Pharmaceutical Name

Trade (marketing or proprietary) name: BOTOX® Cosmetic

Generic (nonproprietary or active ingredient) name: onabotulinumtoxinA injection

Indication and Usage

Reason the product has been approved for sale on the market.

FDA has approved this as a prescription medicine that is injected to improve the look of crow’s feet and frown lines in adults for a short period of time (temporary).

Manufacturer Insert

Ingredients

BOTOX® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum dried purified
botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

Each vial of BOTOX®Cosmetic contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride or 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

BOTOX® and BOTOX® Cosmetic contain the same active ingredient in the same formulation. Therefore, adverse events observed with the use of BOTOX® also have the potential to be associated with the use of BOTOX® Cosmetic.

The recommended dosage and frequency of administration for BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are not known. Lack of Interchangeability between Botulinum Toxin Products.

The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect

Postmarketing safety data from BOTOX® Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

No definitive serious adverse event reports of distant spread of toxin effect associated with
dermatologic use of BOTOX®/BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.

No definitive serious adverse event reports of distant spread of toxin effect associated with
BOTOX® for blepharospasm at the recommended dose (30 Units and below) or for strabismus at the labeled doses have been reported.

Hypersensitivity Reactions

Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.

Pre-Existing Neuromuscular Disorders

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or
neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

Dysphagia and Breathing Difficulties in Treatment of Cervical Dystonia

Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved.

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.

Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.

Cardiovascular System

There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease.

Human Albumin

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Precautions

The safe and effective use of BOTOX® Cosmetic depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering BOTOX® Cosmetic must understand the relevant neuromuscular and/or orbital anatomy of the area involved, as well as any alterations to the anatomy due to prior surgical procedures and avoid injection into vulnerable anatomic areas.

Caution should be used when BOTOX® Cosmetic treatment is used in the presence of
inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s). Reduced blinking from BOTOX® Cosmetic injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulceration, especially in patients with VII nerve disorders. In the use of BOTOX® for the treatment of blepharospasm, one case of corneal perforation in an aphakic eye requiring corneal grafting has occurred because of this effect. Careful testing of corneal sensation in eyes previously operated upon, avoidance of injection into the lower lid area to avoid ectropion, and vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other means.

Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. Covering the affected eye may alleviate these symptoms.

Caution should be used when BOTOX® Cosmetic treatment is used in patients who have an inflammatory skin problem at the injection site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart as these patients were excluded from the Phase 3 safety and efficacy trials.

Needle-related pain and/or anxiety may result in vasovagal responses, (including e.g., syncope, hypotension) which may require appropriate medical therapy.

Injection intervals of BOTOX® Cosmetic should be no more frequent than every three months and should be performed using the lowest effective dose

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Life threatening swallowing and breathing difficulties, Death, Pain in extremity, Increased cough, Injection site pain and hemorrhage, Flu syndrome, Non-axillary sweating, Dry eyes/mouth, New onset or recurrent seizures, Abdominal pain, Brachial plexopathy, Decreased hearing, Diarrhea, Ear noise, Erythema multiforme, Fever, Focal facial paralysis, Glaucoma, Localized numbness, Vomiting, Swelling of your eyelids, Spread of toxin effects: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, urinary incontinence, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, Pharyngitis, Reduced blinking with corneal exposure, persistent epithelial defect and corneal ulceration, Tiredness, Arrhythmia/myocardial infarction with fatal outcomes, Madarosis (loss of eyelashes), Itching, Rash, Red itchy welts, Wheezing, Asthma symptoms, Dizziness or feeling faint, Anaphylaxis, Urticaria, Soft tissue edema, Dyspnea, Loss of appetite, Malaise, Myalgia, Myasthenia gravis, Pruritus, Psoriasiform eruption, Retinal vein occlusion, Sweating, Syncope, Vertigo with nystagmus, Alopecia (baldness), Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water, Dysuria, Urinary retention, Neck pain, Headache, Back pain, Rhinitis

Specific Populations

Pregnancy

Administration of BOTOX® Cosmetic is not recommended during pregnancy. There are no adequate and well-controlled studies of BOTOX® Cosmetic in pregnant women. When pregnant mice and rats were injected intramuscularly during the period of organogenesis, the developmental NOEL (No Observed Effect Level) of BOTOX® Cosmetic was 4 Units/kg. Higher doses (8 Units/kg or 16 Units/kg) were associated with reductions in fetal body weights
and/or delayed ossification.

In a range finding study in rabbits, daily injection of 0.125 Units/kg/day (days 6 to 18 of gestation) and 2 Units/kg (days 6 and 13 of gestation) produced severe maternal toxicity, abortions and/or fetal malformations. Higher doses resulted in death of the dams. The rabbit appears to be a very sensitive species to BOTOX® Cosmetic.

If the patient becomes pregnant after the administration of this drug, the patient should be apprised of the potential risks, including abortion or fetal malformations that have been observed in rabbits.

Breastfeeding

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.

Fertility

The reproductive NOEL following intramuscular injection of 0, 4, 8, and 16 Units/kg was 4 Units/kg in male rats and 8 Units/kg in female rats. Higher doses were associated with dose dependent reductions in fertility in male rats (where limb weakness resulted in the inability to mate), and testicular atrophy or an altered estrous cycle in female rats. There were no adverse effects on the viability of the embryos

Pediatric

Use of BOTOX® Cosmetic is not recommended in children.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

BOTOX® Cosmetic blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX® Cosmetic produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX® Cosmetic

Analytical Deep Dive

What is informed consent?

Alternatives

Looking for alternatives? Here are some products to research:

(1) Isagenix (2) Vital Proteins (3) Perfect Supplements Hydrolyzed Collagen “JUSTTHEINSERTS” for 10% off (4) Hugh and Grace Pure Marine Collagen Peptides “JUSTTHEINSERTS10” for 10% off (5) Mad Hippie Corrective Peptide Serum (6) Better than Botox Bee Venom Magic Roller (7) Herbal Alchemy Firming Serum (8) Just Ingredients Hyaluronic Acid “JUSTTHEINSERTS10” for 10% off (9) Crunchi Golden Light Mutli-Peptide Facial Serum (10) Simply Eden Tallow Serenity Salve “JUSTTHEINSERTS” for 10% off (11) Frownies Facial Patches “JUSTTHEINSERTS” for 10% off (12) Frownies Under Eye Gels “JUSTTHEINSERTS” for 10% off (13) Earth Mama Tinted Mineral Sunscreen (14) Crunchi Facial Sunscreen (15) The Skinny Confidential Ice Roller (16) Osmosis Beauty Rose Quartz Facial Roller and Gua Sha Set (17) Lumebox Red Light Therapy (18) Osmosis Beauty Penetrating Skin Tool (19) Hyland’s Silicea Cell Salts

Frownies Facial Patches

$21.56 with discount | “JUSTTHEINSERTS” for 10% off

Frownies are non-invasive wrinkle reducing patches worn while you sleep or for a minimum of three hours. These patches act to form a cast for the facial muscles, holding them flat, preventing expressions that cause wrinkles, and helping to release tension, smoothing existing lines.

All You Can Face Facial Yoga Sessions

$29 for monthly membership

Exercising your body keeps it healthy and beautiful, but what about your face? We are so used to applying skincare to the face to improve wrinkles, sagging, puffiness and prevent acne or dull-looking skin. Guess what? All these concerns derive from under your skin: it’s either due to lack of blood circulation, insufficient lymphatic drainage, or tensions in the muscles. No wonder we are buying skincare and realize it doesn’t really help much. You need to tackle the problem from its root cause. The All You Can Face program is designed to do exactly that. It will only take you 10 min a day to feel and see results after a couple of weeks if not days. Also, these daily exercises empower you with the knowledge you need to make better choices when it comes to your skin, health, and wellbeing.

Rowe Casa Organics Anti-Aging Face Wash

$22.40 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

As we age, our skin tends to dry out. This soothing face wash can help lock in your natural moisture and protect against free radicals, allowing your skin to bounce back and show fewer signs of aging.

Rowe Casa Organics Anti-Aging Face Toner

$13.60 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

Spritz on this refreshing rose water, witch hazel, and essential oil blend after washing your face to help reduce the appearance of fine lines, wrinkles, and other signs of aging.

Rowe Casa Organics Bakuchiol Face Cream

$28.80 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

Your dry skin will love the hydrating effects of this light cream and the regenerative power of frankincense essential oil with the added tightening benefits of bakuchiol.

Bakuchiol is an antioxidant and anti-inflammatory oil that aids in skin regeneration, derived from bakuchiol seeds in India and is safe to use during pregnancy or while breastfeeding. Use caution in direct sunlight for up to 6 hours after application.

Rowe Casa Organics Anti-Aging Eye Cream

$14.40 with discount | For your first Rowe Casa Organics order, use discount code “JUSTTHEINSERTS” for 20% off.

Helichrysum and cypress are the superstars in this age-defying eye cream. These essential oils increase blood flow and strengthen blood vessels, decreasing the appearance of tired eyes.

Wildling Empress Stone

$69.00

Bestselling patented facial gua sha tool designed to lift, sculpt, tone, and de-puff the skin. Artisan crafted from sustainably sourced Bian stone, an amalgamate of 40+ minerals known for their healing properties.

Pain FAQ

Do you struggle with pain and were recommended medications? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.

Low Dose Aspirin

Have you been recommended low-dose or baby aspirin? Read the manufacturer insert for the ingredient list, known adverse reactions, and much more here.