DaxibotulinumtoxinA

What is DaxibotulinumtoxinA?

Adults can use DaxibotulinumtoxinA to reduce the appearance of wrinkles. Adults can also be treated with DaxibotulinumtoxinA to reduce the symptoms of cervical dystonia. This medication guide does not list all possible uses of DaxibotulinumtoxinA.

Side effects of DaxibotulinumtoxinA

If you experience symptoms of allergy such as difficulty breathing, hives or swelling to lips, face, throat or tongue; seek medical assistance immediately. Botulinum toxin in daxibotulinumtoxinA, also known as Daxxify (Daxxify), can cause the botulinum toxin to spread beyond the injection site. Some people have suffered life-threatening complications after receiving injections of botulinum toxins, including those who received them for cosmetic reasons. If you experience any of the following side effects, call your doctor immediately (up to several days or hours after an injection).

• Hoarseness, difficulty breathing, speaking, or swallowing
• Eye pain, blurred or cloudy vision, drooping lids, dry, itchy, or severely irritated eyelids (your eyes could be more sensitive to sunlight);
• Unusual or severe weakness of the muscles (especially when it occurs in an area not treated with medication);
• If you experience chest pressure or pain, if it spreads to your shoulder or jaw, or if there are irregular heartbeats, this could be a sign.
• Loss of bladder control

Some of the common side effects associated with daxibotulinumtoxin A include:

• Symptoms of a cold, including a stuffy nose and a sore throat
• Pain or swelling where the medication was injected.
• Muscle weakness
• Eyelids that droop
• headache
• Loss of facial muscle movement.

There may be other side effects.Call your physician if experiencing side effects; report adverse events by calling the FDA's hotline: 1-800-FDA-1088.

Warnings

Botulinum toxin in daxibotulinumtoxinA can also spread beyond the injection site. It can have serious and life-threatening effects. If you experience hoarseness, eyelid drooping, serious muscle weakness, bladder problems, trouble talking or breathing, or have difficulty swallowing, talking, or breathing, call your doctor immediately. These effects may occur several weeks after a botulinum injection.

Before you take this drug

Daxxify (daxibotulinumtoxinA) should not be administered if you have an infection in the area where injection will take place, or are allergic to botulinum toxin or any of its constituents.botulinum toxin injection, such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), incobotulinumtoxinA (XEOMIN), or prabotulinumtoxinA-xvfs (JEUVEAU).

If you or a family member have:

• Lou Gehrig’s disease, or Amyotrophic Lateral Sclerosis
• Myasthenia gravis;
• Lambert-Eaton syndrome;
• A side effect of prior botulinum toxins
• A breathing disorder, such as asthma and emphysema.
• Problems with swallowing
• Heart problems
• Bleeding problems
• Facial muscle weakness: (droopy lids, weak forehead, and difficulty raising the eyebrows);
• Dry eyes following botulinum toxin exposure in the past
• A planned operation
• Face surgery is a procedure that involves the removal of skin from your face.
• I received another botulinum injection within the last 4 months.

Unknown is whether daxibotulinumtoxinA, also known as Daxxify (Daxxify), will cause harm to an unborn child. Inform your doctor of any pregnancy or plans to get pregnant.Your doctor can tell you if breastfeeding while taking this medication is possible.

How to take DaxibotulinumtoxinA?

Even when being used cosmetically, DaxibotulinumtoxinA injections (Daxxify) should only be administered by medical professionals. DaxibotulinumtoxinA is injected by the healthcare provider into a muscular area. DaxibotulinumtoxinA injections (Daxxify) should be separated by at least three months. You may need to change the dose of your medication until you and your doctor find out what is best for you. Avoid requesting botulinum injections more than once. Tell your new healthcare provider when you last received a botulinum injection. This medicine will not be more effective if you take it more than the prescribed amount. Also, they may cause potentially adverse side effects.

Details on dosage

Usual Adult Dose for Glabellar Lines:

For a total dose of 40 units, inject 8 units (0.01 mL each) intramuscularly at each of the 5 sites. (two injections each in each muscle corrugator and one in each muscle procerus).
Comments:
Refer to the manufacturer's information regarding specific instructions for administration, such as dilution, needle positioning, and diagrams of injection sites.
Clinical evaluations have not evaluated the safety or effectiveness of a dose given more than three times a year.
You can use it to temporarily improve the appearance of mild to moderate glabellar creases in adults associated with muscle activity.

Adult dose for cervical dystonia:

Divide the dose between the affected muscles and inject 125–250 units intramuscularly.
Comments:
When selecting the initial dose for patients previously treated with botulinum toxins, it is important to consider the previous dose, treatment response, duration, and history of adverse events.
By limiting the dose injected into the sternocleidomastoid, dysphagia can be minimized.
Refer to the manufacturer's information regarding specific instructions for administration, such as dilution.
Adult patients with cervical dystonia can be treated using this product.

What happens if I miss the dose?

Missing a dose of DaxibotulinumtoxinA is unlikely to cause harm, as it is only temporary and given at widely separated intervals.

What happens if I overdose?

Contact poison help at 1-800-222-1222 immediately if ingested poison, or seek immediate medical care. The symptoms of an overdose may not be apparent immediately but may include weakness in muscles, difficulty swallowing, shallow or weak breathing, or loss of mobility anywhere on your body.

What should be avoided?

DaxibotulinumtoxinA, also known as Daxxify, can cause muscle weakness or loss of strength, drooping or blurred eyelids, and affect your reaction. Do not drive or engage in hazardous activities until you have determined how the medicine affects you.

Interaction with other drug

Inform your physician of all medications taken, including:

• Antibiotics such as gentamicin (amikacin), neomycin (paromomycin), streptomycin (tobramycin), kanamycin, etc.
• A muscle relaxer;
• Inhaled anesthetics
• Asthma medication, bronchodilator;
• Cold or allergy medication (benadryl et al.)
• Medicine to treat an overactive bladder
• Medicine to treat parkinson’s disease
• Medicine to treat excessive stomach acid reflux, stomach ulcers, motion sickness, or irritable bowel syndrome
• Seizure medicine.

The list above is not exhaustive, and other medications may also interact with daxibotulinumtoxinA. These include prescription, over-the-counter, and herbal medicines. This list does not include all possible drug interactions.