Hepatalgina Tablets

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Hepatalgina Tablets uses

Hepatalgina Tablets consists of Boldine, Cynara, Dehydrocholic Acid, Deoxycholic Acid, Menthol, Wild Carrot.

Deoxycholic Acid:


1 INDICATIONS AND USAGE

Hepatalgina Tablets is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. (1.1)

Limitation of use: The safe and effective use of Hepatalgina Tablets (Deoxycholic Acid) for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. (1.2)

1.1 Fullness Associated with Submental Fat

Hepatalgina Tablets (Deoxycholic Acid) (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

1.2 Limitation of use

The safe and effective use of Hepatalgina Tablets (Deoxycholic Acid) for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

2 DOSAGE AND ADMINISTRATION

  • 0.2 mL injections spaced 1 cm apart until all sites in the planned treatment area have been injected.
  • Up to 50 injections or 10 mL may be injected in a single treatment. (2.1)
  • Up to 6 single treatments may be administered at intervals no less than 1-month apart. (2.1)
  • See General Considerations for Administration and Injection Technique before injection. (2.2, 2.3)

2.1 Dosage

Hepatalgina Tablets (Deoxycholic Acid) is injected into subcutaneous fat tissue in the submental area using an area-adjusted dose of 2 mg/cm2.

  • A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1 cm apart.
  • Up to 6 single treatments may be administered at intervals no less than 1 month apart.

See General Considerations for Administration (2.2) and Injection Technique (2.3) before injection.

2.2 General Considerations for Administration

Hepatalgina Tablets should be administered by a healthcare professional.

Screen patients for other potential causes of submental convexity/fullness (e.g., thyromegaly and cervical lymphadenopathy).

Give careful consideration to the use of Hepatalgina Tablets (Deoxycholic Acid) in patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome.

Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer Hepatalgina Tablets (Deoxycholic Acid) or to obtain the desired aesthetic result.

Hepatalgina Tablets (Deoxycholic Acid) is clear, colorless and free of particulate matter. Visually inspect Hepatalgina Tablets (Deoxycholic Acid) vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter.

After use, discard any remaining solution in the vial.

2.3 Injection Technique

The safe and effective use of Hepatalgina Tablets (Deoxycholic Acid) depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques.

Health care professionals administering Hepatalgina Tablets (Deoxycholic Acid) must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures .

Avoid injections near the area of the marginal mandibular nerve

Needle placement with respect to the mandible is very important as it reduces the potential for injury to the marginal mandibular nerve, a motor branch of the facial nerve. Injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor muscles .

To avoid injury to the marginal mandibular nerve:

  • Do not inject above the inferior border of the mandible.
  • Do not inject within a region defined by a 1-1.5 cm line below the inferior border (from the angle of the mandible to the mentum).
  • Inject Hepatalgina Tablets (Deoxycholic Acid) only within the target submental fat treatment area.
Figure 1. Avoid the Marginal Mandibular Nerve Area

Avoid injection into the platysma

Prior to each treatment session, palpate the submental area to ensure sufficient submental fat and to identify subcutaneous fat between the dermis and platysma (pre-platysmal fat) within the target treatment area (Figure 2). The number of injections and the number of treatments should be tailored to the individual patient's submental fat distribution and treatment goals.

Figure 2. Sagittal View of Platysma Area

Injecting into the treatment area

Use of ice/cold packs, topical and/or injectable local anesthesia (e.g., lidocaine) may enhance patient comfort.

Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites (Figures 2 and 3).

Figure 3. Treatment Area and Injection Pattern

Do not inject Hepatalgina Tablets (Deoxycholic Acid) outside the defined parameters .

  • Using a large bore needle, draw 1 mL of Hepatalgina Tablets (Deoxycholic Acid) into a sterile 1 mL syringe and expel any air bubbles in the syringe barrel.
  • Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0.5 inch needle, inject 0.2 mL of Hepatalgina Tablets (Deoxycholic Acid) into the pre-platysmal fat next to each of the marked injection sites by advancing the needle perpendicular to the skin.
  • Injections that are too superficial (into the dermis) may result in skin ulceration. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration.
  • Avoid injecting into the post-platysmal fat by injecting Hepatalgina Tablets (Deoxycholic Acid) into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer (Figure 2).
  • If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered.
  • Avoid injecting into other tissues such as the muscle, salivary glands and lymph nodes.
  • Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied.
Figure 1 Figure 2 Figure 3
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3 DOSAGE FORMS AND STRENGTHS

Injection: 10 mg/mL. Hepatalgina Tablets (Deoxycholic Acid) injection is a clear, colorless, sterile solution supplied in 2 mL vials intended for single patient use. Each milliliter of the solution contains 10 mg of Hepatalgina Tablets (Deoxycholic Acid).

  • Injection: 10 mg/mL sterile solution, supplied in 2 mL vials. Each vial is for single patient use. (3)
  • Dilution or admixture with other compounds is not recommended. (3)

4 CONTRAINDICATIONS

Hepatalgina Tablets (Deoxycholic Acid) is contraindicated in the presence of infection at the injection sites.

Hepatalgina Tablets (Deoxycholic Acid) is contraindicated in the presence of infection at the injection sites. (4)

5 WARNINGS AND PRECAUTIONS

  • Marginal mandibular nerve injury: Follow injection technique to avoid this injury. (2.3, 5.1)
  • Dysphagia may occur with Hepatalgina Tablets (Deoxycholic Acid) use. Use in patients with pre-existing dysphagia may exacerbate the condition. (5.2)
  • Submental hematoma/bruising occurs frequently after Hepatalgina Tablets (Deoxycholic Acid) administration. Use with caution in patients who are being treated with antiplatelet or anticoagulant therapy or have coagulation abnormalities. (5.3)
  • Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. (2.3, 5.4)

5.1 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, Hepatalgina Tablets (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).

5.2 Dysphagia

Difficulty swallowing 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).

Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of Hepatalgina Tablets (Deoxycholic Acid) in these patients as current or prior history of dysphagia may exacerbate the condition.

5.3 Injection site hematoma/bruising

In clinical trials, 72% of subjects treated with Hepatalgina Tablets (Deoxycholic Acid) experienced injection site hematoma/bruising .

Hepatalgina Tablets (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.

5.4 Risk of injecting in proximity to vulnerable anatomic structures

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

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6 ADVERSE REACTIONS

  • The most common adverse reactions include injection site edema/swelling, hematoma, pain, numbness, erythema and induration. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Kythera Biopharmaceuticals, Inc. at 1-844-KYTHERA (1-844-598-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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 Hepatalgina Tablets (Deoxycholic Acid) 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).

a Adverse reactions that occurred in ≥ 2% Hepatalgina Tablets (Deoxycholic Acid) treated subjects and at greater incidence than placebo

b Marginal mandibular nerve paresis


Adverse reactions


Hepatalgina Tablets (Deoxycholic Acid)

(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%)

Other adverse reactions associated with the use of Hepatalgina Tablets (Deoxycholic Acid) 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%).

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate and well-controlled studies of Hepatalgina Tablets 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 Hepatalgina Tablets (Deoxycholic Acid) to rats during organogenesis at doses up to 5 times the maximum recommended human dose (MRHD) of 100 mg .

Data

Animal Data

Embryofetal development studies have been performed in rats and rabbits using subcutaneous doses of Hepatalgina Tablets (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 Hepatalgina Tablets (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 Hepatalgina Tablets (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.

8.2 Lactation

Risk Summary

There is no information available on the presence of synthetic Hepatalgina Tablets (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 Hepatalgina Tablets (Deoxycholic Acid) and any potential adverse effects on the breastfed child from Hepatalgina Tablets (Deoxycholic Acid) or from the underlying maternal condition.

8.4 Pediatric Use

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

8.5 Geriatric Use

The clinical trials of Hepatalgina Tablets (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.

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10 OVERDOSAGE

Injection of excessive doses/volumes of Hepatalgina Tablets (Deoxycholic Acid) may increase the risk of adverse reactions.

