KYBELLA SIDE EFFECTS

Last updated on MDtodate: 10/6/2022

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two double-blind, placebo-controlled clinical trials 513 subjects were treated with KYBELLA® injection and 506 subjects were treated with placebo. The population was 19-65 years old, 85% were women, 87% Caucasian, 8% African American. At baseline the population had a mean BMI of 29 kg/m2, moderate to severe submental convexity (graded as 2 or 3 on a 0 to 4 scale) and without excessive skin laxity. Subjects received up to 6 treatments at least 1 month apart and were followed for up to 6 months after the last received treatment.

The most commonly reported adverse reactions are listed below (Table 1).

Table 1. Adverse Reactions in the Pooled Trials 1 and 2a

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%)
a Adverse reactions that occurred in ≥ 2% KYBELLA® treated subjects and at greater incidence than placebo
b Marginal mandibular nerve paresis

 

Other adverse reactions associated with the use of KYBELLA® include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria, and neck pain.

Adverse reactions that lasted more than 30 days and occurred in more than 10% of subjects were injection site numbness (42%), injection site edema/swelling (20%), injection site pain (16%), and injection site induration (13%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of KYBELLA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to KYBELLA® exposure.

Administration site conditions: injection site ulceration, necrosis, alopecia, and scarring.

Immune System Disorders: Hypersensitivity reactions including rash, urticaria, and itching.

Nervous System Disorders: Oral hypoaesthesia and oral paraesthesia.

Procedural Complications: Vascular injury due to inadvertent intravascular injection.

 

SRC: NLM .