel, intradermal [sodium hyaluronate]:

Perlane: 20 mg/mL (1 mL) [derived from or manufactured from bacterial source]

Restylane: 20 mg/mL (0.4 mL, 1 mL, 2 mL) [derived from or manufactured from bacterial source]

Injection, gel, subcutaneous/supraperiosteal [cross-linked hyaluronic acid]:

Juvederm Voluma XC: Hyaluronic acid 20 mg/mL and lidocaine 0.3% [derived from or manufactured from bacterial source]

Injection, solution, intra-articular [hyaluronan]:

Monovisc: 88 mg/4 mL (4 mL) [derived from or manufactured from bacterial source]

Hymovis: 24 mg/3 mL (3 mL) [derived from or manufactured from bacterial source]

Orthovisc: 30 mg/2 mL (2 mL) [derived from or manufactured from bacterial source]

Injection, solution, intra-articular [hylan polymers A and B]:

Synvisc-One: 8 mg/mL (6 mL) [derived from or manufactured using an avian source]

Synvisc: 8 mg/mL (2 mL) [derived from or manufactured using an avian source]

Injection, solution, intra-articular [sodium hyaluronate]:

Euflexxa: 10 mg/mL (2 mL)

Gelsyn-3: 8.4 mg/mL (2 mL) [derived from or manufactured from bacterial source]

GenVisc 850: 25 mg/2.5 mL (2.5 mL) [derived from or manufactured from bacterial source]

Hyalgan: 10 mg/mL (2 mL) [derived from or manufactured using an avian source]

Supartz: 10 mg/mL (2.5 mL [DSC]) [derived from or manufactured using an avian source]

Supartz FX: 25 mg/2.5 mL (2.5 mL) [derived from or manufactured using an avian source]

Injection, solution, intraocular [sodium hyaluronate]:

Amvisc: 12 mg/mL (0.5 mL, 0.8 mL)

Amvisc Plus: 16 mg/mL (0.5 mL, 0.8 mL)

Provisc: 10 mg/mL (0.4 mL, 0.55 mL, 0.85 mL) [contains natural rubber/natural latex in packaging]

Brand Names: U.S.

  • Amvisc
  • Amvisc Plus
  • Bionect
  • Euflexxa
  • Gel-One
  • Gelsyn-3
  • GenVisc 850
  • Hyalgan
  • HyGel
  • Hylase Wound [DSC]
  • Hymovis
  • Juvederm Ultra
  • Juvederm Ultra Plus
  • Juvederm Ultra Plus XC
  • Juvederm Ultra XC
  • Juvederm Voluma XC
  • Monovisc
  • Orthovisc
  • Perlane
  • Perlane-L [DSC]
  • Provisc
  • Restylane
  • Restylane Lyft
  • Restylane Silk
  • Restylane-L
  • Supartz FX
  • Supartz [DSC]
  • Synvisc
  • Synvisc-One

Pharmacologic Category

  • Antirheumatic Miscellaneous
  • Cosmetic Agent, Implant
  • Ophthalmic Agent, Viscoelastic
  • Skin and Mucous Membrane Agent, Miscellaneous

Pharmacology

Sodium hyaluronate is a biological polysaccharide which is distributed widely in the extracellular matrix of connective tissue in man (vitreous and aqueous humor of the eye, synovial fluid, skin, and umbilical cord). Sodium hyaluronate and its derivatives form a viscoelastic solution in water (at physiological pH and ionic strength) which makes it suitable for aqueous and vitreous humor in ophthalmic surgery, and functions as a tissue and/or joint lubricant which plays an important role in modulating the interactions between adjacent tissues. Intradermal injection may decrease the depth of facial wrinkles. Transcutaneous injection for lip augmentation may correct perioral rhytids. Subcutaneous and/or supraperiosteal injection for cheek augmentation may correct age-related volume deficit. In the topical management of wounds and ulcers, sodium hyaluronate protects the skin against friction and abrasion.

