Daxibotulinumtoxina-lanm (Intramuscular)

DaxibotulinumtoxinA-lanm is used for cosmetic purposes to enhance the look of moderate to severe frown lines between the eyebrows (glabellar lines).

DaxibotulinumtoxinA-lanm is a botulinum toxin A product. It acts on the nervous system to relax the muscles.

This medicine should only be administered by your doctor or under their direct supervision.

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and to decide if you should keep receiving it. Blood tests may be needed to check for unwanted effects.

Serious muscle reactions have happened within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these issues could be life-threatening and may need immediate treatment in a hospital or clinic.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and needs immediate medical attention. Call your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness while receiving this medicine.

This medicine may increase the risks of heart rhythm problems (e.g., arrhythmia) or heart attack. These risks are higher if you have heart or blood vessel disease. Check with your doctor right away if you experience dizziness, fainting, fast, slow, or irregular heartbeat, chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, or vomiting.

This medicine may reduce blinking of the eye, tear production, and cause cornea problems. Check with your doctor right away if you notice blurred vision, eye irritation, increased sensitivity of the eyes to sunlight, or any other change in vision during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may cause eye or vision problems, loss of strength, or muscle weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it is important to consider the risks of taking the medicine compared to the benefits it may provide. This decision should be made together with your doctor. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been conducted to determine how age affects the use of daxibotulinumtoxinA-lanm in children. Safety and effectiveness have not been confirmed.

Geriatric

Studies so far have not shown any specific issues in older adults that would limit the effectiveness of daxibotulinumtoxinA-lanm in this age group.

Breast Feeding

There are no sufficient studies on women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
• Cornea or eye problems or
• Heart or blood vessel disease or
• Heart rhythm issues (e.g., arrhythmia) or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle or nerve issue) or
• Myasthenia gravis (severe muscle weakness)—These conditions may increase the risk of serious side effects.

• Breathing issues (e.g., asthma, emphysema) or
• Dysarthria (difficulty speaking) or
• Dysphagia (difficulty swallowing) or
• Dysphonia (voice problems) or
• Ptosis (droopy eyelid) or
• Urinary incontinence (trouble passing urine)—Use with caution. These conditions may worsen.

• Dermatochalasis (excess skin on the eyelids) or
• Facial asymmetry or
• Thick oily skin or deep scars or
• Thinning, weakness, or wasting away of the skin, severe at the injection site—Use with caution. The medicine may not be as effective in these cases.

• Infection at the injection site—This medicine should not be used in patients with this condition.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Drooping upper eyelids
• Partial or slight paralysis of the face

Incidence not known

• Blurred vision
• Change in color vision
• Change in patterns and rhythms of speech
• Chest pain, discomfort, or tightness
• Cough
• Difficulty seeing at night
• Difficulty swallowing
• Dizziness
• Double vision
• Dry eye
• Eye irritation
• Fainting
• Fast, slow, or irregular heartbeat
• Feeling of discomfort
• Fever
• Hives, itching, or skin rash
• Hoarseness
• Increased sensitivity of the eyes to sunlight
• Infection from breathing foreign substance into the lungs
• Joint inflammation
• Loss of bladder control
• Muscle aches and weakness
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Seeing double
• Slurred speech
• Sore throat
• Sweating
• Swollen lymph glands
• Trouble breathing
• Trouble speaking
• Voice changes
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Headache

Incidence not known

• Redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Daxxify

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: DaxibotulinumtoxinA

Find detailed information on biosimilars for this medication.

Your doctor will give you this medicine in a medical facility. It is given as a shot into one of your muscles in your face. This medicine should not be received more than 1 time every 3 months.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use Daxxify™ to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

• What is Daxxify, the recent FDA-alternative to Botox?
• How long does Daxxify take to work?