Dosage and Administration ( |
05/2020 |
Warnings and Precautions ( |
05/2020 |
Adverse reactions | KYBELLA (N=513) n (%) |
Placebo (N=506) n (%) |
Injection site reactions | 492 (96%) | 411 (81%) |
edema/swelling | 448 (87%) | 218 (43%) |
hematoma/bruising | 368 (72%) | 353 (70%) |
pain | 356 (70%) | 160 (32%) |
numbness | 341 (66%) | 29 (6%) |
erythema | 136 (27%) | 91 (18%) |
induration | 120 (23%) | 13 (3%) |
paresthesia | 70 (14%) | 20 (4%) |
nodule | 68 (13%) | 14 (3%) |
pruritus | 64 (12%) | 30 (6%) |
skin tightness | 24 (5%) | 6 (1%) |
site warmth | 22 (4%) | 8 (2%) |
nerve injury b | 20 (4 %) | 1 (<1%) |
Headache | 41 (8%) | 20 (4%) |
Oropharyngeal pain | 15 (3%) | 7 (1%) |
Hypertension | 13 (3%) | 7 (1%) |
Nausea | 12 (2%) | 3 (1%) |
Dysphagia | 10 (2%) | 1 (<1%) |
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(N=256) |
(N=250) |
(N=258) |
(N=258) |
2-Grade Composite Response a | 13.4% | <0.1% | 18.6% | 3.0% |
1-Grade Composite Response b | 70.0% | 18.6% | 66.5% | 22.2% |
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KYBELLA is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.” It is not known if KYBELLA is safe and effective in children under 18 years of age. It is not known if KYBELLA is safe and effective for the treatment of fat outside of the submental area. |
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Do not receive KYBELLA if:
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These are not all of the possible side effects of KYBELLA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for more information about KYBELLA that is written for health professionals. |
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Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2020 Allergan. All rights reserved. KYBELLA® and its design are registered trademarks of Allergan Sales, LLC. Allergan® and its design are trademarks of Allergan, Inc. Patented. See www.allergan.com/patents For more information about KYBELLA |
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