Distribution

Intravitreous injection: Diffusion occurs slowly

Excretion

Ophthalmic: Via Canal of Schlemm

Use: Labeled Indications

Intra-articular injection: Treatment of pain in osteoarthritis of the knee in patients who have failed nonpharmacologic treatment or simple analgesics (Euflexxa, Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, OrthoVisc, Supartz, Supartz FX, Synvisc, Synvisc-One) or nonsteroidal anti-inflammatory drugs (NSAIDS) (Gel-One)

Intradermal:

Juvederm (all formulations except Volbella XC and Voluma XC), Perlane, Restylane, Restylane Lyft, Restylane-L: Correction of moderate to severe facial wrinkles or folds

Juvederm Volbella XC and Restylane Silk: Correction of perioral rhytids in adults >21 years.

Subcutaneous/supraperiosteal: Juvederm Voluma XC, Restylane Lyft: Correction of age-related volume deficit (deep [subcutaneous and/or supraperiosteal] injection) for cheek augmentation in the mid-face in adults >21 years

Ophthalmic: Surgical aid in cataract extraction (Amvisc, Amvisc Plus, Provisc); intraocular lens implantation (Amvisc, Amvisc Plus, Provisc); corneal transplant (Amvisc, Amvisc Plus); glaucoma filtration (Amvisc, Amvisc Plus); and retinal attachment surgery (Amvisc, Amvisc Plus)

Submucosal: Lip augmentation in adults >21 years (Restylane, Restylane-L, Restylane Silk, Juvederm Ultra XC, Juvederm Volbella XC)

Topical cream, gel: Management of skin ulcers and wounds (Bionect, Hylase Wound)

Use: Unlabeled

Treatment of refractory interstitial cystitis

Contraindications

Hypersensitivity to hyaluronate or any component of the formulation

Intradermal/Submucosal: Additional contraindications include history of anaphylaxis or presence of multiple severe allergies (Juvederm [all formulations], Perlane, Restylane, Restylane Lyft, Restylane Silk, Restylane-L); bleeding disorders (Perlane, Restylane, Restylane Lyft, Restylane Silk, Restylane-L); history of hypersensitivity to gram-positive bacterial proteins (Juvederm [all formulations], Perlane, Restylane, Restylane Lyft, Restylane Silk, Restylane-L), or local anesthetics of the amide type, such as lidocaine (Juvederm Ultra XC, Juvederm Ultra Plus XC, Juvederm Volbella XC, Restylane Lyft, Restylane Silk); implantation/injection into sites other than the anatomical spaces recommended per labeling (Perlane, Restylane, Restylane Silk, Restylane-L)

Intra-articular: Additional contraindications include knee joint infections or infections or skin diseases at the site of injection (Euflexxa, Gel-One, Gelsyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, OrthoVisc, Supartz, Supartz FX, Synvisc, Synvisc-One); hypersensitivity to gram-positive bacterial proteins (Hymovis, Monovisc, Orthovisc); systemic bleeding disorders (Monovisc)

Intraocular: There are no contraindications in the manufacturer’s labeling (Amvisc, Amvisc Plus, Provisc).

Subcutaneous/Supraperiosteal: Additional contraindications include history of anaphylaxis or history or presence of multiple severe allergies (Juvederm Voluma XC, Restylane Lyft); patients with a history of allergies to gram-positive bacterial proteins or lidocaine (Juvederm Voluma XC, Restylane Lyft).