11 DESCRIPTION

Hepatalgina Tablets (Deoxycholic Acid) (deoxycholic acid) injection, 10 mg/mL is a clear colorless, sterile solution for subcutaneous use. It contains a cytolytic agent, Hepatalgina Tablets (Deoxycholic Acid), as the active ingredient. The chemical name of Hepatalgina Tablets (Deoxycholic Acid) is 3α,12α-dihydroxy-5β-cholan-24-oic acid, and its molecular formula is C24H40O4, and its molecular weight is 392.57 g/mol. The chemical structure of Hepatalgina Tablets (Deoxycholic Acid) is:

Each 2 mL vial of Hepatalgina Tablets (Deoxycholic Acid) (deoxycholic acid) injection contains 20 mg synthetic Hepatalgina Tablets (Deoxycholic Acid) as the active ingredient and the following inactive ingredients: benzyl alcohol (18 mg), dibasic sodium phosphate (2.84 mg), sodium chloride (8.76 mg), sodium hydroxide (2.86 mg) in water for injection, USP. Hydrochloric acid and additional sodium hydroxide are added as necessary to adjust the formulation to pH 8.3. Each vial is for single patient use.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Hepatalgina Tablets is a cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis.

12.2 Pharmacodynamics

Cardiac Electrophysiology

At therapeutic doses, Hepatalgina Tablets (Deoxycholic Acid) does not prolong the QTc interval.

12.3 Pharmacokinetics

Endogenous Hepatalgina Tablets (Deoxycholic Acid) plasma levels are highly variable within and between individuals; most of this natural bile component is sequestered in the enterohepatic circulation loop.

Absorption and Distribution

Hepatalgina Tablets (Deoxycholic Acid) from Hepatalgina Tablets (Deoxycholic Acid) is rapidly absorbed following subcutaneous injection. After dosing with the maximum recommended single treatment dose with Hepatalgina Tablets (Deoxycholic Acid) (100 mg), maximum plasma concentrations (mean Cmax) were observed with a median Tmax of 18 minutes after injection. The mean (±SD) Cmax value was 1024 ± 304 ng/mL and was 3.2-fold higher than average Cmax values observed during a 24-hour baseline endogenous period in the absence of Hepatalgina Tablets (Deoxycholic Acid). After maximum recommended single treatment dose (100 mg), mean (±SD) Hepatalgina Tablets (Deoxycholic Acid) exposure (AUC0-24) was 7896 ± 2269 ng.hr/mL and was 1.6-fold higher over endogenous exposure. Post-treatment Hepatalgina Tablets (Deoxycholic Acid) plasma levels returned to the endogenous range within 24 hours. No accumulation is expected with the proposed treatment frequency.

Hepatalgina Tablets (Deoxycholic Acid) is extensively bound to proteins in plasma (98%).

Metabolism and Excretion

Endogenous Hepatalgina Tablets (Deoxycholic Acid) is a product of cholesterol metabolism and is excreted intact in feces. Hepatalgina Tablets (Deoxycholic Acid) is not metabolized to any significant extent under normal conditions. Hepatalgina Tablets (Deoxycholic Acid) from Hepatalgina Tablets (Deoxycholic Acid) joins the endogenous bile acid pool in the enterohepatic circulation and is excreted along with the endogenous Hepatalgina Tablets (Deoxycholic Acid).

In Vitro Assessment of Drug Interactions

Results from in vitro studies indicate that Hepatalgina Tablets (Deoxycholic Acid) does not inhibit or induce human cytochrome P450 (CYP) enzymes at clinically relevant concentrations. Hepatalgina Tablets (Deoxycholic Acid) does not inhibit the following transporters: P-gp, BCRP, MRP4, MRP2, OATP1B1, OATP2B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, NTCP, and ASBT.

Specific Populations

Hepatic Impairment

Hepatalgina Tablets (Deoxycholic Acid) has not been studied in subjects with hepatic impairment. Considering the intermittent dose frequency, the small dose administered that represents approximately 3% of the total bile acid pool, and the highly variable endogenous Hepatalgina Tablets (Deoxycholic Acid) levels, the pharmacokinetics of Hepatalgina Tablets (Deoxycholic Acid) following Hepatalgina Tablets (Deoxycholic Acid) injection is unlikely to be influenced by hepatic impairment.

Pharmacokinetic Effects of Gender

Hepatalgina Tablets (Deoxycholic Acid) pharmacokinetics were not influenced by gender.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Hepatalgina Tablets (Deoxycholic Acid).

Hepatalgina Tablets (Deoxycholic Acid) was negative in a battery of in vitro (Ames test and chromosomal aberration assay in human lymphocytes) and in vivo (rat erythrocyte micronucleus assay) genetic toxicology assays.

No effects on fertility were observed in male and female rats administered Hepatalgina Tablets (Deoxycholic Acid) at subcutaneous doses up to 50 mg/kg (5 times the MRHD based on a mg/m2 comparison) once weekly prior to and during the mating period and through gestation day 7 in female rats.

