DAXXIFY (daxibotulinumtoxina-lanm)

There are 0 contraindications.

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Amyotrophic lateral sclerosis
Atherosclerotic cardiovascular disease
Dysphagia
Eaton-lambert syndrome
Myasthenia gravis
Neuromuscular disease
Peripheral motor neuropathy
Respiratory depression

There are 0 moderate contraindications.

There are 31 severe adverse reactions.

More Frequent	Less Frequent
Dysphagia Lagophthalmos Muscle weakness Voice change	Diplopia Fever Infection

Rare/Very Rare

Acute myocardial infarction Acute respiratory distress syndrome Anaphylaxis Aspiration pneumonia Atrioventricular block Botulism Brachial plexus disorder Cardiac arrhythmia Corneal ulcer Dysarthria Dyspnea Entropion Erythema Erythema multiforme Hearing loss Hematoma Hypersensitivity drug reaction Keratitis Muscle atrophy Pneumonia Respiratory depression Seizure disorder Serum sickness Urinary incontinence

There are 64 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Blepharoptosis Bronchitis Cough Dysuria Ecchymosis Eyelid edema Fatigue Headache disorder Influenza Injection site infection Injection site sequelae Nausea Neck pain Ocular irritation Pharyngitis Rhinitis Upper respiratory infection Urinary retention Urinary tract infection Xerostomia	Pruritus of skin Skin rash Visual changes

Rare/Very Rare

Acute abdominal pain Alopecia Anorexia Arthralgia Blurred vision Chest pain Diarrhea Dizziness Dry eye Edema Excessive granulation tissue Eyes vertical deviation Facial palsy Flu-like symptoms Gait abnormality General weakness Heavy feeling Hematuria Hyperhidrosis Hypertonia Hypoesthesia Madarosis of eyelid Malaise Muscle fasciculation Musculoskeletal pain Myalgia Paresthesia Peripheral neuropathy Photophobia Psoriasiform eruption Retrobulbar hemorrhage Sinusitis Stinging of skin Strabismus Symptoms of anxiety Syncope Tinnitus Urticaria Vertigo Vomiting

There are no available data on daxibotulinumtoxinA-lanm use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intramuscular administration of daxibotulinumtoxinA-lanm during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Embryofetal development studies were conducted in rats and rabbits with daxibotulinumtoxinA-lanm. For comparison of animal to human doses based on a body weight comparison, the MRHD is set at 40 units/subject (0.67 units/kg for an average 60 kg subject). Intramuscular administration of daxibotulinumtoxinA-lanm (3, 10 or 30 units/kg) to pregnant rats four times during the period of organogenesis (on gestation days 7, 10, 13, and 16) caused decreased fetal body weight and decreased fetal skeletal ossification at the highest dose, which was associated with maternal toxicity.

No embryofetal developmental toxicity was noted at doses up to 10 units/kg which is 15 times the MRHD. Intramuscular administration of daxibotulinumtoxinA-lanm (0.02, 0.1, 0.48 or 2.4 units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13 doses) resulted in maternal lethality at 2.4 units/kg/day and significant decreased maternal body weight at 0.48

units/kg/day. No embryofetal developmental toxicity was noted at doses up to 0.48 units/kg/day which is approximately equivalent to the MRHD.

There are no data on the presence of daxibotulinumtoxinA-lanm in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for daxibotulinumtoxinA-lanm and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

Among the 406 subjects treated with daxibotulinumtoxinA-lanm in the placebo-controlled clinical trials, 36 subjects were 65 years or older. There was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxibotulinumtoxinA-lanm. Clinical studies of daxibotulinumtoxinA-lanm did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects.