Deoxycholic acid

Name: Deoxycholic acid

Warnings

Contraindications

Presence of infection at the injection sites

Cautions

Marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials; do not inject into or in close proximity to the marginal mandibular branch of the facial nerve

Difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration site reactions (eg, pain, swelling, and induration of the submental area); current or prior history of dysphagia may exacerbate the condition; avoid use in these patients

Injection site hematoma/bruising reported in 72% of patients treated; caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur

Risk of injecting in proximity to vulnerable anatomic structures; to avoid potential tissue damage, should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes, and muscles

Patient Handout

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What is the most important information I should know about deoxycholic acid?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I avoid after receiving deoxycholic acid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Uses for Deoxycholic Acid

Deoxycholic acid has the following uses:

Deoxycholic acid is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.1

Deoxycholic acid has the following limitation of use:

The safe and effective use of deoxycholic acid for the treatment of subcutaneous fat outside the submental region has not been established and such use is not recommended.1

Cautions for Deoxycholic Acid

Contraindications

Deoxycholic acid is contraindicated in the presence of infection at the injection sites.1

Warnings/Precautions

Marginal Mandibular Nerve Injury

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials. To avoid the potential for nerve injury, deoxycholic acid should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). 1

Dysphagia

Difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). 1

Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of deoxycholic acid in these patients as current or prior history of dysphagia may exacerbate the condition. 1

Injection Site Hematoma/Bruising

In clinical trials, 72% of subjects treated with deoxycholic acid experienced injection site hematoma/bruising.1

Deoxycholic acid should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. 1

Risk of Injecting in Proximity to Vulnerable Anatomic Structures

To avoid potential tissue damage, deoxycholic acid should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles. 1

Specific Populations

Pregnancy

There are no adequate and well-controlled studies of deoxycholic acid in pregnant women to inform the drug-associated risk. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk of major birth defects in the U.S. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. In animal reproduction studies, no fetal harm was observed with the subcutaneous administration of deoxycholic acid to rats during organogenesis at doses up to 5 times the maximum recommended human dose (MRHD) of 100 mg. 1

Embryofetal development studies have been performed in rats and rabbits using subcutaneous doses of deoxycholic acid administered during the period of organogenesis. For the basis of comparing animal to human doses, the MRHD is 1.7 mg/kg (100 mg/60 kg). No evidence of fetal harm was observed in rats at up to the highest dose tested (50 mg/kg) which is 5-fold higher than the MRHD of deoxycholic acid based on a mg/m2 comparison. However, missing intermediate lung lobe was noted in rabbits at all dose levels tested including the lowest dose (10 mg/kg) which is 2-fold higher than the MRHD of deoxycholic acid based on a mg/m2 comparison. These effects may be related to maternal toxicity, which was also seen at all dose levels tested. 1

Lactation

There is no information available on the presence of synthetic deoxycholic acid in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for deoxycholic acid and any potential adverse effects on the breastfed child from deoxycholic acid or from the underlying maternal condition. 1

Pediatric Use

Safety and effectiveness in patients below the age of 18 years have not been established and deoxycholic acid is not intended for use in children or adolescents. 1

Geriatric Use

The clinical trials of deoxycholic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 1

Common Adverse Effects

The most common adverse reactions (>20% of subjects) include injection site edema/swelling, hematoma, pain, numbness, erythema and induration.1

Uses of Deoxycholic Acid

  • It is used to improve the look of fat below the chin (double chin).

How is this medicine (Deoxycholic Acid) best taken?

Use deoxycholic acid as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about deoxycholic acid, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about deoxycholic acid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using deoxycholic acid.

Review Date: October 4, 2017

Pharmacology

Deoxycholic acid is a cytolytic drug that physically destroys the cell membrane causing lysis when injected into tissue.

Absorption

Rapid after subcutaneous injection

Metabolism

Not metabolized to any significant extent

Excretion

Feces (as intact drug)

Time to Peak

18 minutes

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, doses administered are ~3% of total body acid pool and are unlikely to be affected by hepatic impairment.

Monitoring Parameters

Monitor postinjection for submental area induration, pain or swelling or marginal mandibular nerve injury.

Deoxycholic acid Pregnancy Warnings

The background risk of major birth defects and miscarriage for the indicated population is unknown. Animal studies did not reveal fetal harm or fertility impairment in rats administered doses up to 5-fold higher than the maximum recommended human dose (MRHD), but missing intermediate lung lobe was noted in rabbits at all dose levels tested including the lowest dose which is 2-fold higher than the MRHD. These effects may be related to maternal toxicity, which was also seen at all dose levels tested. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not assigned

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