What is Juverderm

Juvederm Collection of Fillers consists of 5 different products to temporarily improve volume loss due to aging in all areas of the face.Juvederm products are injectable dermal fillers consisting of hyaluronic acid, a natural complex sugar that bolsters skin elasticity, providing a smooth and supple appearance. Hyaluronic acid is naturally occurring in the body, it depletes with aging giving one a “sunken” look.

Hyaluronic acid works by holding in water at the injection site and acting as a cushioning agent.It adds temporary volume and a smother appearance to the skin.

Juvederm Ultra and Ultra Plus products were developed using Hylacross technology to allow a smother, more malleable gel for sculpting.Juvederm Voluma, Volbella, and Vollure are Allergan’s next-generation dermal fillers, developed using VYCROSS™ technology, which uses an innovative combination of low and high molecular weight HA to improve the cross-linking efficiency of HA chains. This more effective cross-linking allows for a lower concentration of HA to be used, delivering an ultra-smooth gel for a natural look and feel, minimal swelling and bruising, as well as improved duration.

Juvederm Ultra and Ultra Plus

Juvederm Ultra and Ultra Plus received FDA approved in 2006 for the temporary improvement in the appearance of nasolabial folds (the “parentheses” along the side of the nose and mouth).Juvederm Ultra has the added FDA indication for lip augmentation and softening of perioral lines.

The ability of cells to produce hyaluronic acid diminishes with age, often resulting in the formation of facial wrinkles and folds as the skin loses volume.Juvederm Ultra and Ultra Plus add volume back to the injected areas giving a smoother appearance to wrinkles and folds.Lidocaine is in Juvederm injectable gel to minimize discomfort of treatment.The results of Juvederm Ultra and Ultra Plus last 6-9 months.

Juvederm Voluma

Juvederm Voluma one of Allergan’s Next Generation of dermal fillers was FDA approved for use in 2013.Facial volume loss contributes significantly to facial aging.Volume deficits are the result of the loss and repositioning of facial fat.The effect of descending superficial fat-pads can be exacerbated by a decline in structure and support.Above the descending fat pads the skin fibers become loose and sagging with reduced resilience and elasticity.

Voluma is indicated for cheek augmentation to put temporary volume and support back into the cheek area.Results can last 18 months to 2 years.As with other Juvederm products, Voluma has lidocaine in the gel to decrease discomfort of injecting.

Juvederm Volbella

Juvederm Volbella was FDA approved in 2016 to temporarily increase lip fullness and soften the appearance of perioral lines (“smoker’s lines”) around the lips in adults over the age of 21.Volbella temporarily replenishes the natural stores of hyaluronic acid to boost volume, giving a softer appearance to perioral lines and plumper definition to lips.

Juvederm Volbella results can last up to 12 months. As with other members of the Juvederm Family, lidocaine is in the gel to help minimize the discomfort of injecting.

Juvederm Vollure

Juvederm Vollure is Allergan’s newest hyaluronic acid, receiving FDA approval in 2017 for the temporary treatment of nasolabial folds (the “parentheses” along the side of the nose and mouth).The exciting aspect of Vollure is that it lasts up to 18 months. Juvederm Vollure is formulated using VYCROSS technology which binds different molecular weights of hyaluronic acid, contributing to the gels long lasting effects.

What Are The Possible Side Effects?

Most side effects are mild to moderate in nature, and their duration is short lasting (7 days or less). The most common side effects include but are not limited to:

  • Temporary injection site reactions such as redness, pain, swelling, lumps/bumps, bruising, itching, and discoloration.As with all skin injection procedures there is a risk of infection
  • Severe side effects include signs of allergic reaction including, rash, hives, itching, blistering or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing or talking, swelling of the mouth, face, lips or throat
  • Deadly side effects have happened when Juvederm Injectable gel was given into a blood vessel.Seek immediate medical attention if your skin turns white, if you have a change in eyesight or if you are experiencing signs of a stroke like weakness, confusion, trouble thinking or speaking, drooping on one side of the face or change in balance
Are There Any Reasons Why I Should Not Receive Juvederm Injectable Gel?

