DaxibotulinumtoxinA

DaxibotulinumtoxinA is a prescription medication used for temporary improvement in appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.

• DaxibotulinumtoxinA is available under the following different brand names: Daxxify, daxibotulinumtoxinA-lanm

Common side effects of DaxibotulinumtoxinA include:

• headache
• eyelid drooping
• facial paralysis
• loss of the ability to move the muscles in the face

Serious side effects of DaxibotulinumtoxinA include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness

Rare side effects of DaxibotulinumtoxinA include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 50 units/single-dose vial
• 100 units/single-dose vial

Glabellar lines

Adult dosage

• 0.1 mL (8 units) IM each into 5 sites, for a total dose of 40 units.
• Injections in each corrugator muscle and 1 injection in the procerus muscle.
• Administer no more frequently than every 3 months.

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• DaxibotulinumtoxinA has severe interactions with no other drugs.
• DaxibotulinumtoxinA has serious interactions with no other drugs.
• DaxibotulinumtoxinA has moderate interactions with the following drugs:
  • sodium sulfate/magnesium sulfate/potassium chloride
  • sodium sulfate/potassium sulfate/magnesium sulfate
• DaxibotulinumtoxinA has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any botulinum toxin preparation, daxibotulinumtoxinA, or its excipients
• Presence of infection at proposed injection sites

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using DaxibotulinumtoxinA?”

Long-Term Effects

• See “What Are Side Effects Associated with Using DaxibotulinumtoxinA?”

Cautions

• Not interchangeable with other botulinum toxin products
• Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses
• Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products; reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea; if such a reaction occurs, discontinue further injection and immediately institute appropriate medical therapy
• Adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes have been reported for botulinum toxin products; use caution when administering to patients with preexisting cardiovascular disease
• Monitor with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) for increased neuromuscular compromise following botulinum toxin treatment; patients with neuromuscular disorders may be at an increased risk for clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from administration
• Use caution when administering to patients with surgical alterations to the facial anatomy, marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, inflammation at the injection site(s), preexisting eyelid, or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, or the inability to substantially lessen glabellar lines even by physically spreading them apart
• Reduced tear production, reduced blinking, and corneal disorders may occur with the use of botulinum toxins, including daxibotulinumtoxinA; dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines; if symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring the patient to an ophthalmologist
• Spread of toxin effect
  • Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the local injection site
  • Symptoms include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
  • The risk for symptoms is greatest in children treated for spasticity, but symptoms can occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these
• Dysphagia and breathing difficulties
  • Treatment may result in swallowing or breathing difficulties
  • These reactions can occur within hours to weeks after injection with botulinum toxin
  • Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications
  • May be a consequence of weakening of muscles in the injection area that are involved in breathing or swallowing
  • Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin products
  • When distant effects occur, additional respiratory mechanisms may be involved
  • Patients with respiratory disorders who may have become dependent on accessory muscles may experience critical loss of breathing capacity
  • If problems with swallowing, speech, or respiratory disorders develop, immediately seek medical attention
• Drug interaction overview
  • No formal drug interaction studies were conducted
  • Use with caution owing to potential risk with the following:
  • Aminoglycosides or other agents interfering with neuromuscular transmission
  • Anticholinergic drugs
  • Botulinum neurotoxin products
  • Muscle relaxants

Pregnancy and Lactation

• No data are available on use in pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of human or animal milk, its effects on the breastfed infant, or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition