Botox Cosmetic (onabotulinumtoxinA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
OnabotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release at motor nerve terminals.
Botulinum toxin has been used for a wide variety of conditions in which the principal therapeutic aim is to reduce undesired or excessive contraction of striated or smooth (involuntary) muscle. There are 7 structurally similar botulinum toxin serotypes (A, B, C, D, E, F, and G) that differ antigenically and serologically. Currently in the US, there are 3 commercially available botulinum toxin type A preparations (abobotulinumtoxinA (Dysport(R)), incobotulinumtoxinA (Xeomin(R)), and onabotulinumtoxinA (Botox(R), Botox(R) Cosmetic)) and one botulinum toxin type B preparation (rimabotulinumtoxinB (Myobloc(R))).
Units of biologic activity of onabotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB), and these preparations are not interchangeable. (See Cautions: Lack of Interchangeability Among Botulinum Toxin Preparations.) However, the 2 currently marketed formulations of onabotulinumtoxinA (Botox(R) and Botox(R) Cosmetic) are identical, and the manufacturer states that these preparations may be used interchangeably provided the appropriate dilutions and administration techniques for a given indication are used. (See Reconstitution and Dilution under Dosage and Administration: Reconstitution and Administration.)
Generic name: onabotulinumtoxinA
Pronunciation: (BOT-ue-LYE-num)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Botox Cosmetic:
- Glabellar Lines
- Horizontal Forehead Lines
- Lateral Canthal Lines
- Platysma Bands
Also known as: Brow Furrow, Forehead Lines Due To Frontalis Muscle Activity, Horizontal Lateral Canthal Rhytides, Horizontal Rhytides Of Forehead, Platysma Bands Associated With Platysma Muscle Activity, Rhytides Of Glabellar Skin.
Dosing
Dosage of onabotulinumtoxinA should be carefully individualized according to patient response and to the particular condition being treated. When initiating treatment, the lowest recommended dose should be used. Generally, the effective dose when injecting into muscle depends on muscle mass: the larger the muscle, the higher the required dose. However, optimal dosages for a number of conditions in which onabotulinumtoxinA has been used have not been established. If a patient treated with onabotulinumtoxinA fails to respond, clinicians should consider the possibility of an inadequate drug dose, incorrectly reconstituted and/or improperly stored drug solution, and/or misinjection.
The manufacturer states that the maximum cumulative dose of onabotulinumtoxinA (given as Botox(R) and/or Botox(R) Cosmetic) for one or more uses in adults should not exceed 400 units in a 3-month period.
Some clinicians suggest that the interval between onabotulinumtoxinA injections should be as long as 8-12 weeks in patients receiving the drug for noncosmetic indications. In addition, some evidence suggests that the possibility of antibody formation increases with higher doses (exceeding 300 units total dose) and more frequent administration of onabotulinumtoxinA. (See Cautions: Antibody Formation.) However, in the management of hyperkinetic facial lines, some clinicians administer repeat injections of onabotulinumtoxinA 2 weeks after the initial injection if desired results have not been achieved, stating that strict adherence to the manufacturer recommended minimum injection interval of 12 weeks does not appear to be critical with the low doses of onabotulinumtoxinA used for cosmesis (usually less than 100 units total dose).
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Drug interactions
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There are no contraindication interactions for this drug.
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There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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There are no adequate and well-controlled studies of onabotulinumtoxinA in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; most clinicians state that the drug should not be used for cosmetic purposes during pregnancy. Abortion, decreased fetal body weight, and fetal malformations (e.g., skeletal ossification) have been observed in animals (e.g., mice, rats, rabbits) given onabotulinumtoxinA during gestation.
At least one woman who received onabotulinumtoxinA during pregnancy reportedly gave birth prematurely, although a causal relationship to the drug was considered unlikely.
Reductions in fetal body weight and/or delayed ossification were observed in pregnant mice and rats receiving IM onabotulinumtoxinA in doses of 4, 8, or 16 units/kg 2 times during the period of organogenesis (gestation days 5 and 13). The reproductive developmental no-observed-effect level (NOEL) following IM injection of 4, 8, or 16 units/kg of onabotulinumtoxinA was 4 units/kg in pregnant mice or rats. These no-effect doses for developmental toxicity are approximately equal to the human dose of 400 units or 4 times the average high human dose (64 units) for glabellar, lateral canthal lines, and forehead lines on a body weight (units/kg) basis.
Reduced fetal weights and decreased fetal skeletal ossification were observed with IM onabotulinumtoxinA doses of 4 or 8 units/kg in pregnant rats or 0.5 units/kg in rabbits during the period of organogenesis. These doses were associated with substantial maternal toxicity, including abortions, early deliveries, and maternal death. In these studies, the developmental NOEL of 1 unit/kg in rats is approximately equal to the human dose of 64 units based on units/kg, and the developmental NOEL of 0.25 units/kg in rabbits is less than the human dose of 400 units based on units/kg.
Data on the presence of onabotulinumtoxinA in human milk, the effects on the breastfed infant, or the effects of the drug on milk production are lacking. The benefits of breastfeeding should be considered along with the mother's clinical need for onabotulinumtoxinA and any potential adverse effects on the breastfed infant from onabotulinumtoxinA or from the underlying maternal condition.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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