Chemical formula: C₂₄H₄₀O₄ Molecular mass: 392.572 g/mol PubChem compound: 222528
Reproduction studies have been performed in rats and rabbits at exposures up to 1.8 times (rat) and 12 times (rabbit) the exposure at maximum recommended human dose. While they do not indicate direct or indirect harmful effects with respect to reproductive toxicity, inconclusive findings of missing intermediate lung lobe was noted in rabbits in the embryo-fetal toxicity study.
There are no adequate and well-controlled studies in pregnant women. As a precautionary measure, it is preferable to avoid the use of deoxycholic acid during pregnancy.
There is no information available on the presence of deoxycholic acid in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. Because studies in nursing mothers have not been conducted, caution should be exercised when deoxycholic acid is administered to a nursing woman.
There are no clinical data on fertility. Deoxycholic acid did not affect general reproductive performance or fertility in male or female rats at doses up to 50 mg/kg, corresponding to approximately 5- and 3-fold exposure margins, respectively, to the maximum human recommended dose.
No studies on the effects on the ability to drive and use machines have been performed.
The data described in the underlying table reflect undesirable effects reported for deoxycholic acid treated patients who were evaluated in the clinical studies that assessed the use of deoxycholic acid for the treatment of submental fat.
The following side effects have been evaluated in clinical studies with the following frequencies:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Common: Headache
Uncommon: Dysgeuisia
Uncommon: Dysphonia
Common: Dysphagia, nausea
Common: Skin tightness
Very Common: Injection site: Pain, oedema, swelling, anaesthesia, nodule, haematoma, paraesthesia, induration, erythema, pruritus
Common: Injection site: Haemorrhage, discomfort, warmth, discolouration
Uncommon: Injection site: Alopecia, urticaria, ulcer, hypersensitivity
Not known: Injection site; Hypoaesthesia, necrosis*, artery necrosis
Common: Injection site nerve injury
* Adverse reactions related to injection site necrosis were reported as fat necrosis, necrosis, skin necrosis and soft tissue necrosis. These events occurred around the treatment area with affected area ranging between 0.5 cm and 3 cm. In rare cases, the entire submental area was affected.
Overall, the majority of adverse reactions resolved within the treatment interval. The following table presents adverse reactions that have been reported to last longer than the injection intervals of 4 weeks, based on results from the four phase 3 studies (N=758) in deoxycholic acid treated patients.
| Adverse Reactions | Deoxycholic acid | Mean Time to Resolutiona (Range) |
|---|---|---|
| Injection site nerve injury | 3.6% | 53 days (1-334 days) |
| Injection site induration | 23.4% | 41 days (1-292 days) |
| Injection site nodule | 12.0% | 48 days (1-322 days) |
| Injection site pain | 74.1% | 12 days (1-333 days) |
| Injection site sensory symptoms | 66.4% | 46 days (1-349 days) |
| Injection site anaesthesia | 61.6% | 50 days (1-349 days) |
| Injection site paraesthesia | 11.3% | 27 days (1-297 days) |
| Injection site swelling | 78.6% | 15 days (1-218 days) |
| Dysphagia | 1.5% | 22 days (1-142 days) |
a Pertaining to deoxycholic acid group only
In the clinical studies, some of the local reactions, such as induration, nodule, anaesthesia, pain and swelling at the injection site, and injection site motor nerve injury, were reported as not recovered within the duration of the clinical studies.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
