Restylane

Restylane

Manufacturer:

Galderma

Distributor:

Forewide
/
DCH Auriga - Healthcare
Full Prescribing Info
Contents
Restylane/Restylane Lyft: Hyaluronic acid, stabilized.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Cross-linked hyaluronic acid; lidocaine HCl.
Restylane Lyps Lidocaine:. Hyaluronic acid, stabilized; lidocaine HCl.
Description
Restylane/Restylane Lyft: Hyaluronic acid, stabilized 20 mg/mL; Phosphate buffered saline q.s.
Restylane/Restylane Lyft is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin. It is supplied in a glass syringe. The contents of the syringe are sterilized using moist heat. The product is for single use only. Disposable 29G TW (thin-walled) needles sterilized using ethylene oxide are provided. To ensure traceability the patient record label (part of the syringe label) should be attached to patient records.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Cross-linked hyaluronic acid 20 mg/mL; Lidocaine hydrochloride 3 mg/mL; Phosphate buffered saline pH 7 qs ad 1 mL.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 3 mg/mL. The gel is supplied in a prefilled plastic syringe. The contents of the syringe are sterilized using moist heat. The syringe is packaged individually in a blister, with two 27G x ½" (Restylane Defyne/Restylane Volyme) or 30G x ½" (Restylane Kysse/Restylane Refyne) Ultra thin wall needles. The needles have been sterilized using irradiation. The product is for single use only. To ensure traceability the package includes patient record labels that should be attached to patient records.
Restylane Lyps Lidocaine: Hyaluronic acid, stabilized 20 mg/mL; Lidocaine hydrochloride 3 mg/mL; Phosphate buffered saline q.s.
Restylane Lyps Lidocaine is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin with the addition of 0.3% lidocaine hydrochloride. It is supplied in a glass syringe. The contents of the syringe are sterilized using moist heat. The product is for single use only. Disposable 29G TW (thin-walled) needles sterilized using ethylene oxide are provided. To ensure traceability the patient record label (part of the syringe label) should be attached to patient records.
Action
Mode of Action: This product is a filler that adds volume to the tissue, thereby restoring the skin contours of the face or enhancing the lips to the desired level of correction. The volume and the lifting capacity originate from the ability of stabilized/cross-linked hyaluronic acid to bind water.
Performance: Restylane: In a controlled multicenter study with Restylane for the correction of nasolabial folds 70% of the subjects maintained a clinically significant improvement 6 months after treatment.
In a controlled multicenter study with Restylane using a retreatment schedule at 4.5 months or 9 months for correction of nasolabial folds, 95% of the nasolabial folds maintained a clinically significant improvement 18 months after the initial treatment.
Restylane Lyft: In a controlled multicenter study with Restylane Lyft for the correction of nasolabial folds 75% of the subjects maintained a clinically significant improvement 6 months after treatment.
Restylane Defyne: In a randomized controlled multicenter study with Restylane Defyne for correction of moderate to severe nasolabial folds, 69.8% of subjects maintained a clinically significant improvement at 48 weeks after treatment.
Restylane Refyne: In a randomized controlled multicenter study with Restylane Refyne for correction of moderate to severe nasolabial folds, 78.0% and 62.3% of subjects maintained a clinically significant improvement at 36 and 48 weeks after treatment, respectively.
Indications/Uses
Before the first treatment session, it is recommended to contact the local Galderma representative or Restylane distributor for more information about injection techniques and training opportunities. This product is only intended to be administered by authorized personnel in accordance with local legislation.
Restylane: This product is intended to be used for facial tissue augmentation. It is recommended to be used for the correction of wrinkles and for lip enhancement. It should be injected into the middle part of the dermis layer or in the submucosal layer of the lip. For facial areas with limited soft tissue support and soft tissue cover, e.g. the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration are recommended.
Restylane Defyne: The product is intended to augment the volume of facial tissues. It is recommended to be used for correction of severe wrinkles, or to redefine the shape of the lips, cheeks or tear troughs. Depending on the area to be treated and the tissue support, the product should be injected in the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Kysse: The product is intended to restore or augment the volume of the lips. It should be injected into the submucosal layer of the lip. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Lyft: This product is intended to be used for facial tissue augmentation. It is recommended to be used for shaping the contours of the face, the correction of folds and for lip enhancement. It should be injected into the deep layer of the dermis and/or the surface layer of the subcutis or in the submucosal layer of the lip. For facial areas with limited soft tissue support and soft tissue cover, e.g. the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration are recommended.
Restylane Lyps Lidocaine: This product is intended for lip enhancement. It should be administered by submucosal injection. The addition of lidocaine provides a pain relieving effect during treatment.