Dosing: Adult

Surgical aid: Ophthalmic (Amvisc, Amvisc Plus, Provisc): Intraocular: Depends upon procedure (slowly introduce a sufficient quantity into eye)

Osteoarthritis of the knee: Intra-articular:

Euflexxa: Inject 20 mg (2 mL) once weekly for 3 weeks (total of 3 injections)

Gel-One: Inject 30 mg (3 mL) once

Gelsyn-3: Inject 16.8 mg (2 mL) once weekly for 3 weeks (total of 3 injections)

GenVisc 805, Supartz, Supartz FX: Inject 25 mg (2.5 mL) once weekly for 5 weeks (total of 5 injections); some patients may benefit from a total of 3 injections

Hyalgan: Inject 20 mg (2 mL) once weekly for 5 weeks (total of 5 injections); some patients may benefit with a total of 3 injections

Hymovis: Inject 24 mg (3 mL) once weekly for 2 weeks (total of 2 injections)

Monovisc: Inject 88 mg (4 mL) once

Orthovisc: Inject 30 mg (2 mL) once weekly for 3 to 4 weeks (total of 3 to 4 injections)

Synvisc: Inject 16 mg (2 mL) once weekly for 3 weeks (total of 3 injections)

Synvisc-One: Inject 48 mg (6 mL) once

Facial wrinkles/folds: Intradermal:

Note: Formulations differ in terms of recommended injection depth: Juvederm (all formulations except Voluma XC), Restylane, and Restylane-L are intended for mid to deep intradermal injection; Perlane and Restylane Lyft are intended for injection into the deep dermis to superficial subcutis

Juvederm (all formulations except Voluma XC): Inject as required for cosmetic result; typical treatment regimen requires 1.6 mL/treatment site typical volume for repeat treatment is 0.7 mL/treatment site; maximum: 20 mL/60 kg/year

Perlane, Restylane Lyft: Inject as required into deep dermis/superficial subcutis for cosmetic result; median total dose: 3 mL (Perlane); maximum: 6 mL per treatment

Restylane, Restylane-L: Inject as required for cosmetic result; median total dose: 3 mL; maximum: 6 mL per treatment

Cheek augmentation: Subcutaneous/Supraperiosteal: Adults >21 years:

Juvaderm Voluma XC: Inject as required for cosmetic result; typical treatment regimen requires small boluses of 0.1 to 0.2 mL over a large area to volumize and contour the cheek; an additional treatment may be needed to achieve the desired level of correction; maximum: 20 mL/60 kg/year

Restylane Lyft: Maximum: 6 mL per treatment

Lip augmentation: Submucosal: Adults >21 years:

Juvederm Ultra XC: Approximately 2.2 mL to the lips and perioral area; correct to 100% of desired volume effect (do not overcorrect); repeat treatment is generally 1.5 mL; maximum: 20 mL/60 kg/year

Juvederm Volbella XC: Approximately 2.6 mL to the lips and perioral area; correct to 100% of desired volume effect (do not overcorrect); repeat treatment is generally 1.6 mL; maximum: 20 mL/60 kg/year

Restylane, Restylane-L, Restylane Silk: Maximum: 1.5 mL per lip (upper or lower) per treatment session

Perioral rhytids: Intradermal: Adults >21 years:

Restylane Silk: Maximum: 1 mL per correction per treatment session

Juvederm Volbella XC: Refer to lip augmentation dosing

Skin ulcers and wounds: Topical:

Bionect cream, gel: Apply a thin layer to clean and disinfected wound or ulcer 2 to 3 times daily

Hylase Wound gel: Apply liberally to ulcer cavity or wound and to surrounding areas once daily

Interstitial cystitis, refractory (off-label use): Intravesical (off-label route): 40 mg in 50 mL saline intravesically (retain in bladder for at least 30 minutes) once weekly for 4 weeks, then monthly for up to 1 year in patients showing an initial response (Morales 1996)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Intra-articular: Inject directly into the knee joint; do not inject extra-articularly or into the synovial capsule or tissues. Do not use disinfectants containing quaternary ammonium salts for skin cleansing prior to injection. Remove synovial fluid or effusion, if present, prior to injection. If used for bilateral treatment, use a separate syringe for each knee. Refer to manufacturer's labeling for additional instructions on injection technique.

Intradermal/Submucosal/Subcutaneous/Supraperiosteal: Do not inject into a blood vessel. Following injection, slowly massage area so that it conforms to the contour of the surrounding tissue. May apply ice pack to injection site for a short period immediately after administration if treatment area swollen. Refer to manufacturer's labeling for additional instructions on injection technique. Prior to treatment, the patient should avoid taking aspirin, nonsteroidal anti-inflammatory medications, St John wort, or high doses of vitamin E supplements. These agents may increase bruising and bleeding at the injection site.

