Calcium hydroxylapatite, also known as CaHA, is the main ingredient of Radiesse. Radiesse is a water-based material that is injected into the skin. Radiesse belongs to the class of medicines called dermal fillers. Injecting Radiesse into facial skin may give it a firmer, fuller appearance.
CaHA is used in many medical applications, such as dental ridge augmentation and tissue marking. CaHA products are used worldwide for facial and plastic reconstructive surgery.
HIV/AIDS-Related Uses
Radiesse was approved by the FDA on December 22, 2006, for the treatment of facial fat loss (also called facial lipoatrophy). It continues to be studied for this use. Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with HIV who take anti-HIV drugs may develop lipoatrophy.Radiesse is injected into the skin in areas where fat has been lost. It improves the appearance of folds and sunken areas and hides the fat loss. The effects of treatment appear to last at least a year after the first treatment session.Radiesse does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Dosage Form/Administration
Radiesse comes in liquid form that is injected under the skin. Radiesse is available in a single-use, sterilized syringe containing 0.3, 1, or 1.3 mL of solution. In each syringe, CaHA particles are suspended in a water-based solution that is injected into the skin. Only a health care provider with special training should inject Radiesse.
Contraindications
Individuals should tell a doctor about any medical problems before using this medicine.Radiesse should not be used for short-term treatment and should not be used by people allergic to any of the carrier ingredients.
Possible Side Effects
Along with its desired effects, Radiesse can cause some unwanted effects; not all of these effects are known at this time. In most studies, side effects were mild and included redness, swelling, and bruising at the injection site. Individuals should tell a doctor if they have any of these side effects.
Drug and Food Interactions
A doctor should be notified of any other medications being taken, including prescription, nonprescription (over-the-counter), or herbal medications.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use Calcium hydroxylapatite.
Manufacturer Information
Calcium hydroxylapatite
BioForm Medical, Inc.
1875 South Grant St. Suite, #110
San Mateo, CA 94103
Phone: 650-286-4000
Fax: 650-286-4090
Radiesse
BioForm Medical, Inc.
1875 South Grant St. Suite, #110
San Mateo, CA 94103
Phone: 650-286-4000
Fax: 650-286-4090
Last Updated: June 30, 2009
Drug Description
Radiesse is a soft-tissue augmentation product composed of smooth calcium hydroxylapatite (CaHA) particles suspended in a water-based gel carrier. [1] [2]
References
[1] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[2] BioForm Medical, Inc. Press Releases: FDA Approves Radiesse Facial Filler for Two New Aesthetic Indications [press release], December 27, 2006. Available at: http://www.radiesse.com/pdf/pr_122706.pdf. Accessed 06/30/09.
HIV/AIDS-Related Uses
Radiesse was approved by the FDA on December 22, 2006, as a cosmetic dermal filler for use in the long-term correction of facial lipoatrophy associated with antiretroviral treatment in HIV infected people. [1] [2]
References
[1] BioForm Medical, Inc. Press Releases: FDA Advisory Panel Recommends Approval of Radiesse for Two Facial Aesthetic Applications [press release], August 24, 2006. Available at: http://www.radiesse-fl.com/pdfs/AdvisoryPanelApproval_PR.pdf. Accessed 06/30/09.
[2] FDA List Serve Archive: FDA approves Radiesse for treating facial lipoatrophy [press release], December 22, 2006. Available at: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124413.htm. Accessed 06/30/09.
Dosing Information
Mode of Delivery
Subcutaneous injection. [1]
Dosage Form
Single-use syringe containing 0.3, 1, or 1.3 mL of solution with active CaHA particles suspended in each needle in a gel carrier. [2] Radiesse is injected subcutaneously through a very fine needle. [3]
References
[1] BioForm Medical, Inc. Press Releases: FDA Advisory Panel Recommends Approval of Radiesse for Two Facial Aesthetic Applications [press release], August 24, 2006. Available at: http://www.radiesse-fl.com/pdfs/AdvisoryPanelApproval_PR.pdf. Accessed 06/30/09.
[2] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[3] BioForm Medical, Inc. Press Releases: FDA Advisory Panel Recommends Approval of Radiesse for Two Facial Aesthetic Applications [press release], August 24, 2006. Available at: http://www.radiesse-fl.com/pdfs/AdvisoryPanelApproval_PR.pdf. Accessed 06/30/09.