Restylane Refyne: The product is intended to augment the volume of facial tissues. It is recommended to be used for correction of moderate wrinkles, or to redefine the shape of the lips, cheeks or tear troughs. Depending on the area to be treated and the tissue support, the product should be injected in the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Volyme: The product is intended to augment the volume of facial tissues. It is recommended to be used for the correction of facial volume, for instance cheeks and chin. Depending on the area to be treated and the tissue support, the product should be injected into the supraperiostic zone or subcutis. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Dosage/Direction for Use
Needle: The size and the length of the cannula will affect the force needed to extrude the gel. If a thinner cannula is used the resistance during injection may be too high resulting in an increased risk for leakage or separation of the cannula and syringe. The same considerations are applicable for needles.
Restylane: Disposable sterile 29G TW (thin-walled) needles are provided. In case a replacement needle is required a needle within the range of 29-30G should be used.
Alternatively, a sterile blunt cannula 27-28G can be used.
Restylane Lyft: Disposable sterile 29G TW (thin-walled) needles are provided. In case a replacement needle is required a 27G needle should be used.
Alternatively, a sterile blunt cannula 23-25G can be used.
Restylane Lyps Lidocaine: Disposable sterile 29G TW (thin-walled) needles are provided.
Alternatively, a sterile blunt cannula 25-27G can be used.
Restylane Defyne: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (27G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 27G can be used.
Restylane Kysse: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (30G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 25-27G can be used.
Restylane Refyne: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (30G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with arecommended size of 27G can be used.
Restylane Volyme: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (27G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 27G or wider can be used.
Assembly of needle/cannula to syringe: Restylane/Restylane Lyft/Restylane Lyps Lidocaine: Use the thumb and forefinger to hold firmly around both the glass syringe and the luer-lock adapter. Grasp the needle shield (or hub if using cannula) with the other hand. To facilitate proper fastening, both push and rotate firmly. Strict aseptic technique must be followed. Improper assembly may result in separation of the needle and syringe during injection.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Use surgical gloves; unscrew the protective cap from the stopper; carefully remove the stopper from the syringe; firmly screw the needle/cannula with its shield onto the tip of the syringe; remove the shield just before injection.
Treatment Procedure: The patient shall be informed about the indications, expected result, precautions and potential adverse events.
Cleanse the area to be treated with a suitable antiseptic solution and allow it to dry before injection.
To avoid breakage of the needle or cannula, do not attempt to bend or otherwise manipulate it before or during treatment.
Before injecting, remove the air by pressing the rod carefully until a small droplet is visible at the tip of the needle/cannula.
Align the bevel of the needle by turning the syringe on its axis. If a blunt cannula is used, an entry point is made in the skin, for example with a sharp needle of appropriate size.
When using a needle, aspiration prior to injection is recommended to reduce the risk of inadvertent injection into a blood vessel. Inject slowly while pulling the needle backwards.
Injection should stop just before the needle is pulled out from the skin to prevent material from leaking out from the injection site.
Inject slowly. During injection, it is recommended to keep the side hole of the cannula facing downwards, away from the skin surface, to ensure that the flow of the gel is maintained at the correct tissue depth. Inject the gel by gently pressing down on the plunger rod with the thumb or palm of the hand
Do not apply excessive pressure to the syringe at any time. Presence of scar tissue may impede advancement of the cannula/needle. If resistance is encountered the cannula/needle should be partially withdrawn and repositioned or fully withdrawn and checked for function.
It is recommended to change needle/cannula for each new treatment site.
Defects should be fully corrected, but not overcorrected, at each treatment session.
If "blanching" of the skin is observed as a result of over-superficial injection, the whitened area should be massaged gently until it returns to a normal colour.
Restylane/Restylane Lyft: The patient's need for pain relief should be assessed. For optimal patient comfort, topical or local anaesthesia is recommended when treating wrinkles (Restylane) or when shaping the contours of the face and correcting folds (Restylane Lyft). For lip augmentation, anaesthesia through a nerve block can be used.
At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
The correction site should be massaged to conform to the contour of the surrounding tissues.
If there is pronounced skin laxity, it is recommended that the product be injected on two or more separate occasions.
After the first treatment, additional implantations of the product may be necessary to achieve the desired level of correction. Periodic follow-up injections help sustain the desired degree of correction.
Restylane Defyne/Restylane Refyne: At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
Choose from a variety of injection techniques, i.e. serial puncture, linear threading or cross-hatching.
Gently massage the treated area after injection.
Restylane Kysse: At each treatment session a maximum dosage of 1.5 mL per treatment site is recommended.
Choose from a variety of injection techniques, i.e. serial puncture, linear threading or cross-hatching.