Your injector will ask about your medical history to determine if you are an appropriate candidate for the treatment. Juvederm Injectable gel should not be used in patients who have:

  • Severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. Allergy to Lidocaine or any component of Juvederm Injectable gel
  • Patients with a history of allergies to gram-positive bacterial proteins
  • Allergy to lidocaine
  • An active inflammatory process or infection at specific injection sites
  • Pregnancy or breastfeeding.
What Should I Discuss With My Nurse Practitioner Before Treatment?

The following are important treatment considerations for you to discuss with your Nurse Practitioner and understand in order to help avoid unsatisfactory results and complications:

  • Patients who are using substances that can prolong bleeding that include but are not limited to, herbal supplements, vitamins, NSAIDs including aspirin and ibuprofen, anticoagulant or antiplatelet medications, as with any injection, may experience increased bruising or bleeding at injection site
  • If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Juvederm Injectable gel, there is a possible risk of an inflammatory reaction at the treatment site
  • Juvederm Injectable gel should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body’s immune response, as there may be increased risk of infection
  • The safety of Juvederm Injectable gel for use during pregnancy, in breast feeding females or in patients under the age of 18 years old (Voluma 21 years old) has not been established
  • The safety of Juvederm Injectable gel in patients with a history of excessive scarring, such as hypertrophic scarring and keloid formation, and pigmentation disorders has not been studied.
Will the Injections Hurt?

Injections may cause discomfort during and after the injection. Juvederm Ultra/Ultra Plus/Voluma Injectable gel is injected into the skin using a fine needle to reduce injection discomfort, it also contains Lidocaine. Your Nurse Practitioner injector will numb the treatment area to further to minimize the discomfort.

 

Aftercare Instructions

Within the first 24 hours after being injected with Juvederm Injectable gel you should avoid:

  • Extensive sun or heat exposure
  • Alcoholic beverages
  • Avoid strenuous physical activity
  • Avoid massaging or touching the treated areas

The first night:

  • Sleep with your head elevated for one night
  • You may resume skin care products such as retinoid, alpha hydroxyl acids the day after the procedure
  • Tylenol or ibuprofen can be taken for discomfort/pain
  • If there is swelling you may place an ice pack over the swollen area

When Should I Notify My Provider?

Be sure to report any redness and/or visible swelling that lasts for more than a few days or any other symptoms that cause you concern to your Nurse Practitioner.

Within the first 24 hours after being injected with Juvederm Injectable gel you should avoid:

  • Extensive sun or heat exposure
  • Alcoholic beverages
  • Avoid strenuous physical activity
  • Avoid massaging or touching the treated areas

The first night:

  • Sleep with your head elevated for one night
  • You may resume skin care products such as retinoid, alpha hydroxyl acids the day after the procedure
  • Tylenol or ibuprofen can be taken for discomfort/pain
  • If there is swelling you may place an ice pack over the swollen area

When Should I Notify My Provider?

Be sure to report any redness and/or visible swelling that lasts for more than a few days or any other symptoms that cause you concern to your Nurse Practitioner.

JUVÉDERM® Collection of Fillers Important Information

INDICATIONS

JUVÉDERM VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.

JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM VOLLURE™ XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

JUVÉDERM VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.

WARNINGS

  • Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. 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: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
  • Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

PRECAUTIONS

  • In order to minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy
  • Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications
  • The safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies
  • As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
  • The safety for use during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
  • The safety for use of JUVÉDERM VOLUMA® XC in patients under 35 or over 65 years, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years, and JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been established
  • Use with caution in patients on immunosuppressive therapy
  • Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
  • If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site
  • Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
  • The safety of JUVÉDERM VOLUMA® XC injectable gel for use in patients with very thin skin in the mid-face has not been established
  • Patients may experience late onset nodules with use of dermal fillers, including JUVÉDERM VOLUMA® XC
  • Patients may experience late onset adverse events with use of dermal fillers

ADVERSE EVENTS

The most commonly reported side effects for JUVÉDERM® injectable gels were injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, side effects were predominantly moderate in severity, with duration of 2 to 4 weeks; for JUVÉDERM® Ultra XC , JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLLURE™ XC, they were mostly mild or moderate in severity, with duration of 14 days or less; and for JUVÉDERM VOLBELLA® XC, they were predominantly mild or moderate, with duration of 30 days or less.

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan at 1-800-433-8871. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM® Collection are available by prescription only.