14 CLINICAL STUDIES

Two randomized, multi-center, double-blind, placebo-controlled trials of identical design were conducted to evaluate Hepatalgina Tablets (Deoxycholic Acid) for use in improvement in the appearance of convexity or fullness associated with submental fat. The trials enrolled healthy adults (ages 19 to 65, BMI ≤ 40 kg/m2) with moderate or severe convexity or fullness associated with submental fat (i.e., grade 2 or 3 on 5-point grading scales, where 0 = none and 4 = extreme), as judged by both clinician and subject ratings. Subjects received up to 6 treatments with Hepatalgina Tablets (Deoxycholic Acid) (N=514, combined trials) or placebo (N=508, combined trials) at no less than 1 month intervals. Use of ice/cold packs, topical and/or injectable local anesthesia was allowed during the clinical trials. Injection volume was 0.2 mL per injection site, spaced 1 cm apart into the submental fat tissue, which is also expressed in dose per area as 2 mg/cm2. For each treatment session a maximum of 100 mg (10 mL) was permitted over the entire treatment area. Subjects were administered an average of 6.4 mL at the first treatment session, and subjects who received all six treatments were administered an average of 4.4 mL at the sixth treatment session. Fifty-nine percent of subjects received all six treatments.

In these trials, the mean age was 49 years and the mean BMI was 29 kg/m2. Most of the subjects were women (85%) and Caucasian (87%). At baseline, 51% of the subjects had a clinician-rated submental fat severity rating of moderate and 49% had a severe submental fat rating.

The co-primary efficacy assessments were based on at least 2-grade and at least 1-grade improvements in submental convexity or fullness on the composite of clinician-reported and patient-reported ratings of submental fat 12 weeks after final treatment. Additionally, changes in submental fat volume were evaluated in a subset of subjects (N=449, combined trials) using magnetic resonance imaging (MRI). Visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were also evaluated using a 6-question survey, with each question rated from 0 (not at all) to 10 (extremely/very much).

Reductions in submental fat volume were observed more frequently in the Hepatalgina Tablets (Deoxycholic Acid) group compared to the placebo group as measured by the composite clinician and patient ratings (Table 2). The composite response rates by visit are presented in Figure 4.

a At least 2 grade reduction on both the clinician-reported and patient-reported ratings of submental fat

b At least 1 grade reduction on both the clinician-reported and patient-reported ratings of submental fat

Trial 1 Trial 2
Endpoint Hepatalgina Tablets (Deoxycholic Acid)

(N=256)

Placebo

(N=250)

Hepatalgina Tablets (Deoxycholic Acid)

(N=258)

Placebo

(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%
Figure 4. ≥ 2-Grade and ≥ 1-Grade Composite Clinician and Patient Response

Note: Subjects were followed up 4, 12 and 24 weeks after the last treatment. Forty-one percent of subjects received fewer than 6 treatments and entered the post-treatment period earlier than Week 24.

A greater proportion of KYBELLA-treated subjects had at least a 10% reduction in submental fat volume as compared to placebo-treated subjects when evaluated by MRI (43% vs 5%, respectively).

The overall patient-reported satisfaction and self-perceived visual attributes showed greater improvement in the Hepatalgina Tablets (Deoxycholic Acid) group than in the placebo group.

Figure 4

16 HOW SUPPLIED/STORAGE AND HANDLING

Hepatalgina Tablets (Deoxycholic Acid) (deoxycholic acid) injection, 10 mg/mL is a clear, colorless, sterile solution supplied in 2 mL, single patient use vials in the following dispensing pack:

4 vials, NDC 61168-101-04

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).

Hepatalgina Tablets (Deoxycholic Acid) has a unique hologram on the vial label. If you do not see a hologram, do not use the product and call 1-844-KYTHERA (1-844-598-4372).

Each vial is for a single patient use. Do not dilute. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise patients to inform their healthcare professional if they develop signs of marginal mandibular nerve paresis (e.g., asymmetric smile, facial muscle weakness), difficulty swallowing, or if any existing symptom worsens.

Manufactured for Kythera Biopharmaceuticals, Inc., Westlake Village, CA 91362

© 2015 Kythera Biopharmaceuticals, Inc.

Trademarks owned by Kythera Biopharmaceuticals, Inc.