Juvederm (all formulations except Voluma XC) is intended for mid-to-deep intradermal injection.

Juvederm Voluma XC is intended for subcutaneous and/or supraperiosteal injection.

Juvederm Ultra XC is also intended for submucosal injection (lip augmentation).

Perlane is intended for injection into the deep dermis to superficial subcutis.

Restylane and Restylane-L are intended for mid-to-deep intradermal injection (facial wrinkles) or submucosal injection (lip augmentation).

Restylane Lyft is intended for deep dermis to superficial subcutis (facial wrinkles) or subcutaneous and/or supraperiosteal (cheek augmentation).

Restylane Silk is intended for mid to deep dermis (periorbital rhytids) or submucosal injection (lip augmentation).

Ophthalmic: Allow to reach room temperature prior to use. Drug may become cloudy or form a slight precipitate after administration; clinical significance unknown, but cloudy or precipitated material should be removed by irrigation or aspiration

Topical:

Bionect products: Clean and disinfect wound prior to use (do not use quaternary ammonium salts due to potential for hyaluronic acid precipitation), and debride if necessary; apply a thin layer to wound or ulcer without extensive rubbing. After application, cover the area with a sterile gauze pad and if necessary, an elastic or compressive bandage.

Hylase Wound: Clean ulcer or wound with normal saline, remove excess moisture with dry gauze, then apply gel liberally to wound or ulcer and surrounding areas. After application, cover the area with a sterile nonstick gauze pad and adhesive tape/bandage.

Compatibility

Incompatible: Disinfectants containing quaternary ammonium salts may precipitate hyaluronic acid. Detergents and benzalkonium chloride may cause solution to have a milky appearance.

Storage

Amvisc, Amvisc Plus: Store at 2°C to 8°C (36°F to 46°F); do not freeze.

Bionect products: Store at room temperature. Cream and gel may be stored up to 24 months.

Euflexxa: Store refrigerated or at room temperature, 2°C to 25°C (36°F to 77°F); do not freeze. Protect from light. If refrigerated, remove from refrigeration at least 20 to 30 minutes before use.

Gel-One, Hymovis, Supartz FX: Store below 25°C (77°F); do not freeze. Store Hymovis in original package.

Gelsyn-3, Hyalgan, Monovisc, Orthovisc: Store below 25°C (77°F); do not freeze. Protect from light. Store Gelsyn-3 in original package and use immediately once opened.

GenVisc 850, Supartz, Synvisc, Synvisc-One: Store below 30°C (86°C); do not freeze. Store in original package to protect from light.

Juvederm (all formulations), Perlane, Restylane, Restylane Lyft, Restylane Silk, Restylane-L: Store at up to 25°C (77°F); do not freeze. Protect from light. Do not use if gel separates or becomes cloudy.

Hylase Wound: Store at 15°C to 30°C (59°F to 86°F); do not freeze.

Provisc: Store refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. Prior to use, allow refrigerated product to reach room temperature (~20 to 40 minutes). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not always defined and type of local reactions may vary by formulation and site of application/injection.

>10%:

Dermatologic: Skin discoloration at injection site (intradermal, subcutaneous, submucosal 4% to 78%)

Hematologic & oncologic: Bruise (intradermal 14% to 28%; more common in older patients; intra-articular <1%)

Local: Injection site (intradermal, subcutaneous, submucosal): Swelling (8% to 98%), tenderness (17% to 95%), erythema (11% to 93%), bruising (3% to 93%), induration (6% to 92%), pain (3% to 92%; most reports were mild and did not exceed 3 days postinjection), residual mass (3% to 90%), itching (10% to 47%)

Neuromuscular & skeletal: Arthralgia (intra-articular 18% to 25%), joint swelling (knee; intra-articular ≤14%), joint effusion (intra-articular ≤11%)