Gently massage the treated area after injection.
Restylane Lyps Lidocaine: The patient's need for additional pain relief should be assessed. For lip augmentation, anaesthesia through a nerve block can be used.
At each treatment session a maximum dosage of 1.5 mL is recommended for each lip.
If necessary, the injection site should be moulded to distribute the product evenly.
After the first treatment, additional implantations of the product may be necessary to achieve the desired level of correction. Periodic follow-up injections help sustain the desired degree of correction.
Restylane Volyme: At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
Choose from linear threading or cross-hatching injection techniques.
Gently massage the treated area after injection.
Contraindications
Patients presenting with known allergy to hyaluronic acid filler.
Restylane Defyne/Restylane Kysse/Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme: Patients presenting with known allergy to lidocaine or to amide-type local anaesthetics.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Patients presenting with porphyria.
Warnings
Do not inject intravascularly. As for other injectable medical devices, inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis.
If the overlying skin turns a whitish color (blanching), the injection should be stopped immediately and the area massaged until it returns to a normal color.
Do not use in patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.
Do not use where there is active disease, such as inflammation, infection or tumours, in or near the intended treatment site.
Do not inject this product into an area where an implant other than hyaluronic acid has been placed.
Do not resterilize.
Do not mix with other products.
Restylane/Restylane Lyft/Restylane Lyps Lidocaine: Do not inject intramuscularly or intravascularly.
Special Precautions
General considerations relevant to injectable medical devices: Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be observed.
Knowledge of the anatomy of treatment site and special caution are required in order to avoid perforation or compression of vessels, nerves and other vulnerable structures.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
Patients who are using substances that affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
Patients with unattainable expectations are not suitable candidates for treatment.
Do not use the product if package is damaged.
Restylane/Restylane Defyne/Restylane Lyft/Restylane Refyne/Restylane Volyme: Special caution should be exercised when treating areas with limited collateral circulation, due to increased risk of ischemia.
Special caution should be exercised in treating facial areas with limited soft tissue support or soft tissue cover, such as the periorbital area, to avoid formation of palpable lumps.
Patients with pre-existing pigmented dark lower eye lid circles, thin skin and pre-existing tendency toward edema formation are not suitable candidates for treatment of the lower periorbital region.
Restylane/Restylane Lyft/Restylane Lyps Lidocaine: Special caution should be exercised when treating areas in close proximity to permanent implant.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Patients using immunosuppressants are not suitable candidates for treatment.
Special caution should be exercised in treating patients with a tendency to form hypertrophic scars or any other healing disorders.
Do not use the product if the contents of the syringe are cloudy.
Specific considerations relevant to the use of this product: If the product is injected too superficially this may result in visible lumps and/or bluish discoloration.
If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with this product there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if the product is administered before the skin has healed completely after such a procedure.
The patient must avoid exposing the treated area to heat (sunbathing, sauna, steam baths, etc.) or extreme cold until any signs of local inflammation have disappeared.
This product has not been tested in pregnant or breast-feeding women.
Restylane Defyne/Restylane Kysse/Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme: Considerations should be given to the total dose of lidocaine administered if dental block or topical administration of lidocaine is used concurrently. High doses of lidocaine (more than 400 mg) can cause acute toxic reactions manifesting as symptoms affecting the central nervous system and cardiac conduction.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g., certain anti-arrhythmics, since the systemic toxic effects can be additive.
Lidocaine should be used cautiously in patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Restylane/Restylane Lyft/Restylane Lyps Lidocaine: This product has not been tested in children.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Do not use in children.
Restylane Volyme: The product is not indicated for injection other than into the supraperiostic zone or subcutis.
Adverse Reactions
Anticipated injection-related reactions: Injection-related reactions might occur. These reactions include bruising, erythema, itching, swelling, pain or tenderness at the implant site. Typically resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.
Post marketing adverse event reporting: Vascular compromise may occur due to an inadvertent intravascular injection or as a result of vascular compression associated with implantation of any injectable product. This may manifest as blanching, discoloration, ischemia, necrosis or ulceration at the implant site or in the area supplied by the blood vessels affected; or rarely as ischemic events in other organs due to embolisation. Following facial aesthetic treatments isolated rare cases have been reported regarding ischemic events affecting the eye leading to visual loss, and the brain resulting in cerebral infarction. After injections of the nose ischemia/necrosis may occur, especially in patients who had prior rhinoplasty.
Symptoms of inflammation at the implant site commencing either shortly after injection or after a delay of up to several weeks have been reported. In case of unexplained inflammatory reactions infections should be excluded and treated if necessary, since inadequately treated infections may progress into complications such as abscess formation. Treatment using only oral corticosteroids without concurrent antibiotic treatment is not recommended.