Pharmacology
CaHA is the principal inorganic constituent in human bones and teeth. [1] CaHA in Radiesse is a biocompatible, biodegradable material that is synthetically manufactured to be chemically and biologically identical to the natural substance. [2]
Radiesse contains sterile and nonpyrogenic CaHA microspheres in an aqueous carrier of glycerin, sterile water for injection, and sodium carboxymethylcellulose. [3] [4] After the carrier dissipates in vivo, CaHA particles remain below the skin in the injected area. The active ingredient of Radiesse, CaHA, has been studied extensively in the United States and worldwide; it has been proven safe and effective for various dermal filler uses. [5]
Radiesse is injected subcutaneously to increase skin thickness. Its CaHA microspheres appear in x-rays and CT scans. [6] After Radiesse is injected, the gel carrier dissipates in vivo, and CaHA particles remain at the injection site to provide durable bulking treatment. [7] The CaHA particles act by directly filling space in the soft tissue and by providing a microstructure for tissue infiltration. In addition, Radiesse may promote new collagen binding. [8]
A prospective, open-label study of Radiesse for the treatment of lipoatrophy was conducted in 100 HIV infected patients. The primary endpoint of efficacy and secondary endpoint of safety were evaluated at Months 1, 3, 6, and 12. All patients met the primary endpoint of improved aesthetics at Months 3 and 6, and all patients continued to improve by Month 12. [9] [10]
References
[1] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[2] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[3] BioForm Medical, Inc. Press Releases: FDA Approves Radiesse Facial Filler for Two New Aesthetic Indications [press release], December 27, 2006. Available at: Available at: http://www.radiesse.com/pdf/pr_122706.pdf. Accessed 06/30/09.
[4] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[5] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[6] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[7] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[8] BioForm Medical, Inc. Press Releases: FDA Approves Radiesse Facial Filler for Two New Aesthetic Indications [press release], December 27, 2006. Available at: http://www.radiesse.com/pdf/pr_122706.pdf. Accessed 06/30/09.
[9] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[10] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
Adverse Events/Toxicity
Radiesse and other products containing CaHA appear safe and well tolerated. The most common adverse effects with Radiesse treatment are redness, bruising, and swelling at the injection site; all of these side effects appear transient and mild. [1] [2]
Mild to moderate echymosis, edema, erythema, pain, and pruritis have occurred in HIV infected patients receiving Radiesse in clinical trials. Severe experiences were of short duration, were expected, and did not affect treatment outcome. The most common other adverse effect was mildly uneven skin contours and irregularities, which resolved with additional injections. No systemic or serious adverse effects were reported that were associated with treatment. [3]
In a study of Radiesse for the treatment of HIV-associated lipoatrophy, no clinically significant events occurred. Although 51% of patients in this study were considered people of color, depth of color did not appear to predict the occurrence of adverse effects. Thus, Radiesse is considered safe for use in people of color. [4]
When Radiesse was studied for the correction of nasolabial folds in 117 patients, 82% of nasolabial folds treated with Radiesse improved after 6 months. This was a significantly greater percentage than with the control, which showed improvement in only 27% of treated folds (p less than 0.0001). No granulomas occurred; the rate of nodule formation was low and was the same in control and treatment arms. [5]
References
[1] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[2] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[3] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[4] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
[5] BioForm Medical, Inc. Press Releases: FDA Approves Radiesse Facial Filler for Two New Aesthetic Indications [press release], December 27, 2006. Available at: http://www.radiesse.com/pdf/pr_122706.pdf. Accessed 06/30/09.
Contraindications
Radiesse is contraindicated for short-term augmentation or restoration. Radiesse should not be used in patients who are allergic to any of its components (sodium carboxymethylcellulose, sterile water for injection, and glycerin). [1] [2]
References
[1] FDA Dockets Management: A Patient's Guide to Treatment with Radiesse. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_05.pdf. Accessed 06/30/09.
[2] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use Hidroxilapatita de calcio.
Chemistry
Molecular Weight
CaHA particles sized 25 to 45 microns
Physical Description
Flexible, semisolid, cohesive implant. [1]
References
[1] FDA Dockets Management: Radiesse for Soft Tissue Augmentation for the Treatment of HIV-Associated Facial Lipoatrophy. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4233b1_02.pdf. Accessed 06/30/09.
Further Reading
Comite SL, Liu JF, Balasubramanian S, Christian MA. Treatment of HIV-associated facial lipoatrophy with Radiance FN (Radiesse). Dermatol Online J. 2004 Oct 15;10(2):2.
Silvers SL, Eviatar JA, Echavez MI, Pappas AL. Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):34S-45S.
Manufacturer Information
Calcium hydroxylapatite
BioForm Medical, Inc.
1875 South Grant St. Suite, #110
San Mateo, CA 94103
Phone: 650-286-4000
Fax: 650-286-4090
Radiesse
BioForm Medical, Inc.
1875 South Grant St. Suite, #110
San Mateo, CA 94103
Phone: 650-286-4000
Fax: 650-286-4090
Last Updated: June 30, 2009