Miscellaneous: Swelling (intradermal 18% to 28%; more common in younger patients)

1% to 10%:

Cardiovascular: Increased blood pressure (4%)

Central nervous system: Headache (submucosal, subcutaneous ≤7%), dizziness (subcutaneous ≤5%), hyperesthesia (injection site; subcutaneous ≤5%), hypoesthesia (injection site; subcutaneous ≤5%), injection site numbness (subcutaneous ≤5%), malaise (subcutaneous ≤5%), presyncope (subcutaneous ≤5%), tingling in the lips (subcutaneous ≤5%), falling (1% to ≤4%), fatigue (1%), paresthesia (intra-articular 1%)

Dermatologic: Hyperpigmentation (intradermal 9%; postinflammatory; in patients of African-American heritage and Fitzpatrick Skin Types IV, V, and VI), exfoliation of skin (submucosal 2% to 8%), cheilosis (subcutaneous ≤5%), fine wrinkling (subcutaneous ≤5%), local acneiform eruptions (subcutaneous ≤5%), local dryness (subcutaneous ≤5%), papule (injection site; subcutaneous ≤5%), rash at injection site (subcutaneous ≤5%), skin tightness (subcutaneous ≤5%)

Gastrointestinal: Oral herpes (subcutaneous ≤5%), abdominal pain (1% to ≤4%), diarrhea (1% to ≤4%), dyspepsia (1% to ≤4%), nausea (≤4%)

Genitourinary: Urinary tract infection (1% to ≤4%)

Infection: Infection (intra-articular 1%)

Local: Injection site reaction (1% to 6%), injection site nodule (subcutaneous ≤5%), local skin exfoliation (subcutaneous ≤5%), pain at injection site (intra-articular 2% to 5%), swelling at injection site (intra-articular 2% to 3%), infection (intradermal, subcutaneous, submucosal 1%; including abscess/necrosis)

Neuromuscular & skeletal: Limb pain (intra-articular ≤8%), back pain (intra-articular <1% to 7%), puffiness of cheeks (upon waking up; subcutaneous ≤5%), leg pain (including discomfort 1% to ≤4%), connective tissue disease (intra-articular ≤4%), musculoskeletal disease (intra-articular ≤4%), tendonitis (intra-articular 2%), localized osteoarthritis (intra-articular ≤2%), arthrosis (intra-articular 1%), joint stiffness (intra-articular ≤1%)

Ophthalmic: Corneal edema, increased intraocular pressure (postoperative; transient), ophthalmic inflammation (postoperative; iritis, hypopyon)

Respiratory: Upper respiratory tract infection (intra-articular 1% to 6%), nasopharyngitis (submucosal 5%), bronchitis (1% to ≤4%), flu-like symptoms (1% to ≤4%), rhinitis (1% to ≤4%), sinusitis (1% to ≤4%)

Miscellaneous: Laceration (injection site; subcutaneous ≤5%), soft tissue injury (lips; subcutaneous ≤5%), wound (subcutaneous ≤5%), accidental injury (1% to ≤4%)

<1% (Limited to important or life-threatening): Abnormal gait, abscess, bacterial infection, bursitis, capillary fragility, drainage, granuloma, herpetic lesion, hypersensitivity reaction, hypertension, hypotension, injection site infection (abscess/necrosis), keloids, lack of effectiveness of drug, leukocytosis, migration of implant, peripheral edema, popliteal cyst, respiratory difficulty, thrombocytopenia (rare), tissue necrosis, vasodepressor syncope

Warnings/Precautions

Dosage form specific issues:

• Injection (gel): May be administered by intradermal (Juvederm [all formulations except Voluma XC], Perlane, Restylane, Restylane Lyft, Restylane Silk), submucosal (Restylane, Restylane Silk), or subcutaneous and/or supraperiosteal (Juvederm Voluma XC, Restylane Lyft) injection. Treatment may result in bruising/bleeding; use caution in patients receiving or recently exposed (≤3 weeks) to thrombolytics, anticoagulants, or platelet inhibitors. Do not inject into site of active inflammation (skin eruptions such as cysts, pimples, rashes, or hives) or infection. Injection into a blood vessel may cause localized superficial necrosis or may cause occlusion and lead to embolism, ischemia, or infarction. Symptoms of vascular occlusion or embolization (eg, pain disproportionate to the procedure or remote from the injection site, immediate blanching extending beyond the injected area, dusky or reticular-appearing tissue) require intervention. Do not use in vascular-rich areas, such as glabella and nose; vascular embolization/ocular vessel occlusion, such as blindness, and brain vessel occlusion resulting in cerebral infarction have occurred.

• Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Use of Juvederm in patients susceptible to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied; use cautiously. Following use of Perlane, Restylane, Restylane Lyft and Restylane Silk, hyperpigmentation may occur at the injection site and may last for ≤6 weeks after treatment; keloid formation may also occur. Use caution in patients receiving immunosuppressive treatment. Use in patients with prior herpetic eruption may result in reactivation. Delayed inflammatory papules may result from injections, necessitating evaluation and treatment as soft tissue infection. Laser treatment, chemical peeling, or any other procedure based on an active dermal response, there is a risk of acute inflammatory reaction at the injection site if performed following intradermal treatment and before the skin has healed completely. The safety of treatment with concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical, or chemical peeling procedures has not been evaluated. Patient must avoid exposure to ultraviolet rays (sun and UV lamp) or severe cold until swelling and redness is resolved. Treatment site reactions usually improve in ≤7 days (nasolabial folds), <18 days (lips), or <4 weeks (cheek augmentation). Strenuous exercise and ethanol consumption should be avoided for 24 hours following use. Supplemental "touch up" treatments may be required. Use of larger than recommended volumes per injection result in an increase in adverse events; if larger amounts are needed, follow-up treatment sessions are recommended.

• Injection (gel, solution): Intra-articular: Not for use in infected joints; do not use disinfectants containing quaternary ammonium salts for skin preparation (may cause precipitation of hyaluronate). Remove synovial fluid or effusion, if present, prior to injection; do not use in cases of severe intra-articular effusion. Do not inject intravascularly, extra-articularly, or into synovium. Use with caution if venous or lymphatic stasis is present in the leg. Transient increases in reddening or inflammation, pain, or sensation of heat may occur after injection into the knee in patients with inflammatory osteoarthritis. Avoid strenuous or prolonged weight bearing activities for 48 hours after injection. Some products are produced from avian sources; use with caution in patients with hypersensitivity to avian proteins, feathers, or egg products. Use Gel-One with caution in patients allergic to cinnamon.

• Latex: Some products may contain natural latex rubber.

• Ophthalmic: Do not overfill the anterior chamber. Postoperative increases in intraocular pressure have occurred following use of sodium hyaluronate; remove from the anterior chamber at the end of surgery and monitor intraocular pressure closely.

• Topical: Bionect products (cream, gel): Do not use disinfectants containing quaternary ammonium salts for skin preparation (may cause precipitation of hyaluronate).

Other warnings/precautions:

• Appropriate patient selection: Juvederm Voluma XC: Safety for use in patients <35 years or >65 years of age or with very thin skin in the mid-face region has not been established.

• Appropriate use: Restylane Lyft: Safety and effectiveness for treatment beyond one year has not been established.

• Not for IV injection. Do not inject into blood vessels; may cause occlusion, infarction, embolism, or other systemic adverse events.

Monitoring Parameters

Intraocular pressure (ophthalmic formulations); signs and symptoms of excess local inflammation or infection (intradermal formulations)

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Safety for use in pregnant women has not been established.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience bruising, knee rigidity, sensation of warmth in knee, back pain, or muscle pain. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), vision changes, eye pain, severe eye irritation, severe edema, severe injection site irritation, severe knee pain, or white skin (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

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