The prolonged use of any medication, e.g., corticosteroids or antibiotics in treatment of adverse events has to be carefully assessed, since this may carry a risk for the patient. In case of persistent or recurrent inflammatory symptoms, consider removal of the product by aspiration/drainage, extrusion or enzymatic degradation (use of hyaluronidase has been described in scientific publications). Before any removal procedure is performed, the swelling may be reduced by using, e.g., NSAID for 2-7 days or a short course of corticosteroids for less than 7 days, in order to more easily palpate any remaining product.
Post inflammatory pigmentation changes have been observed in clinical studies in people with dark skin (Fitzpatrick Type IV-VI).
For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions.
For reporting of adverse events contact the local Galderma representative or distributor for this product.
Restylane/Restylane Lyft: The following post marketing adverse events have been reported (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the Restylane fillers range of products.
1/1 000 - 1/10 000: Swelling.
1/10 000 - 1/50 000: Bruising, discoloration, erythema, infection, inflammation, ischemia/necrosis, mass, pain/tenderness, papules/nodules.
1/50 000 - 1/100 000: Hypersensitivity, induration, neurological symptoms such as paresthesia, pruritus, short duration of effect.
<1/100 000: Abscess, acne, angioedema, atrophy/scarring, blisters, capillary disorders such as telangiectasia, dermatitis, device dislocation, fistula, granuloma, rash, reactivation of herpes infection, urticaria, visual disturbance.
Isolated rare cases of ischemic events affecting the eye leading to visual loss, and the brain resulting in cerebral infarction, following facial aesthetic treatments have been reported.
Isolated rare cases of ischemia/necrosis affecting the nose have been reported after injection, especially in patients who had prior rhinoplasty.
Restylane Defyne/Restylane Refyne/Restylane Volyme: The following post market adverse events have been reported (non-exhaustive list): angioedema, atrophy/scaring, blisters, bruising, capillary disorders such as telangiectasia, dermatitis, discoloration, erythema, hypersensitivity, induration, infection, inflammation, ischemia/necrosis, mass, neurological symptoms such as paraesthesia, pain/tenderness, papules/nodules, pruritus, reactivation of herpes infection, short duration of effect, swelling and urticaria.
Other potential adverse events that have been reported following injection of hyaluronic acid gels in general and may occur when using the product include the following: abscess, acne, device dislocation, fistula, granuloma, rash and visual disturbance.
Restylane Kysse: The following post marketing adverse events have been reported (non-exhaustive list): angioedema, atrophy/scaring, blisters, bruising, erythema, hypersensitivity, infection, mass, neurological symptoms such as paraesthesia, pain/tenderness, papules/nodules, pruritus, reactivation of herpes infection, short duration of effect, and swelling.
Other potential adverse events, that have been reported following treatment of lips with hyaluronic acid gels in general and may occur when using the product include the following: abscess, acne, capillary disorders such as telangiectasia, dermatitis, device dislocation, discoloration, granuloma, induration, inflammation, and ischemia/necrosis.
Restylane Lyps Lidocaine: The following post marketing adverse events have been reported (non-exhaustive list): abscess, angioedema, bruising, discolouration, erythema, inflammation, mass, pain/tenderness, papules/nodules, pruritus, short duration of effect, and swelling.
Other potential adverse events, that have been reported following treatment of lips with other Restylane fillers, are: acne, atrophy/scaring, blisters, capillary disorders such as telangiectasia, dermatitis, device dislocation, granuloma, hypersensitivity, induration, infection, ischemia/necrosis, neurological symptoms such as paraesthesia, and reactivation of herpes infection.
Caution For Usage
The syringes and needles/cannulas must be discarded immediately after use in accordance with accepted medical practice and applicable national, local or institutional guidelines. The product shall not be reused due to risk for contamination of unused material and the associated risk including infection. Standard precautions apply when handling the needles. Needles should be disposed in a container dedicated for sharp devices.
Storage
Store up to 25°C. Protect from freezing and sunlight.
ATC Classification
D11AX - Other dermatologicals ; Used in the treatment of dermatological diseases.
Presentation/Packing
Restylane: Injectable gel (single-use syringe) 1's.
Restylane Defyne: Injectable gel (single-use syringe) 1's.
Restylane Kysse: Injectable gel (single-use syringe) 1's.
Restylane Lyft: Injectable gel (single-use syringe) 1's.
Restylane Lyps Lidocaine: Injectable gel (single-use syringe) 1's.
Restylane Refyne: Injectable gel (single-use syringe) 1's.
Restylane Volyme: Injectable gel (single-use syringe) 1's.
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