U.S. Patents 8,298,556; 7,622,130; 7,754,230; 8,242,294; 8,101,593; 8,367,649; 8,653,058, 8,461,140; 8,846,066; other patents pending

This Patient Information has been approved by the U.S. Food and Drug Administration

Issued: April 2015

Patient Information

Hepatalgina Tablets (Deoxycholic Acid) TM (kye be' lah)

(deoxycholic acid) injection

What is Hepatalgina Tablets (Deoxycholic Acid)?

Hepatalgina Tablets (Deoxycholic Acid) 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 Hepatalgina Tablets (Deoxycholic Acid) is safe and effective in children less than 18 years of age.

It is not known if Hepatalgina Tablets (Deoxycholic Acid) is safe and effective for use outside of the submental area.

Who should not receive Hepatalgina Tablets (Deoxycholic Acid)?

You should not receive Hepatalgina Tablets (Deoxycholic Acid) if you have an infection in the treatment area.

Before receiving Hepatalgina Tablets (Deoxycholic Acid), tell your healthcare provider about all of your medical conditions, including if you:

  • have had or plan to have surgery on your face, neck, or chin
  • have had cosmetic treatments on your face, neck, or chin
  • have had or have medical conditions in or near the neck area
  • have had or have trouble swallowing
  • have bleeding problems
  • are pregnant or plan to become pregnant. It is not known if Hepatalgina Tablets (Deoxycholic Acid) will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Hepatalgina Tablets (Deoxycholic Acid) passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive Hepatalgina Tablets (Deoxycholic Acid).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine).
How will I receive Hepatalgina Tablets (Deoxycholic Acid)?

  • Hepatalgina Tablets (Deoxycholic Acid) is injected into the fat under your chin (up to 50 injections under your skin) by your healthcare provider.
  • Hepatalgina Tablets (Deoxycholic Acid) injections will be given at least 1 month apart. You and your healthcare provider will decide how many treatments you need.
What are the possible side effects of Hepatalgina Tablets (Deoxycholic Acid)?

Hepatalgina Tablets (Deoxycholic Acid) can cause serious side effects, including:

  • Nerve injury in the jaw that can cause an uneven smile or facial muscle weakness
  • Trouble swallowing

The most common side effects of Hepatalgina Tablets (Deoxycholic Acid) include: swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.

These are not all of the possible side effects of Hepatalgina Tablets (Deoxycholic Acid). Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Hepatalgina Tablets (Deoxycholic Acid).

This leaflet summarizes the most important information about Hepatalgina Tablets (Deoxycholic Acid). If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Hepatalgina Tablets (Deoxycholic Acid) that is written for health professionals.

What are the ingredients in Hepatalgina Tablets (Deoxycholic Acid)?

Active ingredient: Hepatalgina Tablets (Deoxycholic Acid)

Inactive ingredients: benzyl alcohol, dibasic sodium phosphate, hydrochloric acid, sodium chloride, sodium hydroxide and water for injection, USP.

Manufactured for Kythera Biopharmaceuticals, Inc., Westlake Village, CA 91362 ©2015 Kythera Biopharmaceuticals, Inc.

For more information about Hepatalgina Tablets (Deoxycholic Acid) go to www.mykybella.com.


NDC 61168-101-04

Hepatalgina Tablets (Deoxycholic Acid)

(deoxycholic acid) injection

20 mg/2mL

(10 mg/mL)

for subcutaneous use only

Single use vials. Discard unused portion.

Four ready-to-use vials. Do not dilute.

Rx ONLY

KYTHERA Biopharmaceuticals, Inc.

Menthol:


Hepatalgina Tablets (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of Hepatalgina Tablets (Menthol) occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Hepatalgina Tablets (Menthol) has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.

Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.

Hepatalgina Tablets (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Hepatalgina Tablets (Menthol) does not cause an actual drop in temperature.

Hepatalgina Tablets pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Hepatalgina Tablets available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Hepatalgina Tablets destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Hepatalgina Tablets Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Hepatalgina Tablets pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MYOGESIC-CS (MENTHOL ) SPRAY [VETGENIX]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."DEOXYCHOLIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Hepatalgina Tablets?

Depending on the reaction of the Hepatalgina Tablets after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hepatalgina Tablets not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Hepatalgina Tablets addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Hepatalgina Tablets, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Hepatalgina Tablets consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Hepatalgina Tablets useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
> 601
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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