Poly-L-lactic Acid-Carboxymethylcellulose-Mannito

Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol is a prescription medication indicated as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.

• Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol is available under the following different brand names: Sculptra Aesthetic.

Common side effects of Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol include:

• injection site reactions such as bleeding, tenderness or pain/discomfort, redness, bruising, or swelling

Serious side effects of Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol include:

• not available

Rare side effects of Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intradermal suspension

• 367.5 mg/vial (reconstitution required)

Nasolabial fold contour deficiencies

Adult dosage

• Inject using threading or tunneling technique in a grid pattern
• May use up to 4 sessions with 3-week intervals
• Typical injection amount/site is 1 mL
• Maximum injection is 2.5 mL/site

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol has no noted severe interactions with any other drugs
• Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol has no noted serious interactions with any other drugs
• Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol has no noted moderate interactions with any other drugs
• Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to components
• Known history of or susceptibility to keloid formation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Poly-L-lactic Acid-Carboxymethylcellulose-Mannitol?”

Cautions

• Unique injection requirements which include tunneling technique in a grid pattern; use only by a physician trained in the technique
• Do not overcorrect contour deficiency; facial depression is expected to gradually improve over several weeks
• Do not inject in blood vessels; may cause vascular occlusion, infarction, or emboli
• Defer injection if the treatment area is inflamed (eg, cysts, pimples, rash, hives) or infected
• Injection site reactions include the delayed occurrence of papules, nodules, hematoma, bruising-ecchymosis, bleeding, edema, discomfort, inflammation, and erythema
• Safety and efficacy have not been established for use in the lips, periorbital area, during pregnancy or lactation, or in individuals with a history of keloid formation, hypertrophic scarring, connective tissue disease, active inflammatory conditions, bleeding disorders, active hepatitis, serious abnormalities in lab findings (. eg, cancer, stroke, MI), on any immunosuppressive therapy, and/or with any other prior or concomitant treatment at the treatment site
• The microparticles may be visible on CT scans, MRI, or by other imaging techniques
• Embolization
  • Rare, but serious, injuries may occur because of unintentional injection of a soft tissue filler into blood vessels in the face
  • May result in restricted blood supply to tissues and lead to embolization, which could cause vision impairment, blindness, stroke, and damage and/or necrosis of the skin and underlying facial structures

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.
• Lactation
  • Unknown whether distributed in breast milk