Hyaluronic Acid Filler JUVÉDERM VOLUMA® XC: Let's talk about the fillers - Part II.

This is an article about JUVÉDERM VOLUMA® XC injectable gel, which will possibly answer all your questions regarding the filler.

JUVÉDERM VOLUMA® XC injectable gel is a smooth, colorless hyaluronic acid (HA) gel that contains a small quantity of local anesthetic (lidocaine). HA is a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and help the skin retain its natural moisture and softness. The addition of lidocaine helps to improve the comfort of the injection.

JUVÉDERM VOLUMA® XC injectable gel is manufactured using VYCROSS® technology to give a specialized smooth-gel filler that produces long-lasting results at the treatment site.

JUVÉDERM VOLUMA® XC is delivered by an injection into the cheek and surrounding area of the mid-face to correct volume and fullness. In addittion to that, it has been "off-label" used for penile enhancement. It adds volume to the area and results in a smoother contour and more youthful appearance.

How is JUVÉDERM VOLUMA® XC used? It is injected into the area using a small needle or special cannula. It temporarily corrects volume in the area and gives the appearance of a more youthful, smoother skin surface.

Are there any reasons why I should not receive JUVÉDERM VOLUMA® XC injectable gel? Your doctor will ask about your medical history to determine if you are an appropriate candidate for treatment.

• You should not use the product if you have severe allergies with a history of severe reactions (anaphylaxis). Use may result in an allergic reaction, though this is an extremely rare complication.

• You should not use the product if you are allergic to lidocaine or to the proteins used to make the HA in JUVÉDERM VOLUMA® XC (Gram-positive bacterial proteins). Use may result in an allergic reaction.

What precautions should my doctor advise me about? The following are important treatment considerations for you to discuss with your doctor and understand in order to help avoid unsatisfactory results and complications.

• Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site.

• Tell your doctor your age and discuss how your age may influence your decision to use this product. The safety of JUVÉDERM VOLUMA® XC has not been studied in patients under 35 years or over 65 years.

• Tell your doctor if you have a history of excessive scarring (thick, hard scars). The safety of JUVÉDERM VOLUMA® XC injectable gel in patients with a history of excessive scarring has not been studied and may result in additional scars.

• Tell your doctor if you have a history of pigmentation disorders. The safety of JUVÉDERM VOLUMA® XC in patients with a history of pigmentation disorders has not been studied. Use in these patients may result in changes in pigmentation.

• Tell your doctor if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use may result in an increased risk of infection.

• Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may result in increased bruising or bleeding at the injection site.

• Patients who experience skin injury near the site of JUVÉDERM VOLUMA® XC implantation may be at a higher risk for adverse events.

What are possible side effects? In the clinical study, most side effects were moderate (uncomfortable) in nature, and generally lasted 2 to 4 weeks. The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. These side effects are consistent with other injection procedures. Although most side effects will resolve with time, some side effects may persist longer than 30 days. Your doctor may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase (an enzyme that breaks down HA). As with all skin-injection procedures, there is a risk of infection. One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent.

What happens in the office before the injection? Note that each doctor may have a unique process for assessing and treating patients. The following is an example of what you would experience with a typical procedure. (Continued on reverse side.) What happens in the office before the injection? (continued) Before the injection procedure, your doctor will ask you questions about your medical history, as well as your treatment goals. Your doctor will discuss whether you are an appropriate candidate for JUVÉDERM VOLUMA® XC and review what to expect during and after treatment, including possible side effects. Your doctor will also examine your skin in and around the treatment area, and may take photos. Different options for pain management will be discussed, and if pretreatment numbing is desired, a topical such as lidocaine cream, or other anesthetic agent may be used. The treatment area will be cleaned and then prepared with alcohol or other antiseptic. Your doctor may use a pen to mark the area, identifying the planned areas of injection.

What happens during the procedure? After the first injection, your doctor will wait a few seconds to allow the lidocaine to take effect before moving forward with the rest of the treatment. JUVÉDERM VOLUMA® XC will be injected in small amounts over the treatment area until the desired aesthetic outcome is achieved. Your doctor may massage the treatment area gently to assure that the product is evenly distributed. An ice pack may be applied for a brief period following treatment to minimize swelling and reduce pain.

Do the injections hurt? Injections may cause some discomfort during and after the procedure. In the JUVÉDERM VOLUMA® XC injectable gel clinical study, immediately after injection subjects rated injection pain, on average, as a 3 on an 11-point scale where 0 is no pain and 10 is worst pain imaginable. JUVÉDERM VOLUMA® XC injectable gel contains lidocaine to reduce injection site pain. Your doctor may also choose to numb (anesthetize) the treatment area with a topical or injected numbing agent to further minimize discomfort.

What should I expect following the procedure? In the clinical trial the most common side effects were temporary reactions at the treatment site such as tenderness, swelling, firmness, and lumps/bumps. These side effects generally lasted 2 to 4 weeks.

Your doctor will also tell you what to expect following treatment with JUVÉDERM VOLUMA® XC injectable gel.

• Within the first 24 hours, you should minimize strenuous exercise and exposure to extensive sun or heat. Exposure to any of the above may increase temporary redness, swelling, and/or itching at the injection site.

• If there is swelling, you may place an ice pack over the swollen area.

Will I need more than one treatment to achieve my desired result? You should discuss your treatment goals and plan with your doctor. In the clinical study, 82% of subjects received a touch-up treatment 1 month after initial treatment in order to achieve the desired result.

Does the correction last forever? No. While individual results may vary, in the clinical study, the results lasted up to 2 years in a majority of subjects treated with JUVÉDERM VOLUMA® XC. After this, repeat injections are usually needed to maintain your desired result.

WHEN TO CALL YOUR DOCTOR

When should I call my doctor? Call your doctor immediately if you have:

1) White appearance of skin

2) Unusual pain during or shortly after treatment

Be sure to also call your doctor if you have:

1) Significant pain away from the injection site

2) Any redness and/or visible swelling that lasts for more than a few days

3) Any side effect that occurs weeks or months after treatment

4) Any other symptoms that cause you concern

You may also contact the Allergan Product Surveillance line during normal business hours at 1-877-345-5372 to report any side effects.

GLOSSARY

* Anesthetic—a substance that reduces sensitivity to pain

* Hyaluronic acid (HA)—a polysaccharide (sugar) that is naturally in the body. It keeps skin moisturized and soft. HA fillers, including the JUVÉDERM® XC range of products, are a modified form of the HA that is naturally in your body

* Lidocaine—a synthetic compound used as a local anesthetic to decrease pain

* Pigmentation disorder—a medical condition that results in a change in skin color

* Repeat injection—an additional treatment with dermal filler that is given after the effects of the initial treatment have worn off, in order to maintain the desired result

* Topical—a cream or ointment applied on top of the skin and affecting only the area to which it is applied

* Touch-up—an additional injection of a small amount of dermal filler usually given about 2 weeks to 1 month after the initial injection. A touch-up treatment may be necessary to achieve the desired result VYCROSS ® technology—a unique manufacturing process that provides a high concentration of crosslinked HA for long-lasting results. It creates a smooth-consistency gel that flows easily into the skin and provides a smooth, natural look and feel.

An article is prepared by using information provided by Allergan: