Restylane

INDICATIONS

Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

Restylane is indicated for submucosal implantation for lip augmentation in patients over the age of 21.

DOSAGE AND ADMINISTRATION

Directions for Assembly

Assembly of 30 G needle to syringe

For safe use of Restylane, it is important that the needle is properly assembled. Improper assembly may result in separation of the needle and syringe during implantation.

See pictures A through E.

1. Unscrew the tip cap (B) of the syringe carefully.

2. Grasp the narrow part of the needle shield loosely; mount the needle on the Luer-Lok (C) by turning it clockwise until you feel counterpressure.

3. Grasp the wider part of the needle shield firmly (D).

4. Press and turn the needle shield 90° (a quarter turn).

4a. The quarter turn is necessary to lock the needle onto the syringe.

5. Remove the patient record label marked with three small arrows (E) and attach to patient chart.

6. Pull off the needle shield.

Figure A,B,C,D and E

Assembly of 30 G needle to syringe - Illustration

Assembly of 29 G needle to syringe

Use the thumb and forefinger to hold firmly around both the glass syringe barrel and the Luer-Lok adapter. Grasp the needle shield with the other hand. To facilitate proper assembly, both push and rotate firmly.

Assembly of 29 G needle to syringe -  Illustration

Pre-treatment Guidelines

Prior to treatment, the patient should avoid taking aspirin, nonsteroidal anti-inflammatory medications, St. John's Wort, or high doses of Vitamin E supplements. These agents may increase bruising and bleeding at the injection site.

Treatment Procedure

1. It is necessary to counsel the patient and discuss the appropriate indication, risks, benefits and expected responses to the Restylane treatment.

Advise the patient of the necessary precautions before commencing the procedure.

2. Assess the patient's need for appropriate anesthetic treatment for managing comfort, i.e., topical anesthetic, local or nerve block.

3. The patient's face should be washed with soap and water and dried with a clean towel. Cleanse the area to be treated with alcohol or another suitable antiseptic solution.

4. Sterile gloves are recommended while injecting Restylane.

5. Before injecting, press rod carefully until a small droplet is visible at the tip of the needle.

6. Restylane is administered using a thin gauge needle (30 G x ½” or 29 G x ½”). The needle is inserted at an approximate angle of 30° parallel to the length of the wrinkle, fold, or lip. For the nasolabial folds, Restylane should be injected into the mid-to-deep dermis. For lip augmentation, Restylane should be injected into the submucosal layer; care should be taken to avoid intramuscular injection. If Restylane is injected too superficially this may result in visible lumps and/or bluish discoloration.

7. Inject Restylane applying even pressure on the plunger rod. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.

8. Only correct to 100% of the desired volume effect. Do not overcorrect. With cutaneous deformities the best results are obtained if the defect can be manually stretched to the point where it is eliminated. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique.

9. Typical usage for each treatment session is specific to the site as well as wrinkle severity. In a prospective study of midface wrinkle correction, the median total dose was 3.0 mL. Based on U.S. clinical studies, the maximum recommended dose per treatment is 6.0 mL for the nasolabial folds and 1.5 mL per lip per treatment.

Injection Techniques

1. Restylane can be injected by a number of different techniques that depend on the treating physician's experience and preference, and patient characteristics.

2. Serial puncture (F) involves multiple, closely spaced injections along wrinkles or folds. Although serial puncture allows precise placement of the filler, it produces multiple puncture wounds that may be undesirable to some patients.

3. Linear threading (includes retrograde and antegrade) (G) is accomplished by fully inserting the needle into the middle of the wrinkle or fold and injecting the filler along the track as a “thread.” Although threading is most commonly practiced after the needle has been fully inserted and is being withdrawn, it can also be performed while advancing the needle (“push-ahead” technique). To enhance the vermillion of the lip, the retrograde linear threading technique is the most advisable.

4. Serial threading is a technique that utilizes elements of both approaches.

5. Cross-hatching (H) consists of a series of parallel linear threads injected at intervals of five to ten mm followed by a new series of threads injected at right angles to the first set to form a grid. This technique is particularly useful in facial contouring when coverage of the treatment region needs to be maximized.

F. Serial Puncture

Serial Puncture - Illustration

G. Linear Threading (includes retrograde and antegrade)

Linear Threading - Illustration

H. Cross-hatching

Cross-hatching  Illustration

6. Note! The correct injection technique is crucial for the final result of the treatment. Dissection of the sub-epidermal plane with lateral movement of the needle, rapid flows ( > 0.3 mL/min), rapid injection or high volumes may result in an increase in short-term episodes of bruising, swelling, redness, pain, or tenderness at the injection site.

7. When the injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an overcorrection has occurred, massage the area firmly between your fingers, or against the underlying area to obtain optimal results.

8. If so called “blanching” is observed, i.e., the overlying skin turns a whitish color, the injection should be stopped immediately and the area massaged until it returns to a normal color.

9. If the wrinkle or lips need further treatment, the same procedure should be repeated until a satisfactory result is obtained. Additional treatment with Restylane may be necessary to achieve the desired correction.

10. If the treated area is swollen directly after the injection, an ice pack can be applied on the site for a short period. Ice should be used with caution if the area is still numb from anesthetic to avoid thermal injury.

11. Patients may have mild to moderate injection site reactions, which typically resolve in less than 7 days in the nasolabial folds and less than 14 days in the lip.

Sterile Needle(s)

  • Follow national, local or institutional guidelines for use and disposal of medical sharp devices. Obtain prompt medical attention if injury occurs.
  • To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
  • Do not reshield used needles. Recapping by hand is a hazardous practice and should be avoided.
  • Discard unshielded needles in approved sharps collectors.
  • Restylane is provided with a needle that does not contain engineered injury protection. Administration of Restylane requires direct visualization and complete and gradual insertion of the needle making engineered protections infeasible. Care should be taken to avoid sharps exposure by proper environmental controls.

Ordering Information

Medicis Aesthetics Inc. and its distributor, McKesson Specialty, are your only sources for FDA-approved Restylane. Purchasing from any other agent is illegal. To order call 877-520-0500.

HOW SUPPLIED

Restylane is supplied in a disposable glass syringe with a Luer-LokR fitting. Restylane is co-packed with sterilized needle(s) as indicated on the carton, either 30 G x ½” or 29 G x ½”

A patient record label is a part of the syringe label.

Remove it by pulling the flap marked with three small arrows. This label is to be attached to patient records to ensure traceability of the product.

The contents of the syringe are sterile.

The volume in each syringe and needle gauge is as stated on the syringe label and on the carton.

Shelf life and storage

Restylane must be used prior to the expiration date printed on the package.

Store at a temperature of up to 25° C (77° F). Do not freeze. Protect from sunlight. Refrigeration is not required.

Do not resterilize Restylane as this may damage or alter the product.

Do not use if the package is damaged.

Immediately return the damaged product to Medicis Aesthetics Inc.

Manufactured for: Medicis Aesthetics Inc., 7720 N. Dobson Road, Scottsdale, AZ 85256, U.S.A. Manufactured by: Q-Med AB, Seminariegatan 21, SE-752 28 Uppsala, Sweden

Last reviewed on RxList: 7/8/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.