Pharmaceutical Name

Trade (marketing or proprietary) name: JUVÉDERM® Ultra XC

Indication and Usage

Reason the product has been approved for sale on the market.

The FDA has approved this injectable gel for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) as well as for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

Manufacturer Insert

Ingredients

JUVÉDERM Ultra XC is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless, homogeneous gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus species of bacteria, formulated to a concentration of 24 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

JUVÉDERM Ultra XC is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.

JUVÉDERM Ultra XC contains trace amounts of Gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.

JUVÉDERM Ultra XC contains lidocaine and is contraindicated for patients with a history of allergies to such material.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Warnings

The product must not be injected into blood vessels. Introduction of JUVÉDERM Ultra XC 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, including changes in vision, signs of a stroke, blanching of the skin, or 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 (see Healthcare Professional Instructions #13).

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.

Injection site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting ≤ 7 days in wrinkles and typically last ≤ 14 days in the lips.

Precautions

JUVÉDERM Ultra XC is packaged for single-patient use. Do not resterilize. Do not use if package is opened or damaged.

In order to minimize the risks of potential complications, this product should only be used by
healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.

Healthcare professionals are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

Based on preclinical studies, patients should be limited to 20 mL of JUVÉDERM Ultra XC per
60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been
established.

The safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds, lips, and perioral area have not been established in controlled clinical studies.

As with all transcutaneous procedures, dermal filler implantation carries a risk of infection.
Standard precautions associated with injectable materials should be followed.

JUVÉDERM Ultra XC is to be used as supplied. Modification or use of the product outside the Directions for Use may adversely impact the sterility, homogeneity, and performance of the product and it can therefore no longer be assured.

The safety for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.

The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied.

JUVÉDERM Ultra XC should be used with caution in patients on immunosuppressive therapy.

Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal antiinflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at injection sites.

After use, treatment syringes and needles may be potential biohazards. Handle and dispose of these items in accordance with accepted medical practice and applicable local, state, and federal requirements.

JUVÉDERM Ultra XC injectable gel is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe; notify Allergan Product Support at 1-877-345-5372.

If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM Ultra XC, there is a possible risk of eliciting an inflammatory reaction at the implant site. An inflammatory reaction is also possible if the product is administered before the skin has healed completely after such a procedure.

Failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the LUER-LOK® and needle hub connection.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Lack or loss of correction, Inflammatory reaction, Allergic reaction, Necrosis (body tissue death), Infection, Migration, Paresthesia, Dry skin, Headache, Malaise, Vision abnormalities, Flu like symptoms, Abscess, Scarring, Bruising, Nausea, Redness, Swelling, Firmness, Drainage, Dyspnea (shortness of breath), Syncope (fainting), Dizziness, Anxiety, Granuloma (white blood cell cluster that causes a lump on skin or in body), Tenderness, Lumps/bumps, and Discoloration

Specific Populations

Pregnancy and Breastfeeding

The safety for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

JUVÉDERM Ultra XC is a sterile, biodegradable, nonpyrogenic, viscoelastic, clear, colorless,
homogeneous gel implant. It consists of cross-linked hyaluronic acid (HA) produced by Streptococcus species of bacteria, formulated to a concentration of 24 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.

Analytical Deep Dive

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